April 2002 news (Lynda Roth, Sat Feb 22 10:03:08 2003)
COALITION OF SILICONE SURVIVORS
P. O. Box 129 Broomfield, CO 80038-0129
Lynda Roth - (970) 506-9288 Fax (970) 506-9288 (call first)
e-mail: coss1@uswest.net
Website: http://www2.privatei.com/~coss/coss
April 1, 2000
Dear Silicone Survivors and Friends:
This is our first periodic newsletter. There is much to report. We had
hoped to wait until the court resolved some appeals of the Dow Bankruptcy,
but it does not look like this will happen soon enough. We will have to
report on that the next time. We also waited for the FDA to act on the
saline implants, which they just did, approving them with major warnings
about safety. You will read more about this in this issue.
We have also had some computer problems that prevented us from sending out
this issue in April. The computer refused to print mailing labels. It is
now repaired?? At least it prints labels.
I have also had 2 bad colds and one flu in the last 6 weeks, along with
company from several areas. We now have our home back to ourselves, with
just the yard and gardens to tend. The flowers are beautiful.
LEGAL INFORMATION: 3/6/00: From the TCC: Dear Group Leaders, Claimants
and/or Plaintiffs' Attorneys: The Tort Claimants Committee, representing
the interests of all breast implant and other personal injury claimants
against Dow Corning, has received many inquiries about the status of the
bankruptcy case. This Memorandum provides updated information regarding
the status of the Amended Joint Plan of Reorganization (the "Joint Plan")
proposed by the Official Tort Claimants' Committee ("TCC") and Dow Corning
Corporation ("Dow Corning") (collectively, the "Plan Proponents"). This
status report also explains where things stand and what the Committee is
doing to ensure that injured claimants are paid as soon as possible.
On November 30, 1999, Judge Spector of the U.S. Bankruptcy Court in Bay
City, Michigan, issued a Confirmation Order confirming (i.e., approving)
the Joint Plan of Reorganization negotiated between Dow Corning and the
Tort Committee. All objections to the Joint Plan were overruled, however,
several parties have appealed that Order to Judge Hood of the U.S. District
Court in Detroit. After briefs are filed, Judge Hood is expected to hear
argument in April. She may issue her decision as soon as May 2000. After
Judge Hood rules, there may be further appeals to the Sixth Circuit and
possibly to the U.S. Supreme Court. These appeals will likely take at
least the rest of this year, and could stretch into next year. Because at
least some of the appeals raise the issue of the shareholder release
(explained below), the Joint Plan cannot officially go into effect (i.e.,
the "Effective Date") until the appeals are concluded, unless Dow Corning
agrees to waive this condition.
However, while the various appeals are pending, work is ongoing to ensure
that claims can be paid quickly after the Effective Date. The Hon. Mary
Katherine Kennedy, a former Houston, Texas trial judge, has been appointed
as Claims Administrator. With funding approval by the Bankruptcy Court,
she has hired two assistants and has been able to retain much of the
experienced staff from the MDL-926 claims facility to administer the Dow
Corning "Settlement Facility." She is currently developing the forms and
procedures for processing the claims. Once the Effective Date occurs, the
Settlement Facility will thereafter notify registered claimants who elect
to settle, of their opportunity to qualify for, and recover compensation.
Additionally, under the confirmed Joint Plan, a centralized Litigation
Facility will be established to litigate the claims of those who choose not
to settle.
There has been some confusion regarding the "third party release" provision
of the Joint Plan, which bars separate lawsuits against Dow Corning's
shareholders (Dow Chemical and Corning, Inc.) after the Joint Plan goes
into effect. The Joint Plan provides that all "opt out" claims against Dow
and its shareholders will be channeled to one Litigation Facility and paid
out of one settlement fund. The Tort Committee opposed a release of the
Dow Corning shareholders as part of a non-negotiated Plan. However, the
Tort Committee agreed to the release as part of the Joint Plan because it
believed the overall settlement was in the best interests of tort
claimants. The settlement provides up to $2.35 billion in today's dollars
to resolve personal injury claims, more than $500 million more than Dow had
previously offered. Individual settlements for "opt-in" claimants are
similar to (and in most cases better than) those offered by other breast
implant manufacturers.
Four hundred million dollars of the total is earmarked to resolve the
claims of those who "opt-out" and pursue litigation against the Litigation
Facility. The Tort Committee believes (and the Bankruptcy Court has found)
that these funds will be adequate to pay all claims in full.
Judge Spector issued an opinion on December 21, 1999, after the appeals
process on the Joint Plan had already begun, finding that the release
provision could be applied only to claimants who actually voted in favor of
the Joint Plan. Because this decision attempted to change a term of the
Joint Plan negotiated between Dow Corning and the Tort Committee and
approved by 94% of voting claimants, and because it created procedural
confusion, the Tort Committee and Dow Corning moved to set aside that
decision. Since the appeals were already pending before Judge Hood, this
issue was addressed through motions and an appeal to the District
Court. The purpose of these procedures is to clarify that the original
Confirmation Order entered on November 30, 1999, which approved the Joint
Plan as negotiated between the parties, was fully in effect. Judge Hood
has indicated that she will consider these procedural matters along with
the merits of the appeal this Spring.
The Tort Committee continues to believe that supporting the Joint Plan as
negotiated is the best way to bring this case to the earliest possible
conclusion and achieve meaningful payments for tort claimants without more
years of risky and uncertain litigation. The Tort Committee
understands that these matters are complicated and that you may have
further questions. If you have any questions about the procedural status
of the bankruptcy or the appeals, you may visit the Committee at
www.tortcomm.org. You can also e-mail the Committee at
info@tortcomm.org. If you have specific questions regarding whether you
have a timely claim on file, please call the Tort Committee's counsel at
713-225-7250. Until the Joint Plan goes into effect you should not send
medical records, and the Settlement Facility is not yet in a position to
answer questions regarding claim procedures or the merits of specific claims.
Please note that the TCC's law firms serve as counsel for the Tort
Claimants Committee and cannot act as your personal attorneys. The
Official Committee of Tort Claimants was appointed to represent the
interests of all implant claimants on a collective, not individual, basis
in the bankruptcy proceeding. We do not represent Dow Corning and are not
authorized to represent any individual claimant in direct pursuit of her
own personal interests in the bankruptcy case.
The statements contained in this memorandum are only for information
purposes to assist you in better understanding the status of the Dow
Corning bankruptcy case. Please do not construe any of the statements in
this letter as legal advice. We strongly suggest that you confer with
and/or retain personal legal counsel if you feel it appropriate and/or
necessary to assist you with your claim. Please feel free to contact one
of the Telehelp information numbers or websites listed for further
information. Dow Corning Bankruptcy Telehelp and Other Information Sources
List: Dow Corning Bankruptcy Case General Information
Line: 800-651-7030 (recorded message); Implant
Information Center: 800-442-5442; Bankruptcy Court Information
Line: 800-222-7198; TCC Mailing Address: Tort
Claimants Committee, P.O. Box 61406, Houston,
Texas 77208-1406. TCC website: www.tortcomm.org Dow
Corning website: www.implantclaims.com Daticon Systems,
Inc. Mailing Address: P.O. Box 6003, Gales Ferry, CT
06335-6003. Those outside of the United States may access the foregoing
numbers by calling collect to (718) 361-4500.
For inquiries not involving Dow Corning but the different legal case
generally referred to as the MDL Class Action and Revised Settlement
Program, you should contact different numbers: MDL
Hotline: 800-887-6828; MDL Claims
Center: 800-600-0311 (outside the U.S.
call 713/951-9106) MDL Claims Center
Mailing Address: P.O. Box 56666, Houston, Texas 77256.
Detroit (AP) (Jim Suhr): Dow Corning Corp. and attorneys for thousands of
women who sued it over silicone breast implants have no legal right to
appeal a bankruptcy court's opinion now clouding a $3.2 billion implant
settlement, an attorney for the U.S. government argued. Randy Harwell
made the claim in U.S. District Court as part of the second and final day
of an appellate hearing largely over both the settlement deal approved by a
federal bankruptcy judge Nov. 30 and that judge's written opinion three
weeks later.
In that Dec. 21 opinion, U.S. Bankruptcy Judge Arthur Spector said women
opposed to the settlement may sue Dow Corning's parent companies, Dow
Chemical Co. and Corning Inc. Dow Corning has asked U.S. District Judge
Denise Page Hood to set aside Spector's opinion, which the company said
dramatically changed and invalidated the settlement that took years to
reach. But Harwell said the failure by settlement proponents to legally
challenge Spector's November confirmation of the deal within the required
10 days was "a calculated legal risk'' they lost. To the government, a
judge's written opinion now may not be appealed. "They did nothing, and
now they must pay the cost of doing nothing,'' Harwell said of those behind
the settlement.
Glenn Gillett, another attorney for the government, accused the plan's
proponents of "forum shopping'' for "a judge who might render an opinion
more favorable to them.'' Hood said she hoped to decide that matter and
related ones within 30 days. "We're hopeful she will rule soon,'' Dow
Corning spokesman T. Michael Jackson said afterward. "The quicker it moves
forward, the quicker there's closure.'' George Tarpley, an attorney for
Dow Corning, has said the company was prepared to begin paying claimants,
if Spector's opinion he called "an error of law'' gets reversed.
On Wednesday, Tarpley said the opinion, if allowed to stand, could cripple
the settlement approved by 94% of the 112,774 women who last year voted on
it. The deal was part of Dow Corning's $4.5 billion plan to emerge from
Chapter 11 bankruptcy sought in 1995. Under the settlement, Dow Corning
would pay out $3.2 billion to settle claims by more than 170,000 women
blaming various health problems on silicone implants once made by the company.
Washington (AP): The Justice Department sued to recover millions of dollars
spent through federal health care plans to treat silicone breast implant
injuries. It asked that the money come out of a settlement fund for the
thousands of women who were victims. (MDL-926) The government asked the
court to halt settlement payments to victims who used Medicare or other
federally funded health care programs until the federal government gets
reimbursed for its costs. In a lawsuit filed in U.S. District Court in
Birmingham, Ala., the government named as defendants six companies and the
administrator of the settlement fund those companies established to
compensate women injured by the implants. As of last April, 81,000 women
had been sent payments from the settlement fund. The U.S. Food and Drug
Administration banned most use of silicone gel-filled breast implants in 1992.
Friday's lawsuit argues that the six companies and the settlement fund are
liable for reimbursing Medicare and the other federal health care programs
for costs incurred treating implant injuries. The lawsuit did not put an
exact figure on how much the government is seeking, But a Justice
Department statement said it was in the millions of dollars. The Medical
Care Recovery Act permits the government to recover the cost of providing
medical care to people injured as a result of the wrongful acts of a third
party, the department said.
The government "demands payments from the MDL (multi-district litigation)
settlement fund of its reasonable costs or providing to or paying for
hospital, medical, surgical or dental care on behalf of claimants who were,
or will be paid through the MDL settlement fund and-or the common benefit
fund for injuries alleged to be caused by a breast implant,'' the lawsuit
said. Justice spokesman Charles Miller said the lawsuit took this form
because negotiations to recover the money from the implant manufacturers
had been unsuccessful after several years of talks. The government said the
class action settlement provided injured women with $3,000 for surgery to
remove the implants and additional payments for those with diseases or
injuries allegedly caused by the implants.
Of the women who have received payments, from the fund, 17,000 got $3,000
for removal surgery, the lawsuit said. Another 26,000 women also received
payment for a breast implant-related disease and another 10,000 received a
one-time $2,500 payment to waive all future claims. As of last May, 52,118
implant recipients had refused to join the class action, preserving their
right to press their claims individually, the lawsuit said. The lawsuit
said the companies and the settlement fund administrator failed to
determine whether any of the women making claims had been Medicare
beneficiaries before sending them payments from the settlement fund. It
said the defendants had not paid the government on behalf of any
Medicare-treated women who obtained settlement payments. The companies
named in the lawsuit were Baxter International Inc.. Baxter Healthcare
Corp., Bristol-Meyers-Squibb Co., 3M Co., Union Carbide Chemical and
Plastics Co., and Union Carbide Corp. Edgar C. Gentile III was named in his
capacity as escrow agent of the settlement fund.
Washington 3/23/00: Mentor Corp., maker of saline breast implants, is the
subject of a U.S. Food and Drug Administration criminal probe into
allegations of research irregularities in implant studies, USA Today
reported, citing a memo from the FDA's Office of Criminal Investigation.
Mentor's general, Douglas Altschuler, said the allegations were without
merit and were made by two employees fired for harassing co-workers, the
newspaper said. Representative Tom Bliley, a Virginia Republican who
chairs the House Commerce Committee and oversees the FDA, has asked the
agency why it allowed Mentor to come before an advisory panel earlier this
month that gave the company a favorable review, the newspaper said.
On March 1, the expert FDA panel said Mentor's saline-filled breast
implants, already on the U.S. market, are safe enough to merit formal
approval by the agency for use in breast enlargements and in
post-mastectomy breast reconstruction.
USA TODAY (Rita Rubin): Are breast implants safe? A major breast implant
maker that recently got a favorable review from a Food and
Drug Administration advisory panel is the subject of a criminal
investigation by that agency for "allegations of serious irregularities in
breast implant studies." Rep. Tom Bliley, R-Va., chairman of the House
Commerce Committee, which oversees the FDA, wrote Commissioner Jane
Henney, asking why the company was permitted to come before the saline
breast implant panel March 1. Although Bliley's letter does not name the
firm, a memo on March 9 from the FDA's Office of Criminal Investigations
says: "We have an open investigation on Mentor Corporation at this time"
involving allegations of research irregularities. "I note that an open
investigation does not necessarily reflect the credibility of the
allegations," Bliley writes. "Nevertheless, I question why the FDA
proceeded to the Advisory Committee under these circumstances." An FDA
spokeswoman said the agency would not comment until it had responded to
Bliley.
Knowing about it might not have changed the panel's vote. "Ford and GM get
criminal investigations from time to time, but they still make damn good
cars," said panelist Bob Burkhardt, a Tucson plastic
surgeon. Douglas Altschuler, Mentor's general counsel, said the
allegations were without merit and were made by two employees who had been
fired for harassing co-workers. He learned of the inquiry, he said, when he
was contacted in 1998 by the U.S. attorney's office in Dallas, home of
Mentor's plant. "They asked me some questions. I provided responses. I
considered the case closed." The probe is still open, Altschuler said,
because "they're overworked, and someone may not have formally put a closed
sticker on a file." But an FDA spokesman said that "in general, when
there's a criminal investigation, when the issue is resolved, the FDA will
close the case."
From Mentor: The Company has contacted the FDA and although they have
confirmed that there is an investigation stemming from 1998 manufacturing
issues, Mentor is unaware, and the office of the FDA conducting the
investigation, has denied that the investigation has any connection
whatsoever with "allegations of serious irregularities in breast implant
studies" as quoted by USA Today. Mentor has requested that USA Today
provide the Company a copy of the quoted materials; however, USA Today has
declined to do so. "We have complete confidence in the integrity of our
research and believe that the allegations in the article are entirely
baseless," said Anthony Gette, Chief Executive Officer and President of
Mentor Corporation. "Since 1998 Mentor has substantially upgraded every
aspect of its manufacturing facilities and overall compliance
programs. Since that time, we have had two independent expert audits and
one comprehensive FDA audit which have confirmed that the Company is in
substantial compliance with good manufacturing practices. We have every
confidence in our Pre-Market Approval Application for saline breast
implants and believe it will be approved by the FDA on schedule." Mentor
Corporation is a diverse medical products company serving a number of
medical specialties including plastic and reconstructive surgery, urology,
and clinical and consumer healthcare. SOURCE: Mentor Corporation
MEDICAL INFORMATION: MedWatch Updated #'s on Silicone Gel & Saline Implants
reported to FDA: Silicone gel implants: 127,770 reported problems, 109
deaths. Saline implants: 65,720 reported problems, 14 deaths.
Dallas 1/12/00: UT Southwestern Medical Center at Dallas plastic surgeons
have developed a new antibiotic solution that may help reduce or eliminate
capsular contracture, the most common risk associated with cosmetic and
reconstructive breast-implant surgery. The result of capsular contracture
is hardening of the implant, which may cause pain and disfigurement,
interfere with mammography, and require surgery. The cause of capsular
contracture is unknown, although subclinical infections around implants are
suspected. Plastic surgeons attempt to prevent infection by irrigating
implant pockets prior to implantation with various antibiotic solutions.
Using a comprehensive in vitro analysis of different solutions, Dr. William
P. Adams Jr., assistant professor of plastic surgery at UT Southwestern and
chief of plastic surgery at Parkland Memorial Hospital, created a more
effective solution that inhibits all bacterial growth from organisms
commonly found around breast implants. The results of his study were
published in this month's issue of Plastic and Reconstructive Surgery. "I
designed a final optimal solution based on my analysis," Adams said. "I
started with two solutions that others have used, and then developed the
new solution which may make breast-implant procedures safer." As part of
an ongoing clinical trial, Adams has used the improved breast irrigant in
approximately 125 patients undergoing breast augmentation and
reconstruction in the past year and a half. None developed capsular
contracture, but final evaluation will take three to five years.
Adams is an expert on breast-implant aging and technology and has headed
multiple implant-related studies at UT Southwestern. Chad Connor, UT
Southwestern medical student, Dr. Fritz E. Barton Jr., professor of plastic
surgery, and Dr. Rod Rohrich, chairman of plastic surgery, were co-authors
of the research paper.
Washington (AP) 2/15/00 Baffling Rise In Lymphoma Studied: It started with
flu-like symptoms that Michael Locher just couldn't shake. Then an
egg-shaped lump ballooned on his jaw, and his doctor knew - the New York
man was a victim of the nation's baffling rise in lymphoma. Even as many
other types of cancer have leveled off or even dropped, this mysterious
immune-system cancer has been making a stealthy but astounding rise; rates
have nearly doubled since the 1970s.
Is diet to blame? Pesticides? Air pollution? Viruses? Obesity? Nobody
knows. Cancer experts are launching major studies worldwide to find what's
behind this cancer's march. But there is good news: Doctors are testing
highly promising new immunotherapies for the worst type, non-Hodgkins
lymphoma. They include a potent, but still experimental, "monoclonal
antibody'' called Bexxar that carries radiation straight to cancer cells to
zap them without hurting healthy tissue. "This is just amazing," said
Locher, a New York City Transit Authority
engineer whose tumors vanished last fall after he took Bexxar in a medical
experiment. "The results have looked very, very promising," says Dr.
Wyndham Wilson of the National Cancer Institute. "What's even more exciting
is that there are now a whole number of different monoclonal antibodies
coming forward'' to attack numerous varieties of lymphoma. Plus, NCI
scientists are developing experimental vaccines customized to patients'
cancers in hopes of preventing hidden lymphoma cells from staging a
comeback after chemotherapy.
Some 62,300 Americans will be diagnosed this year with lymphoma, in which
vital immune cells stored in the lymph system become malignant. Over 27,000
will die this year. It's a cancer that doesn't make many headlines - lung,
prostate, breast and colon cancer strike more often. Yet some 450,000
Americans are estimated to already be living with lymphoma, one of the few
cancers still rising, and unlike many other cancers, doctors can offer no
advice on preventing lymphoma and have no early-detection tests. About
7,400 of the new cases will be the often curable Hodgkin's disease. The
rest are non-Hodgkin's lymphoma, a catchall term that encompasses some 30
cancer subtypes whose prognosis and treatment all differ. Some are so
slow-growing that patients survive many years, cycling between therapy and
remission and yet more therapy. Others are highly aggressive and rapidly
fatal. Still others fall in between. Non-Hodgkin's lymphoma is the type
rising so dramatically, not just here but in most industrialized countries,
said Dr. Marshall Lichtman of the Leukemia & Lymphoma Society.
The AIDS virus caused some of the increase. Lymphoma is much more common in
people with weakened immune systems. The list of other suspects is long but
unproven: herbicides, pesticides, benzene-polluted air, the Epstein-Barr
virus. One recent study suggests being overweight increases the risk. A new
theory that sunburns lower immune function has scientists considering a
lymphoma link. On the flip side, University of California, San Francisco,
scientists recently discovered people with bad allergies might be at lower
risk. The theory is that allergies might indicate a vigorous immune system
that can handle lymphoma. "The immune perturbations that give you lymphoma
are pretty complex. This is not going to be the equivalent of lung cancer
and smoking, it's going to be a little more subtle to tease out,'' cautions
NCI epidemiologist Patricia Hartge, who just began a large study in
Detroit, Los Angeles, Seattle and Iowa to pinpoint risk factors. Similar
studies are planned in Spain, Germany, Italy and Britain.
But the big news is in experimental immunotherapy - genetically engineering
cells called "monoclonal antibodies'' that seek out cancer and trigger the
immune system to attack it. One, called Rituxan, already is sold,
targeting lymphomas that carry an antigen called CD20. Now scientists are
developing monoclonal antibodies to target CD30, CD22 and CD25 antigens,
and thus treat more types of lymphoma. Bexxar is poised to become the first
radiation-tagged monoclonal antibody, carrying radioactive iodine to zap
lymphoma cells. Manufacturer Coulter Pharmaceutical Inc. will soon seek
government approval for Bexxar to treat certain "low grade'' lymphomas that
relapse after chemotherapy; doctors now are studying if it works against
other types.
Many lymphoma symptoms are common to other illnesses and hard to pin down,
but see your doctor if the following occur for more than two weeks, advises
the Leukemia & Lymphoma Society: Painless swelling of lymph glands in the
neck, armpit or groin. Fatigue, recurrent high fever, night sweats, itching
and/or general aches, sometimes described as flu-like. Weight loss, loss of
appetite, indigestion and abdominal pain or a sense of fullness, which
could come from an enlarged spleen or lymph nodes. Prognosis and treatment
depends on the patient's specific subtype and stage of lymphoma, and there
are new standards to help classify patients properly, said Dr. Wyndham
Wilson of the National Cancer Institute. He advises seeing oncologists who
treat large numbers of lymphoma patients, as they are most likely to be
up-to-date on those standards and the latest treatments.
For information, including clinical trials of experimental immunotherapy,
check the NCI's CancerNet and CancerTrials Web pages at www.nci.nih.gov.
For information on experimental Bexxar treatment, check
www.coulterpharm.com/product/pr.html.
DALLAS 3/25/99 - Two recent studies have enabled UT Southwestern Medical
Center at Dallas plastic surgeons to further elucidate the reasons for
silicone-gel breast implant rupture and aging. The science of
breast-implant aging has received much attention in the past five years,
and it is critical to deliver optimal care to patients with existing
implants or those considering the placement of breast implants," said Dr.
William Adams Jr., an assistant professor of plastic surgery who has
conducted extensive laboratory research on the silicone elastomer, or
implant shell.
The researchers confirmed in a study published in the December issue of
Plastic and Reconstructive Surgery, the journal of the American Society of
Plastic and Reconstructive Surgeons, that the risk of silicone-implant
rupture significantly increases with the age of the implant, corroborating
previous studies. "The life span of these implants was initially presumed
to be unlimited," said Dr. Jeffrey Kenkel, assistant professor of plastic
surgery and a co-author of the study. "However several reports have
demonstrated that the silicone elastomer does have a finite life span." The
UT Southwestern scientists found that the average age of implants that
rupture was 13.4 years. Previous studies that focused on implant rupture
showed that a significant number of implants fail after eight to 10
years. Another UT Southwestern study by Adams, published in the January
issue of Plastic and Reconstructive Surgery, investigated lipid
infiltration as a possible cause of silicone-gel breast implant aging.
Commonly used saline implants are enclosed in a silicone shell.
The team concluded that lipids, absorbed from the blood, infiltrate the
outer silicone shell. This leads to progressive mechanical weakening of
this outer shell and may result in implant aging and rupture. Adams said,
"Our ultimate goal with all of these studies is to use data to take better
care of our patients."
Mycoplasmas: The unsuspected invader Better Nutrition; Atlanta; Feb 2000;
Hugh O Smith; Volume: 62, Issue: 2, Abstract: Smith presents startling
evidence that links chronic fatigue syndrome, arthritis, Gulf War Syndrome,
multiple sclerosis, and other disorders. What these people have in common
are not their symptoms, but something that may be the tip of an epidemic
iceberg that threatens worldwide health, a highly contagious and insidious
stealth-pathogen called mycoplasma. Mycoplasmas are neither viral nor
bacterial; they are pathogens which lack a cell membrane enabling them to
change form, invade other cells with impunity, and play hide-and-seek
within the body's immune system.
Startling evidences linking chronic fatigue syndrome, arthritis, Gulf War
Syndrome, multiple sclerosis, and other disorders. An MS patient mentions
that his wife experiences sympathy pains in her joints. A patient with
chronic fatigue syndrome and fibromyalgia comments in passing of her
chocolate cravings. An arthritis sufferer tells us how she battles
pneumonia and upper respiratory problems all the time. The bad news and
the good news: The bad news is that what these people have in common are
not their symptoms, but something that may be the tip of an epidemic
iceberg that threatens worldwide health. The good news is that we may have
found the common link for a multitude of chronic illnesses, some of which,
patients have been told, are "only in their head."
Chronic fatigue syndrome, fibromyalgia, arthritis, Gulf War Syndrome,
multiple sclerosis, lupus, Crohn's disease, and a host of other disorders
have baffled physicians and caused untold pain among sufferers for years.
Now, there is mounting evidence that these disorders may well be caused by
a peculiar species of a highly contagious and insidious stealth-pathogen:
mycoplasma. The further good news is, if we know the cause, we are more
likely to be able to determine a cure.
What is a mycoplasma? Most of the body's 100 trillion cells have a cell
membrane composed of proteins and fats. The purpose of the cell membrane is
to regulate the passage of nutrients in and out of the cell. Mycoplasmas
are neither viral nor bacterial. They lack a cell membrane enabling them to
change form, invade other cells with impunity, and play hide-and-seek
within the body's immune system causing any number of auto-immune
disorders. According to Lida Holmes Mattman, Pd.D., these forms that are
deficient of cell walls easily move between groups of cells and fuse
together to facilitate "genetic experiments" within the body.
Mycoplasmas infect plants, animals, and humans. They exist on L-arginine
(the amino acid in chocolate). They have the ability to cross the blood
brain barrier, enter the spinal fluid, and cause brain abscesses and
central nervous system lesions. They may be a primary cause of Alzheimer's
Disease, and they can enter the synovial fluid of the joints and cause
rheumatoid arthritis. Mycoplasmas can be transmitted by casual
contact. While mycoplasmas have been around for hundreds of years, their
prominence and importance in diseases of an "unknown nature" have only been
recently discovered by scientists who are now beginning to uncover some
startling evidence. The fact that "this pathogen is being largely ignored
by medical science is criminal," according to Mattman.
Now what? The fact is, most physicians will often not run tests for
mycoplasmas primarily because the culturing of mycoplasmas is difficult and
may take months to obtain any results. Even when they suspect mycoplasma
infection, the standard course of treatment is usually in the form of
antibiotics such as tetracycline or doxycycline, for several months. This
places a huge strain on the liver and kidneys and could be worse than the
condition. For arthritis, the most often prescribed medications are
steroids, such as prednisone and cortisone, and non-steriodal
anti-inflammatory drugs (NSAIDs), both of which can cause serious side
effects and provide only temporary and symptomatic relief, while giving the
pathogens free rein to proliferate. Although giving up pharmaceuticals may
seem a daunting prospect, the following routine is designed to benefit the
patient by killing mycoplasmas and repairing damage they have caused.
Remember: since mycoplasmas can be transmitted by casual contact, if one
person has them, most likely the people with whom he or she lives has them.
As with any new regimen, it is important to check with a healthcare
professional prior to beginning.
Uva Ursi or bearberry (an herb used mainly for bladder infections) is
effective against mycoplasmas. However, to be effective, the body must be
kept alkaline. This herb should be used with the advice of a competent
nutritionist. Uva Ursi should not be used for more than 14 days in
succession. Also recommended are at least 350-700 mg daily of OPCs
(oligomeric proanthocyanidins) to help with free radical damage; 1,000 mg
daily of omega-3 essential fatty acids (especially shark liver oil); and
50-100 mg zinc (do not exceed 100 mg daily). Sugar should be avoided.
References: Baseman, J. and Tully, J. "Mycoplasmas: sophisticated,
reemerging, and burdened by their notoriety," Emerging Infectious Diseases
3:21-32, 1997. Cassell, G.H. and Cole, B.C. "Mycoplasmas as agents of human
disease," New England Journal of Medicine, 304(2), 80-89, Jan 8, 1981.
Chiodini, Rodrick J. Ph.D. "Crohns disease and the mycobacterioses: a
review and comparison of two disease entities,' Clinical Microbiology
Reviews, January 1989. Mattman, Lida H., Ph.D. Cell Wall Deficient
Forms-Stealth Pathogens, 2nd Edition. Boca Raton, FL: CRC Press, 1993.
Nicolson, G.L. Ph.D. "Diagnosis and treatment of mycoplasmal infections in
Persian Gulf War Illness-CFIDS Patients," International journal
Occupational Medicine Immunology And Toxicology 5:69-78, 1996. Nicolson,
G.L. and Nicolson, N.L., "The isolation, purification and analysis of
specific gene-containing nucleoproteins and nucleoprotein complexes,"
Methods of Molecular Genetics, 5:281-298, 1994. Zheng, X, et al. "Isolation
of Mycoplasma hominis from a brain abscess," Journal of Clinical
Microbiology, 35(4):992-4, April 1997. (Author note) Hugh 0. Smith, Ph.D.,
is a researcher at Life Sources, Inc., a clinic in Fair Oaks, California,
which examines blood samples to determine nutritional deficiencies and
potential risk factors.
2/27/00: Britain's best selling sweetener was condemned as dangerous and
potentially toxic in a report compiled by some of the world's biggest soft
drinks manufacturers - who now buy tons of it to add to diet drinks. Coca
Cola, Pepsi and other manufacturers produced the report in the early l980s
before the sweetener aspartame, had been approved for use in America. It
warns that it can affect the workings of the brain, changes behavior and
even encourages users to eat extra carbohydrate, so destroying the point of
using diet drinks. The documents were unearthed last week under freedom of
information legislation. It follows a decision by researchers at King's
College in London to study suspected links between aspartame intake and
brain tumors.
Britons drink more than 9 billion cans or bottles of pop a year, of which
about half contain artificial sweeteners. Aspartame, made by Monsanto and
also marketed under the name NutraSweet, is 200 times sweeter than normal
sugar and is used in many popular low caloric foods and drinks. It has
been declared safe in a number of studies and has been approved for use in
both America and Europe. There has, however, always been concern at the
tendency to break down, producing methanol, which is both toxic in its own
right and which breaks down further to produce formic acid and
formaldehyde, phenylalanine, another breakdown product of aspartame, is
also dangerous to people with phenyketonuria, a common enzyme deficiency.
The 30 page aspartame report was drawn up under the auspices of America's
National Soft Drink Association (NSDA) whose governing body at the time
included senior Coca Cola and Pepsi executives. It says: "We object to the
approval of aspartame for unrestricted use in soft drinks." It then lists
ways in which aspartame was believed directly to affect brain chemistry,
including the synthesis of vital neurotransmitters such as
serotonin. Other papers obtained with the NSDA documents show the Food and
Drug Administration also had misgivings. Despite this it approved
aspartame. Dick Adamson, of the NSDA, said that in l983, he evaluated the
data on aspartame and posed a number of questions. Once they were
answered, it no longer had concerns about the safety of aspartame in
carbonated drinks. Ben Deutsch, a spokesman for Coca Cola, referred
questions to the NSDA.
4/4/00: Denmark's males face a new challenge (By environment correspondent
Alex Kirby.) Almost half of 700 Danish army recruits have been found to
have sperm counts low enough to make it hard for them to father children.
The recruits, aged from 18 to 20, had significantly lower counts than men
in another sample born about 10 years earlier. While the researchers
describe their findings as "difficult to explain", environmentalists
believe exposure to one group of chemicals is a factor. The research is
significant because it is the first study of sperm counts in a random
sample of healthy young men. It is published in Human Reproduction, the
journal of the European Society of Human Reproduction and Embryology. The
research, conducted between 1996 and 1998, tested 708 men reporting for a
compulsory military medical examination.
General deterioration: It found that 43% of them had sperm counts low
enough to lead to decreased fertility, in other words, to make it difficult
for them to reproduce. The authors, all from Denmark, say there is
published evidence "that male reproductive function seems to have
deteriorated considerably in the past four to five decades". But clinical
studies on semen quality have dealt with selected groups: candidates for
vasectomy, semen donors, infertility patients, and volunteers. "Studies of
semen quality, reproductive hormones and testicular size in unselected
populations of young males have not previously been reported." They
describe the sperm concentrations they found in the sample as "surprisingly
low", and are at a loss to explain them. "It remains to be seen whether
these findings are generally applicable to populations of young men in the
industrialized countries. Denmark seems to have relatively high rates of
male reproductive abnormalities."
The World Wide Fund for Nature says it believes that a factor in the low
sperm counts is exposure to endocrine-disrupting chemicals. Low dose
effects These are chemicals which can interfere with the normal functioning
of the body's hormonal control systems and seriously affect health. They
do so by mimicking naturally occurring hormones, or by activating or
blocking hormone receptors or hormone production. And they can take effect
at very low doses. Known disrupters include some phthalates (used in many
plastic goods, including toys), Bisphenol A (used in plastic bottles, the
plastic lining of food cans, and elsewhere), and TBT, an anti-fouling paint
for boats. Elizabeth Salter, the head of WWF's European toxics programme,
said the Danish study "proves that reduced sperm production is real and
common". Before the 1930s there were very few man-made chemicals. Today
everyone in Europe is exposed constantly to a cocktail of hundreds of
man-made chemicals.
"This study is a wake-up call to the European Union, which must act now to
reduce human exposure to chemicals that are known to interfere with
hormones." WWF has criticised the European Commission's plan to
concentrate research on about 30 or 40 endocrine disrupters as inadequate.
Dr Rob Taalman, of CEFIC (the Chemical Industry Council of Europe) told BBC
News Online: "I think the Danish finding is very odd. "There must be an
explanation, but I can't think of one, unless Denmark has some peculiar
regional factor. "We take this problem very seriously, and we do want to
understand it. But studies suggesting both a decrease and an increase in
sperm counts seem to be in balance."
San Francisco (AP) 5/5/00: Pharmaceutical maker Genentech Inc. has warned
doctors that the breast cancer drug Herceptin is linked to 15 deaths and 47
other adverse reactions in patients. In a letter to doctors sent Thursday,
the company said the adverse effects included allergic shock and extreme
respiratory distress. "We sent the letter to oncologists to heighten their
awareness and educate them about infrequent adverse events that can occur
in certain patients," Genentech spokesman Neil Cohen said.
An estimated 23,000 patients have been treated with Herceptin. Severe
reactions to Herceptin had not occurred in clinical trials before the drug
gained Food and Drug Administration approval in 1998, Cohen said. But
sometimes reactions can't be foreseen in trials, he said. "A lot of times
you might see some safety issues once the drug gets put into a larger
patient population," Cohen said. Cohen said he didn't know when the
company first heard of the deaths and reactions, but analysis had confirmed
the link to Herceptin. In nine of the 15 deaths, symptoms arose within 24
hours of the time Herceptin was administered, according to the
letter. Genentech is working with the FDA to have the drug's label amended
to reflect the new risks, Cohen said. Herceptin is used to treat breast
cancer patients that have too many copies of the HER2 gene. A healthy
version of this gene produces a protein that signals cells to grow and
multiply normally. But in women with too much HER2, the breast cells
reproduce out of control and spread throughout the body. Herceptin, an
antibody, blocks excess HER2, shrinking and eliminating tumors.
Washington: Research on women's health lacking despite law, studies find:
5/7/00: Robert Pear, NY Times News Service: Researchers who receive
federal money often flout a federal law that requires them to analyze the
effects of new drugs and treatments on women, three new studies have
found. Experts say health care for women may suffer as a result because
researchers overlook important differences between the sexes in clinical
trials evaluating new methods of treating or preventing disease. he
conclusions of the three reports are somewhat surprising because the
Clinton administration has emphasized the importance of women's health, and
Congress has been prodding the National Institutes of Health to pay more
attention to the issue. One study is about to be issued by the General
Accounting Office, an investigative arm of Congress. The others, by an
academic physician and several scientists, will be published this summer
in The Journal of Women's Health , which focuses on diseases that pose
particular risks to women.
Researchers in the emerging field of "gender-based biology" have found that
men and women sometimes report different symptoms of the same disease, and
that certain drugs are more effective in one sex than the other, or produce
more severe side effects in one sex. Scientists receiving federal money
generally include women as subjects in their clinical research, as the
government requires. But they often ignore the requirement that they
analyze their data to see whether women and men respond differently to a
given treatment, the reports said. The purpose of including women,
officials said, is not to satisfy quotas but to acquire scientific
knowledge that can be generalized to the entire population of the United
States. That knowledge, they said, can lead to major improvements in care.
Rule not enforced: In the report to be issued this month, the General
Accounting Office found that while the National Institutes of Health "has
made substantial progress in ensuring inclusion of women in studies," it
has not enforced the requirement for researchers to examine whether women
and men fare differently in such clinical studies. Moreover, it said, the
NIH, the government's main sponsor of biomedical research, has done a
haphazard job of tracking data on research that involves or affects women.
As a result, the figures are not always accurate or consistent. And the
General Accounting Office has found that many clinical trials financed by
the National Institutes of Health "were designed to include women, but not
in numbers high enough to allow analysis that would definitively measure
different outcomes for men and women."
Phyllis E. Greenberger, executive director of the Society for Women's
Health Research, an advocacy group that worked with Congress on the 1993
law, said the findings confirmed what she had come to suspect. "The GAO
report substantiates our concern that sex analysis is not routinely being
done in research supported by the NIH," she said. Don Ralbovsky, a
spokesman for the National Institutes of Health, said agency officials had
no immediate comment on the report.
Lack of analysis: A separate study, being published in The Journal of
Women's Health, found that few researchers analyzed their data to determine
whether prescription drugs, surgical procedures and preventive measures,
like changes in diet or behavior, had different effects on women and men.
"Analysis of outcomes by sex is sorely lacking," wrote the study's authors,
Dr. Regina M. Vidaver and colleagues at the Society for Women's
Health Research and George Washington University.
Dr. Vidaver, a molecular biologist, and her colleagues reviewed research
published from 1993 to 1998 in four of the nation's leading medical
journals, including The New England Journal of Medicine and The Journal of
the American Medical Association, to see whether researchers had analyzed
the data by sex. Some scientists said they had had difficulty in
recruiting women to participate, in part because women had child-care
obligations more often than men did. The third study, by Dr. Katherine D.
Sherif of the MCP Hahnemann School of Medicine in Philadelphia, found that
a small proportion of published research, less than 15%, did any analysis
of the differences in results for men and women.
NEW YORK, May 04 (Reuters Health) Inexpensive, easy-to-clean plastic
materials used to cover walls and floors may put young children at
increased risk of developing respiratory tract problems, results of a
recent study suggest. Researchers found that children who lived in homes
in which the walls were covered with plastic materials were more likely to
suffer from problems of the lower respiratory tract such as persistent
wheezing, a prolonged cough and phlegm. These children were also more
likely to be diagnosed with asthma or pneumonia, the report indicates.
However, the study could not conclusively prove that the wall coverings
were the cause of the respiratory ailments. It is possible that parents
installed such coverings because the children had respiratory problems.
"Emissions from plastic materials indoors may have adverse effects on the
lower respiratory tracts of small children," write Dr. Jouni Jaakkola and
colleagues in the May issue of the American Journal of Public Health, the
Journal of the American Public Health Association. Such materials can emit
chemicals, such as plasticizer agents used in the production of polyvinyl
chloride. "These chemicals may cause airway inflammation and thus increase
the risk of bronchial obstruction, asthma, and perhaps susceptibility to
respiratory infections," the authors add. Jaakkola, of the Nordic School
of Public Health in Goteborg, and colleagues at the University of Helsinki,
Sweden, and Oxford University in the UK surveyed the parents of more than
2,500 Finnish children aged 1 to 7 years. The investigators found that
plastic wall materials were present in less than 3% of homes and that about
2% of all the children had asthma. The researchers did not actually measure
the amounts of chemicals in the homes of the children.
"Given the vast number of chemicals present in plastics and other building
materials, it is not feasible to measure all of the relevant compounds in
indoor air," Jaakkola's team notes. Their findings "provide additional
evidence that indoor plastic materials may emit chemicals that have adverse
effects on the lower respiratory tracts of small children," according to
the report. The results "warrant further attention to the types of plastic
materials used in interior decoration. Source: American Journal of Public
Health 2000;90:797-799.
Clues to Chronic Fatigue Syndrome: HealthNews from the publishers of The
New England Journal of Medicine, 5/5/00: The Story: Even years after its
identification in 1988, the debilitating illness known as chronic fatigue
syndrome (CFS) continues to frustrate both patients and their doctors. The
syndrome's many nonspecific symptoms, such as fatigue, muscle and joint
aches, and difficulties with sleep, memory and concentration, occur in a
myriad of other illnesses, so they can't easily be linked to any single
physical cause. Even patients who fit the strict criteria for CFS must
frequently endure test after test to rule out other possible reasons for
their symptoms. And because the syndrome is so difficult to pin down,
controversy remains over whether it has a physical cause at all.
Diagnosing Chronic Fatigue Syndrome: There is no diagnostic test for
chronic fatigue syndrome. Instead, patients must meet the following strict
criteria for diagnosis: New and debilitating, persistent or relapsing
fatigue that lasts at least six months. No other physical or mental
conditions, including substance abuse, that might cause prolonged
exhaustion. Four or more of the following: substantial short-term memory
or concentration problems, sore throat, tender lymph nodes, muscle pain,
multi-joint pain, new or increasingly severe headaches, unrefreshing sleep,
or malaise that lasts more than a day after exercise.
But evidence supporting a physiological basis for CFS is growing. The
latest finding, published in the February American Journal of Medicine,
identifies a new immune-system protein that appears to be more common in
people with CFS than in those who don't have the disease. Belgian and
French researchers studied 57 people diagnosed with chronic fatigue, 28
healthy volunteers and 25 people with depression or fibromyalgia, a
rheumatologic syndrome with some CFS-like symptoms. They found the new
protein, called 37 kDa 2-5A, in 88% of those with CFS but in only 28% of
the other two groups combined. With no currently available diagnostic test
for CFS and no effective treatment, patients and researchers alike are
eager for clues to the illness. Will the discovery of this new protein lead
to a test for CFS, or maybe even a treatment? The Editors
The Physician's Perspective: Anthony L. Komaroff, M.D. Because physicians
cannot diagnose CFS by physical examination and because there is no
diagnostic laboratory test, some doctors have debated whether the syndrome
has a biological basis or is only "imagined." The primary significance of
this new study is that it adds to the evidence that chronic fatigue
syndrome is real. More specifically, the study finds that one small part of
the immune system, a part thought to play a role in fighting viral
infections, is activated in many patients with CFS. It also confirms the
findings of a previously reported study by U.S. researchers that noted the
presence of a novel immune system protein in people with CFS. Scientists
require this kind of reproducibility before accepting a finding as
valid. Many of the studies that support a biological basis for CFS have
compared people with CFS to healthy individuals of the same age and sex.
Some have also included patients with other fatiguing illnesses, such as
depression and multiple sclerosis. Using different techniques for examining
the brain and the immune system, these studies found specific, objective
biological abnormalities in patients with CFS more often than in the
comparison groups. These include abnormalities in the autonomic nervous
system as well as in a part of the brain called the hypothalamus.
My colleagues and I who study CFS think it is plausible that a state of
chronic immune system activation, particularly in the brain, could cause
the symptoms of CFS. That theory, however, is very hard to prove. We don't
yet know why the immune system is chronically turned on, but it is
plausible that the body is fighting against something it recognizes as
foreign, such as an infectious agent. But so far, no specific infectious
agent has been identified as the cause of CFS. Unfortunately, none
of the abnormalities found thus far can be considered a means for
diagnosing CFS. A perfect diagnostic test for CFS would be abnormal in
every patient with the syndrome and normal in everyone else, including
people with other fatigue-related illnesses. By that standard, there are
virtually no perfect diagnostic tests for any illness. However, many tests
are close enough to being perfect that the medical community accepts them
as diagnostic.
Is this latest finding likely to lead to a diagnostic test for CFS?
Perhaps, but important hurdles must be overcome, and that could take
several years. First, the test has to be tried on many more CFS patients
and would need to detect abnormal levels of the protein in more than 90
percent to 95 percent of those tested. Second, it has to be tested on many
more healthy people and on those with other illnesses that cause fatigue,
and the protein must be shown to be absent in 90 percent to 95 percent of
those people. Third, the test itself will have to be performed reliably by
large numbers of laboratories; the test reported in this study currently is
performed in only a handful of places. For now, there is no proven
treatment for CFS. Many doctors find that low doses of tricyclic
antidepressants help, probably by giving patients more hours of deep,
restorative sleep. But this treatment has not yet been evaluated
scientifically. Some studies have shown that cognitive-behavioral therapy,
which helps patients cope with and overcome some of their difficulties with
daily living, is useful as well. In my view, there is now very strong
evidence that a biological basis for CFS exists, but this study will not
convince some skeptics. I believe that the burden of proof is now on the
skeptics to show that there is no basis for the suffering of patients with
CFS. And it is no longer appropriate for any doctor to tell a patient with
CFS, "It's all in your head."
Anthony L. Komaroff, M.D., has studied CFS for 15 years. He is a professor
of medicine at Harvard Medical School and a senior physician at Brigham and
Women's Hospital in Boston. 1996-2000.
ALTERNATIVE MEDICINE: Dr. Kolb's Silicone Treatment
Protocol: http://www.plastikos.com/siliconpt.html SILICONE TREATMENT
PROTOCOL: LEVEL I: 1. Avoid land animal protein (red meat, pork, and
chicken) and restrict dairy products. Deep sea fish are allowed, cod,
salmon, mackerel, and herring. 2. Emphasize fresh fruits, vegetables and
whole grain. a. Eat 50% raw foods. b. Avoid night shade plants (potato,
tomato, bell pepper, eggplant) c. Clean the fruits and vegetables in a
lemon and saltwater solution before eating. d. No sweets, candies,
pastries. e. No bananas and limit the citrus fruits. 3. Drink 8 glasses of
either filtered or distilled water a day. 4. Recommend a weekly program of
walking followed by stretching. Program Schedule: 5 min warm up 3 days on,
30 min walk one day off, 10 min stretch 2 days on 5 min warm down one day
off. 5. Liver detox with Turmeric 600 mg 3 times a day or eat curry powder
(cooked) 40 gm a day. Milk thistle is also an herb that aids in liver
detoxification. 6. Supplements: a. Natural Multivitamin with minerals,
one twice a day. (Skip it if you take thymic formula with vitamins) b.
Vitamin C with flavonoid 500 mg 4 times a day. c. Flax seed oil, one
tablespoon/100 pounds of weight a day. (Helps the body to eliminate
silicate) d. Inositol 500 mg two 3 times a day. Natural Source; Beans,
lentils, nuts, oats, rice, wheat germ, cantaloupe, citrus (except lemon),
whole grain. e. Thymic factors 3 twice a day to 6 twice a day, depending
on severity of immune/autoimmune problems. f. Ginkgo biloba 40 mg 3 times
a day. Avoid two weeks prior to surgery. g. Bromelain 300 mg 3 times a day
or eat 1/3 pineapple a day. (Note: Phytopharmica makes a supplement called
CurcuMax that contains Curcuma Root Extract & Bromelain which are natural
anti-inflammatory agents.) h. Immunocal one packet (10gm) twice a day is
recommended to
rebuild intracellular stores of glutathione. i. If sulphur levels are low,
MSM 1/4 teaspoon per 30 lbs. body weight dissolved in liquid orally once
per day. Capsules are available. j. Olive
leaf extract one 500mg capsule twice a day for three days then two 500mg
capsules twice per day. 7. Stress management: a. Relaxation exercises. b.
Meditation.
LEVEL
II: 1. See Silicone Treatment Protocol Level I. 2. For patients with
symptoms of candidiasis (fatigue, muscle aches, diarrhea, abdominal cramps,
memory loss, vaginal yeast infections) we recommend: Use of yeast diet (see
the Yeast Connection or other popular books) and acidophilus or other
probiotics or a yeast program such as Harmony Formulas Candida Program, may
require oral Nystatin 5 cc three times/day if ever on antibiotics, and may
require Diflucan 200 mg a day for 10-14 days if liver function tests are
normal and you are not on any medicines which should not be taken with
Diflucan, i.e. Seldane, Propulsid, some diabetic medications, some
anticholesterol medications and some anti-hypertensive medications..
Sporanox 100 mg 2 each day with food for 3-6 weeks may be needed if stool
yeast tests show yeast is resistant to Diflucan. Add Lipolic acid 200 mg
p.o. q.d. while on Diflucan or Sporanox. Ask your physician or Dr. Susan
Kolb if you feel you have candidiasis. IV therapies are also available for
candidiasis. Additional natural yeast therapies include garlic/oregano oil
and enteric-coated caprylic acid. 3. For patients with longer and more
severe silicone exposure, we recommend: Intravenous therapy to include
trace minerals and vitamins to help restore missing nutrients and
hydroxylate the crystallized silicate in the tissue so it can more readily
be eliminated. We recommend IV therapy twice a week for four weeks.
Transfusion time is 1-2 hours. Cost of IV vitamins is $75 per IV treatment
and cost of membrane stabilizer is $65 per IV treatment. For more toxic
patients, IV treatment with a membrane stabilizer once a day x14 days then
3 times per week for 2 weeks is recommended.
4. Endermologie for tissue lymphedema. Cost is $85 per treatment. This is a
physical means of clearing the lymphatics, especially of the upper
extremities and chest wall, which may be blocked by silicone. Lymphatic
massage may also be helpful. 5. Hypnotherapy to deal with the anger. Women
often feel angry due to the circumstances surrounding the breast implants
or due to the lack of sensitivity of the medical community to the patient's
illness. Anger is a toxic emotion that can block the healing process, and
hypnotherapy is an effective means to release the anger so healing can
proceed. 6. Additional nutritional therapies: In addition to thymic
factors and vitamin formulas, we recommend anti-inflammatory nutrients such
as grape seed extract and Pycnogenol. Beta 1.3 D Glucan (Beta Gold) may
also be effective as an immune system enhancer. MgN3 250 mg capsules 2-4
capsules 4 times a day for 2 weeks then 2 twice a day helps to increase
natural T killer cells. Cellular Forte with IP6 also helps enhance the
immune system. Super Malic 8-12 per day is effective in the treatment of
fibromyalgia. Aloe vera juice 3oz 3 times per day. DHEA supplementation if
deficient in DHEA. Melatonin supplementation
for sleep disorders. 7. Modified fasting: A fast lasting one to three
days using vegetable broth and organic diluted apple juice combined with
oral aloe vera gel (2 cups a day) to cleanse the colon.
8. Colon Cleansing: Used as an adjunct to fasting to cleanse the lower
colon of toxins. Colon therapists are available. Coffee enemas to assist
the liver detoxification. 9. Detoxification programs such as Metagenics
Ultra clear Plus. 10. Energy medicine. Techniques to enhance the immune
system and release toxic emotions from the body to help facilitate healing.
11. Saunas and/or hot baths with Epsom salts for mild hyperthermia.
15-20 minutes - 3 times per week Add Liquid Needle Body Soaks to hot baths
as directed. 12. Chelation Therapy: Recommended especially if testing shows
heavy metals that chelate with EDTA. Combined with ozone. (Alternate days
ozone, chelation) or HBO (hyperbaric oxygen) depending on availability. 13.
Homeopathic preparations prescribed for cellular detoxification.
Please note that there is an individuality as to presentation as well as
biochemistry of each silicone intoxicated patient. Not necessarily all of
the above is necessary and that for some individuals only part or an
addition to this protocol may be important.
The "Bad News" Bacteria Now Resistant to Antibiotics: "Streptococci,
staphylococci, mycobacteria, clostridia, pseudomonas, enterobacteriaceae,
spirochetes, salmonella, and the full family of anaerobes are among the
vast number of "bad news" bacterial organisms that have become resistant to
antibiotics. On the other hand, few therapies rival the success of
antibiotics, which have helped cure millions of people of syphilis,
pneumonia, tuberculosis, meningitis, gonorrhea, and the myriad of "staph,"
"strep," and other infections that would otherwise be disabling, if not
fatal. However, bacteria have shown amazing ingenuity in developing
resistance mechanisms that render potent antibiotics ineffective. The
public now faces the same dangers from bacterial infections that were
present before the discovery of antibiotics."
"With each successive wave of antibiotics produced since the sulfa drugs
just before World War II, bacterial organisms have rallied with biochemical
self-defenses. Genetic particles conferring resistance to one or several
antibiotics have been passed among bacteria by sexual reproduction, and
those particles have enabled the germs to become resistant to drugs they
had never met." "The problem of resistance has worsened and the list of
better defended organisms has kept growing. Even fifteen years ago, the
federal Centers for Disease Control and Prevention in Atlanta reported
widespread resistance in the bacterium that causes leprosy to dapsone, the
main drug used to treat the disease. This tragedy has led to an elevation
in the number of leprosy cases throughout the world." "Among other
examples of resistant organisms are bacteria that cause tuberculosis,
gonorrhea, cholera, salmonellosis, and pneumonia. Best known, perhaps, is
the case of staphylococci which, beginning as long ago as the 1950s, became
resistant to penicillin and then to other antibiotics such as methicillin.
Infections caused by methicillin-resistant staphylococci hit hard at
patients in hospitals, and the problem is continuing even today. The
problem is particularly serious in the tertiary care hospitals that treat
the most severely ill patients with burns, trauma, cancer, and other
disorders. The problem of mutant bacteria has
become worldwide. In England and Wales, for instance, over the past
twenty-five years, doctors have noted a tenfold increase in urinary tract
infections caused by bacteria that are resistant to the antibiotics that
once had worked against them."
"There undoubtedly had been an overuse of antibiotics in general, which
exacerbated the resistance phenomenon among pathological bacteria. Misuse
has led to further lessening of antibiotics" effectiveness, loss of lives,
and rising costs of treating infections. It turns out that the United
States is better off than some countries, where antibiotics are purchased
over the counter without prescriptions, leading many people to treat
themselves for ailments that do not require antibiotic use." "Still, some
North American physicians continue to prescribe antibiotics unnecessarily,
as in treatment of viral infections, for which they are ineffective. In the
United States and elsewhere, antibiotics are used in feedstuffs to aid the
growth of animals for commercial purposes. Consequently, many consumers are
overwhelmed with antibacterial substances, ingested in our meat and poultry."
"Fortunately, all of us today have the new/old, natural and nontoxic answer
for counteracting antibiotic-resistant bacteria, in the form of
crystallized calcium elenolate that is present in the oleuropein of olive
leaves. This hydrolysized compound of the oleuropein substance is powdered
and encapsulated as a food supplement." "Finally, the pressure has been
taken off pharmaceutical industry researchers who are no longer coming up
with new drugs to intervene in the antibiotic resistance cycle. The
American medical consumers have olive leaf extract."
"Knowledge of the medicinal properties of the olive leaf dates back to the
early 1800s, as described in the last chapter, when pulverized leaves were
used in a green drink to lower high fevers. A couple of decades later,
green olive leaves were taken again in liquid form as a treatment for
malarial infections. But it wasn't until 1995 that the actual individual
therapeutic component in olive leaves, elenolic acid with its salt, calcium
elenolate-was uncovered. This discovery now provides the public with a
highly effective food supplement which acts as a true illness preventive
measure." "It works to stop the onset of such health problems as colds and
other viral diseases, fungal, mold, and yeast invasions of many kinds,
bacterial infections both minor and major, and protozoan parasitic
infestations. Used by itself in a high enough dose, olive leaf extract will
expel flukes and other worms invading humans and animals. More than
prevention, olive leaf extract offers a new safe and effective therapeutic
modality in the ongoing battle against active disease processes."
"Olive leaf extract is an antifungal agent. It obliterates fungal, yeast,
or mold infestations such as athlete's foot, ringworm, thrush, vaginal
yeast infections, and many other disorders that arise from microscopic
plant invaders." "Olive leaf extract is an antiparasitic as well, killing
or driving out other microscopic animals or plants that live in or on the
human body. Chemical components of the olive leaf work against various
endoparasites that thrive inside the body, such as two particular organisms
offered here as examples, the amoeba Entamoeba histolytica and the protozoa
Giardia lamblia. The same olive leaf components eliminate ectoparasites,
tiny animals which live on the body's surface like mites and ticks." (This
information provided by: a_wrichmond@fuse.net
Amanda Richmond
Michael Fumento, 5/7/00: They say the Canadian Mounties always get their
man. They did this time, though their man was a 17-year-old boy. The
heinous crime for which he was sought? Wearing Aqua Velva cologne and
Dippity Do hair gel to his school near Halifax, Nova Scotia. Don't get me
wrong; I think any guy who wears Dippity Do should be sent down to
Singapore for a good caning. And Aqua Velva? Please. But the actual offense
was violating his school's ban on anything with a fragrance. Anything. And
laugh if you want at those silly Canadians, but their fragrance phobia may
prove the first successful invasion of the U.S. since the War of 1812.
It all began in Halifax, about a decade ago. Now, about 80 percent of
Halifax's 146 schools now have some form of scent-free policy.
Anti-fragrance policies also appear to be the norm at most of the city's
workplaces. Most of the city's public institutions, and a number of private
businesses, now request or demand that workers be scent-free. The Halifax
Chronicle-Herald prohibits its 350 employees from using perfume, after
shave, scented deodorant, shampoo or even strong-smelling mouthwash on the
job. A 1,400-employee telephone service center has declared itself
off-limits to fragrance. Reminders pop up on computer screens when
employees log on, presumably reading "Big Brother Is Smelling You." Warning
signs are posted in toilets reminding workers not to use toiletries.
Violators are sent home to take a shower (No soap or shampoo, please) on
unpaid time.
Now the phobia is spreading. In Ottawa, the public bus system discourages
wearing fragranced products, while a local hospital has embarked on a No
Scents Is Good Sense campaign. On Prince Edward Island, off the East Coast,
a joint declaration from an employer and its union recently recommended
banning perfumes and aftershaves from government offices. And although
Canada is hardly litigious compared to the United States, a Toronto
resident filed suit against a neighbor for invading her air space with
cooking smells. Stifle that smirk, though. Such lunacy may be coming soon
to a neighborhood near you. In early April, the New York Times ran an
article titled, "Banned from Classroom: Scented Products." In it we are
told, Students at Western Connecticut State University in Danbury taking
any of [the classes of two professors] receive more than a syllabus when
they first meet. They obtain a list of what they can't wear or bring to
class, including perfume, scented soap, deodorants, shampoos and
conditioners, hair spray, mousse, freshly dry-cleaned clothes and chewing gum.
And that doesn't mean popping or cracking gum, which ought to be a capital
offense. Just having the gum in your person is forbidden. Whether full-body
searches are required, the article does not say. There is not the least
hint in the Times piece that the Multiple Chemical Sensitivity the
professors claim to suffer has been disavowed by such astute bodies as the
American Medical Association, the American Academy of Allergy and
Immunology, the Board of the International Society of Regulatory Toxicology
and Pharmacology and the American College of Physicians.
Indeed, there's nothing that qualifies as science that indicates that -
while a few persons among hundreds of millions may have allergic reactions
to this perfume or that deodorant - there is anybody with a true health
reaction to artificial smells as a whole anymore than there is anybody who
reacts to any product beginning with the letter "f." Fragrance phobia is a
mania, nothing more. Like so many other manias from which people suffer, it
is spread by anti-chemical activists, Internet innuendo, newspaper and
magazine reporters who treat alleged victims as experts while ignoring the
real experts, and by a handful of doctors who rake in the big bucks by
treating the fragrance-phobes. Manias based on unidentified odors are
well-documented in the medical literature. Indeed, it appears to have been
one such at a Halifax hospital that launched Canada's scent storm troopers.
In D.C., there was an episode at the Dirksen Senate Office Building
cafeteria last August in which nine persons were rushed to the hospital.
The apparent cause? A hidden bag of onions. A year earlier, no fewer than
170 students and others sought emergency treatment at a Tennessee high
school after a teacher whiffed a foul odor. The cause of the odor may
never be known, but the cause of the outbreak? Mass hysteria, according to
a report in the Jan. 13, 2000, issue of the New England Journal of
Medicine. Yet to paraphrase (sort of) Sonny & Cher, the bleat goes on.
San Francisco's Ecology House, a refuge for fragrance-phobes, forbids even
more products than do the Connecticut professors. The San Francisco Chapter
of the Sierra Club has urged action to discourage the use of fragranced
anything anywhere in public. Fragrance products worn by people a block
away adversely affects the chemically sensitive, claims one activist from
just north of San Francisco. A block away? "Why should we have brain
damage because people are wearing toxic chemicals," the late influential
California activist Julia Kendall asked author James Bovard. Her agenda?
"Basically, we want to destroy the fragrance industry."
Yes, along with our prerogative to smell nice. If those fragrant-phobic
fruit cakes want to make body odor a virtue, that is their right. But if
they try to take my Polo or Calvin Klein, they'll have to pry the bottles
from my cold, dead but nice-smelling fingers. Michael Fumento is a senior
fellow at the Hudson Institute, where he specializes in health and safety
issues. (None of these writers seem to know a thing about chemical
sensitivity. Lynda)
COMMENTARY: THE SAGA OF THE FDA HEARINGS ON BREAST IMPLANTS: Gaithersburg,
Md., 2/29/00 (PR Newswire)- The benefits reported by women with
saline-filled breast implants far outweigh the risks, according to the
presidents of both the American Society of Plastic Surgeons (ASPS) and the
American Society for Aesthetic Plastic Surgery (ASAPS). Both organizations
did testify at the U.S. Food and Drug Administration's (FDA's) hearings on
the safety and effectiveness of saline-filled breast implants, March 1-3 in
Gaithersburg, MD. "Plastic surgeons have seen first-hand how a woman's
quality of life can be tremendously improved by this procedure," said C.
Lin Puckett, MD, ASPS President. "Every plastic surgeon can provide
numerous stories about women whose self-confidence flourished after
augmentation mammaplasty." "The high satisfaction rate, and the
determination of so many women to undergo a surgery with the knowledge that
it is not a perfect operation, suggests just how deeply the benefits are
felt," said Fritz E. Barton, Jr., MD, ASAPS President. "I can tell you
unequivocally that the vast majority of patients who have breast
augmentation would make the same choice again."
Both organizations take the position that women should be fully informed of
the potential risks and benefits and should have the right to
choose. These hearings mark the end of a regulatory process that began in
the 1980's, when the FDA categorized saline-filled breast implants as Class
III devices, requiring the highest level of premarket review. In June
1999, a report by the National Academy of Science's Institute of Medicine
supported the general safety of implants, stating that there is, "no
definitive evidence linking breast implants to cancer, immunological
diseases, neurological problems or other systemic diseases."
ASPS is the largest organization of board-certified plastic surgeons in the
world. ASAPS is the leading organization of board-certified plastic
surgeons who specialize in cosmetic surgery. Members of both organizations
are certified by the American Board of Plastic Surgery.
Gaithersburg, Md., 3/2/00 (Reuters) The two most popular brands of
saline-filled breast implants are safe and effective and should stay on the
U.S. market, a federal advisory panel said Thursday after reviewing new
data on possible complications. The committee said, however, that the
company that makes a third brand of saline implants did not present enough
information to prove the benefits of its product outweighed its
risks. Saline implants first hit the market more than 25 years ago when
the FDA had no authority to determine whether they were safe. The agency is
scrutinizing them now because of concerns about complications such as
infections and rupturing.
The FDA usually follows its panels' advice and is expected to decide
whether to officially approve the implants later this year. Breast
implants are more popular than ever. About 150,000 women received them last
year. Most are filled with saline, or salt water. Silicone-gel implants
were banned for most women in 1992 over safety concerns. The panel
recommended the FDA approve implants made by Inamed Inc.'s McGhan Medical
unit and Mentor Corp., two California companies that lead the breast
implant market. "The data shows these implants are reasonably safe and
effective," said panel member Dr. Phyllis Chang of The University of Iowa
College of Medicine after studying McGhan's results. But panelists said
they were not reassured by data from Poly Implant Prostheses (PIP). They
said the U.S. study the company presented did not include enough patients
that were followed for an adequate time to truly evaluate the device risks.
Panel member Boyd Burkhardt, a plastic surgeon from Arizona, said he wanted
to support PIP's implants because he thought their design would
"dramatically" reduce the rate of infections. But he found the company's
data incomplete and found it difficult to understand that the company was
"as ill prepared as you appear to be." PIP President Rick Hawk responded
by saying the study results showed there was, "reasonable assurance of
PIP's implant safety and effectiveness." Earlier, McGhan said a one-year
study of more than 2,500 women showed the most common problem was
contraction of scar tissue around the implants, which can cause changes in
breast appearance and deflation. That occurred in 7.2% of women who had
breast augmentation and in 12.5% of women who had breast
reconstruction. Leakage or deflation happened to 3.6% of women who had
augmentation and 2.6% of reconstruction patients. An FDA official who
analyzed the company's studies said the risk of complications increased
over time. Dr. Sahar Dawisha said 95% of reconstruction patients had
reported some type of complication after five years. Studies on serious
ailments such as connective tissue or autoimmune diseases were not designed
well enough to draw any conclusions about whether they were related to the
implants, Dawisha said.
PAD GIRLS: An old-fashioned solution for mastectomy patients is the
prosthetic breast and bra. - N.Y. Post: Tamara Beckwith: A FDA advisory
panel has just heard alarming evidence about the failure of saline breast
implants but still recommended they stay on the market. At hearings in
Washington, the panel learned that 60% of women with cosmetic breast
implants and 85% of breast-cancer survivors who used saline suffered
complications within four years. More disturbingly, the panel heard that
27% of saline implants were removed within three years of surgery because
patients suffered painful scar tissue, infection, or the implant
ruptured. Despite this, the advisory panel last month voted in favor of
the implants as long as women were warned of their potential risks and
complications. The panel's recommendation is likely to be followed by a
Food and Drug Administration ruling, but women who opt to use the devices
and 130,000 American women did last year should be aware that some experts
on the panel rejected its summation "The failure rate of these implants
is much higher than I would have expected for a mechanical device," says
one panel member who requested anonymity. "If it were a mechanism for joint
replacement, for example, I wouldn't have voted to approve it. But at the
end of the day you have to weigh risks and benefits. There was no evidence
they caused serious disease, and [they] may be invaluable for women
undergoing reconstructive surgery after breast cancer."
DURING the hearings, women displayed implants that had been taken from
their bodies that were blackened with fungus and which they said had caused
infections, breast pain and repeated surgeries. Even so, plastic surgeons
have touted the implants as a safe and effective option for women since
1992, when the FDA banned use of silicone-gel-filled implants after
receiving reports that they triggered autoimmune diseases. Silicone-gel
implants are available only to women requiring breast reconstruction after
breast-cancer surgery. "Women are grown-ups and capable of making the
decision of whether or not they want saline breast implants," says breast
expert Susan Love MD, author of "Susan Love's Breast Book" and founder of
the breast-health Web site www.susanloveMD.com. "There's no evidence that
they're life-threatening, and as long as women are completely informed of
the risks that they may rupture or cause an infection there's no reason why
they shouldn't remain on the market. "The most frustrating thing about
saline implants, doctors say, is their high rupture rate. In the studies
presented to the FDA, implants in up to 9 percent of reconstruction
patients and 3 percent of augmentation patients deflated within three
years. Most patients opt to get their implants redone which can cost
another $5,000. A 40-year-old housewife whose saline implants ruptured
three times in the past 15 years said she spent $20,000 for repeat
surgeries. "It was totally traumatic the first time it happened," said the
woman, who did not want to be identified. "I was in the shower and I came
out and I looked like a mastectomy patient my right boob was totally
gone. "Nevertheless, the woman says the results have been worth it: "I
went from a double-A to a C cup," she says. "I had no self confidence and
felt like a freak before the implants. Nothing would fit (no clothes). It
was a nightmare putting on a bathing suit. I'm much happier with my breasts
now."
Other risks from saline implants include capsular contracture, or
tightening of natural scar tissue around the devices, which can cause
breast hardening and pain and usually requires surgery. Saline breast
implants can also make a clear and accurate mammography more
difficult. "You take more views, or X-rays, to counter that, but there's
always a fear that some of the breast tissue won't be seen as well," says
one New York radiologist.
Nevertheless, studies show there's no increased rate of breast cancer in
women with breast implants. Saline breast-implant opponents say there are
other serious health issues associated with implants. "The salt water may
not always remain sterile and is an ideal place for mold and bacteria to
grow, which could potentially cause a severe infection, especially if the
implant ruptures," warns Diana Zuckerman, head of the National Center for
Policy Research for Women and Families. "I've seen a couple women with
moldy implants, but that's very, very rare," says Marguerite Barnett, a
plastic surgeon in Venice, Fla., and an expert in implant problems. "When
we first started taking implants out in the early 1990s lawyers would have
them boxed up. After sitting in a closet they'll grow mold but that's not
the condition they're in when they come out of the women."
Eileen Swanson, a 48-year-old from New Jersey who spoke against the
implants at the hearings, says she's horrified at the FDA panel's positive
findings. "I'd tell any woman, run, don't walk, away from saline breast
implants," she says. "Women are under the perception they're safe, but
they're not." Swanson says she opted for saline-filled implants after a
double mastectomy in 1989 because there was talk then of silicone
gel-filled implants leaking and causing health problems. Right away, she
encountered problems. Her right implant deflated in the recovery room. Her
left side had difficulty healing and there was tremendous swelling. A year
later, she underwent two more surgeries to replace her implants and once
again experienced severe swelling. "The left side swelled all the way up
to my collarbone," she recalls. "At one point the implant could even be
seen through my wound. "Less than a month later, she started experiencing
joint and muscle pain, overwhelming fatigue, and hair loss. But when she
went back to her plastic surgeon, she was told horrifying news: Her
symptoms were similar to those of patients with silicone gel
implants. "For the first time, I was told the shells of my saline implants
were made of silicone," she recalls." I said I wanted the implants out
immediately, but my doctors refused. They said it would be like undergoing
the trauma of a mastectomy again to get them out. I said, 'I don't care. I
want them out.' A year later, her implants were removed.
Right now, doctors say they feel saline is the best and safest option for
women seeking implants. Breast-cancer survivors have a more natural
looking option: a flap reconstruction, which usually involves removing a
flap of skin from the abdomen along with the accompanying muscle, fat and
blood supply and reattaching it to the chest wall. But for women looking
to boost their breasts for aesthetic reasons, saline is the only show in
town.
WASHINGTON (Reuters) - Saline-filled breast implants made by Inamed Inc.'s
McGhan Medical unit and Mentor Corp., the two leading makers of the
products, are safe and effective for continued use, U.S. health officials
said Wednesday. The implants have been sold in the United States for more
than two decades, but the Food and Drug Administration had never formally
approved any of the brands. The FDA decided to review saline implants after
safety concerns arose over silicone-gel implants, which it banned for most
women in 1992.
WASHINGTON (AP) FDA Approves Saline Breast Implants: The Associated Press
(Lauran Neergaard): The government approved saline-filled breast implants
Wednesday, ruling that the implants made by two California companies can
stay on the market. The Food and Drug Administration's decision came
despite warnings from its own advisers that the implants break open at
"alarmingly high'' rates and require women to undergo repeated
surgeries. "Women should understand that breast implants do not last a
lifetime,'' warned FDA medical devices chief Dr. David Feigal. About
130,000 American women received saline-filled breast implants last year
even though the FDA had never declared the implants safe. They sold
because of a government loophole. But recently the FDA decided they could
only continue selling if manufacturers proved they are safe. Wednesday, the
agency ruled that brands sold by the two largest manufacturers, Mentor
Corp. and McGhan Medical, both of Santa Barbara, Calif., can remain on the
market. But the FDA's formal approval came with lots of warnings for
women. Over 20 percent of women who get saline-filled breast implants need
additional surgeries within three years, most because patients suffered
painful scar tissue or an infection or the implant broke and leaked. The
risk is worse for women who get the implants after breast cancer surgery
than for women who choose cosmetic breast enlargement, the FDA warned. Some
39 percent of cancer survivors need additional surgeries within three years of
their original breast implant.
WASHINGTON (Reuters) - Saline-filled breast implants made by Inamed Inc.'s
(IMDC.O) McGhan Medical unit and Mentor Corp. (MNTR.O), the two leading
makers of the products, are safe and effective for continued use, U.S.
health officials said Wednesday. The implants have been sold in the United
States for more than two decades, but the Food and Drug Administration had
never formally approved any of the brands. The FDA decided to review saline
implants after safety concerns arose over silicone-gel implants, which it
banned for most women in 1992. An FDA spokeswoman said the agency decided
McGhan and Mentor's saline implants "could remain on the market despite the
relatively high complication and failure rates'' seen in company studies of
the products. Other companies that make implants that do not hold FDA
approval must stop distributing the products after May 15, the spokeswoman
said. Breast implants are more popular than ever. About 130,000 women
received them last year.
Mentor, Inamed's Saline Breast Implants Win US FDA Approval Santa Barbara,
California, May 10 (Bloomberg) -- Mentor Corp. and Inamed Corp. won U.S.
Food and Drug Administration approval to market saline-filled breast
implants, ending years of controversy during which implants were sold
without FDA review or approval. In officially clearing the implants for
sale, the FDA followed the recommendations of an expert advisory panel that
found in March that the companies' saline implants were safe enough to
remain on the market. The agency approved the devices for use in breast
reconstruction after cancer treatment, and for cosmetic augmentation in
women over the age of 18. Breast implants first became available in the
1960s, before the agency began regulating medical devices. When Congress
expanded the FDA's mission to include devices, implant makers were allowed
to keep their products on the market without submitting safety data. As of
1997, more than 1.5 million women in the U.S. had either silicone or saline
breast implants.
In 1992, the FDA pulled most silicone implants from the market amid
concerns that they might be linked to diseases, although independent
scientific task forces have since failed to find a link between the silicon
devices and any major disease such as lupus, cancer or rheumatoid
arthritis. Still, local complications are common. Saline implants
frequently deflate and the devices can trigger hypersensitivity, numbness,
infections and painful hardening of the tissues of the chest.
According to data presented to the panel on Mentor's implants,
complications are more common among women who receive saline implants for
reconstructive purposes after a mastectomy, than among women simply seeking
enlargement. After three years, only 27% of women who got Mentor saline
implants for reconstructive surgery remained free of complications,
according to an FDA analysis. Supporters of implants, though, argue that
these risks are outweighed by the psychological benefits offered by
implants, especially in cases where they are used for reconstruction after
cancer treatment. Inamed sells implants through its subsidiary, McGhan
Medical Corp.
Implants made by three smaller competitors, all U.S. offices of foreign
companies, must quit selling in the United States by Monday. Women's
health advocates condemned the decision. "The standard of safety is at a
new low at FDA,'' said Diana Zuckerman of the National Center for Policy
Research for Women and Families. "Here you have the benefit which is
cosmetic and the risks which are serious health problems.'' The FDA's
independent scientific advisers in March had recommended approval of the
implants, despite declaring that they break open and leak at "alarmingly
high'' rates. The panel heard testimony from dozens of women claiming the
implants caused pain and disfigurement, while some cancer survivors said
they were important for their emotional recovery. The FDA's ruling was not
a ringing endorsement. But the agency noted that many women desperately
want these implants, 130,000 got them last year despite the safety
uncertainty, and in company studies, many women said they were happy
despite all the implants' complications.
"Women should understand that breast implants do not last a lifetime,''
warned FDA medical devices chief Dr. David Feigal. "One of the things they
should consider is they've got about a 1 in 6 chance of facing another
surgical operation'' within three years of implantation, he added. Too many
Americans have gotten breast implants without understanding that, he
said. To make sure women get that message, the FDA wrote a booklet
describing the risks that plastic surgeons were ordered to give potential
patients before the day of surgery, so women can decide if implants are
worth trying. Women should demand the booklet if their doctor forgets to
offer it, Feigal said. And the longer women have implants, the more
likely they are to suffer a side effect, FDA scientists say. Up to 73% of
patients in one study suffered at least one side effect. In addition to
pain, leakage and reoperations, other side effects include loss of nipple
sensation, asymmetry, and wrinkling or puckering skin at the implant site.
(Not to mention the fact that women who had their implants removed, for any
reason, were removed from the study and their problems therefore remain
unreported. Lynda)
My testimony to the FDA Advisory Panel: Ladies and Gentlemen of the Panel:
I am a social worker (MSW) and the leader of a support network for women
with breast implants. I am here today to represent the many women who are
unable to come. There are numerous reasons for their absence, among them
the inability to afford a trip, illness, and their feelings that they could
not speak eloquently enough to get their points across. Many fear the
publicity of dealing with a private medical matter in such a public
forum. Many are embarrassed that they made this medical decision only to
become ill and become a burden to their families and friends. They hide
their shame. Some fear the legal repercussions of being public while
legalities still exist over these devices.
I am here today to tell you my experiences with these women and with saline
filled silicone breast implants. Our network has existed since 1990 and
has about 5500 members; about 25% being women who have had only saline
filled silicone implants. A few of these women do not have problems, but
are concerned. The vast majority have medical problems caused by their
implants. As saline filled silicone implants become more popular, the
percentage of calls coming from women with these breast implants has
mushroomed. In the last three years, our calls have consisted of more and
more saline implantees, nearing 50% today. Our network provides
information free of charge throughout the world to those who cannot afford
to pay for it and we do provide a newsletter for $25 annually. We are
incorporated as a 501c3 non-profit organization. I have traveled many
places in the world to arrange conferences, meetings, and to impart
information on breast implants.
Silicone is not biologically inert, although it may be chemically
inert. The silicone in the shell contains many chemicals which react when
placed in a biological setting. Some of these chemicals are known to be
harmful to the body. I am sure you have a list of all the contents of the
shell of these devices. I urge you to read about the harmful effects of
each. These are not inert devices. Bio-chemical reactions can and do
occur. When implants are removed, often scar tissue remains. Some of
these harmful chemicals that slough off the shell will remain in the chest
causing further reactions. Foreign bodies are known to cause
reactions. The calcium deposits that form in scar tissue resemble
cancerous tissue on mammograms. Screening for cancer is much more
difficult with any implant.
Women who have had cancer are known to have a suppressed immune system. I
am one such woman, and, although at the time the implant seemed like a
great idea, it was probably the biggest mistake of my life. It almost cost
me my life. Women who have suppressed immune systems should not be exposed
to products that are known immune system suppressants.
The manufacturers of saline (that goes into these implants) are on record
as stating that their solution is not meant for long-term implantation into
the human body. It is a dated solution, and one that can not be guaranteed
to remain sterile. Generally the date is less than a year from the time of
implantation. Sterility is only as good as the conditions of the operating
room and the cleanliness of the medical persons involved. In addition,
sterility is never 100%, even with all the modern ways we have to sterilize
medical devices. Implants are micro-porous; they exchange fluid with the
body. Anything in the implants can get into the body, and vice versa. We
all have bacteria and fungi in our bodies. This leads to the incubation of
nightmarish microbes that cause serious damage. Saline implants can and
do rupture, often. Besides the risks of the original surgery, women are
exposed to repeated surgeries for years to come. The FDA reportedly has
over 25,000 claims of injury from these saline-filled silicone devices. We
have heard that our government is here to protect us. What have they done
about these claims?
Some of the most common problems reported to us are: Deflation of the
implant, often within a few weeks, hard and painful breasts, shifting of
the implant so that it has to be surgically moved back where it belongs,
body aches and joint pains, loss of energy, unexplained rashes (often on
the chest and neck), burning , twitching and weakness of the muscles, and
short-term memory loss. Many women report significant hair loss all over
their bodies, including eyebrows and eyelashes, and this problem usually
reverses with implant removal. Women also report skin and nipple
necrosis. Testing often reveals antibodies to silicone.
I would like to specifically address the studies that the manufacturers
have conducted, the so-called five-year studies. First I want to mention
the lack of informed consent. Product label inserts are not often given to
the women. Women often have these implants placed without hearing a word
about possible problems. They report being given papers to sign when they
have been prepped for surgery and have been given a sedative. They report
being given papers to sign after the surgery before they are fully
recovered from anesthesia. I have heard from more than a dozen symptomatic
women in the last 3 years who have never been contacted by their plastic
surgeon after implantation with saline implants, despite the fact that they
were told they were in a study about the safety of these devices. These
women's symptoms remain unreported. If I have heard from this many (and
other group leaders have heard from at least this many), how many others
remain unreported. These women are all part of a study being done by
McGhan and Mentor. The plastic surgeons that insert the implants are
collecting this data. This greatly reduces or eliminates any scientific
validity of this study.
Another problem is that a study that only goes for 5 years can hardly
define risks that may take 20-30 years to discover, as in the case of
asbestos. We know for a certainty that women with silicone implants often
do not show symptoms for at least 6-8 years. For some it is 15 years or
more. What possible value can a biased study, one in which not all the
plastic surgeons follow up with patients and that only goes for 5 years,
have? This certainly calls into question the accuracy of the data from
these studies that you will hear at this PMA meeting. These saline-filled
silicone implants studies need to be followed by unbiased researchers for
at least 20 years before we can know what damage they will do to many of
the recipients.
I have heard doctors joking about these "studies", stating that they are a
study in name only. I seriously doubt that any of these doctors, who make
money from placing implants, are going to come here and admit that these
studies are not scientifically valid. A survey of all women implanted
should be done to find out how many had problems and how many have reported
these to their plastic surgeons. This should not be done by the
manufacturers of implants or the plastic surgeons. The FDA should closely
monitor these studies and check the accuracy of the information provided
regarding these.
Women call our network with illnesses a few years after implantation,
stating that they have never heard from their plastic surgeons. When they
do finally call their surgeon, complaining of symptoms, they are told that
these symptoms could not possibly be from their implants. I heard from one
of these women again recently, and after almost 4 years, she had not once
heard from her California plastic surgeon, despite the fact that she was
told that she was enrolled in a study. She finally called his office to
report problems and was told that her problems are not of the type implants
cause. I am including the e-mail of one woman who contacted me less than
three weeks ago. She had her saline implants for 4 months and was already
symptomatic. When she contacted her plastic surgeon, he told her it was
not due to the implants. She has persisted and he has removed them, but
with great reluctance. I am sure he will not report that her medical
problems are related to her implants. I do not believe that is in an
uncommon problem. From the reports I get from women and other support
group leaders, this is an extremely common situation. Complaints are being
brushed off as merely inconsequential problems not related to saline breast
implants. Those of us who speak out are called fanatical, hysterical
women. I am a serious, practical, intelligent and educated woman. I am
dedicated to informing people on this issue that harms more than just the
women of our society.
I have seen the pictures of the horrible fungi and bacteria that grow in
implants. I have one here with me. I have known the women from whose
bodies these implants were removed. I have seen their disastrous health
problems. Studies must be done to determine what happens to women with
saline implants that have bacteria and mold growing in them, especially
when they rupture inside the women's bodies. These need to be longer than
1,3, or 5 years. After 6-7 years, the incidence of rupture dramatically
increases. We are asking you to advise the FDA to protect us from these
dangerous products and their side effects. I am sure you are privy to
FDA's list of concerns about the autoimmune problems caused by
saline-filled implants. I have included a copy with this testimony.
If this meeting is not a serious effort to evaluate the safety of saline
implants, but instead a rubber stamp to please the manufacturers by
approving their products, then I ask that you make absolutely certain that
all women are, at least a week before the surgical, given the important
information about side effects. They need to be informed of the wealth of
information available. They need to be given this without bias or comments
by the physician. Often concerns are just waved away with a sweep of the
hand and a statement that we don't have any problems with these. My group
members report this same paternalistic response from their plastic
surgeons. Maryland is a good example. The state has an excellent policy
of informed consent regarding implants, but the policy is more impressive
on paper than in reality. This informed consent itself would save many
lives and much heartache for years to come, but unfortunately, many of the
doctors reportedly ignore the law and fail to comply.
There is an increasing problem with younger and younger women desiring and
getting breast implants. The age range from 13-17 is not
unusual. Although some (few) plastic surgeons refuse to implant women so
young, most can and do take these young women (children) as patients. They
are not yet old enough to understand the lifetime of surgeries and problems
that may occur. They just want to feel good about their bodies and want to
fit into their peer groups. Ethically and morally, these women should not
be candidates for surgery, yet they are being given breast implants. Their
parents need to be truly informed of all the problems at least a week prior
to surgery so that they can make better decisions. Often these young
women's bodies are not finished with development, yet they are being
exposed to surgeries.
We have heard about the social aspects, the self-esteem issues, the
self-worth issues, the feel good about myself now reports. There are many
social aspects that are just the opposite. The families of women who
suffer from these devices also suffer. The children suffer when their
mother is unwell. The whole family often unravels. The emotional costs
are tremendously high. Some women commit suicide to escape the very real
pain, not just the physical pain caused by their implants. These women
simply can no longer face their indifferent doctors and their families who
are tired of dealing with the medical problems that implantees suffer from.
Aside from this, women in increasing numbers are being granted disability
for their breast implant problems. This certainly includes saline implant
women. In fact, women who have had long term saline implants are often
worse off medically than their silicone sisters are. Women who were
implanted with saline implants in the 70's are often quite ill today. I
know quite a few of these women. I am often grateful that I am not in
their shoes. Many have lost their husbands due to their
illness. Taxpayers are picking up the burden of these very ill
women. They are often of SSD and on Medicaid. When women are on
disability, their children also get checks. Having women ill, besides
being economically devastating to their families, it is also an issue that
costs all of us. We ignore the fact that many people are needlessly being
made ill and will, in the future, cost us even more.
Women must now sign away their rights to sue for damages if these devices
injure them. Before they can receive the implants, they have to agree to
never sue the manufacturer; otherwise they will not be given the
implants. This seems to fly in the face of reason. If they are being told
that these devices are safe and FDA approved, then they should not be
restricted from suing for damages. The manufacturers know these devices
are not safe.
In conclusion, I thank this panel for your time and hope that you make a
decision to require more study on saline implants before any approval so
that the women of this country and, indeed, the world will benefit from
this hearing. Lynda Roth, Coalition of Silicone Survivors
Washington: Hearst News Service (By Eric Rosenberg): Silicone breast
implants, virtually banned in the United States since 1992, may be back
on the market in the next several years. Dr. Paul Schnur, president of the
American Society of Plastic and Reconstructive Surgeons, said the U.S. Food
and Drug Administration is rethinking the issue because recent scientific
studies have failed to show a link between implants and diseases, and
because implants today are better quality than earlier models. "As I talk
to the FDA, I think they honestly now believe that these are safe devices,"
said Schnur, the chairman of the plastic surgery department at the Mayo
Clinic's branch in Scottsdale, AZ. "Now they say, `All the research has
come in, and they look pretty good.' " He thinks "it is a very definite
possibility" that silicone implants will be back on the market in the near
future. Then-FDA Commissioner David Kessler in 1992 ordered that
silicone-filled implants be removed from the market because the
manufacturers had not proven them "safe and effective." More than 1
million U.S. women carried the implants at the time. Currently, two
companies, Mentor Corp. and McGhan Medical Corp., both of Santa Barbara,
Calif., make silicone gel implants. Both firms are pursuing business
strategies that assume the FDA will lift the ban in the not-too-distant
future. Dow Corning, once the largest manufacturer of silicone breast
implants and currently in bankruptcy reorganization, quit the breast
implant business due to the financial strain caused by 19,000 lawsuits
brought by women who believe that implants sparked their ailments.
WASHINGTON (Reuters) Lisa Richwine: Members of Congress on
Thursday questioned U.S. health officials' decision to
allow saline-filled breast implants to remain on the market after
studies found they carried risks of health complications. The Food and
Drug Administration announced late Wednesday that it would permit the two
leading implant makers to keep selling the products but stressed that
women should be warned about risks, including the possible need for repeat
surgeries. Studies by the companies, Inamed Inc.'s McGhan Medical unit
and Mentor Corp., found more than 20% of women with implants required
surgery to remove or replace them. Other complications included breast
pain, leakage or deflation and hardening of tissue surrounding the
implants. "Why would the FDA allow such devices into the marketplace when
they are likely to cause pain, hardship, distress and added expense for
thousands of women?'' asked Rep. Roy Blunt, a Republican from
Missouri. Blunt has asked the House Commerce Committee to hold hearings on
the FDA decision, his spokesman said. Other members said they were
appealing to the FDA for more information. "The FDA itself has recognized
that there were concerns about these implants, and we hope to monitor the
situation with the FDA,'' said Representative Ron Klink, a Democrat
from Pennsylvania.House Commerce Committee Chairman Thomas Bliley, a
Virginia Republican, wants to know why the FDA is allowing Mentor to
continue selling its implants despite an ongoing criminal investigation, a
committee spokesman said. Committee staff members have asked the FDA to
provide a private briefing on the matter next week, the spokesman
said. "We are concerned about the fact FDA moved forward on this,'' the
spokesman said. "We will continue to press them to give some sort of
rationale to Congress and the American people.''
Richard Hazleton, former CEO of Dow Corning, said, "I can't conceive of any
circumstance where we would" return to making breast implants. David
Barella, an executive vice president at McGhan, is confident that the ban
"eventually" will be lifted. The company is making sales projections
showing silicone sales eventually outpacing sales of saline-filled implants
that are allowed on the market. The reason for the market optimism is
because of silicone's similarity to breast tissue. Right now, almost 95
percent of the company's implant sales are for saline implants. "Once we
get approval to market the program, we expect a significant piece of saline
(sales) to begin to switch over to silicone," Barella said. Within a few
years of silicone's re-introduction, Barella projects that sales will tilt
to 75%t silicone and 25% saline implants.
Bobby Purkait, Mentor's senior vice president for science and technology,
also said it's likely that the FDA will reverse the ban in the near future.
Purkait said the quality of silicone implants "is far superior" to what it
was five years ago. Dr. David Feigal Jr., head of the FDA's medical
devices branch, said the agency would lift its ban on the implants
when manufacturers can prove that the devices are "safe and effective,"
the agency's standard for allowing them to be marketed. In FDA-approved
studies, the two companies are collecting the data that they believe will
prove the safety of the devices. This policy suggests that the FDA believes
the implants are at least reasonably safe. "If we thought that these
things were never going to go anywhere and were awful and couldn't be
manufactured in a way that their use would be acceptable, then we would not
approve even the experimental studies," said Feigal.
Ray Duhamel, McGhan's vice president for regulatory affairs, said that by
2002, the firm will have submitted all the required safety data to FDA, and
then the FDA will make a ruling. Feigal said the FDA likely will ask an
independent advisory panel of scientists and physicians to make a
recommendation to the agency. The FDA wants the companies to include
within the safety data detailed information about how often the silicone
implants rupture. The information then would enable women to weigh the
risks and benefits of implants and make informed decisions about
whether to have them inserted. "That's the time when the products can
come back on the market," said Feigal, the FDA's director of the center for
devices and radiological health. The FDA's position is that even if
implants rupture, they shouldn't necessarily be kept off the market.
"We feel that if we can get accurate information, then it is a decision for
a consumer with her physician," he added. When it banned silicone gel
implants in 1992, the FDA allowed the devices to continue to be available
for certain women, namely breast cancer patients seeking reconstructive
surgery after mastectomy operations; women with congenital breast
deformities; and women with existing implants that ruptured but who can't
have the other main type of breast prosthetic, implants filled with saline,
or salt water. If and when the FDA lifts the ban, the agency also wants
the implants to carry warning labels, much like over-the-counter and
prescription drugs carry warnings of possible side effects. Those side
effects include the possibility that implants could shift
after surgery; scar tissue that forms around the implant could cause
painful hardening in the chest; and implants could rupture, leaking all or
some of the contents into the body.
"The vast majority of products always have some setting in which they have
complications and other settings in which they perform well," said Feigal.
"The issue is how to get the best description of the complications and the
potential complications to women." In an effort to address the FDA's
concerns about rupture, a new type of silicone is under study at both
companies. Called cohesive silicone, it is much more viscous than ordinary
silicone with the consistency of molded jello. Should a rupture occur,
cohesive silicone would tend to stay put rather than leak into the body.
The Dallas Morning News, 5/07/00, Mark Curriden: Juries on Trial: First of
two parts: So the roof on that new house you bought leaks like a cheap
pen. Plan to sue the real estate agent for fraud? Forget it. Take your
company to court because the boss made unwanted advances? Don't count on
it. You may have promised never to sue and don't know it. And if a panel
of fellow citizens hands up a $2 million verdict to punish that doctor who
botched your knee operation, don't start fantasizing. A judge will probably
be required to dramatically reduce it. That's not how the system works, you
say? Well look again. Bit by bit, case by case and state by state,
Americans' celebrated right to trial by jury quietly is being
diminished. Lawmakers, judges and private lawyers, through a wave of
individual actions, collectively are reducing the role of jurors and their
ability to dole out justice as they see it, according to a six-month study
by The Dallas Morning News and the Southern Methodist University Law Review.
Decreasing involvement: The cumulative impact of more than a decade of
whittling and tinkering has narrowed people's fundamental constitutional
guarantee to have their disputes, and, at times, their life and liberty,
decided by their peers. More and more matters once decided by juries are
being handled by judges or private arbitrators or are being banned from the
courtroom entirely. "The American jury is in serious trouble," says
Valerie Hans, a University of Delaware psychology professor and recognized
authority on the role of juries in the national culture. "The influence
that juries have in determining societal rights and wrongs, determining
what's acceptable and what's not, has been gradually sliced away."
Not everyone thinks the emerging trend is bad. Some lawyers, judges and
business leaders believe that the 223-year-old jury system is showing
signs of age and needs significant reforms. They point out that courts are
clogged with an ever-increasing number of legal disputes and that without
these changes, the justice system may collapse. Some social scientists
argue that today's lawsuits have become too complex for citizen juries to
resolve. Some advocates of change say juries are too unpredictable, too
easily manipulated by lawyers, too quick to sympathize with individuals who
take on big corporations and too easy on crime. "Some of these reforms are
long overdue," says Victor Schwartz, a law professor at the University of
Cincinnati School of Law and general counsel of the American Tort Reform
Association. "The jury system has flaws that are being exploited, and it
needs tweaking."
Even the most avid advocates of the jury system agree that the trend is not
the result of a massive conspiracy to eliminate juries. Instead, analysts
say, it is driven by an eclectic group of activists, each with their own
agendas and concerns, many of whom disagree with the reforms being proposed
by each other.
The shrinking role of juries in Texas: Legal experts say no state has seen
the role of juries more altered during the last decade than Texas. For
example: Texas juries no longer decide workers' compensation cases; a
special state commission does. Juries' efforts to punish corporate and
individual wrongdoers in civil cases are capped by state law at $200,000,
no matter how bad the conduct or the injury. Texas judges have been
instructed by the high court to more carefully screen cases before they get
to a jury and to more thoroughly scrutinize jury verdicts. Accountants,
doctors, lawyers, engineers and real-estate agents no longer can be sued
under the state's consumer protection laws. Tobacco companies also are
protected against lawsuits from sick smokers in Texas.
Around the Country: Some examples of limits placed on the right to a jury
trial and on the powers of juries. Punitive damages: Eliminated in some or
all cases in Louisiana, Maryland, Michigan, Nebraska, New Hampshire and
Washington. Capped at amounts ranging from $75,000 in Maine to $500,000 in
Alabama, Arkansas, Indiana, Ohio and Oklahoma. Limited by the amount of
actual damages. In Colorado, for example, a jury that awards $100,000
actual damages in a personal injury or products liability case can give no
more than an additional $100,000 in punitive damages. Capped in cases
involving non economic damages, such as pain and suffering or mental
anguish, at amounts ranging from $150,000 in Maine to $1 million in West
Virginia. Eliminated for pain and suffering or solace in wrongful-death
cases in the District of Columbia.
Time limits for filing on certain lawsuits: Two years for malpractice
suits against doctors in Indiana, Louisiana, New Hampshire and South
Carolina; seven years in Massachusetts. 10 years for suits against bridge
builders in Louisiana. One year for negligence suits by injured skiers
against ski resort operators.
Cases now decided only by judges, rather than juries: All patent
infringement, bankruptcy and employee retirement insurance program cases in
federal courts. Consumer fraud in Illinois. Infant injuries at birth in
Virginia. Vaccine negative reactions in North Carolina. Issues now
decided only by judges: The legitimacy of expert testimony in all civil
and criminal cases. Questions of motivation in criminal trials in 16
states and in the federal courts.
Source: Research by The Dallas Morning News and Southern Methodist
University Law Review. In recent years, however, members of the nation's
highest court have expressed concern. Supreme Court Justice Antonin
Scalia, noted for his conservative legal views, just two months ago
blasted those who try to subvert the power and sovereignty of juries. And
in a 1996 opinion, he wrote: "It is not for us to decide that the Seventh
Amendment, has outlived its usefulness."
No one records all the rules and decisions of the huge and decentralized
jury system. But consider some of the most visible changes of recent years
documented by The News and SMU researchers: Thirty-four states, including
Texas, limit the amount of money that civil juries can award. Forty-two
states have restricted the types of cases that juries can hear. Federal
appeals courts and the high courts of more than a dozen states have taken
whole areas of decision-making away from juries. Depending on the type of
case, for example, judges now evaluate expert witnesses or determine
the motives of criminal defendants. Thousands of companies, including
leading personal computer makers, require customers to surrender all rights
to jury trials in future disputes as a condition of doing business. Many
companies demand the same of employees. Though legal, such agreements are
often buried in what seems to be routine paperwork and are signed
unknowingly. More judges are reversing verdicts or halting cases before
they get that far - powers they have long had but historically have used
sparingly. Recent Texas Supreme Court rulings, for example, encourage
judges to more closely scrutinize certain kinds of verdicts and require