COALITION OF SILICONE SURVIVORS

P. O. Box 129 Broomfield, CO 80038-0129

Lynda Roth - (303) 469-8242 Fax (303) 466-4084 e-mail: coss@siliconesurvivors.net

Website: http://www.siliconesurvivors.net

June 1998

Dear Silicone Survivors and Friends:

UPCOMING EVENTS: Committee on the Safety of Silicone Breast Implants: July 22-24, 1998, Cecil and Ida Green Building, 2001 Wisconsin Ave. NW, Washington, DC. PLEASE NOTE THAT THE LOCATION FOR JULY 24th PUBLIC MEETING HAS BEEN CHANGED TO THE AUDITORIUM, NAS MAIN BUILDING, 2101 CONSTITUTION AVENUE, NW. PLEASE USE THE C STREET ENTRANCE. (Due to limited seating, advance registration is strongly recommended.) You may register by e-mail at: silicone@nas.edu.

If you would like to attend the sessions of this meeting that are open to the public or need more information please contact: Patricia Spaulding: 202/334-1318 Fax: 202/334-2939 E-mail: PSpauldi@NAS.edu,

Wednesday, July 22, 1998

INSTITUTE OF MEDICINE, National Academy of Sciences, Committee on the Safety of Silicone Breast Implants, Second Meeting of the Committee on the Safety of Silicone Breast Implants, Scientific Workshop, 1998, Cecil and Ida Green Building, Room 130, 2001 Wisconsin Ave. NW, Washington, DC, AGENDA 8:15-8:30 a.m. Welcome and Introductions, Maureen Henderson, MD, Chair. EPIDEMIOLOGY & OBSERVATIONAL STUDIES, 8:30-9:00 a.m, Update on NCI's Follow-up of Women with Augmentation Mammoplasty, Louise Brinton, PhD, National Cancer Institute, Lori Brown, PhD, Food and Drug Administration. 9:00-9:30 a.m. Clinical Results with McGhan Breast Implants, Raymond C. Duhamel, PhD, McGhan Medical Corporation. 9:30-10:00 a.m., Silicone Breast Implant. Epidemiology in Scandinavia, Joseph McLaughlin, Ph.D., International Epidemiology Institute. 10:00- 10:30 a.m. Break. IMMUNOLOGY, 10:30-11:00 a.m., Silicones as Immunological Adjuvants, John Naim, Ph.D., Rochester General Hospital. 11:00-11:30 a.m., Peritoneal Silicone Granulomas and Plasma-cytoma Genesis in Mice, Michael Potter, MD, National Cancer Institute. 11:30 a.m.-12:00 p.m., Immunopathology and T Cell Receptor Gene Expression in Capsules Surrounding Breast Implants, Fred Miller, MD, Ph.D., Food and Drug Administration. 12:00-1:00 p.m. Lunch. COMPANY DATA (MENTOR AND DOW CORNING). 1:00-2:00 p.m., Potential Extractables (quantification, exposure and toxicology). Roger Wixtrom, PhD, Environ, Silicone in Animal Models of Autoimmunity - Unpublished Immunotoxicity Testing Results. Kimber White, MD, Medical College of Virginia, Antibodies to Silicone, Further Findings Regarding Adjuvancy of Silicone Elastomer and Gel, Noel Rose, MD, Johns Hopkins University, Results from 5-year Prospective Clinical Study of >21,000 Women with Silicone Gel-filled Breast Implants Clinical Data for Saline-Filled Breast Implants, Bobby Purkait, PhD, Mentor Corporation. 2:00-3:00 p.m.: Summary and Overview of the Safety of Major Components of Breast Implants, Robert Meeks, PhD, Dow Corning Corporation. Compositional Studies of Silicone Breast Implants: An Update on Silicone-Immune System Interactions, Thomas Lane, PhD, Dow Corning Corporation, An Update on Silicone-Immune System Interactions, Paal Klykken, PhD, Dow Corning Corporation. SURGERY, PATHOLOGY, RADIOLOGY, 3:00-3:30 p.m.: Detection of Silica and NMR in Breast Implant Capsules, V. LeRoy Young, MD, Washington University School of Medicine. 3:30-4:00 p.m., Work of the University of Florida Interdisciplinary Group on Silicone Nancy Hardt, MD, University of Florida. 4:00-4:30 p.m., Analysis of Risk Factors Associated with Silicone Breast Implant Rupture, Lu-Jean Feng, MD, Case Western Reserve School of Medicine and Mt. Sinai Medical Center. 4:30-5:00 p.m. MR Evaluation of Breast Implant Rupture, Michael S. Middleton, Ph.D., MD, University of California, San Diego.

Thursday, JULY 23, 1998

INSTITUTE OF MEDICINE, National Academy of Sciences, Committee on the Safety of Silicone Breast Implants, Second Meeting of the Committee on the Safety of Silicone Breast Implants, Committee Meeting, Closed Session-not open to public.

Friday, July 24, 1998

INSTITUTE OF MEDICINE, National Academy of Sciences, Committee on the Safety of Silicone Breast Implants, Public Hearing, July 24, 1998, AUDITORIUM, NAS MAIN BUILDING, 2101 CONSTITUTION AVENUE, NW. Agenda available in July.

LEGAL: Important Dates, Deadlines and Recent Developments: From MDL-926 Home Page: 5/19/98--Order 27M entered, declaring that McGhan Medical Corp. (a California corp.) and INAMED Corporation have defaulted in payment of their obligations under RSP and modifying terms of injunction that had prohibited Lindsey class members from instituting or pursuing litigation against those companies and their affiliates regarding post-8/84 McGhan implants. This means that the Claims Office will mail release forms to post-8/84 McGhan implant recipients with respect to distribution of the 80% share of such potential distributions being funded by 3M and Union Carbide. It is, however, anticipated that there will be a presentation to the court of a proposed "limited-fund" Rule 23(b)(1) mandatory class settlement involving all claims against INAMED and its various subsidiaries (including McGhan), which national counsel for the plaintiffs believe might maximize the potential benefits recoverable by implant recipients from the INAMED (Cox-Uphoff) group of defendants. Any such proposed "limited-fund" class recovery would have to be reviewed by the court and could be approved only after appropriate notice to (and hearing of objections from) the affected class-members.

Revised Settlement Program. Bristol, Baxter and 3M implant-recipients. As of April 29, 1998, approximately $757,000,000.00 has been distributed to Bristol, Baxter, and 3M implant recipients. Advance payments ($5,000 for Current Claimants; $1,000 for Other Registrants) have been sent to some 79,000 recipients of Bristol, Baxter, or 3M implants, with an additional $3,000 explantation benefit sent to some 15,500 recipients. Additional payments, ranging from $5,000 to $95,000, have been sent to approximately 22,300 Current Claimants who elected to receive approved benefits under the Fixed Benefit Schedule and whose benefits exceeded their advance payments. Payments ranging from $32,500 to $195,000 have been sent to approximately 150 Current Claimants, Other Registrants and Late Registrants whose claims under the Long-Term Benefit Schedule have thus far been approved. The Claims Office is continuing to work with claimants whose claims, under both benefit schedules, still have some deficiencies and is reviewing Long-Term Benefit Schedule claims filed in the last few months. Initial reviews and re-reviews of all claims are now being completed within three months of receipt of the claims or written request for re-review.

Payments under Bioplasty distribution plan. As previously indicated, the Bioplasty reserve was sufficient to allow full payment of the late and corrected Bioplasty claims. Payments under Mentor distribution plan. As previously indicated, the Mentor reserve (approximately $1.3 million) was not sufficient to allow payment in full of the late and corrected Mentor claims (approximately $2.6 million). The court on February 12, 1998, approved a plan for distribution under which those Mentor claimants who were late in filing or who made mistakes in their claims are being paid at a rate roughly one-half of the amount received by timely claimants. Please do not call the Court, the Claims Office, or the Escrow Agent to complain about the amount of these payments; there is simply nothing more than can be done to try to ameliorate the problems caused by late or incorrect claims. No further Mentor claims can be accepted.

Optout report, 3/16/98. (Note: this represents a near-final report, subject basically only to a relatively few pending requests/appeals involving efforts to opt-out/opt-in after the established deadlines): 7,116 domestic implant recipient exercised "first round" optout rights during 1994 and did not rejoin the settlement class. (3,209 optouts did elect to rejoin the settlement class) 12,222 domestic registrants exercised "second round" optout rights before being sent status letters 32,679 domestic registrants exercised "second round" optout rights after receiving their status letters, 10,090 had submitted satisfactory proof of Bristol, Baxter, or 3M implants. 652 had submitted satisfactory proof only of post-8/84 McGhan implants 2,047 had not, according to their proof of manufacture, received an implant from any of the settling defendants (and hence were not eligible to participate in the RSP.) 19,890 had not submitted any proof of manufacture (and hence it is unclear whether or not they were eligible to participate in the RSP). Foreign Settlement. Claims Office has mailed preliminary notices to unrepresented foreign claimants and to all attorneys representing foreign claimants, listing the manufacturers and brands of implants that are covered in a revised foreign settlement and providing forms for potentially eligible foreign claimants to request the detailed notice of the settlement when it is available. The Claims Office is working with the court, the Foreign Claimants Committee, and the settling defendants in preparing these detailed notices. It is anticipated that the provisions of the detailed notices will be resolved during May. For information on MDL-926, contact: Settlement Claims Administrator (Ann Cochran); P.O. Box 56666; Houston, TX 77256 (or 1600 Smith; Suite 3300; Houston, TX 77002); 800-600-0311; 713-951-9106; 713-951-9427 (FAX). To request forms or notify address changes, fax to 713-951-7010 (new number).

Claims Assistance Office (legal advice for unrepresented claimants); P. O. Box 3590; Cincinnati, OH 45201-3590; 513-665-9770; 513-665-9250(FAX).

E-Mail: mdl926@your-net.com

National Plaintiffs Liaison Counsel (Francis Hare; Michael Rediker--Annette L. Fincher, Office Manager); 2008 2nd Ave. North; Birmingham, AL 35203; 800-960-6784; 205-252-0423

Important Dates, Deadlines and Recent Developments: 5/29/98--Final details on the Foreign Settlement Program are nearing completion. The court expects that a Notice containing these details will be completed by June 15, 1998, and then be mailed, as well as posted on this webpage.

5/19/98--Order 27L entered, designating Judge Frank Andrews as court's representative to rule on appeals from decisions by Claims Administrator. (These notices are from MDL-926 Home page.)

May 22,1998, Jill Haake, TIMES WRITER Women with silicone-gel breast implants might have one more telemarketer making calls to their homes -- Dow Corning Corp. On Thursday, attorneys for Dow Corning argued before U.S. Bankruptcy Judge Arthur J. Spector that the company should be allowed to call creditors in order to solicit votes for its Chapter 11 reorganization plan. The arguments were part of a day-long hearing where attorneys for Dow Corning and the women tried to iron out how they will solicit votes once creditors are mailed a plan to vote on. Neither side objects to hiring solicitation firms. Dow Corning wants the court's approval to hire D.F. King of NY and a committee for the women wants to hire The Altman Group, also of NY. Both sides plan to mail literature and possibly put ads in magazines as part of their solicitation efforts. But the sides clash when it comes to soliciting votes via telephone.

Dow Corning has proposed that employees at a D.F. King call center, or telephone bank, call creditors, urging them to vote in favor of their plan. Attorneys for the women want a call center set up to receive calls from women who have questions about the plan. Attorneys for Dow Corning argued that there's no law preventing them from soliciting votes by phone as long as they don't provide messages that are inaccurate or misleading. "Everybody agrees it's OK to solicit," said George Tarpley, an attorney for Dow Corning. "We just have to be careful." But attorneys for the women said creditors' privacy rights would be threatened if their telephone numbers are given out to solicitors. and they said there would be no way to monitor the discussions to check Dow Corning's messages.

Should Dow Corning be allowed to solicit votes over the phone, the women want the court to pre-approve the solicitors' scripts and monitor the calls, possibly by requiring Dow Corning to provide the court with recorded tapes of calls periodically. Spector put off ruling on the matter on Thursday, though, saying he has plenty of time to research the issues because a reorganization plan still needs to be approved. Spector has yet to approve a proposed reorganization plan from the Michigan-based silicone manufacturer because he still must decide whether a plan from the women should be introduced, too.

Dow Corning: Implant Recipients Ask For Right to File Alternative DOW CORNING BANKRUPTCY PLAN: Dow Has Filed Three "Legally Flawed" plans to date. The womens' plan would speed claim resolutions: After Dow Corning has filed three plans for bankruptcy reorganization, two of which were rejected by the federal judge overseeing the bankruptcy, the committee representing breast implanted women is asking for the right to file their own plan. The committee's motion and plan proposal will be filed in the court of U.S. Bankruptcy Court Judge Arthur J. Spector. The womens' motion to lift Dow's exclusive right to offer a bankruptcy reorganization plan details their alternative plan and addresses the weaknesses of the Dow Corning plans. Specifically, it would offer a $2.5 billion base payment for women, and require Dow Corning to pay an additional $1.3 billion if they fail to prove implants cannot cause or exacerbate systemic illness, symptoms, or immune system dysfunction. The women's plan would speed up the claims process, making compensation available to the women almost immediately. Implant recipients say the third Dow plan filed in February would take up to a decade to pay currently sick women's claims. They also say Dow's plan unfairly penalizes women who agree to have their implants removed. Under the Dow plan, women who accept payment for explantation would be required to waive any right to future claims against the company, even if their implants have fallen apart in the body, their breasts have to be completely removed, or the women later become ill.

"Dow Corning's plan offers injured women too little too late, and would keep the courts tied up in decades of litigation," said Ed Blizzard, an attorney for the women. "Dow's had three chances to devise a reasonable solution. Each time they've refused to negotiate, and have offered inadequate, unfair and legally flawed plans. Our proposed plan is not a negotiating tactic. It cuts to the bottom line and offers the court a confirmable plan." Federal Judge Arthur J. Spector has twice refused to accept earlier Dow Corning plans. In November he called the company's request to approve their plan in the face of a possible "no" vote by claimants a "fantasy." Last May the judge found that Dow appeared to be "stalling" by "making a show of seeking consensus without making the slightest effort toward that end." "Dow Corning has held the negotiating process hostage," said Sybil Niden Goldrich, the womens' representative on the Tort Claimants' committee and director of the Command Trust Network. "Women are sick, many are dying, and many are bankrupted by their medical bills. Waiting another decade for justice is simply not an option." "Dow has used its exclusive right to file its own reorganization plan to coerce women into accepting an unfair agreement," said Blizzard. According to the womens' attorneys, the company's tactics are in direct violation of Congress' interpretation of U.S. bankruptcy law. When Congress adopted the bankruptcy code, it stated, "The exclusive right gives the debtor undue bargaining leverage, because by delay he can force a settlement out of otherwise unwilling creditors ... The debtor is in full control, often to the unfair disadvantage of the creditors."

The Tort Claimants Committee's motion asking for the right to file an alternative plan includes some of the following details: Compensation: $2.5 billion base payment, followed by an additional $1.3 billion if the company fails to prove implants cannot cause or worsen systemic illness, symptoms, or immune system dysfunction. Timeliness: Claims could begin being processed as soon as the plan is finalized and the proper administrative mechanism has been established. Women who choose to pursue the top level of compensation for disease claims would have to wait until the resolution of a summary judgment motion on whether implants are linked to systemic illness. Explantation: All women will be able to have their implants removed, or be compensated if they've already been explanted and may still pursue their claims against Dow Corning. Due Process: Women who are dissatisfied with the options available under the committees' plan may pursue an individual jury trial. However, because the settlement plans for rupture and disease are more realistic than the Dow Corning proposal, fewer women are likely to sue individually, thus resolving the claims more quickly. "I am very hopeful that we will be allowed to file the committee plan," says Goldrich. "Women have been waiting for justice for years; our plan offers a fair settlement so they can get closure and move on with their lives." "Dow Corning has been earning nearly $300 million a year under bankruptcy protection, yet women who have flawed products in their bodies, which were sold to them with a lifetime guarantee by this company, simply cannot afford medical care," Goldrich finished. (Fenton Communications). Judge Spector has not yet ruled on this motion.

Under bankruptcy rules, solicitation of votes should not begin until the disclosure statement is approved and the solicitation packages have been mailed. Because of the large number of potential claimants/voters, it is likely that a 30-60 day period may be needed after court approval before the voting process can begin. Once begun, the process will take 60 days and follow certain safeguards and procedure that were the subject of the May 6 hearing (Judge Spector's Court), including: 1) that only the original ballot forms will be accepted and counted: 2) that the ballot forms must be mailed to a balloting agent charged with counting the ballots at the right location (or they will not be counted): 3) that there are two recorded helplines for obtaining information (800) 222-7198 and Dow's number (800) 651-7030; 4) that no interim voting results be made public: and 5) that individual voters/claimants may file separate objections concerning unique issues related to their claims. Any comments or questions may be directed to the Tort Claimants Committee, P.O. Box 61406, Houston, TX 77208-1406. Dow Corning bankruptcy hotline: 800-651-7030.

PENDING: Class Certification: INAMED's motion for certification of mandatory settlement class. Conference of counsel held with court on 8/12/96. Several additional conferences have been held during 1997 and 1998 in anticipation of 11th Circuit's deciding the pending appeals that have suspended all obligations to make payments under Revised Settlement Program.

PENDING: Potentially dispositive motions: Koken's Motion for Reconsideration (of Order No. 25, denying Koken's motion to dismiss for lack of personal jurisdiction). Fully briefed and submitted. Awaiting decision.

New Mexico: A N.M. court (Bernalillo) will allow expert witnesses for the plaintiff but will disallow causation evidence. No date has been set for trial in this case. Bristol-Myers Squibb filed a motion which sought to exclude all causation evidence in the trial of Gonzales vs. BMS. BMS argued that only 19 studies have epidemiological evidence and none support the conclusion that implants cause known disease (of course all these studies were paid for, at least in part, by the manufacturers). This argument has been successful in several cases.

An Australian woman's lawsuit against Dow Corning was dismissed by the New South Wales Court of Appeal. The court held that Christine Patos, who had sued two physicians and the manufacturer, had presented no evidence that Dow Corning had manufactured the implants used in her. Moreover, the court found that the lower court should not have granted an extension of time to commence her lawsuit.

A London appellate court found a plastic surgeon liable to a breast implant patient (25,000 pounds) because he breached the standard of care (did not inform patient before performing surgery). Dr. James Harvey-Kembla performed the augmentation surgery competently but failed to give Carol EXWIFE of Basildon, Essex, sufficient information. He had not asked her how large she wanted her breasts to be. She underwent 7 surgeries to increase her breast size by one cup. The judges were sympathetic to her and found the plastic surgeon negligent in failing to ascertain what the patient wanted from the surgery and whether the intended surgery would meet her expectations.

The California Supreme Court has heard oral arguments (Artiglio vs. Corning, Inc., No. 8057133) as to why Dow Chemical should be liable for harm caused by silicone implants manufactured by its subsidiary, Dow Corning. The female member of the panel, Justice Joyce Kennard, took the lead in questioning counsel for both sides. She was concerned about holding Dow Chemical responsible for research done on silicone decades before it was used in implants, fearing that such a liability would result in a 'chilling effect' on science. The defendants contend that Dow Chemical never conducted tests on the safety of silicone use in medical devices, while the plaintiffs argue research was done from the 1940's through the 1960's. If the court buys the plaintiffs' arguments, plaintiffs who can no longer recover from Dow Corning (bankrupt) may reach into the deep pocket of Dow Chemical. Courts in NY and MI have excluded Dow Chemical from the controversy, but LA and NV courts have yet to make a final determination. U.S. District Judge Sam Pointer (MDL-926) already held, in 1993, that Dow Corning may have relied on Dow Chemical's research.

The California Supreme Court granted review to the plaintiffs in the Artiglio case after the lower appellate court granted summary judgment to Dow Chemical in 1996. Atty. James Pantone (San Diego, Pantone and Spangler) argued the Dow Chemical may not have tested the safety of the implants directly, but it was instrumental in the testing of the basic silicone used by Dow Corning. Consequently, he said, under Section 324A of Torts, Dow Chemical would be liable. He claimed the Dow Chemical was aware the Dow Corning was testing low molecular weight silicone oils for "one reason and one reason only", their use in medical devices. Defense atty. Michele Odorizzi (Chicago, Mayer, Brown & Platt) denied that allegation and countered that Dow Chemical's research in the 1940's dealt only with industrial use. There was no way, other than clairvoyance, she said, that Dow Chemical scientists could have foreseen the use of silicone in medical devices. A decision will be made sometime in the future by the California Supreme Court. The preceding four items are from Medical-Legal Aspects of Breast Implants, 5/98.)

MEDICAL INFORMATION: Scientists Say Atypical Disease, Some Cancers may be Linked to Silicone Breast Implants. Painful, Severe Tissue Problems Are Frequent Side-Effect of Implants: Independent scientists participating in a women's health conference reiterated that atypical connective tissue disease and some cancers may be linked to silicone breast implants. The U.S. FDA had convened a panel to discuss breast health in general at the Epidemiology of Medical Devices in Women conference, but much of the emphasis was on the safety of silicone breast implants. Dr. Louise Brinton, of the National Cancer Institute, moderated the panel. Brinton is currently conducting what is expected to be the most definitive study to date on silicone breast implants and disease.

The FDA's Dr. S. Lori Brown presented information on the local and systemic problems associated with implants before the panel. Reinforcing research from a study she co-authored last fall, Brown stressed that atypical disease (a common constellation of similar, often debilitating symptoms seen among implanted women) has not been "ruled out." Last spring an NIH panel called for more research and funding to establish diagnostic criteria for atypical illness. Furthermore, said Dr. Brown, there is evidence of potential associations between breast implants and cancers. Panelist Dr. Dennis Deapen from the University of Southern California School of Medicine reported that lung and vulva cancers were of particular concern. Brown also said that local tissue complications (such as capsular contracture, rupture, infection, chronic pain, hematomas, extrusion, and silicone migration) are substantial and deserve more attention. She referred to a 1997 Mayo Clinic study which found that 1 in 4 silicone breast implanted women require a additional surgery within 5 yrs. due to severe medical complications related to implants.

The results of Dr. Brinton's study are anticipated this fall. This government funded research follows an estimated 13,000 women and combines a review of medical records with some clinical follow-up. Studies by the U.S. FDA, the National Cancer Institute and other independent bodies have shown that the great majority of silicone breast implants leak and fall apart in the body over time. Potentially toxic silicone has been shown to travel throughout the body, lodging in vital organs. Last fall the FDA upheld their 1992 decision to keep silicone breast implants off the market saying there was not adequate proof of their safety. (This information comes from the Home Page of Fenton Communications, 5/8/98.)

Potentially Toxic Silicones Leak From Implants, Travel to Ten Vital Organs: Brain, Uterus Among Organs Affected: Low molecular weight silicones leak from breast implants and collect in ten vital organs, says a peer-reviewed article published in the March 2nd issue of the American Journal of Pathology. Using animal models, the researchers found the highest levels of silicone in the brain, uterus, ovaries and lungs. This is the third in a series of studies by the Baylor College of Medicine, which examined the leakage and migration of low molecular weight silicones (LMWS) from implants. The Baylor researchers expressed concern over the effects of LMWS on vital organs, based on earlier studies (1)which indicated that LMWS may mimic the biological activity of central nervous system drugs or estrogens. In particular, one form of low molecular weight silicones (LMWS) shows "an affinity for estrogen receptors," says the most recent Baylor study, raising the possible effect of this chemical on the female hormonal system. Existing scientific literature also suggests that certain LMWS, including those identified by the Baylor team, "may have potent activities that mimic, for example estrogen or CNS [central nervous-system]- active drugs," according to 2nd Baylor study.

"The wide spread distribution of low molecular weight silicones and their persistence raises the issue of possible untoward consequences," says the March 2nd study, which also found the silicones present after one year in most organs. In their earlier study, the Baylor researchers wrote that LMWS "exhibit a variety of potentially toxic biological activities." The possible harmful effects of silicone are particularly disconcerting as the great majority of breast implants rupture, spreading silicone throughout the body. A recent paper by FDA researchers reported that 95 percent of implants rupture after 20 years.

Studies, such as the Baylor series, are beginning to explore the possible biological mechanism linking silicone breast implants to the debilitating symptoms which plague many women with the devices. Commonly referred to as "atypical connective tissue disease," these symptoms include cognitive dysfunction, severe joint and muscle pain, incapacitating fatigue and skin abnormalities. Dow discovered years ago that silicone stimulates the immune system. Some researchers believe this stimulation causes these atypical symptoms. The metal platinum has been found to leak from implants along with LMWS by the same Baylor researchers, as published in the December 1, 1997 issue of Analytical Chemistry. Platinum "exhibits significant toxicity" in the body and in lab tests. The authors concluded, "the documented leakage of [low molecular]-silicones and heavy metals from apparently intact implants raises troubling questions about the biological fate of these newly liberated compounds within tissues." The researchers noted that the LMWS was injected into the animals and that the pattern of migration of silicone may not be identically replicated by a silicone breast implant. However, they noted that they are concerned about "adverse biological effects." LMWS are among several types of silicone used in all silicone gel-filled breast implants.

Series of three Baylor studies: "Low Molecular Weight Silicones Are Widely Distributed after a Single Subcutaneous Injection in Mice," Lieberman, Lykissa, et al. American Journal of Pathology, 3/98 152: 645-649. "Release of Low Molecular Weight Silicones and Platinum from Silicone Breast Implants," Lebovitz, Lykissa, et al. Analytical Chemistry, Dec 1997; 69(23): 4912-4916. "Detection and Characterization of Poly (dimethyl-siloxane)s in Biological Tissues by GC/AED and GC/MS," Lebovitz, Lykissa, et al. Analytical Chem., 1997; 69: 1267-72. Related Problems, Bendz, Lindquist, Eds.; a) La Vier, et al. In Biochemistry of Silicon and Plenum Press: New York, 1978, pp 473-513. b) Hayden, JF, Barlow, SA, Toxicol. Appl. Pharmacol., 1972; 21: 68-79. c) Carlisle, EM. Science, 1972; 178: 619-621. For info., Contact Suzanne Turner or Karin Wallestad, Fenton Communications (202) 822-5200. 3/16/98,

Dow press release exaggerates findings of three silicone breast implant studies: Experts call studies "inconclusive". Three new studies about the potential harmful effects of silicone-gel breast implants do not fully support, and in some instances appear to contradict, the claims of a press release issued by silicone manufacturer Dow Corning, according to four scientific experts with a long history in the field. Dow Corning, used the three studies in a Feb. 17 release to suggest that breast implants have been given a clean bill of health. According to the release, women with implants had "no increased incidence of either atypical or typical connective tissue disease." However, the Dow Corning release overstated and in some cases was misleading about the findings of the studies, according to the four experts, two medical doctors, an immunologist and an epidemiologist. Data from the studies casting doubt on Dow's position was not included in the release. Moreover, in some instances, the data actually indicates a reason for concern about the safety of implants. "It appears from some of the data that women with implants may have a higher risk factor for certain health problems," said Dr. Shanna Swan, an epidemiologist at UC Berkeley. One of the studies reported high rates of several classical rheumatic diseases among certain groups of implanted women. A second study indicated higher rates of atypical connective tissue disease symptoms such as cognitive dysfunction and peripheral neuropathy (numbness in the extremities). Atypical disease is a category grouping together the unique set of symptoms which are common to women with silicone breast implants. Dow exaggerated the importance of these studies, which are inconclusive and filled with flaws," said Dr. Robert Garry, a Tulane University immunologist and microbiologist. Two of the three studies were subsidized by Dow. "Dow has a history of funding studies that don't ask the right questions, don't do proper follow-up & consequently give the appearance of clearing the company when that simply is not the case," continued Dr. Garry.

The three studies were hindered by limited methodologies, according to the four experts. This problem went unmentioned in Dow Corning's release although several of the shortcomings are acknowledged by the researchers themselves in their written reports. The studies also failed to take a separate look at the sub-group of women with ruptured implants and local complications, who appear, from clinical observation, to comprise the sub-population of women at greater risk. The experts who were asked by Command Trust Network to analyze the studies are: Gary Solomon, MD an attending physician in the rheumatology division of the Hospital for Joint Diseases, Orthopaedic Institute with academic appointments at Mount Sinai School of Medicine and New York University School of Medicine; Douglas Shanklin, MD, a professor of pathology and of obstetrics and gynecology and a member of the graduate faculty at the University of Tennessee in Memphis; and previously mentioned, Dr. Robert Garry and Dr. Shanna Swan.

Dow Corning's press release selectively quotes the study saying, "little evidence of increased relative risk of connective tissue disease in the silicone breast implant group," and concern about atypical autoimmune disease is "not supported by our results." However, Dow neglects to mention that in the study's summary the researchers wrote, "a segment of the implant population reported a higher prevalence of unusual symptoms that could not be attributed to CTD." Furthermore, the study found...symptoms normally grouped together as part of the "atypical" disease syndrome: pain, numbness and cognitive dysfunction, were reported at a significantly higher rate by women with implants. Numbness in the extremities (peripheral neuropathy) was reported by 26 percent of those with implants, compared to 15 percent of the women in the control group. "Thought problems" (cognitive dysfunction) were reported by 32 percent, compared to 17 percent among the controls. And muscle pain (myalgia) was reported by 25 percent, compared to 16 percent of controls. The study focused on 9,200 women with implants identified through a billing registry in Canada, but only 17 percent volunteered to be involved, severely limiting the significance of the findings. "This extremely low participation rate allows for huge biases," Dr. Swan said. A close scrutiny of the data reveals that approximately one of five women (219 of 1,112) had additional surgery for their implants. This ratio is consistent with a 1997 Mayo Clinic study that reported one in four recipients required repeat surgery within five years due to local complications caused by implants. Uppsala University, Sweden. Nyren, et al, British Medical Journal, Feb 1998. (Dow Corning Funded)

According to the Dow release the study "found no evidence of a link between breast implants and connective tissue disease." But...for four of the five classical connective tissue diseases listed in the study, women who underwent breast-implant surgery for cosmetic reasons had an elevated risk when compared to rates in the Swedish population. Their risk for Sjogren's Syndrome was five times higher than for women in the general Swedish population; their risk for dermatomyosistis was seven-fold higher; for systemic lupus it was more than double; and for rheumatoid arthritis it was 30 % higher. In the case of the fifth classical connective tissue disease, scleroderma, which is often implicated in the scientific literature as a possible side-effect of silicone implants, the researchers admitted their methods were not refined enough to "detect a moderate increase in the risk." Because the study was restricted solely to women who had been hospitalized for classical connective tissue disease, it would greatly underestimate the rate of women with atypical symptoms, who often are not hospitalized but are treated almost exclusively on an out-patient basis. "Given the low rates of hospitalization for connective tissue disease this is a serious shortcoming of the study," said Dr. Gary Solomon. St. John's Hospital and Western General Hospital, Livingston and Edinburgh, Scotland. Park, et al, Plastic and Reconstructive Surgery, Feb 1998.

Again, Dow Corning's press release selectively quotes the authors saying, "the study failed to find any case for a link between silicone gel-filled breast implants to connective tissue disease." But, Dow neglects to mention the researchers' own admission of the study's serious weakness, which is "low statistical power to detect moderate relative risks." In addition... While the study did not specifically address the issue of atypical connective tissue disease, researchers did find evidence that women with implants had a two-fold higher incidence of some atypical symptoms, e.g. fatigue, telegangiecstasia (dilation of blood vessels) and photosensitivity. The study was small (only 317 women with implants) and had limited statistical power. For certain diseases, the risk ratio could not be detected unless it reached a magnitude of sixteen-fold. Smaller increases in risk, which would have important health implications, would have gone undetected.

On average the women were examined less than six years after receiving implants, too short a period in which to detect diseases with a long latency. The group of implanted women evaluated in this study had very low levels of specific auto-antibodies (ANA's) levels much lower than those reported in other studies or in control populations of healthy women. This suggests that the testing methods lacked sensitivity to reliably detect auto-antibodies. In addition, in none of the three studies, did researchers look at a uniform set of laboratory studies such as biomarkers for rheumatic diseases. Lack of reliance on biomarkers limited the ability of the studies to detect early disease. Dow Corning has frequently overstated the results of industry-funded studies on breast implants, claiming that they give silicone implants a clean bill of health. Their selective funding of certain types of studies, coupled with a massive PR machine, has been called a "sophisticated form of lawsuit science" by Norman Anderson, MD in his article "Lawsuit Science: Lessons From The Silicone Breast Implant Controversy." Anderson was chair of a series of FDA panels on silicone breast implants and member of the 1992 FDA Panel which placed a moratorium on implants. (Fenton Communications.)

Washington 5/26/98 (Reuters) A new product made of human skin cells won U.S. Food and Drug Administration (FDA) approval for use in treating certain kinds of wounds on Tuesday. The product, called Apligraf, is made of human skin cells mixed with collagen cells from cattle. It is made by Canton, MA-based Organogenesis (ORG - news). The FDA said it had approved the product for use in treating venous skin ulcers, which are hard to heal because of a lack of blood flow to the skin. "This condition is estimated to affect thousands of Americans each year, and its treatment often requires multiple surgeries,'' the FDA said in a statement. "Although Apligraf will not eliminate the need for standard treatment, it use may enhance and shorten the healing process.'' Novartis Pharmaceuticals Corp (NOVZn.S) has global marketing rights to Apligraf, the company said in a statement. In addition to venous leg ulcers, Apligraf has been studied in burns and in skin surgery. A trial is under way in diabetic ulcers and one is expected to begin in bedsores, also known as pressure sores, later this year. Experts say tissue engineering is starting to transform the way patients with flesh wounds are being treated. Apligraf is made with live cells from the foreskin of a newborn's penis, used because babies are regularly circumcised and the tissue is young and available, mixed with tissue from a cow. "Its special composition allows it to provide wound protection and to foster the growth of healthy new skin,'' the FDA said.

BOSTON (AP) Doctors revealed that they have successfully tested a drug that's part of the first new class of antibiotics to be developed in more than a decade. At a conference on infectious diseases, doctors said the drug linezolid has become the first new antibiotic to be selected for trials among humans. An increasing number of common bacteria strains have mutated to become resistant to common antibiotics, sending doctors and researchers scrambling to come up with new medicines. "There's a real need now for new drugs," said Dr. Robert C. Moellering Jr., associate physician-in-chief at Beth Israel Deaconess Medical Center and a Harvard Medical School professor. "This drug is exciting. It's unique in terms of the way it works, which means that many resistant bacteria will not be cross-resistant to this drug."

If approved by the FDA, linezolid would be used to fight "gram-positive" bacteria, which cause such ailments as pneumonia and skin infections. Overuse of antibiotics kills off vulnerable strains of bacteria and favors those with traits that can resist antibiotic action. In its most recent trials, linezolid, being developed by Kalamazoo, Michigan-based Pharmacia; Upjohn, was tested on more than 300 hospitalized patients. Success rates for treating pneumonia and other illnesses were 90% or higher. Moellering said it's unlikely that, if approved, the drug would be available before 2000. "It's not going to be new drugs alone that [provide] a solution," said Dr. Timothy Brewer, program director for the International Society for Infectious Diseases and a tuberculosis researcher at Brigham and Women's Hospital in Boston. "We also need more appropriate use of antibiotics and national policies to increase awareness," he said. "When you go to the doctor with a cold, you shouldn't be expecting to get antibiotics."

LOS ANGELES (Reuters), Mark Egan--A leading cancer group said it was unrealistic to expect that new anti-angiogenesis drugs would cure cancer in humans within two years. Anti-angiogenesis drugs, which inhibit tumors by starving them of their blood supply, have been front-page news this month because of reports the drugs angiostatin and endostatin cure cancer in mice. "I think these are very hopeful signs but to think of a total cure in two years from one particular compound is perhaps overstatement,'' Dr. Robert Mayer, president of the American Society of Clinical Oncology, told reporters in Los Angeles. "Recent comments were perhaps hyperbole. These drugs and new approaches ... are novel ways of treating the cancer cell but I don't think any investigator thinks of them as a substitute for what we have now,'' he said. Mayer was apparently referring to a New York Times report May 3 that quoted Nobel laureate James Watson as predicting cancer could be cured within two years in the wake of progress with the drugs developed by the biotech company EntreMed Inc. The front-page article spurred an explosion of interest in EntreMedand the drugs angiostatin and endostatin and helped boost its shares by some 500 percent the next day. Watson, a co-discoverer of the "double helix'' structure of DNA, disputed the quotation that the New York Times published. The two drugs are naturally occurring proteins that block growth of blood vessels that feed tumors. They were discovered by Dr. Judah Folkman, a cancer researcher at Children's Hospital in Boston, and licensed to EntreMed. In the May 3 New York Times article Watson was quoted as saying: "Judah is going to cure cancer in two years.'' Mayer said the drugs may advance cancer treatment when used in conjunction with existing therapies such as chemotherapy. Mayer was attending the American Society of Clinical Oncology (ASCO) annual meeting at which 20,000 doctors will discuss new approaches to treat cancer, second only to heart attacks as a cause of death in the United States. Half of those diagnosed with cancer do not survive. About 1.2 million Americans will be diagnosed with cancer this year with about 565,000 expected to die of the disease in 1998. Dr. Allen Lichter, president-elect of ASCO, agreed that anti-angiostatin drugs were not a miracle cure for cancer. `The idea that there is a single pathway in every cancer and if you just fix that one pathway you will cure all cancer is fanciful and experience tells us that is unrealistic,'' Lichter said. `I think anti-agiogenesis will be another important arrow in our quiver. We will attack cancer with it but the concept that this will lead to one final (cure) is just not realistic.'' He said the key to curing cancer is increased funding for clinical trials, which he said were critically under funded. "Clinical research is much like planting seeds, we put them in the ground and we water them and they bear fruit.'

Am J Neuroradiol 1998 Mar;19(3):519-22 (ISSN: 0195-6108); Abrahams JJ; Caceres C, Department of Diagnostic Radiology, Yale University School of Medicine, New Haven, CT 06520, USA. Silastic implants used to augment the chin during cosmetic surgery may cause erosive bone changes and complications. We describe the radiologic appearance of these changes and the dental CT reformatting programs by which they may be assessed. Multiplanar CT scans of four patients with Silastic chin implants were evaluated retrospectively for implant density, presence and size of bone defects, relationship of defects to root apices, relationship of defects to mental foramen, and associated findings. The dental CT software program was instrumental in delineating the relationship between the bone defects and the root apices.

"Today, nearly 40 percent of American women, aged 18 to 60--some 50 million--use hair dyes. That these products, as a class, remain unlabeled for their human cancer hazard is one of the worst public health scandals today. Because of the loopholes in the Federal Food, Drug and Cosmetic Act, these killer products continue to bear no warning whatsoever of their very real cancer hazard. Specifically, use of permanent and semipermanent hair dyes is associated with increased risk of non-Hodgkin's lymphoma, multiple myeloma, and Hodgkin's disease. Researchers from the National Cancer Institute estimate 20 percent of all cases among women of non-Hodgkin's lymphoma, the disease that killed Jacqueline Kennedy Onassis (who dyed her hair), are due to women's use of commercial hair dye products. The risk seems to be greatest among users of dark shades.

The evidence is also suggestive of an association with breast cancer, as reported in "The Breast Cancer Prevention Program" (Macmillan 1997). The dye para-phenylenediamine, used in virtually every commercial permanent and semipermanent hair coloring product, was, in fact, shown in 1986 to be carcinogenic to the breast following oxidation with hydrogen peroxide--precisely as these products are used by women. Further evidence of risk comes from studies of hairdressers that have provided clear evidence both men and women in this profession are at increased risk for bladder and other cancers. Finally, hair dyes may also pose a risk to children whose mothers use them shortly prior to conception or during pregnancy. In fact, the risk of childhood cancer could be increased by as much as tenfold. The fact that the hair color industry is legally exposing millions of women to carcinogenic chemicals without label warnings is, in part, due to legislation governing cosmetics dating to the 1938 Federal Food, Drug, and Cosmetic Act. At that time, intensive special interest lobbying on behalf of the hair dye industry persuaded Congress to exempt the dyes used in these products from government regulation. Under the Act, only an acute health hazard warning is required to be included on product labels that blindness might result from use on eyelashes and that a preliminary test should be conducted to avoid allergic reactions.

This legislation, however, shouldn't excuse the Food and Drug Administration's inaction on this issue. The fact is that the FDA has never gone to Congress asking for regulatory authority over hair dyes. Nor has it advocated explicit labeling of hair dyes for their carcinogenic hazard. The FDA has always bowed to lobbying pressure from the hair dye industry. The dirty secret behind hair dye's glamorous facade remains concealed in a complicit unspoken pact between Congress, the beauty industry, and lobbyists." "Follow these guidelines when selecting a hair coloring product: Read labels. Avoid choosing any product whatsoever listing any phenylenediamine-based chemical. Look for the disclaimer on the package, which cautions about the ingredients which may cause skin irritation and to perform a preliminary test, as well as against using for eyelash or eyebrow dyeing as it may cause blindness. Such warnings on the label mean that the product contains ingredients which are exempt from the provisions of the Food, Drug and Cosmetic Act, including deadly phenylenediamine-based dyes. There is some evidence that most of the cancer risk of hair dyes is attributable to the darker shades. Some mainstream manufacturers have begun offering hair coloring products to which they've added herbal extracts, and then they call these products natural. Every line, however, contains deadly phenylenediamine dyes."

ALTERNATIVE MEDICINE: No space this month!! See the attached information On the Weston Project that was provided by IBIIG.

INFORMATION AVAILABLE: If you want information on antioxidants, minerals, vitamins, coral calcium, shark liver oil, etc. contact Lynda at (303) 469-8242. If you are trying to get better by using drugs and doctors, you may find that you are getting worse or not improving at all. Covering symptoms will not help you heal. Every drug is a toxin. I found my way to healing by avoiding these prescriptions and using natural means.

PERSONAL COMMUNICATION: I have been working in the yard, planting flowers, a garden, cutting out tree limbs, digging, spading, raking, hoeing, etc. This is the first summer that I have been able to do this. I must still be improving. My natural healing and nutritional program is working!! I hope yours is also!! I speak with women all the time who have switched to naturopathic or homeopathic healing and are finding it works best!! I hope all who are not doing well will consider this option!!

IMPORTANT: Dow-Funded Studies Say "No Problem" by John C. Stauber and Sheldon Rampton. Breast implant makers and plastic surgeons have spent vastly more money on PR, attorneys, and lobbying than the women who are suing them for damages. Thanks to PR, the industry has achieved a remarkable reversal, persuading large sectors of the news media that it is the victim of politics, greed and "junk science." New York Times reporter Gina Kolata has typified the trend, penning stories such as "Implant Lawsuits Create a Medical Rush to Cash In," which portrays the 400,000 women who have joined a class-action lawsuit against the industry as greedy opportunists goaded on by slick attorneys. Similar stories have appeared on 60 Minutes and PBS-TV's Frontline. At the heart of this line of defense is a strategy outlined by Burson-Marsteller in 1991 as Dow was preparing to withdraw from the breast implant market. "Research continues regardless of the disposition of the business," advised one memo. In order to achieve the long-term goal of rehabilitating Dow's reputation, B-M argued, the company would have to produce scientific data from seemingly independent, "third party" sources, which it could point to as proof that silicone was safe. In 1992, B-M warned that the company's "credibility is still low. Of course, company and its employees will play a key role in disseminating message. But . . . core of message must be scientific, third-party support. Research studies already announced will be helpful when done. . . . We must begin by identifying supportive science, scientists, across the spectrum of uses for silicone; training and supporting them to get our message out; . . . using them proactively to brief the trade, general and business media; . . . using them reactively as a 'truth squad' to refute antagonists."

Frontline's February 1996 program on the silicone controversy provided a textbook example of this strategy in action. It built its case around the opinions of Dr. Marcia Angell, editor of the New England Journal of Medicine, which Frontline described as "the most prestigious medical journal in the world." Angell has overseen the publication of the two best-known epidemiological studies to date on breast implants--one by the Mayo Clinic, the other by Harvard researchers and Brigham & Women's Hospital--both of which found "no evidence" that implants cause serious long-term illness. "What was so startling to me," Angell told Frontline, "was the disconnect between the science . . . and what was happening in the courts and what was happening at the FDA and what was happening in public opinion. The disconnect was amazing." Over 90,000 women have provided evidence to the FDA of health problems that they attribute to their implants. Angell dismissed these complaints as "coincidental" and argued that "Passion, anecdotes, claims, testimonials will not settle this issue. It can only be settled by science."

Based largely on Angell's characterizations, Frontline portrayed FDA Commissioner David Kessler as somone who was "horrified" by the results of his 1992 decision to ban cosmetic use of silicone breast implants, and who now believes that science has proven them safe. In fact, however, Kessler has continued to repeat his concerns. In April 1996, a month after the Frontline piece aired, Kessler joined several other physicians in authoring an article for the Annals of Internal Medicine which found methodological flaws in all 13 of the epidemiological studies which have been performed to date on systemic health problems related to implants. According to the article, "Some of the problems common to these different studies include (1) sample sizes inadequate to rule out rare outcomes, (2) study methods inappropriate for detecting atypical syndromes, (3) poor choice of comparison group, and (4) inadequate duration of follow-up or information-gathering techniques that may have biased the detection of implants or clinical outcomes."

What Angell and Frontline never mentioned, moreover, were the numerous scientific studies that have found evidence of silicone-related illnesses and which have been published in medical journals including the Annals of Plastic Surgery, The Journal of Aesthetic Plastic Surgery, The American Journal of Clinical Pathology, The British Journal of Plastic Surgery, Plastic and Reconstructive Surgery, The Journal of the American Medical Association, Arthritis & Rheumatism, and The Archives of Pathology and Laboratory Medicine. Pure Science or Pure Hoopla?

Despite its prestige, moreover, the New England Journal of Medicine is not as pristine and infallible as Frontline would have the public believe. In fact, the journal has lent itself to junk science in the service of PR on several prior occasions. In 1982, for example, a federation of French artificial-insemination centers used the NEJM to promote a misleading study that raised female fears of infertility by claiming that women who pass the age of 30 stand a nearly 40 percent chance of being infertile. Actually, the true rate of infertility at that age is only 13.6 percent, according to authoritative research by the U.S. National Center for Health Statistics.

Not only did the NEJM publish the French study--whose conclusions were eventually abandoned even by its own authors--it added an accompanying editorial, moralizing that women should "reevaluate their goals" and have babies before starting careers. In another case in 1986, the NEJM published one study and rejected another which reached opposite conclusions about the antibiotic amoxicillin, even though both studies were based on the same data. Scientists involved with the first study had received $1.6 million in grants from the drug manufacturer, while the critic had refused corporate funding. NEJM proclaimed the pro-amoxicillin study the "authorized" version. Five years later, the critical study finally found publication in the Journal of the American Medical Association, and large-scale testing of children showed that those who took amoxicillin actually experienced lower recovery rates than people who took no medicine at all.

Like the French fertility survey and the amoxicillin study, both of the breast implant studies published by NEJM were heavily funded by partisan sources. Dow Corning and other manufacturers funneled funding into the Mayo Clinic Study through the Plastic Surgery Educational Foundation (PSEF) of the American Society of Plastic and Reconstructive Surgeons. The Harvard-Brigham study claims it did not receive direct funding from Dow, but according to plaintiff's attorney Stephen Sheller, the company did provide corporate grants to the hospital totalling at least $7 million during the period that the study was underway. Sheller bases that figure on depositions taken from Peter Schur, a professor at Brigham who supervised one of the major authors of the study. Schur also admitted in December 1994 that during the course of the Harvard-Brigham study, he was also working for $300 an hour as a consultant and expert witness for law firms defending implant makers. Simultaneously, he was editor of Arthritis & Rheumatism, a medical journal in which he had published an article defending implant safety while rejecting submitted studies that found links between implants and health problems. Schur's associate editor at Arthritis & Rheumatism was Dr. Matthew Liang, also a Brigham & Women's professor who moonlighted as a consultant for the manufacturers' law firms and who worked on the Harvard-Brigham study.

After their multiple roles were disclosed, Liang and Schur resigned from a second Harvard implant study, also funded by Dow Corning, to avoid "the appearance of conflict of interest." Liang has also admitted giving information about the first Harvard study to Dow while the study was in progress, but has refused to provide information that would clarify whether Dow actually had a hand in shaping the study's methodology. In fact, critics of implants, such as Ben Lilliston of the Cancer Prevention Coalition in Chicago, have found numerous flaws in the method of both studies. "Perhaps the most significant problem with the studies is their time frame," Lilliston says. "Most researchers who have studied women with implants say that it usually takes 10 years or more for symptoms to develop. In the Mayo Clinic study, women had the implants in for a mean of 7.8 years. In the Harvard study the mean was 9.9 years." Since the real boom in implant popularity occurred in the late 1980s, two-thirds of all women with implants have not had them long enough to start showing symptoms yet. "It's easy to get a negative study; you just look too soon," agrees Shanna Swan, an epidemiologist from the University of California at Berkeley. "This is not unlike R.J. Reynolds funding a study that examines people in their thirties, and finding no increased risk of lung cancer."

In addition, breast implant plaintiffs point out that the Mayo and Harvard-Brigham studies did not look for the "atypical" cluster symptoms that most women report. Instead, they looked for traditional connective-tissue diseases, such as rheumatoid arthritis and lupus. Most researchers studying "silicone associated disease" believe that it is a nontraditional disorder with its own set of unique characteristics. "We're dealing with atypical disorders. Anyone who read the literature going back to the 1970s would have known that you need to look beyond classical diseases," says Dr. Gary Solomon, the associate director of rheumatology at the Hospital for Joint Diseases Orthopaedic Institute in New York City. "It is frankly disturbing that these medical studies did not consider this." Critics also say that the studies do not look at enough women to produce meaningful statistical results. "To detect even a doubling in the baseline rate of scleroderma, you would need to have at least 30,000 women in your study," says Dr. Solomon.

Finally, women who have suffered illnesses fault the studies for relying on questionnaires and old medical charts, where atypical symptoms are less likely to have been noted than firm disease diagnoses, while failing to examine the women themselves. Neither study involved physical examinations or even interviews with any of the women under study. "Every study we see seems to focus on the attorneys and the epidemiology studies," says implant recipient and activist Janice Ferriell. "Why don't they look at us, and figure out what's going on?" "I have breast implants. I know," says Mary Feller, another implant litigant from San Rafael, California. "I've suffered all of those undefinable, diffuse symptoms: severe fatigue, night sweats, terrible headaches, stiff shoulders, neck and jaw." Feller says the medical studies remind her of "the old joke about the drunk looking for his money under the lamppost because that's 'where the light is.' The same thing is happening with implants. The disease is out there in the dark, but the medical community insists on looking under the lamppost, probably because the light is provided by Dow."

From Down Under: The Therapuetic Goods Administration in Australia is conducting a new investigation into silicone breast implants at this present time. This information came from a silicone survivor in Australia. An in-depth interview on Foxtel in Australia with a current affairs interviewer, who is held in high esteem, is being prepared for broadcast soon. The Minister for Health will also be included in this interview. From the recent turn around by the Australian media, breast implants are once again very hot news. The interesting thing regarding this new interest is that the whole issue of the safety of breast implants is being viewed objectively and the plight of the women told truthfully. Two new blood tests have been developed in the U.K. for silicone detection and the effects on the human body. This information courtesy of Margo Cameron (Scotland). The June or July issue of the U.K. magazine Cosmopolitan will contain a large article on breast implants for anyone who is interested. I hear it is good! We have had several women call us saying it has been published now, so look for it!!

WASHINGTON: President Clinton has tentatively chosen a New Mexico cancer specialist as commissioner of the Food and Drug Administration, officials said. She would become the first woman in the post. Dr. Jane Henney, vice president of the University of New Mexico's Health Sciences Center, is undergoing routine background checks. Administration officials said Clinton hoped to announce her nomination within weeks. Henney, 51, was a close deputy to former FDA Commissioner David Kessler from 1992 to 1994, giving her hands-on experience in running the agency that regulates 25 percent of the national economy, drugs, medical devices, foods and cosmetics.

That's a boon to the White House and Sen. Edward M. Kennedy (D., Mass.), who has pushed Clinton to nominate Henney. Her link to Kessler has raised concerns among Senate Republicans who disliked his aggressive style. In six years at the post, Kessler propelled the FDA to a much higher profile, fighting underage smoking by taking on the powerful tobacco industry and strongly enforcing medical regulations. "Whoever is going to replace Dr. Kessler is going to face tremendous scrutiny" to win Senate confirmation, said a Democratic Senate aide. Sen. Daniel R. Coats (R., Ind.), whose support is pivotal, has begun questioning the White House about Henney's positions on tobacco and approval of the abortion pill RU-486. "He wants to better understand the [potential] nominee," said Coats spokesman Tim Goeglein. Many drug companies wanted Clinton to keep acting Commissioner Michael Friedman, also a cancer expert, who has run the FDA for 14 months in what the industry terms a more collegial atmosphere. "You want someone who brings out the best in people, which was one of the attributes of Dr. Friedman," said Peter Teeley of Amgen Inc. But he called Henney "pretty impressive."

Important Warning: "I received a telephone call from an individual identifying himself as an AT&T Service Technician who was conducting a test on our telephone lines. He

stated that to complete the test we should touch nine (9), zero (0), the pound sign (#) and then hang up. Luckily, we were suspicious and refused. Upon contacting the telephone company we were informed that by pushing 90# you give the requesting individual full access to your telephone line, which allows them to place long distance telephone calls billed to your home phone number. We were further informed that this scam has been originating from many of the local jails/ prisons. I have also verified this information with UCB Telecomm.

Please be aware. This sounds like an Urban Legend - IT IS NOT!!! I further called GTE Security this morning and verified that this is definitely possible. DO NOT press 90# for ANYONE. The GTE Security department requested that I share this information with EVERYONE I KNOW!!! Could you PLEASE pass this on. (This information came from the internet.)

BOOKS: We have most of the major books on silicone disease. Contact us if you wish to purchase one!!

THIS MONTH'S POEM: No space this month!

THE OPINIONS EXPRESSED IN THIS NEWSLETTER ARE THOSE OF THE EDITOR AND ANY CONTRIBUTORS AND ARE NOT TO BE CONSTRUED AS MEDICAL OR LEGAL ADVICE. ANY ARTICLES OR INFORMATION SUBMITTED MAY BE EDITED BECAUSE OF SPACE, CONTENT OR GRAMMATICAL ERRORS.

LYNDA ROTH, EDITOR

PREVIOUS NEWSLETTER INFORMATION: Previous issues of newsletters available: $2 each U.S., $3 Foreign. 1/93 is the first available issue. Please indicate months' desired and proper sums. Some covered subjects: Auto-immune 1/93; Fibromyalgia 2/93; Medical Testing 3/93; Sjogren's 4/93; Vasculitis 4/93; Arthritis 5/93; Chronic Fatigue 6/93; Lupus 7/93; Irritable Bowel Syndrome & Inflammatory Bowel Disease 8/93; Insurance 8/93, 9/93; Misc. Med. Info. 9/93; Multiple Sclerosis 10/93; Spasmodic Torticollis 10/93; Hypoglycemia 11/93; Antibodies 12/93; Reflex Sympathetic Dystrophy 1/94; Misc. Med. Info. II 2/94; Scleroderma 3/94; Costochondritis 4/94; Peripheral Neuropathy 4/94; Class Action 5/94; Fungal Infections 6/94; Hypercalcemia (low calcium) 7/94; Raynaud's Phenomenon 8/94; Fibromyalgia Update 9/94; Sarcoidosis 10/94; Free Radicals 11/94; Porphyria 12/94; Interstitial Cystitis 1/95; Mixed Connective Tissue Disease 2/95; Flap Procedures 3/95; Misc. Med. 4/95; Thyroid Disease 5/95; Stress 6/95; Natural Healing 7/95; Adrenal Malfunctions 8/95; Multiple Myeloma 9/95; DHEA 10/95; Chelation Therapy 11/95; Sleep Disorders 12/95; Meniere's Disease 1/96; 33 Tips to Improve Your Health 2/96; Amino Acids 3/96; Enzymes 4/96; Minerals 5/96; Aluminum Toxicity, DHEA Update 6/96; Addictions & Food Sensitivities 7/96; Misc. Med. Info. IV 8/96; Misc. Med. Info. V 9/96; Misc. Med. Info. VI 10/96; Misc. Med. Info. VII 11/96; Transcient Ischemic Attacks 12/96; Symptoms of Breast Implant Problems 1/97; Pap Tests 2/97; Parasitic Infections 3/97; B-Complex Deficiency Syndrome 4/97; Myofascial Pain Syndrome 5/97; Inositol 6/97; Misc. Med. Info. VIII 7/97; High Blood Pressure 8/97; Plaquenil 9/97; Misc. Med. Info. IX 10/97; Misc. Med. Info. X 11/97; Gastroesophageal or acid reflux 12/97; Smoking Dangers 1/98; Misc. Med XI 2/98; Multiple

Chemical Sensitivities 3/98; Misc. Med. XII 4/98; Misc. Med. XIII 5/98; Legal info. and info. on Alternative Medicine Info. contained in most issues.

Dear Sisters in Silicone,

Please read the following components carefully. It is important! If you

have or had a silicone or saline implant...........these components are in

you.

Many of you have achieved some measure of recovery and think you are on

the mend and have this thing beat. Many more of you are very ill and

secretly believe that you are dying. Many have died. Thousands of you

have children who were born to you after you got your implants and they too

are ill. Even if they don't seem ill, you know that the research shows the

silicone crossed your placental barrier and the components listed below are

also in your child's blood, suppressing their immune system. Some of our

children have now grown up and are giving birth to sick children. It is

now afflicting the next generation.

This legacy of poison is a time bomb waiting to go off and we are finally

now able to do something about it. We have a choice. We can leave these

poisons in our body or flush them out. Dr. Floyd Weston and Leonard

Haimes MD. have created a Homeopathic Antidote and Liver Cleanse, designed

especially for us and our children. It will antidote the following

components and will be available within weeks for pennies per day. It is

designed to be self managed and will take between one and a half - two

years to complete.

Methyl Ethyl Ketone, Cyclobexanone, Isopropyl Alcohol, Denatured Alcohol,

Acetone Urethane, Polyvinyl Choloride, Lacqer Thinner, Acid Stearic, Ethyl

Acetate, Epoxy Resin, Epoxy Hardener, Amine, Printing Ink Toluene, Freon,

Silicone, Flux, Solder, Metal Cleaning Acid, Zinc Oxide, Formaldehyde,

Talcum Powder, Color Pigments, Cyanoacyrylates, Ethylene Oxide, Carbon

Black, Hexanone 2, Methylene Chloride, Benzine Oakite (cleaning solvent),

Naptha (rubber solvent), Xethyl, Hexone, Thixon-OSN-2, Phenol,

Chlorplatinic Acid, and Silica. (Heavy metals such as Aluminum and Platinum

are used as catalysts in turning the liquid into a gel). Chemicals that

are used in breast implants: from S.I.S. It is important to know that NO

breast implant (saline or silicone gel) has ever been approved by the FDA.

The Weston Project antidotes these components + Staph. & Strep.

Weston / Haimes Project Concept:

Imagine a clog in your sink. No matter how much water or good things you

poor in to that sink the sludge builds up and begins to get nasty. It's a

swamp of filth.

Pretend the clog in the pipe is your liver. Now imagine cleaning out that

clog in your body and watching the silicone and it's poisonous components

run down the drain. The liver is clean and the body releases the

antidoted poison. Imagine getting better.

Please read the enclosed information. Dr. Weston has agreed to provide it

to you so you might explore an opportunity to recapture your health. This

will be your only notice. This mailing is a gift from a very fine man who

cares deeply for our cause and has spent many hundreds of hours, and what I

would consider a fortune, working to put an end to our suffering. He is

asking for nothing in return but that it be priced so that the poorest of

the poor can afford to antidote herself and her children. Blessings,

Jill

I.B.I.I.G

The Idaho Breast Implant Information Group

P.O. Box 5363 Boise, Idaho 83705

phone: (208) 345-1972

fax: (208) 388-3913 E-mail: ibiig@yberhighway.net

NEWSLETTER SUBSCRIPTION INFORMATION

Check your mailing label for expiration date. The

date is right after your name. We are unable to notify

you individually of expiration dates. If your expiration

date says June 98, that is the last newsletter you will

receive without a renewal. We no longer take

MC/Visa!!!!

YOUR HELP IS NEEDED NOW TO

KEEP US AFLOAT. IF WE HAVE

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