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



August 1998

Dear Silicone Survivors and Friends:

The newsletter is late because of the Washington trip and my relapse from the heat and humidity. I have not felt well since I returned. Also, my daughter and three children just moved in with me and it is much more difficult to get things done with four more people (especially 3 children) in the house. I enjoy them, but it is more work!!

For those of you who asked about the Good Morning America segment that I was on, I do have a couple of taped copies. Since I did it at 5:00 A.M. Colorado time (via remote camera), I certainly looked tired (2 hours of sleep). The copies cost me $7.00 each and there is about $1.00 shipping charge. I only have 5 copies, so if you really still want one, just call and see if there are any left. Also, if anyone taped the MSNBC show I did last Oct. With the Chicago woman from Y-Me, I would like to see it. Since it was live, I have never had a chance to view it.

UPCOMING EVENTS: In Congress: A bill (H.R. 872 ) to establish rules governing product liability actions against raw materials and bulk component suppliers to medical device manufacturers, and for other purposes: The Biomaterials Bill (H.R.872) has passed both the House and Senate. Please call the White House and register your opposition to this bill that would exempt suppliers of materials from any legal action. This bill is pro-business and anti-consumer. It would have made it impossible to sue the manufacturers of our silicone. It will harm future victims of medical and other devices. Manufacturers can work together to make devices that contain other components in order to avoid legal action if their product harms someone. They already have the ultimate protection: Bankruptcy!! We have seen that in action already with Dow Corning. Remember Johns Mansville and the asbestos situation? More human guinea pigs or lab rats, anyone?????

To make it crystal clear for those who may not be following this very closely, the Biomaterials Bill protects the makers of raw materials, EXCEPT the suppliers of silicone gel and silicone envelopes used in silicone gel breast implants. The bill's provisions do not extend to suppliers of silicone gel and silicone envelopes used in silicone-saline breast implants. In other words, those of us with saline implants, or solid implants, or any implants WITHOUT silicone gel, are not protected. We cannot sue the makers of the raw material. No matter WHAT they put in it.

LEGAL: For those unsure of their Dow Corning claim status, dial (313) 961-4940. Be prepared for a recording that will ask you to punch in your name or social security number. Another recorded voice will give you your status. SAN FRANCISCO--Women in California who charge that Dow Corning Corp.'s silicone breast implants caused them health problems may not sue its parent company, Dow Chemical Co., the California Supreme Court ruled. The 6-1 decision means that women in California will be limited to sharing in the tentative $3.2-billion deal that Dow Corning announced to settle claims from about 170,000 plaintiffs across the country. Women in some states have been able to sue Dow Chemical for additional damages. California women no longer have that option. "These women have been deprived of their ability to have their claims heard by a jury," said plaintiffs' lawyer James Pantone. "Now they are stuck with remedies provided to them by the bankruptcy proceedings." Those proceedings began in May 1995, when Dow Corning, a company jointly owned by Dow Chemical and Corning Inc., filed for bankruptcy court protection because of thousands of suits filed by women alleging that its implants made them ill.

In part to get around the limits on the damages that might be collected in those bankruptcy proceedings, women across the country have pursued claims against Dow Chemical. They argued that the company should be held liable because it had performed toxicology tests on silicone in the 1940s and 1950s that had shown potential dangers from the chemical. The company had failed to disclose the dangers posed by silicone compounds, the plaintiffs argued. Some states have allowed such claims to go forward. In 1995, for example, a Nevada jury awarded $14.1 million to a woman who sued Dow Chemical because she charged that her Dow Corning breast implants made her ill. Dow Chemical's appeal of that case is before the Nevada Supreme Court. In other states, including New York and Michigan, appellate courts have dismissed similar cases. Dow Chemical and Dow Corning still insist that silicone implants posed no health risk to women. Dow Chemical cites epidemiological studies by the Harvard Medical School, the Mayo Clinic and other medical centers that have found no increased health risk from silicone breast implants, and no evidence that leakage from the implants damages the autoimmune system.

Lawyers on both sides of the long-running implant litigation said that although the California Supreme Court's decision directly affects only plaintiffs in the state, it may influence the decisions of the many state high courts that have not ruled on the issue. Attorneys for the company plan to bring the ruling to the attention of the Nevada Supreme Court, and expect to use it in about 13,000 similar lawsuits pending in other states, said Dow Chemical attorney Michele Odorizzi. Odorizzi said she was delighted by the ruling. "It certainly means that the cases in California with respect to Dow Chemical are over, finally," she said. An estimated 40,000 people have Dow Corning silicone implants--mostly women who had implants to augment or reconstruct their breasts. Suits filed by thousands of women against Dow Chemical were coordinated before a San Diego judge, who dismissed the claims in 1994, saying that Dow Chemical had no duty under California's liability laws to protect consumers of the implants because it had not tested or designed them. An appellate court upheld that dismissal in September 1996.

The court's decision did not address the fundamental question of whether silicone implants cause the myriad diseases that some women have charged, including lupus, arthritis and other ailments. It only addressed the question of whether Dow Chemical could be held liable for whatever damage implants might cause. The court ruled in favor of Dow Chemical on the grounds that at the time the company conducted its research, there was no way to know that silicone compounds would later be used for breast implants, which were first made in 1962. "Any possible consequence for plaintiffs.... was exceedingly attenuated and remote" at the time that Dow Chemical conducted its research, Justice Kathryn M. Werdegar wrote for the court. Justice Stanley Mosk was the lone dissenter in the case. The justices "were very taken with the foreseeability notion-how could you have foreseen the medical uses of silicone in the late 1940s and '50s, when the bulk of Dow Chemical's research was being done?" said Odorizzi, who argued the case before the court. Dow Chemical maintains that its scientists were testing only for the effect of industrial silicone on workers who might come in contact with it during the manufacturing process, not for its effect on the body if used as an implant.

The California Medical Assn., the California Chamber of Commerce and the Medical Device Manufacturer's Assn. had submitted briefs to the court siding with Dow Chemical. They argued that a ruling in favor of the women would have a chilling effect on scientific research. "If you find somebody liable because they did toxicology research on a raw material, are they subsequently liable for every product ever made of it?" Odorizzi asked. But plaintiffs, their lawyer's and their advocates expressed outrage over the ruling. The California decision "is a tragic setback for women who we believe suffered injury as the result of the manufacturing of a product that Dow Chemical could have helped prevent," Pantone said. "It is just one more time a big manufacturer is getting away with murder," said Cristy Warschaw, who runs a support group, Women in Health, for people with silicone implants in Los Angeles and Orange counties.

Boston, July 16 (Bloomberg): Baxter International Inc.'s health-care unit must pay $2.5 million to a Massachusetts woman injured when her silicone-gel breast implants ruptured, a court ruled. The Massachusetts Supreme Judicial Court upheld a lower-court jury's decision that Florence Vassallo's breast implants were defective, causing chest pain and scarring. Vassallo's award came after the first silicone breast-implant trial in the state's history, her lawyers said. Thousands of women in the U.S. and abroad have sued companies including Baxter, which assumed some liability for the implants in its 1985 acquisition of American Hospital Supply Corp., seeking billions of dollars in damages for faulty devices. While juries have found the implants caused diseases, several large scientific studies have found no link. "Today's decision by the court should be required reading for every medical-device manufacturer who questions whether thorough product testing is a necessary investment before marketing begins,'' said Fredric Ellis, Vassallo's lawyer. In October, a Texas jury found their breast implants wren't defectively designed or made in a lawsuit brought by three women against Baxter International. As many as 2.5 million women in North America have received silicone-gel breast implants since they were introduced in 1962. Since then, the devices have been linked to hardening of the breast, rupture and enlargement of the lymph nodes. Vassallo received the implants in 1977.

Florida Breast Implant Trial Results in Summary Judgment for 3M (PRNewswire) 21-JUL-98; ST. PAUL, MN., announced that Judge Elizabeth A. Kovachevich of U.S. District Court, Middle District of Florida, Tampa Division, issued a summary judgment in favor of 3M on a silicone breast implant case. In pre-trial rulings on evidence. Judge Kovachevich ruled in 3M's favor on both scientific evidence and on local injury claims in the case involving plaintiff Pamela Jeye. This is another in a series of judgments for the defense, where plaintiffs have failed to come up with sufficient proof of systemic disease caused by silicone breast implants, and disallowing testimony by the plaintiffs' experts. The defense has won a vast majority of recent rulings in breast implants lawsuits.

"This is a tremendous victory for science," said Carol Ley, M.D., 3M's associate medical director. "We sympathize with someone who is ill, but this suit and others like it are not based on scientific evidence. The safety of medical products should be decided by legitimate scientists, not by plaintiffs' attorneys and their hired experts. And, over 20 epidemiological studies have shown no link between silicone breast implants and disease." Cable News Network, Inc.

This plaintiff was schededuled for trial and then her attorney decided that he could not win her case so he put her back in the settlement, but he forgot to cancel her court dates. Therefore, the result looks bad, but I suppose it is not.

Our good friend Marva made the news lately. Here is the article: Implant Case Continued San Diego Daily Triancript, July 22, 1998: Although he gave Marva Smith additional time to find an attorney in her legal battle against 3M on Wednesday, Superior Court Judge Robert J. O'Neill had some harsh words for the plaintiff's bar. "There are seven women who are trying to find counsel and none of them have met with any general success," O'Neill said. "I'm not looking forward to dealing with seven in pro per plaintiffs in breast implant litigation." Smith has been without representation since last November when O'Neill granted the request of her lawyers, Pat Barry and Scott Harris, to withdraw from the case. Given that it costs plaintiff's attorneys about $200,000 to bring an implant case to trial, and no one in California ever has beaten the so-called "tri-manufacturers", 3M, Bristol-Meyers-Squibb and Baxter, at trial, O'Neill said it was understandable that many lawyers were gun-shy. (Don't you think they should have considered this before they took the cases?) When I was in Washington, DC, I heard that a class action suit for saline implant women was registered in Denver. I have no info. on this, but am working to find out. I hope it is true. I will try to have more on this soon. MEDICAL INFORMATION: REGENSBERG, Germany (U.S. Newswire) The president of a European medical group today gave silicone a clean bill-of-health, calling it an "essential material" in implants and medical devices that often mean the difference between life and death for patients who rely on them. "In all fields of medicine and surgery, implants and medical devices made of silicone are essential not only for well-being, but often for survival," said Dr. Marita Eisenmann-Klein of Germany, president of the European Committee on Quality Assurance and Medical Devices in Plastic Surgery (EQUAM). "Silicone is the best material available for these devices," she said. Dr. Eisenmann-Klein's comments were based on a "Consensus Declaration on Breast Implants" issued by her group on July 4. EQUAM includes representatives from all European countries. The declaration constituted a strong rebuke to critics of silicone breast implants in the United States and Europe. It came at a time when biomaterials such as silicone are becoming more expensive and increasingly hard to get as the result of lawsuits targeted against suppliers of raw materials and component parts and medical device manufacturers. The lawsuits have alleged links between the devices and a variety of diseases, a connection that Dr. Eisenmann-Klein disputed. EQUAM's declaration was reinforced last week in London by Great Britain's Medical Devices Agency, which released an exhaustive year-long review in London exonerating silicone gel breast implants as the culprit in a wide range of auto-immune and connective tissue diseases affecting women. Numerous other updated studies continue to show that silicone gel-filled breast implants do not cause cancer nor other malignant diseases, Eisenmann-Klein noted. Dr. Eisenmann-Klein also noted that conclusive clinical, immunological and epidiemiological studies by more than 20 respected medical and academic institutions have shown that the silicone implants do not cause auto-immune or connective tissue disease. "There is no scientific evidence that such things as silicone allergy, silicone intoxication, atypical disease or a 'new silicone disease' exist," she added. The body's normal reaction to a foreign body such as an implant does not constitute "immune disease," she said. "The implants pose no danger to pregnancy, breast-feeding nor to the health of breast-fed children," she said. "Laboratory tests for the detection of silicone have no medical value," Dr. Eisenmann-Klein added. "No specific antibodies against silicone have been detected," she said.

While endorsing the use of silicone in implants and medical devices, Dr. Eisenmann-Klein said that patients with breast implants need regular follow-up medical care and, if indicated, appropriate imaging of the breast. Her group believes that there is a great need for an EU standard for breast implants and she urged European nations to reach a consensus on this issue soon. Dr. Eisenmann-Klein urged continued clinical and basic research to improve breast implants and other technologies used in plastic surgery.

EQUAM is comprised of leading physicians from Germany, The Czech Republic, Greece, Lithuania, South Africa, The Netherlands, Bulgaria, Italy, Latvia, Switzerland, Norway, Finland, Sweden, Israel, Spain, Poland, Austria, Belgium and Denmark. It was created in 1992 with a mission of providing quality assurance standards for medical devices used in plastic surgery. Dr. isenmann-Klein is a noted plastic surgeon and the head of the Department of Plastic Surgery at Caritas-Krankenhaus Hospital in Regensberg, Germany.

WASHINGTON (AllPolitics, 7/30): A partisan procedural fight has stalled health care reform legislation in the Senate. Democrats and Republicans are blaming each other for the gridlock that may delay consideration of the "patient-protection" legislation until September. GOP sources say more than 50 Republican Senators have agreed to vote for the "patient-protection" legislation they introduced just two weeks ago. If that count is accurate the Democrats' "patient bill of rights" would have no chance in a floor vote. But Clinton Adminstration advisors have warned that problems in the GOP's bill may be grounds for a veto. Since the Republicans are five Senators short of the 60 votes needed to avoid a compromise, Democrats could reshape the GOP legislation through floor amendments.

Senate Majority Leader Trent Lott has offered limited debate and votes on the competing proposals. But Senate Minority Leader Tom Daschle will not agree to the Republican restrictions. "It is their fault ... we want to do health care now," says the Mississippi Republican. "In order to do that we're going to have to have ... some reasonable limit on amendments." "On a bill of this magnitude we shouldn't be limited," the South Dakota Democrat says. "What are they afraid of? ...we'll come back in September with a major orchestrated battle on HMO reform. On Wednesday a group of Senators tried to break the gridlock on the election year plans to regulate health insurance by proposing a compromise. Under a deal worked out by Sen. John Chafee (R-R.I.), Bob Graham, (D-Fla.), Arlen Specter, (R-Pa.), Joseph Lieberman, (D-Conn.) and Max Baucus, (D-Mont.) both Republicans and Democrats would sacrifice parts of their current legislation.

COMMENT: The real deal here is that the Republicans in Congress want to keep anyone from being able to sue their HMO if they have problems getting proper health care. Don't let them fool you with the gobbly-de-gook talk!! They are protecting big business (The HMO's) against the poor consumer (again)!!!!!

Dan Rutz (CNN): Chemotherapy treatment for breast cancer patients several months before surgery may mean the difference between losing a breast to the disease or undergoing a less extensive operation, according to a new study. The study, published in the August issue of the Journal of Clinical Oncology, finds chemotherapy several months before surgery shrinks breast tumors by more than half, in eight out of 10 patients. "This study is a new approach to the treatment of early and middle-stage breast cancer," said Dr. Bernard Fisher of Allegheny University of Health Sciences. The study indicates more women, including those with large tumors, might be able to safely undergo conservative surgery that cuts away a tumor rather than completely removing a breast.

Delaying the operation for chemotherapy treatment does not appear to increase the risk of cancer relapse. "It can be used in any woman with the understanding and the total freedom that she's not being shortchanged by this kind of therapy," Fisher said More women may be able to undergo preliminary chemotherapy to reduce extensive breast cancer surgery. Dr. Toncred Styblo of Emory University in Atlanta, said the time may come when most chemotherapy will be given before, rather than after, breast cancer surgery. "It downstages the cancer," he said. "So we find, statistically, that women who have preoperative chemotherapy have fewer lymph nodes involved with cancer than women who don't."

Fisher said there is another advantage to chemotherapy treatment. If the drugs work against large, measurable tumors, it is likely they'll take care of invisible, lingering cells that can sprout new tumors years later. "Prior to this, one would have to wait until a woman had a failure in three years or five years," he said. "Then you say, the therapy she took didn't do so good." Fisher said now that it's clear presurgical chemotherapy is safe, it will be possible to speed new drug testing.

COSTA MESA, Calif. (BW HealthWire) 7/31/98: Indifference & neglect characterize a long history of failures by the FDA in properly regulating the sterilization equipment, sterilant, disinfectant and infection control industry. An exclusive expose in Biomedical Market Newsletter (May 31 issue) reveals that when the FDA finally did inspect 23 sterilant/disinfectant manufacturing facilities, it found serious deficiencies in over 50% of them. Also, 150 major and minor incidents are reviewed and analyzed in this issue for the first time in history......

London: The Commons health watchdog demanded answers after the Express challenged a Government investigation into the safety of breast implants. The Express found all 15 doctors involved in the key women's issue were men. The all male team was approved by former Health Minister Baroness Jay, now Minister for Women. There were six male doctors on the "independent" Government review panel. But we can reveal they called in another mine medics as advisers ~ all men. Women doctors, nurses and patients were excluded from the decision making. The Express can also reveal that leading American experts believe the decision not to ban the silicone implants could cost lives.

The implants have been banned in the US, Canada, France and Japan after claims that they can cause crippling diseases and obscure breast tumours during cancer screening. David Hinchliffe, MP, who chairs the powerful Select Committee on Health, said, "I am writing immediately to the Secretary of State for Health. And your dossier is now on his desk. The Express has raised serious concerns about this review. I understand that there is great anger, especially among women, about the way this review has apparently been handled. Professor Robert Garry, of the Tulane School of Medicine in New Orleans, testified against silicone to the review. He said he has written to the Government to reverse their decision. Another who gave evidence, Welsh GP Sarah Myhil, maintained that 81 of her patients have been damaged by silicone implants. She called for a probe into how the review members reached their decision.

The Health Department's investigation team admits relying on two of their own old reports plus reports from silicone manufacturers, as well as independent medical literature. Meanwhile, MP Margaret Ewing said she was "stunned" to be told by Public health Minister Tessa Jowell in a Commons written answer that France was the only country banning silicone implants when this did not appear to be the case. WASHINGTON, Jul 24 (Reuters): A 13-member expert panel assembled by the Institute of Medicine (IOM) heard testimony Friday from scientists and patients on the safety of silicone breast implants. The testimony came on the last day of a 3-day meeting on the implants convened by the IOM at the request of the National Institutes of Health. The panel included immunologists, toxicologists, surgeons, and oncologists. Many experts said that no evidence has linked the implants to any autoimmune, neurological or any other serious disorder. But many of the women who had implants and other scientists attending argued otherwise, saying that more study was needed. Testimony centered on three areas: the potential for implants causing disease; the potential for rupture or failure, leading to explantation (removal of implants); and potential toxicity or carcinogenicity of silicone implants. Midway through the morning, Kathy Keithley Johnson, president of the Columbia, Missouri-based Toxic Discovery Network, said her group had filed a "class action'' lawsuit against the Food and Drug Administration (FDA) and the American Society of Plastic and Reconstructive Surgeons (ASPRS). Johnson said the Network's 7,000 members allege that both the FDA and the ASPRS are negligently allowing implantations to continue in the face of known dangers. The group wants to halt procedures "until sufficient evidence is presented that these products can be implanted without significant risk to consumers.''

An ASPRS spokesperson said it had not yet been notified of a suit. When asked if he thought the Society could be held liable for the actions of its members, ASPRS Vice President Dr. C. Lin Puckett, said "I would submit that it cannot.'' Earlier, Puckett told the IOM panel, "There are now over 20 epidemiological studies that indicate no significant relationship between breast implants and known autoimmune diseases.'' Many of those speaking repeated that sentiment. But others said there may be some scientific basis for the large numbers of women reporting the disorders. Sidney Wolfe, director of Public Citizen's Health Research Group, said workers with occupational exposure to silica (a component of the implant envelope) have reported autoimmune disorders. Michael Raymond Harbut of Wayne State University, said he had documented cases of Dow Chemical workers treated for allergies, asthma, pruritus, and other conditions due to exposure to chemicals used in silicone gel manufacture. Implant contractures and ruptures were also discussed. Bruce Cunningham, a professor of plastic surgery at the University of Minnesota and representative of the American Society for Aesthetic Plastic Surgery, said his ongoing studies of saline implants suggest a failure rate of 5.5% to 6%. He said his studies could be used to estimate silicone implant failure rates. But Eugene Goldberg of the University of Florida (Gainesville), said his study of explants, with data on 5,500 patients so far, shows that 30% are explanted within 5 years and half within 10 years. He said the repeated surgeries were dangerous to women. "This is a very serious health problem that needs to be addressed,'' said Goldberg. The IOM panel is expected to issue its conclusions from the meeting in a year.

NOTES ON THE PROCEEDINGS - PART 1: DONALD J. SCHAEZLER, PH.D., P.E., CIH:

EPIDEMIOLOGY AND OBSERVATIONAL STUDIES: On the first panel were reports by Louise Brinton of the National Cancer Institute and Lori Brown of FDA.

The NCI is well into a large epi study of women with augmentation mammoplasty. The NCI study is designed to address weaknesses of some prior epi studies like Mayo, Harvard, Hennekens. These prior studies relied on records primarily, with some questionnaires administered by mail. There was no follow up, detailed evaluation of symptoms, or physician visit. Success rate was low. The new study has 13,000 women who had BI augmentation (bilateral, non-cancer) and 4000 women who had other plastic surgery are in the control group. All the women are from the SE or Wash DC areas to avoid overlap with other studies and to avoid Texas, which has a very large amount of litigation ongoing. After identifying a large population of prospective women, a great deal of effort was spent locating them and then administering detailed questionnaires by phone. 18 plastic surgeons are doing individual follow up with patients. The success rate is over 70%.

The analysis of results with respect to diseases (cancer, connective tissue disease, etc.) and symptoms will be analyzed for external Standardized Incidence Rates (SIR) and for internal Relative Risk (RR). The first analysis will compare incidence of diseases to the recognized incidence in the general population. The second will compare the incidence of diseases and symptoms to those in the control population. They will also try to define the constellation of symptoms unique to this group of women. The studies will identify Confounding Factors, bias, role of implant type, etc. and will have "stratified" analysis of results viz-a-viz these factors. Evaluation of cancer effects should be available Fall 98. Connective tissue disease effects should be early 99. SUMMARY: This is a well-designed, extensive study; it should remove many of the problems of older studies. The investigator seems very sensitive to women's issues.

Brown's FDA study is using a subset of the NCI study for a special study on local complications, i.e. infections, pain, stromas, contracture, expulsion, migration, rupture, bleed. Brown recognizes that previous reports show migration, chronic infection, ulceration, pain, numbness, granulomas, etc.

This investigator is also sensitive to women's issues. She pointed out that FDA received 94,000 reports of problems with silicone implants and that 23% - 63% of implants have been reported to rupture. FDA has picked 1247 women from Brintons Alabama group. The study will build on Brinton's survey and checkup results by doing MRIs and by reviewing surgery records. They will then analyze results for the local complications mentioned above. Results will be in early 99. SUMMARY: This study is also well-designed and will use new MRI analyses to estimate rupture rates, making this a first study to have goo rupture rates on a non-problem-referred group of women.

The second panel had Dr. Duhamel from McGhan, who reported on McGhan's internal studies to be used for FDA regulatory requirements. Studies segregated women into Augmentation, Reconstruction, and Revision categories. Separate studies have been or will be completed for silicone and saline, and will address Core and LST purposes (FDA definitions). The studies are preliminary at this time but will eventually extend for 10 years. The IDE has been submitted and FDA has given preliminary approval to begin PMA study. PMA expected in 2001, after 2 years of results. Preliminary results form a pre-Core study indicate: 1% infection rate; 14% contracture at 5 yrs; 4% rupture at 5 yrs (mostly the saline part of double lumens); 9% explanation at 5 yrs (38% for a pretty small population of Recon. patients, which they dismissed as non-representative because of small numbers); high degree of satisfaction. The presenter added an anecdotal observation that every polyurethane explant he has seen show evidence of biodegradation. [Note: Manufacturers may not be too happy with this comment.] [Note: The 4% rupture at 5 years is actually consistent with results of Feng, Middleton (afternoon sessions) who went on to show very high rupture rates after 12 + years.] SUMMARY: Not too remarkable; a lot is planned compared to what has actually been accomplished to date. The time period even for the pre-Core study is too short to make conclusions relative to other reports and studies.

Dr. Leroy Young of U. Missouri gave an interesting report on evaluation of silicone and silica in capsule material. He spent considerable time trashing Shanklin's microscopic work and then explaining the intricacies of light microscope (including polarized light) strengths and weaknesses and features of birefringence, crossed polarization brightness, refractive index, etc. Apparently a number of materials appear as bright objects under light microscopy, including calcium carbonate, talc, starch, and silicone. Crystalline silica, in fact, will not show as well in a very thin section. Young went onto describe a more sophisticated infrared procedure, Laser Raman Microprobe Spectroscopy (LRM), and pushed for its acceptance as the standard for pathological analysis of breast tissue. He also spoke about a newer Solid State NMR procedure which is more suitable than the procedures used by Garrido several years ago, when he postulated the appearance of small amounts of crystalline silica from silicone degradation (a phenomenon not accepted by most). Young conducted two small studies with only a few subjects in which he sent slides of capsule material to Garrido for the newer NMR and to others for LRM. The studies identified silicone but no silica in the samples, by both analyses. COMMENT: Small but good quality studies; need to hear Garrido's opinion of the relevance to his prior work. For one thing, his first study may have looked at other tissues than capsules. Young's comments on light microscopy are correct, I believe. His comments on NMR need confirmation by an expert, which he obviously is not.

IMMUNOLOGY: John Naim started this session with a presentation on adjuvancy effects of silicone. Adjuvancy is the NON-SPECIFIC enhancement of a SPECIFIC immune system response to an antigen. The specific response might be production of antibodies (humoral immune response), activation of T-cells (cellular immune response), an inflammatory response with the production of cytokines (immune system messenger cells). Silicone gel has been shown to be a strong humoral adjuvant and a weak cellular adjuvant; oil is a weak adjuvant; elastomer (shell) silicone has not been studied enough to say. Key to silicones role is the formation of an emulsion with the antigen. This is usually done by homogenization of the specific antigen, e.g., bovine serum, with the silicone. This draws the criticisms that it is the oil/water emulsion that is important, not the silicone chemicals, that homogenization is not an in vivo (in the body) process, and that homogenization may alter the silicone chemicals. A very important question is whether silicone can induce or enhance Autoimmune reactions (immune responses to "self", i.e., normal body chemicals like nucleic acids or proteins). To date, silicone has been shown in animals to have an adjuvant effect but not an induction role on its own. However, in new studies, with a different mouse as the test organism, there is possible direct induction of IgM anti-nuclear antibodies (ANA); this study is being expanded.

A new area of research is Monocyte Macrophage Activation with the production of Cytokines. Naim's work indicates that the reaction of a protein with a hydrophobic surface (like silicone) leads to more cytokine production than without the surface. The protein is the cause of cytokine production; the silicone is an adjuvant. Other polymers, like polystyrene, have a similar, but perhaps lesser effect than silicone. [Note: other presentations later in the day connected cytokines to possible autoimmune responses.] SUMMARY: Naim's work indicates that silicone can act as an adjuvant in several ways and that it may be able to induce an autoimmune response directly, not just have an adjuvant effect. The mechanism may involve adsorption of proteins from the body onto the silicone surface.

Michael Potter of NCI spoke about silicone and the induction of Plasmacytomas (types of cancers) in susceptible mice. The importance is that this is an animal model for some types of cancers in people. The model presented is that granulomas are formed around foreign materials; the granulomas are invaded by mutant B-cells, which proliferate uncontrollably, becoming a tumor. The inflammatory response to the foreign body, including Cytokine production is important in this process. Incidentally, anti-inflammatory agents may be able to block the cancer process in the mice. COMMENT: Potter shows another aspect of the possible role of silicone in starting an inflammatory process which leads to an immune system aberration.

Fred Miller of FDA spoke about environmental agents which can create rheumatic autoimmune (AI) deficiency conditions. Certain drugs, vinyl chloride, silica (crystalline), and infectious agents have been shown to cause these AI diseases. The issue now is: can silicone also do this? He also began with the foreign body/inflammatory response, including the roles of phagocytes, T-cells, B-cell aggregates, and collagen proteins. The production of Monoclonal vs. Polyclonal cellular aggregates was a key distinction. And the question of whether the response can expand into a systemic response is really important. Then he talked about dermatomyocytis symptoms in response to Breast Implants and the correlation of symptoms to individual genetic markers of immune system type (Human Leukocyte Antigens, HLA). COMMENT: This all seemed very important, but the presentation was too rapid and too advanced to capture the import entirely.

COMPANY DATA (MENTOR AND DOW CORNING): MENTOR: Four speakers presented information, including three consultants, one of whom was Dr. Noel Rose. Dr. Rose is one of the premier immunologists in the country. I was surprised to hear him speak as an obvious member of Mentor's team. (He has testified for the defense.)

Dr. Wixtrom, the first speaker, had a desk-top (i.e., no real results) presentation of the risk of extractable chemicals from silicone. He said D4 (a low molecular wgt cyclic siloxane) has known toxicity and is present at less than 50 ppm in the gel. He said this is an insignificant amount of Dr compared to its NOAEL (No Observed Adverse Effects Level) dosage in mammals of 2.3 mg/kg/day. This Is a legitimate comparison; it does not address the effects of other LMS (low molecular wgt silicones), the much higher concentrations observed by others, or the issue of the route of exposure and actual absorption of D4 in the quoted toxicology experiments. (For SBI, the route of exposure is by implant, and the absorption is 100%; in other studies the route may be by ingestion, and absorption from the gut may be low). He also spoke about Platinum, claiming it is present in its elemental or zero-valence state, which is a non-toxic state. This can be contrasted to Cis-Plat, a powerful anti-tumor drug, in which Pt is present in the +6 state, and chlorplatinate, the original form of the catalyst, also a +6 compound. [This is very important; a speaker Friday contradicted this statement.] Finally he spoke about silica in the shell; he said it is amorphous and is not expressed on the surface of the shell because it is enveloped in the silicone structure. He quoted electron microscopy analysis as proof.

Dr. White, a consultant, mentioned the NTP (Natl Toxicology Pgm) studies; he said they show no toxic, immune, or host resistance effects. They show reduction in Natural Killer Cells, but no effect on tumor resistance. He then related results of Mentor Study and said there were no effects. He disputed results of Naim relative to Adjuvancy and of Golblum relative to antibody production. He reported on studies of a mouse model for human SLE. The test showed no increased auto-antibody production for silicone implanted in the mouse. The test did show the expected increase for exposure to mercuric chloride and d-penicillamine (?).

Then Dr. Rose spoke on Autoimmunity, which requires epidemiologic evidence and Bioplausibility. There is no epi evidence for causation of autoimmune disease. He then rejected the plausibility of: 1. silicone as an antigen directly (not chemically plausible); 2. silicone as a hapten (i.e., its adsorption on to a protein, causing it to become an antigen; no pathologic evidence); 3. silicone as an Adjuvant (only the gel is effective, but only if homogenized; he could not reproduce Naim's results); 4. exacerbation in predisposed animals (no evidence).

Finally Dr. Purkait of Mentor spoke directly on the Mentor study. This study has 20,000 patients. He reported infection, capsular contracture, and rupture results to be within normal ranges. Rupture was only 1.3%, but that was only after 5 years. Prospective clinical studies with saline implants are in progress.

DOW CORNING: DC had 3 speakers, all DC employees: Dr. Lane spoke on silicone bleed. He said previous results by Yu(?) Indicated bleed rates of 0.3 grams per year and compare favorably to DC data. Importantly, he indicated that even high molecular wgt components of silicone bleed; this means D4, for example, are still at low concentrations in the bleed material. He reported about 100 ppm of D4 and D5 and non-detectable Platinum and Fluorine. Results were somewhat different in products with a Barrier Coat (Silastic I) and those without (Silastic II). [This is important; it contradicts recent data by Baylor which indicates a greater concentration of LMS in the bleed material.]

Dr. Meeks reported on toxicology studies. He said PDMS (Poly-dimethyl siloxane, i.e., silicone) above MD4M (small polymer with only 4 siloxane units) had very low volatility, absorption by the body, or toxicity. Two studies reported were important. In the first, radio-labeled (C14) PDMS gel was implanted into mice without an implant shell. At about 20 weeks the mice were sacrificed, autopsies, and analyzed radiographically. There was rapid urinary excretion of silicone (molecular wgt not reported) and some migration to lymph nodes. There was no overt toxicity. [This raises a lot of questions; we need to see the results in writing.] In the second study rats were exposed (by inhalation) to 7, 70, and 700 ppm D4 in air in order to study Absorption, Distribution, Metabolism, and Elimination of D4. After 7 days, they found: 1. Some CO2; 2. Most D4 accounted for in feces, urine, expired air (non-absorbed); 3. Slow elimination in the blood, because of typical lipo (fat) solubility.; 4. Some liver enzyme induction; 5. Fat accumulation. A brief study with human volunteers studied results of inhalation exposures to D4. In summarizing these results Meeks said there are 2 primary metabolites of D4 (in answer to questions they were identified as dimethylsilanediol and methylsilane triol); he said these are reactive and recombine to form other compounds. He also said that adsorption of D4(?) is 5%-10% orally, 8% dermally, and only 1% dermally with humans. He also sais there was evidence of increased liver wgt, perhaps due to rapid cell division and induction of Cytochrome P450 enzyme, but that the liver returned to normal after removal of D4. [This begs the question of what if D4 cannot be removed, as in the case of SBI.] Finally, he characterized the potential toxicity of D4 in SBI women, as calculated from DC and other studies. Using 0.3 grams/yr bleed, 700 ppm D4 in the bleed, 2 300 cc implants, LOAEL of 500 ppm in air for 6 hours per day, with 5% absorption of D4 from the air, the margin of safety was calculated to be more than 3 million. He said a margin of 100 is usually considered safe. [His calculations appear correct; the safety factor probably should be 1000; this ignores other components of bleed].

With respect to Platinum, he reiterated it is in the zero-valent form; he said it is present at 1 ppm in gel, 10 ppm in shell. He said the form of Pt may be sensitizers but are not toxic or allergenic like chlorplatinate. [Others dispute the 1 ppm and valence state.] NOTE: I believe the DC data virtually prove that some silicones (perhaps the cyclic ones) can be metabolized and/or chemically converted to silicic acid in the body. This is the soluble form of silica and is in equilibrium with amorphous silica and perhaps certain silicates. This is the first time this has been so clearly demonstrated and contrasts sharply to denials of biochemical reactivity and conversion to silica.]

Dr. Klykken spoke on carcinogenic properties of silicone. He rejected relevance of the so-called solid state tumorogenesis in rats, to which FDA agrees, he says. New studies show no increased cancer attributable to silicone exposure.

SURGERY, PATHOLOGY, RADIOLOGY This session had four speakers, none of whom had a hidden agenda, and each of whom appeared open-minded.

Dr. Nancy Hardt of U. Of Florida reported on her results as part of a multi-disciplinary team of researchers investigating silicones. Her work involves the pathological examination of capsule tissue samples from SBI women. She uses FTIR (Fourier Transform Infrared), similar to the LRM method Young reported on but for different types of sample preparation. She found silicone, urethane (some samples), but no silica in samples. Specifically, she found: 1. Macrophages with vacuoles filled with silicone, surrounded by protein. 2. Amorphous protein, probably collagen, surrounding refractive material, probably silicone. 3. Wall-to-wall histiocytes with fine silicone. 4. Lymph nodes with vacuoles, probably with silicone. 5. Blood vessels in the capsule with Macrophages and silicone She investigated whether the capsule could be considered a Bursa. A bursa is evidently surrounded by a synovium, a unique tissue without a barrier to migration. Apparently Macrophages and fibroblasts are important to this distinction, and Capsules and Bursae are very similar. She reported on the use of very fine carbon particles as tracers for migration from the SBI/Capsular surface. Such particles aligned themselves at the surface and migrated to the capsule material and to lymph nodes. They also formed carbon granulomas deep in the capsular tissue. She surmised silicone and carbon might take the same route. Laboratory analysis of body tissues of SBI patients demonstrated increased silicon, probably as silicone, in the brain, spleen, and other tissues; the increases were greater if the implant had ruptured. COMMENT: The importance is apparently the association of protein, especially collagen, with Macrophages around migrating silicone.

Dr. Lu-Jean Feng of Case Western Reserve School of Medicine spoke about her research over 7 years on SBI ruptures. She first explained the different generations of SBIs. Generation 1 61 - 72 thick shell; Generation 2 73 - 80 thin shell; Generation 3 81 - 88 thick, barrier coat, Silastic II, some with polyurethane; Generation 4 after 88 textured. Of 1619 explanted SBIs, all by Dr. Feng, 94% reported problems, local or systemic. She identified 16 factors, such as time, contracture, pocket location, local symptoms, type SBI, mfr, etc. Her results indicated1. 72 % rupture after 15-19 years; 2. 76 % rupture if implanted 1974-1977; 3. 62 % rupture if implanted 1961-1974, or approximately the Generation 1 implants; 4. The retro-pectoral position is somewhat protective; 5. No relationship to systemic symptoms; 6. Polyurethane and double lumen types were the most protective. COMMENT: This work confirms the high rupture rates reported by others but is for a referred group of women, which may bias the rupture rate upwards. Dr. Feng is very professional and her presentation was very well done.

Dr. Michael Middleton of UC San Diego spoke about his experience with MRI analysis of Breast Implants. He analyzed about 800 implants, about 400 of which ruptured. His accuracy was defined by (numbers are approximate). True Negatives (negative by MRI and by explant) 400; False Negatives (negative by MRI, ruptured according to explant) 100; True Positives (ruptured by MRI and according to explant) 300; False Positives (ruptured by MRI, negative by explant) 6. COMMENT: MRI, done correctly, is very accurate for diagnosing ruptured Breast Implants. It may underestimate the true rupture rate somewhat.

Dr. Marilyn Lightfoote of FDA spoke on Immunological effects associates with silicone Breast Implants. She used a rat model analog for thyroiditis, an autoimmune disease. She found: 1. Autoantibodies to collagen produced in rats injected with silicone oil or silicone gel; 2. Anti-Nuclear Antibodies (ANAs) stimulated in rats injected with silicone oil or silicone gel; 3. Injected silicone migrated to distal sites after one year; 4. In swollen joints there was evidence of inflammatory process after two years. Pilot human studies were also conducted on women with and without Connective Tissue Disease (CTD) and with and without Silicone Breast Implants. The results indicated Autoantibodies and ANAs were detected in women with Silicone Breast Implants, with or without CTD. COMMENT: This is potentially VERY important. It directly refutes claims, such as Mentors, that there no immune effects associated with silicone. It is very encouraging that FDA has already found these effects and is conducting further studies.

NATIONAL ACADEMY OF SCIENCES INSTITUTE OF MEDICINE COMMITTEE ON THE SAFETY OF SILICONE BREAST IMPLANTS: PUBLIC MEETING - JULY 24, 1998: PANEL I: Dr. Sidney Wolfe, Public Citizen's Health Research Group: Situation similar to wide-spread occupational exposures. Recited the types of responses demonstrated: solid state carcinogenesis (apparently the Plasmacytomas in mice studied by Potter and others), silica and CTD, silica present in shell, genotypes associated with Autoimmune Disease; many lines of evidence, recently summarized by a Canadian researcher. Susan Scherr, Ntl Coalition for Cancer Survivorship: Cancer victims need to keep options open. No connection to disease; cited recent IRG study. Dr. Lin Puckett, ASPRS: Read ASPRS statement; newer studies reinforce previous clinical opinions and give reassurance; cited IRG, European Community Study; says normal Foreign Body Reaction, not an Immune Disease. Dr. Elizabeth Connell, Emory Univ and former Co-Chair of FDA Panel: Recalled two rounds of FDA hearings she participated in. Epi studies show no relationship. Same results in Sweden, Scotland, England, Europe. Martha Murdoch, Ntl Silicone Implant Foundation, Silicone Survivor: Gave her case history; loss of insurance and incurability; 240,000 adverse reaction reports filed.

PANEL II: Dr. Bruce Cunningham, ASAPS: Failure rate is only remaining issue; research on saline Breast Implant failures; saline failures more easily demonstrable, represent worst case because lack of lubrication; only 5% - 6% failures up to 10 years; attacked Goldberg (see below). Anne Adams, Silicone Survivor: Case History; has had silicone granulomas removed as recently as 6/98, 23 years after implantation; cited over 450,000 damage claims. Dr. Eugene Goldberg, Univ of Florida: Not just failure problem but also multiple Revision Surgeries; cavalier attitude toward this development; Mayo study showed 24% revision surgeries within 5 years; his data shows 32%. He cited 32 papers representing 5500 explanations as basis for failure rate evidence. The Gold Standard is condition on explanation, so the only reliable data are based on explanted devices. Latest compilation shows 30%, 50%, and 70% failure rates after 5 years, 10 years, 17 years, respectively; rate is approximately 6% per year. This is not junk science. There is a controlled release of silicone oil with a local inflammatory response, NOT a normal foreign body reaction. He also stated the committee lacked biomaterials expertise; saline implant is not a proper analog for silicone implants because of chemical differences in shell. Kim Hoffman, Silicone survivor: Case History. Admitted to Mentor Adjunct Study and can attest to Protocol Violations; failure to record her problems with the implants despite her total disability; failure of her plastic surgeon to report problems. This was not the end, panels continued all day with both sides presenting evidence and their personal stories. I am hoping that we are able to obtain copies of all testimony presented. Our women did an excellent job of testifying before this FDA panel!! (Lynda) Many, many more people, including Dr. Pierre Blais, testified before this panel before the day was over. There were too many to count and too many to recount the testimonies. They did a great job for us!! Some of the afternoon testimony for the manufacturers spouted the same old rhetoric that we have heard for years. I tuned it out because I just don't want to use what little energy I have for negative things!! (Lynda)

DALLAS, TX, July 21, 1998, Drugs that lower blood cholesterol levels may work by increasing the amount of a chemical that relaxes blood vessels, helping them regain flexibility, according to a study reported today in the journal Circulation. The chemical, nitric oxide, signals blood vessels to open and close in response to the body's changing need or increased or decreased blood flow. Individuals with elevated cholesterol have an impaired ability to relax, or dilate, their blood vessels, which researchers attribute to a problem in nitric oxide. In individuals whose cholesterol levels were lowered by the drug fluvastatin, more nitric oxide was produced, improving dilation.

"Cholesterol-lowering therapy has been associated with a decrease in deaths from heart disease and this improvement in dilation may be one way that the drug works," said Roland Schmeider, M.D., professor of medicine, University of Erlangen-Nuremberg, Germany. Researchers already know that cholesterol-lowering helps prevent fatty deposits that can clog blood triggering a heart attack or stroke. The study finds that lowering cholesterol also improves dilation of blood vessels.

WESTPORT, July 27, 1998 (Reuters): Dutch researchers have found that rheumatoid arthritis patients with hay fever tend to have less severe disease. The reason, according to the researchers, lies in the ratio between type 1 and type 2 T cells. In the current issue of Annals of the Rheumatic Diseases, Dr. Catharina M. Verhoef and colleagues, at University Hospital Utrecht in the Netherlands, explain that type 1T-cell activity is important in cellular immune responses, including the cytokine activity that leads to joint inflammation in rheumatoid arthritis. Type 2 T cells, on the other hand, play a role in humoral immune responses, including atopic allergies. In normal individuals, both types of T-cell activities counterbalance each other. In patients with rheumatoid arthritis, however, T1 cells predominate, while T2 cells predominate in individuals with atopic allergies. Now, Dr. Verhoef and her team have discovered that in 304 patients with rheumatoid arthritis, the prevalence of hay fever was only half that in 339 control subjects without the disease. Furthermore, the 12 rheumatoid arthritis patients in the study who did have hay fever had fewer and less severe symptoms, and less radiologic evidence of joint damage than the nonallergic rheumatoid arthritis patients.

"The clinical data were related to peripheral blood T1/T2 cell balance," the authors report. "[A] lower [interferon gamma/interleukin-4] ratio was observed for [rheumatoid arthritis] patients with hay fever, indicating a comparatively increased T2 cell activity in [these] patients." The investigators conclude that their findings "...argue in favour of the exploration of treatments aimed at regulation of a possible imbalance in T1/T2 cells activity in [rheumatoid arthritis]." Ann Rheum Dis 1998;57:275-280.

ST. PAUL, MN, July 21, 1998, A new study has found muscle abnormalities in people with reflex sympathetic dystrophy, a disorder involving chronic pain in the arms or legs that can lead to severe disability. The study is published in this month's issue of Neurology.

Monday, July 27, 1998, Shari Roan, Times Health Writer: Uninformed Consent: Hospital forms are so full of gobbledygook that patients often don't know what they're signing, a report finds. If you've ever checked into a hospital to undergo a laparotomy with a cholecystectomy and colectomy with colostomy, you know just how ponderous those consent forms you're asked to sign can be. (In English, you would be consenting to abdominal surgery with removal of your gallbladder, part of your colon and an opening made from the colon to the abdominal wall.) Who knew? That is precisely the point of a praiseworthy analysis reported recently in the medical journal Surgery. Researchers perusing informed consent documents used for surgery and other medical procedures found them to be so complicated that patients need to be high school graduates to understand most forms. About one-quarter of the forms required education at the college level. And a patient would need the equivalent of a PhD to comprehend 9% of them. That means people may sign documents with only the vaguest notion of what they are consenting to. Only 28% of Americans have attended college, and 72 million people are marginally or functionally illiterate.

Which sort of makes the term "informed" consent a joke. "The forms are very complex," says the lead author of the paper, Dr. Kenneth Hopper, a professor of radiology at Penn State University's College of Medicine. "I think what happens is a lot of them are written by hospital lawyers and have a lot of legalese, and many patients won't understand the verbiage. But the biggest value of a consent form is not as a legal tool, but as a tool to inform patients." The analysis is important, says Rick Wade, senior vice president of the American Hospital Assn., because medical professionals need to continually assess their efforts to educate patients. "Studies like this are very useful. If you look at where these studies appear, they are in publications read by physicians. And that is the way you motivate change." The study analyzed 616 consent forms submitted from hospitals around the country. A computerized writing program measured the forms' readability, quality of writing, use of descriptive words, jargon, excessive number of words or words that most people don't understand.

Legally, informed consent is based on three elements. 1) The patient must understand the procedure, its risks, potential benefits and the alternatives, if any. 2) Consent must be given willingly and without duress. 3) The patient must be mentally competent. Still, the particulars of the informed-consent process have been the subject of debate for many years. Typically, the major issue is: Just how much information should the patient have or need? "What sparked my interest is that, in radiology, there is always the question of should you tell, and how much should you tell?" Hopper says. "There have been some [suggestions] that doctors have to be careful not to upset the patient with too much information. I felt the more patients know, the better."

Clearly, most people are nervous before a medical procedure. Moreover, people who are sick are rarely thinking as clearly as they might otherwise. And, Hopper notes, being sick makes people feel powerless and more willing to turn their fate over to anyone who might help them. "I think patients who are sick just want to get well. I wonder if sick patients don't ask enough questions because they just want to get well," he says. But, Hopper says, a patient's trust shouldn't be abused by medical personnel who fail to inform them fully. "I'm still amazed day to day that I can introduce myself to someone I've never met, and some of them give me more trust than they would their minister, their priest or their spouse. Only a few patients will ask you your qualifications. But they'll undress for you and they'll tell you their secrets." Moreover, he says, there is no proof that a lot of information makes patients more nervous. "All patients are anxious. The more you tell them, the more knowledgeable they are, the less upset they are. Also, I think they are more able to tolerate the procedure."

"There is no ill intent here" on the part of hospital personnel, Hopper says. "But patients want to learn and know." Generally, there should be enough time for the patient to read a detailed consent form and discuss it with the doctor or friends and relatives. Only emergency room doctors are authorized to dispense with consent forms and act in the patient's best interest if there is no time to do otherwise, he says. "But even in most emergencies, there is usually time to consent, an hour or two," Hopper says. "And 95% to 98% of consent forms are routine forms, and there is plenty of time." Most states have laws stipulating the minimum of what informed consent forms should include and when they expire. Most consent forms expire in a few days, but that varies by state. For example, Hopper found that, in general, Texas hospitals tended to have the longest consent forms and New Hampshire the shortest. In California, there is no standardized consent form except for special procedures with permanent consequences, such as sterilization or hysterectomy. In most states, there is great latitude among individual hospitals, surgery centers and doctors' offices. In the study, the number of words in consent forms ranged from 58 for a hospital in Georgia to 4,217 for one in Louisiana. Hopper and his colleagues are urging medical associations to create a standard, simplified consent form. "Even if it's not mandatory [that it be used], a standard consent form would be a good idea. And it should be [tested] by having people read it to see if they understand it," he says. There have been discussions in California about the value of using a standardized consent form. But the California Medical Assn., which represents most physicians in the state, is opposed to such a form, says Alice Mead, legal counsel for the CMA. "Our position has been that consent forms are fine, but the most important thing is an adequate dialogue between the patients and physician," she says. "We think [a standard consent form] can lead to detriment as far as patient information. Physicians may be more apt to rely on a form if it's required and may falsely believe that it's OK with the patient." Barring a move to a standardized form, Hopper and others offer the following suggestions for improvements: Foremost, Hopper encourages the use of consent forms with a lot of blank spaces. "I love blank lines because then the doctor has to fill [them] in with specifics.

"The smart patient should begin to educate themselves about all of their options. They should ask, 'If I have any concerns about this consent form, whom do I call?' We should back up and involve the patient earlier." Finally, Hopper recommends that patients be accompanied by a relative or friend who will read the consent form and ask critical questions. "The best person to ask a lot of questions is the person with the patient," Hopper advises. "The more advocates you have, the better off you are."

You may obtain a MedWatch form to report problems from implants by calling (800) 332-1088. For an updated version (for silicone survivors) to describe all your symptoms, contact: CANDO, Marlene Keeling, 12615 Misty Valley, Houston TX 77066, Fax (281) 444-5468 Phone (281) 444-4796. This form allows you to give more information that could help the IOM Committee.

ALTERNATIVE MEDICINE) Plymouth Meeting Pa., July 1 (PRNewswire) Magainin Pharmaceuticals Inc. announced publication of preclinical ata in the July 1 issue of Cancer Research for Squalamine, an angiogenesis inhibitor currently in phase I clinical testing for the treatment of patients with solid tumors. The article reported that Squalamine successfully blocked angiogenesis in several animal systems and inhibited solid tumor growth in vivo. These experiments were onducted in collaboration with Dr. Henry Brem, Professor of Neurosurgery and Director, Neurosurgical Oncology, at the Johns Hopkins School of Medicine, Baltimore, MD. The results of this collaboration demonstrate Squalamine's ability to intervene early in the angiogenic cascade by interfering with endothelial cell growth, attachment of endothelial cells to substratum, endothelial cell migration, maintenance of blood vessel patency and vessel growth in the presence of angiogenic stimuli. As a result of this research, Magainin and Johns Hopkins scientists believe they have gained a better understanding of Squalamine's mechanism of action, especially when the angiogenic stimulus comes from tumors. "These data certainly give us a better understanding of how Squalamine works in combating tumor growth,'' said Michael Zasloff, M.D., Ph.D., Executive Vice President and Vice Chairman of Magainin and the discoverer of Squalamine. "These results affirm that Squalamine acts early in the angiogenic cascade which leads to abnormal blood vessel formation. Squalamine as a consequence has the potential to be useful in the treatment of disease where angiogenesis is important. Magainin hopes to eventually prove that Squalamine can slow or stop solid tumor growth in humans.''

Data highlights from the Cancer Research article include: Squalamine significantly reduced the growth of gliomas greater than 75% (p less than 0.002) which were implanted in the flanks of rats. - Tissue culture experiments demonstrated that Squalamine has specificity for endothelial cells in vitro by selectively inhibiting their growth. At the same time, there was no evidence of impact on tumor cell lines in culture. Squalamine demonstrated antiangiogenic properties in 4-day chick embryos by rapidly constricting the smallest capillaries and reducing blood transfer throughout the yolk sac capillary network. Squalamine given locally from a polymer implant in a widely used model of angiogenesis eliminated new blood vessel formation stimulated by a rabbit VX2 tumor transplanted to the normally avascular rabbit Cornea and reduced subsequent tumor growth. The data also suggest that tumors are unlikely to develop resistance to Squalamine because it targets growing endothelial cells and not genetically unstable tumor cells. Angiogenesis, the process of budding and growth of new blood vessels from existing blood vessels under the stimulus of a variety of growth factors, is an essential event in many physiological processes such as tumor formation. In tumor-induced angiogenesis, endothelial cells lining blood vessels are activated by mitogens produced by the tumor cells and surrounding stroma and eventually grow into and around the tumor, nourishing it and allowing it to thrive.

Squalamine was first discovered in 1992 in the body tissues of the dogfish shark by a team led by Dr. Zasloff. It is the first of a class of naturally occurring, pharmacologically active, small molecules known as aminosterols which are under development at Magainin as human therapeutics. In addition to the data discussed in Cancer Research, Squalamine was previously shown in preclinical studies to inhibit the growth of lung and breast cancers in animals and to reduce the spread of tumor metastases. Phase I clinical testing of Squalamine was initiated in December 1997 at the Cancer Therapy and Research Center (San Antonio, Texas) under the direction of Dr. Gail Eckhardt and at the Lombardi Cancer Center of Georgetown University (Washington, D.C.) under the direction of Dr. Michael Hawkins. Magainin Pharmaceuticals Inc. is a biopharmaceutical company engaged in the development of medicines for serious diseases. The Company's development efforts are focused on anti-infectives, oncology, and pulmonary and allergic disorders.

Squalamine is in the Shark Oil that I take to fend off infections and colds!! It is available through HTN. Call me for more info.

PERSONAL COMMUNICATION: I am organizing Survivors of Saline. My goal is to get saline women together for these purposes: 1. To validate our problems by being able to present numbers of affected women to political and medical organizations. 2. To share any new information/research which comes out. 3. To help each other with ways to heal, including "To Capsulectomy Or Not To Capsulectomy!" Of course, women may remain anonymous if they choose, but I also hope to have an open mail list that women will participate in. I am also working on a website, but am finding that pretty slow going. (the ever-present brain fog... sigh.) I hope you will send this to your mail lists. Though this will largely be an online endeavor, I am including my name and address to give to those who do not have computers. I can't promise that I will send regular newsletters. I don't want to get into being a nonprofit, simply for the reason that I feel I can only handle so much. If anyone has questions about the founder of this group, please feel free to ask, either me, or anyone else. I am completely open. Eileen Swanson Hodgkins (soon to drop the Hodgkins)
217 1/2 Eighth Ave. Haddon Heights, NJ 08035
609.547.9114

IMPORTANT: DEPARTMENT OF HEALTH & HUMAN SERVICES; Public Health Service; Food and Drug Administration; Center for Biologics Evaluation and Research; Bethesda, MD 20892; 27 July 1998: Subject: Silicone study: The following announcements of our studies have been approved by our FDA IRB for distribution to interested parties. I appreciate your interest and help with our studies. Sincerely, Frederick W. Miller, MD, PhD; Senior Investigator and Medical Officer; Laboratory of Molecular and Developmental Immunology; Division of Monoclonal Antibodies; Center for Biologics Evaluation & Research; Food & Drug Administration; NIH Building 29B, Room 2G11, HFM-561, 8800 Rockville Pike; Bethesda, MD 20892; Telephone (301) 827-0659; Fax (301) 827-0852; email: millerf@cber.fda.gov

REQUEST FOR REFERRAL OF PATIENTS WHO HAVE DEVELOPED MONOCLONAL GAMMOPATHY OR MYELOMA AFTER SILICONE IMPLANTS OR INJECTIONS.

The Laboratory of Molecular and Developmental Immunology of the Food and Drug Administration invites referral of patients for a study of the possible relationship between silicone implants or injections and monoclonal gammopathy of undetermined significance (MGUS) or myeloma. We are studying subjects who received any type of silicone implant and later were diagnosed as having MGUS or multiple myeloma. We are also recruiting, as comparison groups, individuals with MGUS or myeloma who never had silicone implants, as well as those with implants who are well and have no evidence of disease. Enrollment consists of completion of a questionnaire and donation of a blood sample.

REQUEST FOR REFERRAL OF PATIENTS WHO HAVE DEVELOPED MYOSITIS OR SCLERODERMA AFTER SILICONE IMPLANTS OR INJECTIONS.

The Laboratory of Molecular and Developmental Immunology of the Food and Drug Administration invites referral of patients for a study of the possible relationship between silicone implants or injections and myositis or scleroderma. We are studying subjects who received any type of silicone implant and later were diagnosed as having any form of myositis (including polymyositis or dermatomyositis) or scleroderma (including progressive systemic sclerosis, morphea or CREST syndrome). We are also recruiting, as comparison groups, individuals with these disorders who never had silicone implants, as well as those with implants who are well and have no evidence of disease. Enrollment consists of completion of a questionnaire and donation of a blood sample.

For further information please contact: Frederick W. Miller, M.D., Ph.D.; Laboratory of Molecular & Developmental Immunology, CBER, FDA; Building 29B, Room 2G11, HFM-561; Bethesda, MD 20892; Phone: 301-827-0659; Fax: 301-827-0852; INTERNET email: millerf@cber.fda.gov.

THIS MONTH'S POEM:

DC Meetings

     By Lynda Roth Went off the Washington
To the IOM Committee
To listen to discussions on
The silicone tittie.

Heard the manufacturers
Proclaim them fine
And many women
Who were sick and dying!

Our doctors told them
Just how bad these deviceswere
And the committee listened
God, I hope they heard!!

We lit a candle
For those who are gone
And held a silent vigil
Near the Capitol lawn.

Did we accomplish
What we went there for?
I pray that we did
For it is a war!

I believe the truth
Will eventually be known
When that will happen
Is known by God alone!!

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; Baylor Studies 6/98; Hyperbaric Oxygen 7/98; Legal info. and info. on Alternative Medicine Info. contained in most issues.

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EXPENSES ARE STILL THE SAME!! PLEASE HELP IF YOU CAN!! WE DON'T WANT TO

QUIT HELPING OTHERS!!!!!!!!!!!!!!

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

EVER HELPED YOU, PLEASE HELP

US WITH A GENEROUS DONATION !!!

Please return this portion with your subscription or renewal or include the pertinent data with your check or money order. We no longer take MC/Visa!

Name ___________________________________________

Annual Subscriptions: Individual ($25.00 U.S.-- $35.00 Foreign (U.S.Funds)________________________________________

Address__________________________________________

Phone_____________________________________________

FAX_______________________________________________

Prior newsletters-Month,Yr._______________________

Amount Enclosed (U.S. Funds)_______________________

Mail to: Coalition of Silicone Survivors (COSS) The Coalition of Silicone Survivors is a not-for-profit, tax-exempt corporation.

PO Box 129, Broomfield, Co. 80038-0129

C.O.S.S. 06/01/98

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