Implant Veterans of Toxic Exposure

Breast Implants Safety and FDA Regulation

This document was provided to Congress by the Congressional Research Service. It explains what Congress was told about the dangers of breast implants in 1992. With documents we have seen in the past two years, we know now that this document contains misrepresentations. Before sending this to your Congressman/woman, please make note of those misrepresentations.


CRS Report for Congress
(Congressional Research Service - The Library of Congress)

Breast Implants Safety and FDA Regulation
Judith A. Johnson
Specialist in Life Sciences
Science Policy Research Division

September 9, 1992

Summary
Breast implants have been used in the United States for more than 30 years, predating passage of the medical device law in 1976. Between 1 and 2 million American women have had breast implant surgery. The most common type of implant is a silicone rubber envelope filled with silicone gel. The Food and Drug Administration (FDA) has received approximately 5000 complaints about the safety of breast implants since 1983. Aside from the general risks associated with any surgery, concerns about the safety of breast implants fall into two categories: adverse effects, that occur at the site of the implant; and unknown long term risks (such as autoimmune diseases or cancer) of having these devices implanted in the body for the life of the patient.
FDA is currently in the process of evaluating possible risks associated with the use of silicone gel-filled breast implants. On November 12-14, 1991, a meeting of the FDA Advisory Panel on General and Plastic Surgery Devices (composed of outside experts) was held to review the applications submitted by silicone gel-filled breast implant manufacturers and to advise FDA on the safety and efficacy data contained in the applications. The advisory panel voted against approving the applications submitted by the four companies seeking approval. However, the panel recommended to FDA that, despite the appalling paucity of safety information, silicone gel-filled breast implants should remain on the market for all women (under very restricted conditions) while the companies collect the required safety and long term health effects data.
After the November panel meeting, additional information became available to FDA on the safety of breast implants. The information consisted of internal Dow Corning memos and documents, as well as reports from rheumatologists which described a rise in autoimmune disorders in breast implant patients. This new information increased FDAs concern over the long term integrity of the silicone implant in the body and the possible adverse effects of rupture or leakage of silicone. As a result of these concerns, on January 6, 1992, FDA called for a moratorium on the use of silicone gel-filled breast implants.
On February 18-20, 1992, the FDA advisory panel met again. The panel recommended that future silicone-gel-filled breast implant surgery be limited only to women participating in scientific protocols. Women requiring reconstruction with silicone gel-filled implants because other alternatives are not suitable would be allowed to participate in the protocols. However, the panel was more restrictive in its recommendation for women desiring implants for cosmetic reasonsThe panel recommended that studies be designed for answering scientific questions about the safety of the implants and that only enough breast enlargement patients be included to provide answers to these questions. On April 16, 1992, FDA announced that silicone gel-filled breast implants will be available only in controlled clinical trials. FDA will continue to evaluate the possible risks associated with the use of silicone gel-filled breast implants.

The Congressional Research Service works exclusively for the Congress, conducting research, analyzing legislation, and providing information at the request of committees, Members, and their staffs.

The Service makes such research available, without partisan bias, in many forms, including studies, reports, compilations, digests, and background briefings. Upon request, CRS assists committees in analyzing legislative proposals and issues, and in assessing the possible effects of these proposals and their alternatives. The Services senior specialists and subject analysts are also available for personal consultations in their respective fields of expertise.
CONTENTS
Breast Implants: Safety and FDA Regulation
INTRODUCTION 1
MEDICAL DEVICE AMENDMENTS OF 1976 3
FDA PROPOSED AND FINAL RULES ON BREAST IMPLANTS 3
FDA REVIEW OF MANUFACTURERS DATA 4
FDA ADVISORY PANEL MEETINGS 5
FDA DECISION ON SILICONE GEL-FILLED BREAST IMPLANTS 8
FASIS OF FDA DECISION: DEFICIENCIES IN SAFETY DATA 12
Cancer 12
Cancer Detection: Mammography 14
Cancer Treatment in Women with Implants 14
Immune Related Disorders 15
Implant Rupture 16
Granulomas 16
Capsular Contracture 18
DOW CORNING IMPLANTS 20
POLYURETHANE COATED IMPLANTS 21
BIOPLASTYS MISTI GOLD IMPLANT 22
CONGRESSIONAL ACTION 22
DISCUSSION 23
CONCLUSION 25

APPENDIX: RESOURCES FOR BREAST IMPLANT INFORMATION 26

BREAST IMPLANTS: SAFETY AND FDA REGULATIONS
INTRODUCTION
Use of breast implants in this country began in the early 1960s. Since that time, between 1 and 2 million American women have had breast implant surgery. Prior of the January 1992 moratorium, about 150,000 women had this type of surgery each year, about 20 percent for reconstruction after mastectomy and the remaining 80 percent for augmentation of healthy breast tissue. The most common type of implant is a silicone rubber envelope filled with silicone gel. An alternative to the silicone gel is the saline filled implant, in which the silicone rubber envelope is filled with a sterile salt water solution. Silicone gel-filled breast implants have been by far the most popular variety, accounting for 90 percent of implants.
FDA has received approximately 5000 complaints about the safety of these devices since 1983. Aside from the general risks associated with any surgery, such as infection and delayed wound healing, concerns about the safety of breast implants fall into two categories. One set of concerns are adverse effects which occur at the site of the implant. Examples include: (1) capsular contracture, the painful or disfiguring tightening of scar tissue around the implant; (2) rupture of the implant (due to injury or normal wear over time) requiring its removal; (3) increase or decreased sensation in the breast; (4) calcium deposits in the breast tissue which can cause hardening and pain; and (5) decreased ability to detect breast cancer both on clinical examination and using mammography.
The second set of concerns associated with breast implants have to do with the unknown long term risks of having these devices implanted in the body for the life of the patient. Even if they do not rupture, implants may leak small amounts of silicone, some of which can drift to other parts of the body. Many experts believe that the leaked silicone has caused autoimmune diseases1 (such as scleroderma, lupus erythematosus, rheumatoid arthritis, and Sjogrens syndrome) in some breast implants patients. Questions have also been raised about a possible increase risk of cancer due to the leaked silicone. Studies performed by Dow Corning, a breast implant manufacturer, showed that when silicone gel is implanted in laboratory rats, it caused a particular type of cancer, called a fibrosarcoma.
In response to the Dow Corning studies, Public Citizens Health Research Group, a nonprofit consumer advocacy organization, petitioned FDA in November 1988 to ban silicone gel-filled breast implants. They estimate that a total of 1.4 million complications have occurred in women with implants, including: 155,500 women with ruptured implant or infections: 123,300 with hardened breasts to scar tissue formation; and more that 310,000 women with uncomfortably firm breasts. These estimates are based on figures provided by the American Society of Plastic and Reconstructive Surgeons (ASPRS) in their study of a sample group of breast implant patients. Because the study included only women who still had implants at the time the information was collected, Public Citizen thinks that the above numbers probably do not reflect the most serious adverse reactions caused by the devices. Using the data from FDA on women who had their breast implants surgically removed, Public Citizen estimates that in 1990 and 1991 more than 9000 women had this surgery because of severe complications due to the device, and that over the last 20 ears as many as 50,000 surgeries to remove breast implants may have been performed.
ASPRS, whose 4,500 members represent more than 90 percent of U.S. plastic surgeons, has played a central role in the controversy. Augmentation surgery reportedly often takes less than an hour to perform, costs as much as $4500 per patient, and accounts for at least half of many members practices.2 Until the controversy surrounding silicone gel-filled breast implants became widely publicized in the fall of 1991, breast augmentation with silicone implants was the second most common procedure after liposuction.3 4 The number of implant surgeries performed decreased following media coverage concerning the safety of the device. ASPRS raised more than $4 million in order to lobby for keeping implants on the market.5 The lobbying campaign included advertising in major newspapers. The National Womens Health Network, a Washington DC health advocacy group, filed a claim with the Federal Trade Commission on November 8, 1992, accusing ASPRS of false and misleading advertising. 6 One month before the November 1991 meeting of the FDA advisory panel on breast implants (see page CRS-5), the ASPRS paid the travel and lodging expenses for 400 women with implants to come to Washington, along with 200 plastic surgeons, to meet with Members of Congress to discuss their fears that breast implants would be withdrawn from the market by FDA.
FDAs authority to regulate breast implants is based on legislation enacted in 1976. By amending the 1938 Food, Drug and Cosmetic Act (21 U.S.C. 360c), the Medical Device Amendments of 1976(P.L. 94-295) established a comprehensive system for the regulation of medical devices which are intended for human use. What follows is a brief discussion of the amended Act and the series of proposed and final rules which led up to the FDAs Advisory panel meetings, the moratorium, and ultimately to the agencys April 16, 1992 decision that silicone gel-filled breast implants will be available only under special conditions.
MEDICAL DEVICE AMENDMENTS OF 1976
The Medical Device Amendments of 1976 revised the 1938 Federal Food, Drug and Cosmetic (FFD&C) Act and gave the FDA new authority in assuring the safety and effectiveness of medical devices. Like other devices that were on the market in 1976, breast implants were not allowed to remain on the market with the understanding that FDA eventually would require manufacturers of certain devices to demonstrate their safety and efficacy. Several other devices, such as heart valves and intrauterine devices, have already gone through this process.
The amended FFD&C Act requires that all devices for human use marketed in the United States before passage of the 1976 Amendments (preamendment or grandfathered devices) may be classified by FDA into one of three regulatory classes, Class I, Class II, or Class III. Class I devices present minimal potential for harm to the user and are often simpler in design that Class II or Class III devices. Class I devices are required to comply with General Controls, the minimum level of requirements by the agency. Examples include enema kits, elastic bandages, and pipetting and diluting systems for use in clinical laboratories. Most medical devices fall into the Class II category. Class II devices are subject to FDA performance standards in addition to General Controls. Examples of Class II devices include powered wheelchairs and certain pregnancy test kits.
Class III entails the highest level of regulation. New Class III devices must have approved Premarket Approval Applications (PMAs) before they can be sold in this country. In general, Class III devices are life sustaining or are implanted in the body. Examples of Class III devices include implantable pacemakers, and infant radiant warmers. Devices marketed after passage of the 1976 amendments which are considered to be substantially equivalent to a preamendment device are placed in the same class as the preamendment product. New devices which are not substantially equivalent to a preamendment device are automatically placed in Class III.
FDA PROPOSED AND FINAL RULES ON BREAST IMPLANTS
Breast implant manufacturers have been aware for some time that FDA would require data on the safety and efficacy of these products. In 1977, an FDA advisory panel recommended that breast implants should be classified as Class II devices. However, in the January19, 1982 Federal Register (F.R. p. 2810). FDA indicated in a proposed rule its intention to classify breast implants as a Class III device. The agency stated that because these devices are implanted in the body and because there was insufficient information at that time to determine if a Class I or Class II classification would provide reasonable assurance of the safety and efficacy of the devices, it was necessary for FDA to classify both saline and silicone-gel-gilled breast implants as Class III devices. The proposed rule listed and discussed the health risk factors associated with both types of breast implants which the agency found to be of most concern.
On June 24, 1988 (F.R., p 23856), FDA published a final rule classifying breast implants as Class III devices, and therefore each breast implant manufacturer would be required to submit a PMA on the device it marketed in the United States. PMAs for preamendment Class III devices cannot be required by FDA until 30 months after a device is classified as a Class III device, or 90 days after promulgation of a separate regulation requiring Premarket approval of the device, whichever occurs later. The June 24 final rule started the 30-month clock for submission of PMAs to the FDA on or before December 31, 1990. The final rule also published FDAs responses to comments received on the 1982 proposed rule. These responses provide further clarification of the agencys concerns about the health risks of these devices.
On May 17, 1990, FDA published a proposed rule (F.R., p20568) requiring PMAs from silicone gel-filled breast implant manufacturers; the final rule was published on April 10, 1992, (F.R., p 14620), requiring that PMAs be submitted within 90 days in order to keep the devices on the market. (FDA plans to request the same information from saline-filled implants in the near future.) Therefore, on July 9, 1991, the PMAs on silicone gel-filled breast implants were due to the FDA. Both the proposed rule and the final rule provide further discussion of FDAs views on the health risks of the device. Under the FFD&C Act, the agency had 180 days (until January 6, 1992) to review the PMAs and decide whether to approve or disapprove a device. Manufacturers are allowed under the amended FFD&C Act to continue to market their products during this period.
FDA REVIEW OF MANUFACTURERS DATA
In August 1991, FDA notified three silicone gel-filled breast implant manufacturers that it had not received enough data to conduct a review of their devices and gave companies 10 days to appeal the decision or their implants could not continue to be marketed. One of these companies, Surgitek, a division of Bristol-Myers, was the manufacturer of the polyurethane coated breast implant which is discussed in more detail near the end of this report.
FDA did not accept for review studies on seven silicone gel-filled implant models submitted by four companies (Dow Corning; McGhan Medical Corp.; Mentor Corp. and Bioplasty.) but cautioned the companies that there were significant problems in their applications that could prevent the agency from resolving crucial safety and effectiveness questions.7 On September 12, 1992, FDA sent to these four manufacturers deficiency letters which stated that the data provided in the PMAs involved too few women, too few side effects, and had been collected over too short a time. 8 The agency indicated that the studies submitted thus far were so weak that unless further data were gathered all silicone gel-filled breast implants would be banned.
On September 26, 1991 (F.R., p49098), FDA informed manufacturers that they must include information for patients on the risks associated with breast implants (both silicone gel-filled and saline) in the package insert shipped with the device. FDA made this requirement because it had received reports that women considering implant surgery had not been informed of the risks connected with its use. Implants which do not include the patient insert would be removed from the market by FDA. The agency strongly urged physicians to pass the risk information on to patients prior to scheduling implant surgery. FDA believes, however, that information currently available is insufficient to warrants the surgical removal of the implants because any surgical procedure carries a certain amount of risk.
FDA ADVISORY PANEL MEETINGS
On November 12-14, 1991, a meeting of the FDA Advisory Panel on General Plastic Surgery Devices (composed of outside experts) was held to review the PMAs submitted by silicone gel-filled breast implant manufacturers and to advise FDA on the safety and efficacy data contained in the PMAs. The panels advice is not binding on the FDA, but is advice is carefully considered in making the agencys final decision. During the often emotional meeting, the panel heard from groups who feel that implants essential to women who lose their breasts to cancer and women who desire breast augmentation to improve their self image. The panel also heard from women who have experienced painful and disfiguring side effects at the breast implant site as well as women who have other serious adverse health effects which many experts believe are associated with the presence of these devices in the body.
Many women who already have breast implants fear that if the devices are removed from the market they will be unable to get replacements if needed in the future. Some testifying before the panel believe that if silicone gel-filled breast implants are banned, some women may delay treatment for breast cancer because they would not be allowed access to the device. However, only 10 percent of mastectomy patients elect to have breast implant surgery. In addition, saline-filled breast implants and other surgical procedures such as autologous tissue transplant, which uses the patients own tissue, would be available. The tissue transplant procedure is relatively expensive, about $20,000 for each breast, and the surgery is technically more difficult and time consuming. Tissue is removed from the abdomen, buttocks or back and used to reconstruct the breast.
At the November meeting, the advisory panel voted against approving the PMAs submitted by the four companies. The panel stated that the companies had failed to present the convincing evidence that the law requires to show that the devices are safe. However, the panel recommended to FDA that, despite the appalling paucity of safety information, silicone gel-filled breast implants should remain on the market for all women (under very restricted conditions) while the companies collect the safety and long term health effects data. The panel did not recommend restricting manufacturers profits from the sale of the device during this period.
In his opening statement before the November advisory panel meeting, FDA Commissioner Dr. David Kessler reminded the advisory panel that FDA is not required to prove that breast implants are unsafe. On the contrary. Manufacturers have the responsibility of showing, by presenting valid scientific evidence, that their breast implants are safe and effectivethat is, that the risks are acceptable in light of the benefitsthe burden of proving safety rests with the manufacturer. In another part of his statement, Dr. Kessler stated that Even if risks exist, an application may be approvable if these risks are well understood and quantified, and if they are outweighed by the benefits of the device. On the other hand, if the risks are unknown or poorly quantified, the benefits side of the equation must be correspondingly higher in order to justify approval. Breast implants are not considered medically essential, even for the reconstruction patient, and this may weigh heavily in FDAs final decision-making process.
After the November panel meeting, additional information became available to FDA on the safety of breast implants. The information consisted of internal Dow Corning memoranda and documents as well as reports from medical specialists which described an increase in autoimmune disorders in breast implant patients.9 The Dow Corning documents surfaced as a result of litigation, and had not been submitted to FDA earlier because the judge in the court case had been requested by the company to seal the file.10 Such court files are often sealed in product liability suits, medical malpractice suits and suits involving environmental release of toxic chemicals, and therefore agencies such as the FDA may not have access to certain valuable information on the safety of the products they regulate. Because such secrecy orders may be contrary to the public interest, several states (Florida, New York, and Texas) have passed laws limiting their use, and the California Senate passed similar legislation on January 30, 1992. 11
The series of Dow Corning memoranda indicate that in 1976 the company was under severe time constraints to develop a new more natural implant with a fluid-like gel in response to a competitors product which had captured half of Dow Cornings share of the market. 12 The company reportedly also wanted to have the new product on the market before the medical device legislation became law because it expected that Congress would exempt devices already being marketed from safety tests. 13
The documents show that as early as January 1975, Dow Cornings own research staff called for more tests on the safety of the new silicone gel-filled implant, particularly on the occurrence of gel leaking through the envelop. The memoranda indicate that the new breast implant was used in women before animal studies were completed. When the animal studies were completed, there were indications that the gel migrated and caused inflammatory reactions in the animals. In one two-year Dow Corning study, silicone gel-filled implants were implanted in four beagles; one dog died during the experiment, and another developed a large tumor next to the implants 14 When the company published the results of the study, however, the 1973 article stated that the dogs remained in normal health. 15
In addition to the animal studies, memoranda from the companys salesmen complained of the device becoming oily from the gel leaking through the envelop. A memo in response suggested that the silicone gel-filled implants should be washed off before they were shown to plastic surgeons. In one memo, a salesman expressed his opinion that a decision to market a questionable lot of greasy implantsas to rank right up there with the Pinto gas tank. 16 Dow Corning believes that the implants are safe, and argues that the internal documents do not provide a complete picture of the companys review of the device.
This new information increased FDAs concern over the long term integrity of the implant in the body and the possible adverse effects of rupture or leakage of silicone. As a result of these concerns, on January 6, 1992, FDA called for a voluntary moratorium on the use of silicone gel-filled breast implants. The moratorium remained in place until the new information on the safety of silicone gel-filled breast implants was reviewed by the advisory panel and FDA made a final decision on the panel[s recommendation.
On February 18-29, 1992, the FDA advisory panel met again. It recommended that future silicone gel-filled breast implant surgery be limited only to women participating in scientific protocols 17. Women requiring reconstruction with silicone gel-filled implants because other alternatives are not suitable would be allowed to participate in the protocols. However, the panel was more restrictive in its recommendation for women desiring implants for cosmetic reasonsThe panel recommended that studies be designed for answering scientific questions about the safety of the implants and that only enough breast enlargement patients be included to provide answers to these questions. 18
FDA DECISION ON SILICONE GEL-FILLED BREAST IMPLANTS
On April 16, 1992, FDA announced that silicone gel-filled breast implants will be available only under special conditions, which eventually will be limited to clinical studies. According to FDA Commissioner Dr. David Kessler, the goal of the decision is to significantly limit the use of silicone gel breast implants while vigorously pursuing the necessary research about safety.19 In addition to performing the clinical studies, manufacturers will be required to perform laboratory studies on the chemical composition and toxicity of the silicone gel that leaks through the breast implant envelop, on the strength of the envelop, and its resistance to rupture, and the physical and chemical changes that the implants may undergo in the body. 20 The president of Mentor Corporation, Dennis Condon, estimates that the new restrictions will decrease the total number of breast implant patients for reconstruction and augmentation from about 150,000 per year in the U.S. to less than 25,000 per year. 21 Mentor and McGhan are the two remaining manufacturers of silicone gel-filled breast implants in the U.S.
The implants will be made available in three stages. In Stage 1, patients with an urgent need for reconstruction with silicone gel-filled breast implants will be allowed immediate access to the device, and will not have to wait until protocols are the studies are conclusively decided upon by the agency. FDA estimates that several hundred to a thousand qualify as urgent need patients. The plastic surgeons group, however, estimates that about 9000 women in the U.S. will qualify for Stage I. 22 Patients with an urgent need are defined by the FDA as follows:
Women with temporary tissue expanders in place for breast reconstruction following mastectomy, who need to complete their reconstruction with gel-filled implants; or
Women with silicone gel-filled breast implants who need replacement or revision for medical reasons, such as rupture, gel leakage or severe contracture; or
Women having mastectomies before the open availability protocols are in place, for whom immediate reconstruction at the time of mastectomy is medically and surgically more appropriate than implantation at a For women in this category, physicians must document that saline implants are not a viable alternative. 23
In order for a woman to obtain silicone gel-filled breast implants in Stage 1, her surgeon must certify that she fits one of the three urgent need categories. She will be required to sign an informed consent form which outlines the risks associated with the use of silicone gel-filled breast implants. Manufacturers will not be allowed to ship the breast implants until they see a copy of a patients informed consent document. 24 The ASPRS believes that the FDA-mandated document overstates the risks of silicone gel-filled breast implants. To place the risks of the devices in perspective, ASPRS has prepared [their own] consent document which the plastic surgeon may give to the patient along with the FDA informed consent document. 25 The patient must also agree to enroll in a registry so that she may be notified concerning new information on the implants.
In Stage 2, manufacturers will set up studies which will enroll any woman who needs silicone gel-filled breast implants for breast reconstruction. The so-called open availability protocols must be approved by FDA before they can begin. According to Commissioner Kessler, the devices will become available for Stage 2 studies as soon as the participating device manufacturers develop the protocol for the studies and meet other FDA prerequisites, including the preparation of a distribution and accountability system for the implants. 26 According to one report, FDA intends to hold the companies responsible for ensuring that doctors comply with terms of the reconstructive surgery protocols. If the companies hear of any misconduct by doctors, they are supposed to investigate the allegations immediately and take appropriate remedial actions. 27
On July 24, 1992, FDA approved Mentor Corporations protocol for clinical studies of their silicone gel-filled breast implant. The studies will exclude women who are pregnant or nursing; have an abscess or infection; have been diagnosed with lupus or scleroderma; have uncontrolled diabetes or other diseases which effect healing; have incompatible tissue characteristics; or who are an unwarranted surgical riskAt least 3000 surgeons are expected to participate as clinical investigators in the study. 28
Women eligible for Stage 2 include those who have had breast cancer surgery, severe injury to the breast, a medical condition causing severe breast abnormality, or who require replacement of an existing implant for medical reasons (such as rupture). The patients physician must certify that saline implants are not a satisfactory alternative. All women in Stage 2 studies will be required to sign an informed consent form and enroll in a registry. Both the woman and her physician must agree to abide by the conditions and followup required under the protocol. 29
Stage 3 studies will include both reconstruction and augmentation patients. In contrast to Stage 2s open availability protocols, Stage 3 patients must meet eligibility requirements as stipulated by the clinical protocol sponsored by device manufacturers. 30 These will be carefully controlled research studies for each model of silicone gel-filled breast implant that the manufacturer wishes to continue marketing. The studies will focus not only on specific safety questions (such as the frequency of calcium deposits, rupture, leakage, and capsular contracture, interference with mammography, and changes in the sensation of the breast), but also will evaluate the psychological benefits of breast implants. The studies will be limited to the number of patients required to answer the safety and efficacy questions with statistically reliable data. FDA must approve Stage 3 studies before they can begin.
In the case of women seeking breast augmentation, it is estimated that only about 2000 to 5000 of such women will be allowed in the Stage 3 research study. 31 32 FDA Commissioner Kessler estimates that the number of augmentation patients in Stage 3 may be hundreds or maybe a couple of thousand women. 33 Women desiring silicone gel-filled breast implants for augmentation will not be allowed access to the device outside the clinical studies; any such use of the device will be considered illegal by FDA. Saline-filled implants will continue to be available for augmentation and reconstruction surgery. As is the case in Stage 2, the womans physician must certify that saline implants are not a satisfactory alternative. Women in Stage 3 studies must sign an informed consent form and enroll in a registry, but they will also be followed more closely to check for problems related to the implants. Because it will take more time to design Stage 3 studies, they will not begin as rapidly as Stage 2 studies.
Stage 3 studies will not answer questions about possible long-term risks (such as cancer or immune-related disorders) of silicone gel-filled breast implants. Such questions will be addressed by studies of women who already have implants. Two studies (sponsored by the manufacturers) have begun at the New York University and the University of Michigan; the results are expected in three to five years. FDA is working with current and former manufacturers to set up a centralized registry so that women with implants can be notified quickly of significant new findings about the devices. 34

A third study, sponsored by the National Cancer Institute (NCI) will begin in 1992. NCI is planning a five year $2.1 million study of more than 9000 women with breast implant augmentation. In the Senate report on the 1992 appropriation bill for the Department of Health and Human Services (S.Rept. 102-104), the Senate Appropriation committee called upon NCI to conduct a longitudinal study of the risks associated with breast implants. The NCI study will attempt to answer questions about cancer, autoimmune diseases and other complications caused by the device, such as interference with mammography and early detection of breast cancer through clinical examination. The study also plans to include women who have received polyurethane coated breast implants in order to determine if they are at increased risk of cancer.
Six members of Congress (Reps. Marilyn Lloyd, Mary Rose Oakar, Patricia Schroeder, Olympia Snowe, Henry Waxman, and Ted Weiss) signed an April 6, 1992, letter to NIH Director Bernadine Healy expressing concern that the NCI study does not include breast cancer patients who have chosen implants for reconstruction purposesWhile we understand that studying cancer patients would make a study more complicated and expensive, we believe it is essential that cancers patients be included.
The FDA is allowing patients access to the device for reconstruction as a public health need, and therefore insurance companies may continue to cover this procedure if they are so inclined. In the case of breast augmentation, most insurances did not pay for such surgery before the moratorium. Manufacturers will now be required to obtain an investigational device exemption from FDA before conducting a clinical trial on the use of silicone gel-filled breast implants for breast augmentation. Implants for augmentation would be considered an experimental procedure, which is not usually covered by insurance plants. Following the moratorium and the withdrawal from the market of several breasts implants manufacturers, the price of implants has increased from $450 to more than $1000. 35
BASIS OF FDA DECISION: DEFICIENCIES IN SAFETY DATA
Some critics of FDAs April 1992 decision argue that 30 years of using silicone gel-filled breast implants in the United States has not shown the devices to be unsafe. However, the 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act require that the manufacturer must prove that the device is safe and effective, not that the FDA produce proof that the device is unsafe. Following enactment of the 1975 Amendments, silicone gel-filled breast implants were allowed to remain on the market with the understanding that FDA would eventually require that such devices would have to meet the same standards as the new devices. FDA has determined that there are serious deficiencies in the safety data on silicone gel-filled breast implants submitted by the manufacturers. Dr. David Kessler, Commissioner of the FDA, has indicated that even after more than 30 years of use involving more than 1 million women, adequate data to demonstrate the safety and effectiveness of these devices do not exist. 36
Cancer
The possibility that silicone gel-filled breast implants could cause cancer is one potential risk associated with use of this device. Studies performed by Dow Corning found that silicone gel implanted in laboratory rats caused a particular type of cancer, called a fibrosarcoma, to develop in the animals. However, laboratory rats seem to develop sarcomas in response to many implanted inert materials and the phenomenon is thought to be species specific. Silicone has not yet been shown to cause cancer in human subjects. Two studies have looked for breast cancer in women who had breast augmentation surgery and both studies found no increase in breast cancer compared with the general population.37 38 However, since cancers may sometimes develop 20 to 30 years after exposure to a chemical, these two studies, which followed the patients for an average of ten years, may not have studied women for a long enough period of time. Other studies are underway (at New York University, the University of Michigan and NCI) which will be looking at the long term risks of breast implants, including cancer.
It is unclear if other cancers, besides breast cancer, might be associated with the use of silicone gel-filled breast implants. However, silicone has been used in medical applications, such as a lubricant for syringes, since World War II. In its solid form, silicone is used to coat pacemakers and to make medical tubing, prosthetic joints, hydrocephalus shunts, penile implants and implanted drug delivery systems.39 Medical grade silicone (simethicone or dimethicone) is used in many drugs, including over the counter medications for adults (Digel) and children, as well as infants (Mylicon, an anti-colic medication). Currently, silicone is used extensively in the food, beverage, and cosmetics industries. It is estimated that an insulin-dependent diabetic may inject 25,000 to 50,000 microdroplets (25 to 50 grams) of silicone over a lifetime. It has been argued that if there were an associateion between the use of silicone and the development of cancer or other diseases in humans, it would have been determined by now.
There is also apprehension over the possible risks associated with one particular type of breast implant. About 10 percent of implanted silicone gel-filled breast implants have a polyurethane foam coating. The coating is thought to decrease the occurrence of the most common complication of breast implant surgery, capsular contracture (discussed on CRS-16). In April 1991, the manufacturer (Surgitek) voluntarily stopped marketing the foam-coated implants when concerns were raised about the potential cancer risk from TDA (2,4-toluene diamine), a chemical breakdown product of polyurethane. TDA is classified by the Federal Government as a hazardous chemical. Workers handling TDA are advised to wear rubber gloves, plastic coveralls and respirators. 40 TDA has been shown to cause cancer in laboratory animals, but a link to cancer in humans has not been conclusively proven. Trace amounts of TDA have been found in the urine and breast milk of women with this type of implant. FDA has conducted its own tests and confirmed that under laboratory conditions, TDA is produced when polyurethane breaks down. The agency is requiring the manufacturer to perform further studies.
According to the FDA, there is not enough evidence to justify having polyurethane-coated breast implants removed because of concerns about cancer. 41 In fact plastic surgeons have found that removing polyurethane-coated implants can be disfiguring and lead to chronic infection, drainage from the breast and skin ulceration.42 The foam begins to break down after one week in the body. If the implant is removed before the foam breaks down completely (which is thought to occur after 18 months), tiny pieces of the foam may be left behind causing infections which are very difficult to treat.
CANCER DETECTION: MAMMOGRAPHY
Another concern is the possibility that silicone gel-filled breast implants can decrease the ability to detect early breast cancer both on clinical examination and through the use of mammography. FDA cautions that it is especially important for women who are at high risk for breast cancer to consider this carefully before implant surgery. Silicone gel appears opaque on mammograms, and therefore such breast implants could hide the occurrence of a breast tumor. Because of this, other types of implants materials, such as peanut oil, are being investigated. However, breast implants of any composition can impede the interpretation of mammograms, more because of the compression of breast tissue than because of the opacity of the implant.43 In spite of this, the American College of Radiology believes that an adequate examination can be achieved with commonly available techniques, and does not support restricting the use of breast implants. 44 45 FDA warns that since mammography involves the compression of the breast, implants may be weakened or ruptured during the procedure.
CANCER TREATMENT IN WOMEN WITH IMPLANTS
Regardless of whether silicone gel-filled breast implants are ever found to cause breast cancer, some women with implants will develop breast cancer and require treatment for the disease. The presence of the implant may not only delay the diagnosis of early breast cancer, but a report in the medical literature indicates that cancer treatment may result in complications for women specifically related to the implants. 46 Lumpectomy and whole-breast irradiation is currently the preferred treatment for early-stage breast cancer. The report found that more than half of breast augmentation patients in the study had significant capsular contracture (painful or disfiguring tightening of scar tissue around an implant) in the irradiated breast following completion of cancer treatment. Some of the patients required additional surgery to correct the poor cosmetic results from the scar-tissue contracture.
IMMUNE RELATED DISORDERS
Concerns have been raised about reports of immune-related disorders, such as scleroderma, lupus erythematosus, rheumatoid arthritis, and Sjogrens syndrome, in some women with silicone gel-filled breast implants. These are relatively rare disorders in which the body attacks its own tissues as though they were foreign. These disorders can cause long-term, serious health problems. Symptoms include pain and swelling of joints; tightness, redness or swelling of the skin; swollen glands or lymph nodes; unusual and unexplained fatigue; swelling of the hands and feet; and unusual hair loss. 47 Patients may experience a combination of these and other symptoms. 48
There have been about 80 cases reported in the medical literature alleging an association between breast implants and immune-related disorders. The interval between implant surgery and onset of symptoms ranged from 6 to 15 years in one report.49 In some cases when the implant is surgically removed, the patients condition improves. However, accounts correlating breast implants with the development of immune disorders have been criticized as being individual case reports, most without adequate laboratory study, clinical documentation, or follow-us. 50
Because long term studies of women with breast implants compared with an appropriate control group are not available, it is not known if autoimmune disease is occurring at a higher rate in such women than in women without breast implants. However, internal Dow Corning memoranda indicate that in the mid 1970s the company was studying the possibility of using silicone as an adjuvant in vaccine trials in order to increase the level of immune system response to the vaccine agent. 51 Such studies would tend to support the theory that silicone gel which has leaked from an implant could be stimulating the immune system in some women, thereby causing the observed immune-related disorders. Researchers at the University of Texas have found antibodies that attack silicone in women with breast implants who were also suffering from autoimmune diseases.52
The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) are calling for applications for studies focused on the short-term and long-term effects of silicone on the immune system and it function and how these effects might contribute to the initiation of immune-related disorders.53 NIAID plans to award about three grants and NIAMS plans to make one grant; total funds available for the first year are no more than $650,000.
IMPLANT RUPTURE
The durability of silicone gel-filled breast implants is another area with many unanswered questions. Because the augmentation patient may often be a young woman in her 20s, it is important to have information on how long the device would be expected to last in the body. For example, should a 20 year old breast augmentation patient expect to have her implants surgically replaced, due to rupture or other complications (such as capsular contracture), every five years or every ten years the rest of her life? The FDA Commissioner has stated that we know more about the lifespan of automobile tires than we do about the longevity of breast implants. 54 The Commissioner has further delineated his reservations about the integrity of silicone gel-filled breast implants as follows:
Although manufacturers reports suggest a frequency of asymptomatic rupture between 0.2 and 1.1 percent, preliminary findings presented at the FDAs advisory panels meeting in February suggest that in 4 to 6 percent of asymptomatic women with implants the devices have ruptured. It is never possible to predict with certainty how a device will function 10, 20, or 30 years after its implantation, however, even basic characteristics that have some value in predicting future performance, such as tensile strength and fatigue resistance tested through cyclic loading, are lacking in this case. The chemical composition of the gel that leaks into the body when a breast implant ruptures is unknownSerious questions remain about the ability of manufacturers to produce the device reliably and under strict quality controls. 55 Until these questions are answered, the FDA cannot legally approve the general use of breast implants filled with silicone gel. 56
Breast implants can rupture due to injury or normal wear over time. If an implant has ruptured, FDA recommends that it be removed. However, it may be very difficult for the surgeon to remove all the silicone gel which has escaped from the implant envelop. If the silicone gel has migrated away from the breast to other areas in the body, it may be impossible to identify all such sites and remove the gel. Surgery to remove breast implants can take two to five hours. The cost of implant removal has been estimated at between $1000 and $5000, 57 but may be as high as $20,000 depending on the complications encountered during the procedure.58 While most group health insurance plans already cover the cost of treating implant complicationssome insurers may label implant problems a pre-existing condition, and therefore, will not pay for removing the device. 59
In addition to these financial and insurance difficulties, women with breast implants reportedly are having difficulty in finding plastic surgeons willing to remove the device. 60 Some plastic surgeons tell breast implant patients that removal of the device will cause deformity, and they encourage such women to get replacements even if theyre not interested. 61 According to a member of the Boston Womens Health Book Collective, the lack of surgeons willing to remove implants seems fairly wide spread. 62 Plastic surgeons may be hesitant because of potential lawsuits since removing the implant may be seen as admitting it is unsafe. Some have speculated that insurance companies may also be advising surgeons not to remove breast implants.
Even critics of FDAs April 1992 decision concede that breast implant rupture can be difficult to diagnose. Unless the patient experiences symptoms (such as pain, breast implants, or change in breast contour or shape), rupture will remain undetected. It is unknown at what frequency such silent rupture occurs. Physical examination does not always detect rupture and at the present time there are no totally reliable imaging methods for this objective either. Although mammography is often used to diagnose rupture in symptomatic women, it is not completely accurate for this purpose and FDA does not recommend routine mammograms to detect silent ruptures. Because mammography utilizes ionizing radiation, it should be avoided if possible in younger patients because of the risk of cancer. Imaging methods which do not use ionizing radiation, such as ultrasound, and magnetic resonance imaging (MRI), are still being examined for their utility in detecting implant rupture. FDA does not recommend these methods for routine screening of women with silicone gel-filled breast implants.
GRANULOMAS
Regardless of whether or not the silicone gel-filled implant is intact, such devices leak small amounts of silicone into the body; this is often referred to as gel bleed. Scar tissue may develop around loose silicone gel, which can result in the formation of tumor-like masses called Granulomas. 63 64 Such masses can be physically deforming. Although Granulomas can be surgically removed, their removal may cause further scar formation and deformity, not to mention the anxiety the patient may experience while waiting for the results of the biopsy report.
CAPSULAR CONTRACTURE
Capsular contracture, the often painful or disfiguring tightening of scar tissue around the implant is the most common complication of breast implant surgery. One plastic surgeon describes capsular contracture as follows:
Even in the best of hands and even with the most reliable prosthesis in terms of manufacture and origin, the major risk of a fibrous capsule still persists. As a result of this complication, the most beautiful operation is doomed to failure with sometimes severe and always unacceptable morphological and psychological implications. 65
When foreign materials, like silicone, are placed within the body tissues, a fibrous membrane, called a capsule, forms around the implanted material. Contraction of the capsule and compression of the pliable gel implant results in breast firmness. These levels of contracture are measured on a scale of 1 to 4: one is so soft that it is virtually undetectable and 4 is as hard as a grapefruit. This contracture can occur immediately after surgery or many years later and can appear in one or both breasts asymmetrically. 66 In some implant patients, a thick capsule forms within a few weeks of implant surgery;67 in other studies this complication occurred up to 11 years later. 68
Polyurethane foam-coated breast implants also develop capsular contracture, but possibly at a lower rate. However, some surgeons speculate that the foam may only delay the occurrence of contracture. One study reported contracted capsules in 22 percent of smooth implants versus 13 percent of polyurethane coated implants.69 Another report found fibrous capsules in 2 to 3 percent of patients with polyurethane coated implants versus 50 percent with uncoated silicone gel-filled implants. 70 The hardness of the breast may be related to the thickness of the capsule that forms around the implant. 71 In one report of six severe cases of capsular contracture, this complication caused atrophy of mammary glad tissue and the underlying muscle. 72 Placing the implant beneath the chest muscles is thought by some surgeons to decrease the incidence of hard breasts due to capsular contracture. A report in the literature, however, noted that some patients have experienced pain and deformity with this placement of the implant. 73 Surgical exploration of the patients determined that the muscles had become detached from the ribcage, requiring removal of the implant or repair of the muscle.
FDA warns that capsular contracture can make it more difficult to detect breast cancer. The agency recommends surgery to remove the scar tissue in order to correct the problem if the patient requires relief from pain or disfigurement. Closed capsulotomy, a non-surgical procedure in which the doctor forcefully squeezes the breast to break up scar tissue, should NOT be performed. 74 This procedure can rupture the implant and is also not recommended by the manufacturers of some breast implants. However the ASPRS states that:
Some physicians, based on clinical experience, feel that closed capsulotomy is an appropriate treatment in some patientsThe decision to undertake this procedure, as for any surgical procedure, should be decided by consultation and agreement between physician and the patient. 75
Contracture can recur after corrective surgery or closed capsulotomy.
DOW CORNING IMPLANTS
On March 19, 1992, Dow Corning Corporation announced that it will stop manufacturing its silicone gel-filled breast implant. On April 14, 1992, the company announced that it was withdrawing its PMA for silicone gel-filled implants and has started to recall all unused implants from medical practitioners. Prior to the moratorium, Dow Corning was the leading manufacturer of silicone gel-filled breast implants in this country with a 30 percent share of the market. About 750,000 Dow Corning silicone gel-filled implants have been sold and implanted, according to the company. Dow Corning will continue to provide silicone gel to other implant manufacturers until it is no longer obligated to do so under existing contracts.
Dow Corning stated that the reason the company is leaving the market is not because they believe the device is unsafe. According to the companys chairman, breast implants have never been a profitable product for Dow Corning and with the controversy surrounding the implant, there would be little possibility of business improving. Sales of the silicone gel-filled breast implant amounted to less than one percent of Dow Cornings total sales last year of $1.85 billion, and the company claims that implants have never been more than one percent of total sales.
Although Dow Corning had $ 250 million in liability insurance, it is confronted with numerous lawsuits filed by women who claim that silicone gel-filled breast implants have injured their health. Several verdicts have gone against Dow Corning, including one for $7.4 million in California last December. 76 Estimates of potential company liability range up to more than $1 billion.
Dow Corning will be setting aside $10 million for research on the safety questions associated with the use of its breast implants. The company also stated that it will offer up to $1200 per patient to assist women with Dow Corning implants whose physicians recommend that the implants be removed, but the women cannot afford the surgery. Dow Corning will not require women receiving financial assistance to sign a release protecting the company from future lawsuits in return for the money. However, in the past, Dow Corning had asked women to sign such agreements. 77 In February 1992, the company had originally offered $1000 in financial assistance to women unable to pay the cost of surgically removing their breast implants. Implant removal costs range between $1000 and $5000, but may be as high as $20,000 with complications. Some insurers may consider implant problems a pre-existing condition and refuse to pay for removing the device. (See page CRS-15)
POLYURETHANE COATED IMPLANTS
In August 1991, FDA notified Surgitek, a division of Bristol-Myers Squibb Co., that it had not received enough data to conduct a review of its silicone gel-filled breast implants and gave the company 10 days to appeal the decision or its implants could not continue to be marketed. 78 In September, Bristol-Myers Squibb announced that it would not appeal the agencys decision, and that it was withdrawing from the breast implant business. The companys state reason was that it could not meet FDAs deadlines for submitting safety data. Bristol-Myers plans to continue to conduct research on the safety of its polyurethane implants.
In 1991, Bristol-Myers Surgitek was the sole manufacturer of the polyurethane foam coated silicone gel-filled breast implants (trade names: Meme, Optimeme, and Replicon). According to a March 25, 1992, article in the Wall Street Journal, the device was originally manufactured by Heyer-Schulte Corp., a medical device company located in Santa Barbara, CA. 79 In the mid 1970s Heyer-Schulte officials became concerned over reports of inflammation caused by the implant and decided to stop making it. Subsequently, the implant was made by Aesthetech, a Paso Robles, CA, company, and marketed by Natural Y which was based in Los Angeles. Aesthetech was bought by Cooper Cos., a New York health-care conglomerated, in 1987; in December 1988 Cooper sold Aesthetech to Bristol-Myers Surgitek unit. 80
About 10 percent of implanted silicone gel-filled implants have the polyurethane foam coating. The intended purpose of the foam coating on the implant was to decrease the risk of capsular contracture(discussed on page CRS-17. The polyurethane foam used to coat the implant is made by Scotfoam of Eddystone, PA. The foam is primarily used in air filters for cars and carpet cleaning equipment. Scotfoam never intended that its product would be used in medical applications, and only learned of use of the foam on breast implants as a result of a Florida lawsuit. In 1987, when Scotfoam found out that its industrial foam product was being used to coat breast implants, they told the implant manufacturer that Scotfoam didnt recommend its product be used in people. 81 The discovery process of the Florida liability lawsuit (which involved Aesthetech) determined that the hazardous chemical TDA (discussed on page CRS-12) was produced when polyurethane foam is chemically broken down.
According to the March 25th Wall Street Journal article, FDA first became aware of a potential problem with the polyurethane-coated implant in October 1981.82 At that time Natural Y was marketing the product. An FDA consumer safety officer wrote in a memorandum that the prosthesis is covered with a polyurethane foam which may tend to disintegrateIn addition, certain polyurethanes are known to be carcinogenic. The article states that FDA did not investigate this information and did not discover that TDA is produced when polyurethane foam disintegrates until a chemist involved in the discovery process of the Florida liability lawsuit wrote to the agency.
BIOPLASTYS MISTI GOLD IMPLANT
In July 1991, Federal marshals in Minneapolis seized 800 silicone gel-filled breast implants made by Bioplasty under the trade name Misty Gold because the company had made misleading and unproven claims about the devices. The companys advertising stated that the implant allowed for easier detection of breast tumors using mammography and reduced the risk of the breasts hardening. FDA also ordered Bioplasty to recall more than $740,000 of the Misti Gold implants it had sold. 83 FDA had previously warned the company against claiming that its product was superior to others. In March 1992, Bioplasty announced that it would stop making breast implants. 84
CONGRESSIONAL ACTION
On December 18, 1990, the Human Resources and Intergovernmental Relations Subcommittee of the House Committee on Governmental Operations held a hearing on FDA and the regulation of silicone gel-filled breast implants. 85 In February 1992, Rep. Ted Weiss, Chairman of the Subcommittee, asked the Justice Department to conduct a criminal investigation into whether Dow Corning misbranded its silicone implants by making false statements and misleading safety claims and misrepresenting its research results to medical professionals and FDA regulators. 86
The Breast Implant Informed Decision Act (H.R.3783) was introduced in the House on November 14, 1992. The bill conditionally requires States to enact laws which require physicians and surgeons to inform individuals who have breast implant surgery of the risks associated with and the complications arising from such surgery. Passage of such a law would be necessary for the State to qualify for Federal funds under Title V (Maternal and Child Health Block Grants) and Title XIX (Medicaid) of the Social Security Act and Title XIX (Block Grants) of the Public Health Service Act. 87
DISCUSSION
FDA Commissioner Kessler has indicated that the April 16, 1992 decision on silicone gel-filled breast implants was one of the most controversial decisions ever made by the agency. 88 The decision has been criticized by some as being paternalistic and sexist. 89 Dr. Norman Cole, president of the ASPRS, stated that we continue to be disappointed that the government has placed itself in the role of judging the morality of a womans reason for choosing breast implants. The needs of women who seek augmentation of their breasts are poorly understood by those who do not share this desire. 90
In an editorial in the New England Journal of Medicine, the executive editor of the publication, Dr. Marcia Angell, contends that the benefits of breast implants are subjective, personal judgments about the quality of life, and therefore are given short shrift by the agency. 91 Dr. Angell charges that Dr. Kessler may be holding breast implants to an impossibly high standard; since there are no benefits, there should be no risks. 92 Others argue women should be allowed to make their own decisions about the risks versus the benefits of breast implants. Dr. Kessler counters this argument with the following:
If members of our society were empowered to make their own decisions about the entire range of products for which FDA has responsibility, then the whole rationale for the agency would cease to exist. People would simply communicate directly with manufacturers to design their own drug regimens or select medical devices. 93
On the other end of the spectrum are those who feel that no one should be exposed to the unknown levels of risks associated with silicone gel-filled breast implants. Dr. Sidney M. Wolfe of Public Citizens Health Research Group (which petitioned FDA in 1988 to ban silicone gel-filled breast implants) stated that FDA would have been more responsible to reject the advice of the advisory committee and call this who things off. 94
In response, FDA agrees that the manufacturers have not sufficiently demonstrated the safety of breast implants and therefore the device should not be generally available. At the same time, FDA believes that these is a legitimate public health need for the limited continued availability of the device, especially for the breast cancer patient who feels that reconstruction is an integral part of the treatment of this disease. 95 The Medical device Amendments of 1976 provide an exception to the requirement that devices have to be demonstrated to be safe and effective in order to remain on the market, and that is when there is a public health need for the device.
Although FDAs decision has drawn a significant level of criticism, many have commended FDA on a rational solution to a difficult and complex dilemma. Even the critics have found some merit in the decision. Dr. Norman Cole, president of the ASPRS, stated that This is the first sign that science, logic and compassion are being returned to the review process for these devices. Throughout this debate, our great concern has been for the women who are most affected by the restrictions on the use of this device. We are relieved that their most pressing needs will now be addressed. 96
The president of the American Society for Aesthetic Plastic Surgery, Edward Truppman, welcome the wide access to silicone implants for reconstruction, but at the same time he complained that the decision to treat implants for cosmetic purposes as experimental will only confuse women. 97
The president of Mentor Corporation, Dennis Condon, stated that I think its a very fair decision for everyone. The patients who really need this device will continue to have access to it. The agency will be able to answer its questions and the manufacturers will be able to continue with their testing. 98
The co-founder and director of counseling at Y-Me, Ann Marcou, called FDAs decision just about the best decision that could have been made. Its really what I would call a compassionate decision. It helps women with breast cancer, who are in a terrible dilemma, and also establishes a basis to collect some solid scientific research. 99 Y-ME is an information and support group for breast cancer patients.
Esther Rome, of the Boston Womens Health Book Collective, declared the FDA decision a big step forward in regulating these devices. 100 However, she referred to a memo that the ASPRS wrote to FDA a few years ago which suggested that small breasts are really a diseaseWhos going to define serious congenital deformities? 101 In FDAs August 3, 1992, announcement of the agencys approval of Mentors clinical studies, the FDA recognizes that severe breast or chest deformityis a subjective assessment, the physician must judge the severity of the deformity and certify that there is a medical need for corrective surgery. 102
In a statement released on the day of FDAs final decision, Rep. Ted Weiss called the decision a reasonable compromise. Any women who now chooses silicone implants will understand that she is participating in a massive experiment. Rep Marilyn Lloyd, while expressing concern over the rigid FDA rules, hailed the plan as a victory for women who had their health put on hold by the FDAs moratorium. 103
CONCLUSION
As with many complex health policy decisions, there probably will never be a consensus on the right course for FDA on the issue of silicone gel-filled breast implants. Perhaps the best fallout from the debate surrounding breast implants is that the public is re-exposed to the idea that the practice of medicine is still filled with uncertainties, and there are no guarantees. According to the FDA Commissioner, The public needs to understand that when a device is implanted, there is no such thing as zero risk. We have to be willing to expect that there will be problems 15 or 20 years down the road. 104

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APPENDIX: RESOURCES FOR BREAST IMPLANT INFORMTION

1. Breast Implant Manufacturers
Bioplasty (800)328-9105
Bristol Myers Squibb (Surgitek) (800)634-4397
Dow Corning (800)442-5442
Mentor (800)525-9151
McGhan (800)624-4261
2. Food and Drug Administration (FDA)
For information on Breast Implants (800)532-4440
(800)945-6380 or (301)443-3170
To Report Problems with Breast Implants (800)638-6725

3. American Society of Plastic and Reconstructive Surgeons (800)635-0635

4. Other Organizations Providing Breast Implant Information

American Silicone Implant Survivors (ASIS) (314) 821-0115
Breast Implant Information Foundation (714) 830-2433
Citizens Coalition for Truth in Science (202) 628-0752
Command Trust Network (213) 556-1738
Maryland Department of Health 410) 225-6774
Medic Alert, Breast Implant Registry (800) 344-3226
Or (800) 892-9211
National Womens Health Resource Center 202) 293-6045
National Womens Health Network (202) 347-1140
Public Citizen Health Research Group (202) 833-3000
Scleroderma Support Group (714) 892-5297
U.S. Pharmacopia (800) 638-6725
Western NY Breast Implant Foundation (716) 433-6432
Y-Me (800) 221-2141