Over the course of ten years, one of the most popular breast implants - made of the same industrial foam used in furniture upholstery - was ignored by the FDA, barely tested by its manufacturer, and promoted by doctors who were given shares of the profits. Thousands of women believed the implants were safe. They were wrong.

    There seemed to be no reason not to have new breasts. Would any surgeon amputate an arm or a leg and not offer a replacement? "This is why I thought it would be easy to be reconstructed and complete my cancer process," Goldrich says. She discovered that at least twenty thousand women each year were having their breasts reconstructed with silicone-gel implants following cancer surgery, and another eighty thousand were electing to have implants for cosmetic reasons. Goldrich interviewed three reputable plastic surgeons before settling on Dr. Kurt Wagner; each assured her that the procedure would be simple with very little risk involved. "My surgeon seemed confident, so I too was confident," she says.

    But immediately after Wagner inserted the foam-covered implants in July 1983, Goldrich developed an infection. When her bandages were removed over two months later, she had her first good look at herself in the bathroom mirror. "My heart sank," Goldrich says. "There were two baseball-shaped protrusions from my chest wall and a small red scar clearly visible two inches below them. Those were breasts? They were hard as rocks. Nothing like the milky, flesh-toned breasts that I had expected."

    Desolate, she put on her shirt and curled up into a ball on her bed. "I thought of myself as a two-time loser," she says. "First cancer, and now this. My body had obviously rejected the implant." Two years later, after five surgeries and countless days of pain and suffering, Goldrich had a different idea of what had gone wrong. By then, news had trickled out about the dangers of breast implants: they hardened, they ruptured, they blocked a mammogram's ability to screen for cancer. Goldrich already had to live with fears about a recurrence of her breast cancer, but now she has a new worry. There is reason to believe that the leakage of silicone and a chemical from the implants' foam could itself cause increased risks of inflammatory diseases or cancer.

 

.   BEHIND THE STORY       When reporter Nicholas Regush first co-wrote a documentary for the Canadian Broadcasting Corporation on breast implants in 1980, the main controversy was whether the implants were hardening in women's bodies. "There were a lot of people, even plastic surgeons, talking about the need for a moratorium on implants, and the documentary basically highlighted that," Regush says. The film caused a bit of a stir, but nothing really came of it. Even so, Regush kept his eye on the progress of implants off and on over the course of the decade.     Then, in 1988, Dow Corning released a report saying that implants were proving carcinogenic in rats. The day he read the report, Regush went to see one of Montreal's most prominent plastic surgeons, who only wanted to talk about the Même. "The doctor told me he wouldn't implant the Même in any woman, because the company couldn't tell him what happened to the foam in the body," Regush says. "By the time I'd left the office, I heard enough to make me concerned."     Regush started digging and uncovered Canadian health - department memos indicating a suppressed controversy over the Même. A few weeks later, he came across a University of Florida study showing that the Même's foam released a carcinogenic substance in laboratory tests. In January 1989, Regush published an article in the Montreal Gazette, the first major story to appear anywhere about the Même and its potential cancer risks. The paper was flooded with calls from all over the world requesting copies of the piece, and the debate on the safety of breast implants subsequently landed on the floor of Canada's Parliament.     Regush has kept on the story ever since, systematically investigating Surgitek, the Même's most recent manufacturer, as well as the FDA'S history of inattention to implants. He's published about forty news stories on the Même; his Mother Jones piece draws from those articles as well as from original research that delves further into the reasons that an untested medical device was implanted in 200,000 women. "The implant situation has made me realize, more than anything I'd done, just how bad the treatment is that women receive from medicine, science, and even doctors," Regush says. He also says that the story doesn't end here: "I'm still concerned about the ongoing lack of proper guidelines and public discussion on what women should be considering about implants." .

 

    Breast implants, of course, are not the only form of plastic surgery that has gained popularity in recent years. The numbers of face-lifts, tummy tucks, liposuctions, nose jobs, and lip implants have all skyrocketed over the last decade, as has the number of doctors who perform them. "Everywhere you look, there are impossible and conflicting images of women," says Robin Lakoff, coauthor of Face Value: The Politics of Beauty. "Women are made to believe that love and approval from men are dependent on the right image. That desperation will continue until women become looked upon as full people rather than just body parts."

    About 750,000 women a year elect to have cosmetic surgery, spurred on by ubiquitous images of the body beautiful, by husbands or boyfriends, and by doctors' newspaper ads that make nip-and-tuck look as easy as highlighting one's hair. In Houston last March, plastic surgeon Dr. Franklin Rose took out an ad in the Houston Chronicle, explaining that the "cultural influence is such in this city that for a woman to feel attractive usually includes a Mercedes, a gold Rolex, and three or four operations-nose, breasts, liposuctions. It's just part of living in this city in a certain way, in a certain socioeconomic strata." The ad ends like this: "The Texas woman is a combination of many things, not the least of which is a surgeon's scalpel."

    But breasts, more than thin thighs or a smooth brow, are most potent as a symbol of women's sexual self-worth. So it's not surprising that over 2 million women have had breast implants, and 130,000 more seek them each year. Breast augmentation is a $450-million-a-year business, as the American Society of Plastic and Reconstructive Surgeons, Inc., a lobbying group of 4,500 doctors, is well aware. During a "practice enhancement" campaign in the early eighties, the group issued a memo to the FDA, asserting, "There is a substantial and enlarging body of medical information and opinion to the effect that these deformities [small breasts] are really a disease" that, left uncorrected, results in a "total lack of well-being."

    Among the most popular "cures" for this "disease" over the last decade has been the Même implant, a silicone-gel sac with a unique polyurethane foam cover that was supposed to prevent breast hardening. Since its development in 1982, the Même has captured over a quarter of the current implant market; over 200,000 women carry the Même in their bodies. But in spite of the large numbers of women opting for the "improved" implant, the foam used for its cover-originally manufactured for use in such things as furniture upholstery, oil filters, and carburetors-went almost completely unmonitored for eight years.

    It wasn't until last April that the Food and Drug Administration released a report showing that, in conditions similar to those in the body, the foam can release the chemical 2,4-toluenediamine (TDA), which causes liver cancer in rats and is a suspected human carcinogen. Days after the announcement, the Même's manufacturer, Bristol-Myers Squibb, pulled the implant from the market and, in September, the company closed down its plastic-surgery unit that produced the Même.

    Most of the Même's recipients thought that they were making a relatively risk-free decision to augment their breasts. They were never warned of the implants' potential dangers. There are now several dozen injury suits against the three successive manufacturers of the Même. In one recent case, a New York jury awarded a woman $4.45 million (the case is under appeal); in another, a California woman settled out of court for $450,000. A class-action suit against Bristol-Myers Squibb is being prepared in Canada.

    Some lawyers are predicting that these suits, along with the several hundred in process against the makers of other types of breast implants, will eventually rival the multibillion-dollar litigation fight against A.H. Robins, which manufactured the Dalkon Shield IUD. But as with the Robins suit, financial reparations won't change this simple fact for many women: They were told the Même implant was safe, that it wouldn't hurt them, by manufacturers and doctors who should have known better-and the dangers were then ignored by the government agencies that were supposed to protect them.

    It is early morning in Ottawa. Pierre Blais, a private consultant on medical products, is in the basement laboratory of his home. As the Canadian government scientist who blew the whistle on the Même in January 1989, Blais has been inundated with requests from former implant users and their doctors and lawyers. Sets of damaged Même implants and other silicone-gel types without the foam arrive by courier almost daily from different parts of the United States and Canada, along with medical records and mammogram results. The packages are beginning to pile up in the living room upstairs.

    Among the eighty or so sets of damaged implants he's received so far, Blais says that ones with broken covers are the most common. The gel released from the silicone sacs has often seeped into armpits and lymph nodes. In one typical case, an implant deflated, and leakage on both sides began to erode the user's ribs. Some of the women who have contacted Blais have also complained of symptoms ranging from sharp pain in their breasts and pelvic regions to inflammation and severe fatigue. "I'm not only worried about the potential of the implants to cause cancer," says Blais, a small, wiry fifty-one-year-old, "but also that their chemical constituents may wreak havoc in the body over the long term."

    Right now, Blais is examining two Même implants. Only they don't look much like implants. The two buckets on his desk that are holding the products are filled with greenish gel. That is what is left of fifty-two-year-old Janie Cruise's surgically implanted breasts. It took almost seven hours on March 1, 1990, for doctors at the University of California Medical Center in Los Angeles to make unexpectedly large incisions under Cruise's breasts and then scrape out the seemingly endless amounts of infected green ooze from her chest wall. The smell of the infection was so bad that the chief surgeon became ill.

    While Cruise's case may be extreme, Blais says that her history is all too typical. Cruise, then forty-four, was living in Southern California when she decided to get implants. Her seven-year marriage had just fallen apart, and she was facing re-entry into the singles scene. Encouraged by a close friend - "Janie, you'll look flawless!" - Cruise handed over a few thousand dollars for what seemed like a miracle cure for her sagging self-confidence. "My girlfriend planted the seed and it started growing," Cruise says. "I especially wanted to look nice in a bathing suit."

    Cruise's plastic surgeon, Dr. Howard Sterling of Fullerton, California, assured her that the Même, a new implant, would keep her breasts soft and give her a "happy surgery." The doctor was known to brag that his own wife was a pleased Même user.

    Within a couple of days after her surgery on November 22, 1983, Cruise felt severe pain in her left breast, but Sterling shrugged it off. "He said his wife had similar pain, and he called us both big babies," Cruise recalls. "So I never bothered going back to him."

    The following year, Cruise quit her job as a regional sales manager for a piano distributorship and moved from California to Florida, hoping to start a new life. The breast pain journeyed with her. Then came the severe headaches, fatigue, muscle and joint pain, numbness in her right hand, bronchitis, and gastrointestinal ailments; often, when she would wake up in the morning, her chest felt like someone was sleeping on it. All of these symptoms and more, she says, "sort of evolved over a period of a year and a half."

    She visited one medical specialist after another - about two dozen all told. She took medication for her pain, enrolled in pain clinics, tried biofeedback, and talked with a psychologist. Nothing helped. "There was not one single suspicion voiced that my symptoms might be linked to the implants," she says. Cruise began blaming her medical problems on the damp Florida weather. Now she is waiting for Blais's evaluation of the evidence: Did her implants break because of design, or because of the use of substandard raw materials?

    Blais believes that most, if not all, of these products will fail in time. He says women who assumed that their doctors could be counted on to give them safe and effective breast implants misplaced their trust. "Plastic surgeons have been putting in a lot of junk that has been very poorly manufactured," he says. "It's never been made to last, and that means a lot of women are going to have broken implants and leaking gel and other chemicals and debris moving through their bodies. I'm very fearful that the health problems we are seeing today with all the implants are merely a hint of the disaster to come."

    Dr. Howard Sterling doesn't much remember Janie Cruise, one of his earliest Même recipients. Didn't she once send him porno-type pinups? No, wait. That was someone else. Oh, so Cruise had some problems. A lot of pain? Really? "Well, she never reported any of them to me," he says, ending that topic of discussion.

    But Sterling, who intermittently clears his throat and speaks very quickly into the phone, does want to talk about the Même. In fact, he boasts that he is "probably one of the plastic surgeons who has implanted the most Mêmes in the whole damn U.S. of A."- roughly 670 sets of the implants. Though he's never formally studied his Même patients, Sterling volunteers that most of them, including his wife, two daughters, and "girls" in his office, have had "beautiful experiences." His complication rate runs about 15 to 20 percent, but he says that's mostly because some of the implants harden.

    Sterling did have some fleeting concerns about the Même in 1983, the same year that Cruise had her surgery. Some of his patients were developing blood blisters between the implant's foam layer and the inner silicone-gel bag. The accumulation of blood made the implants heavier. "When I took the Mêmes out, I could see that parts had a shiny surface, indicating that there was little or no adhesion there to the foam," he explains.

    Why did he continue implanting the Même? "Because it didn't make breasts harden to the same extent as other implants did, and it was the best thing available at the time," he replies. And by 1984, his cases of blood blisters had dropped dramatically, perhaps partly because Sterling had stopped giving his patients an anti-inflammatory drug for infection control that was linked to blood-clot formation.

    Sterling also believed that the Même had a long history of safety because it was similar to the Natural-Y, a foam-covered implant developed for mastectomy patients. One of that implant's developers in the late sixties was Sterling's mentor, Dr. Franklin Ashley, who headed the plastic-surgery department at the University of California at Los Angeles. The other was Harold Markham, who became president of Natural-Y Surgical Specialties, Inc., and eventually masterminded the development of the Même. Schooled in advertising and marketing, Markham was previously a medical-device salesman and consultant.

    Ashley's published claims of good test results initially generated only sporadic clinical interest in the Natural-Y. Some doctors reported difficulties in removing the Natural-Y cleanly when hardening or infection developed. They said that the foam got entangled with breast tissue. In spite of that, by the late seventies, the implant had gained the faithful support of a small group of plastic surgeons, and Natural-Y, Inc., began work on a lighter, more-streamlined foam-covered implant, primarily for cosmetic purposes-the Même. "Because the Même was supposedly an improved design, we [plastic surgeons] assumed it was probably safe," Sterling says. "The company said it was. All we really knew is what the company told us."

    The company couldn't have provided Sterling with much in the way of clinical trial data on the Même. For example, it had sponsored a small, uncontrolled study, which followed only eighty-one Même recipients over eighteen months. Dr. Steven Herman, the New York City plastic surgeon who published the study in 1984, claimed excellent results for the implant. However, there was something Herman didn't mention: according to a detailed 1986 deposition, which includes a description of cutting checks, Markham claims that Herman undertook the study in exchange for a royalty on Même sales. (Herman continues to deny receiving any compensation from the company.)

    Early animal studies on the Même, which the company cited to plastic surgeons as further proof of the implant's safety, were of the shortcut variety, according to Pierre Blais. As senior scientific advisor to Canada's Health Protection Branch, an agency similar to the FDA, Blais reviewed numerous types of implants, and a colleague had brought the Même to his attention. "Their approach [to testing] was rudimentary," he says. "Sorely lacking was toxicological testing for the presence of chemical by-products of the foam in the body over the short and long term. Concerns had been raised by biomaterials scientists since the early sixties about the potential of some polyurethane foams to release toxic substances, if not carcinogens. But this issue was apparently not a priority for the company."

    Blais would later learn that, until June 1988, the Même's manufacturer had incomplete knowledge about the foam's chemical structure and the way the foam was produced. Instead of scientific study, the company relied heavily on promotional literature to sell the Même, including numerous testimonials from plastic surgeons about the "excellent results" they were getting with the implant. The anecdotes were packaged in the form of information bulletins by Markham's daughter, Jacqueline, who had a master's degree in fine arts. In a September 1986 bulletin, she stated emphatically that "there is absolutely no theoretical or factual basis for concerns about cancer with our foam."

    From 1987 until the implant was pulled from the market in April 1991, the right to manufacture the Même was sold twice: once to Cooper Surgical, part of the Cooper Companies, Inc., of New York, which primarily manufactures optical products, and then to Surgitek, a division of Bristol-Myers Squibb. In its grab for the implant market, Surgitek trumpeted the success of an Atlanta plastic surgeon, Dr. T. Roderick Hester, whose enthusiasm for the Même was such that he had implanted it in about twelve hundred women, almost doubling Sterling's mark. Like Sterling, Hester did not run a controlled study on his patients. But he did publish some data in Perspectives in Plastic Surgery in 1988, claiming that the Même was performing very well indeed; he was later forced to admit that his research was not carried out in a particularly rigorous manner. Meanwhile, he was paid a thousand dollars a crack on at least four occasions to speak at conferences on behalf of the Même; once, Surgitek paid his travel expenses to California so he could "explain clinical stuff" to company employees. "It's standard practice among surgeons to receive a small honorarium in exchange for their time," Hester says.

    The FDA has long been empowered to require more rigorous studies on breast implants. The agency could easily have directed manufacturers to conduct detailed studies on every aspect of the Même, especially its foam cover. But again and again, over two decades, FDA officials bowed to the interests of plastic surgeons and manufacturers and turned their backs on the women who used breast implants.

    In 1976, Congress passed amendments to the Federal Food, Drug, and Cosmetic Act, enabling the FDA to regulate the use of medical devices, including breast implants. But it wasn't until 1982 that the agency showed signs of making a move. With an eye on the lobbying by plastic surgeons, who were represented on its medical-device advisory panel, the FDA declined to take strong regulatory action. Instead, it only proposed that implants be placed in a category indicating that there was insufficient evidence to provide reasonable assurance of their safety and efficacy. It took another six years, during which time approximately half a million women received implants, for the FDA to notify manufacturers that they would be required to submit safety and efficacy data on their products for review. And it wasn't until last April-another thirty months and approximately 330,000 implants after the notice-that the ruling was finalized.

    According to investigations by the Human Resources and Inter-Governmental Relations Subcommittee, headed by Manhattan Democrat Ted Weiss, the concerns of FDA scientists about breast implants were blocked by higher-level agency officials for fifteen years. The FDA's press office says that the agency had more important regulatory priorities in mind, such as heart valves and AIDS drugs. But an independent federal report on the workings of the agency, conducted last May, places matters in much broader perspective. Various congressional assessments of the FDA also paint a picture of an agency severely cannibalized in the eighties by the Reagan administration's deregulatory philosophy and stingy funding, an agency that increasingly became more protective of business than of consumers. "FDA's inaction on breast implants was typical," says Weiss. "Unfortunately, the ruling philosophy has been 'Let the buyer beware!' "

    It was only in late 1987, after several women had filed personal-injury suits against Natural-Y and more than ten thousand Mêmes had been put in, that someone at Cooper Surgical began to take notice of the incomplete information available on the Même's foam. In one court case, University of Florida biochemist Chris Batich testified that he had demonstrated how the foam could release cancer-causing TDA under harsh, chemical conditions. After reviewing that testimony, Tom Powell, a Cooper Surgical vice-president, called chemist Ed Griffiths, product manager at Scotfoam Corporation, the foam's manufacturer. Griffiths confirmed that the product could release at least a small amount of the chemical.

    Griffiths had assumed that Cooper Surgical was using the foam for an industrial application. "My eyes popped out when Powell explained his company was buying the foam from a jobber in Los Angeles and using it as a covering for a breast implant," he recalls. "They had been using our foam for many years, and it was the first time that I or anyone else at the company had heard about it." Griffiths then advised Powell that Scotfoam didn't recommend such use in implants due to a lack of long-term data on the foam's suitability and health effects. "I wanted him to know that we had no expertise in determining the suitability of the foam in medical applications and it was his - the end user's - responsibility."

    Cooper Surgical apparently got the message, although there was no attempt to pull the Même from the market. In a series of letters exchanged between the two companies, dated from January 11, 1988, to August 3, 1988, the Même's manufacturer expressed the desire to conduct basic studies on the foam, which would characterize its chemical stability. To that end, Scotfoam provided Cooper Surgical with its formula and ingredient lists for the foam under an "absolute secrecy agreement."

    By year's end, a new, eight-month animal study sponsored by Cooper Surgical had been concluded at the Veterans Administration Medical Center in Nashville, Tennessee. Its purpose was to determine what happened to miniature polyurethane-coated breast implants at the site of implantation in rats. In one test, pathologist Steven Woodward found that the foam size decreased at least 50 percent in two to eight months. Woodward concluded that the lost foam was strong evidence that the material broke down after implantation. "The logical extension was more detailed site studies and a look at the breakdown products [of the foam]," Woodward says now.

    Cooper Surgical appeared interested in following up on Woodward's findings. Documents show that the company initiated studies in 1988 to examine the chemistry of the foam and its breakdown products. But in December of that year, Cooper Surgical sold the Même production plant to Surgitek, a subsidiary of Bristol-Myers Squibb-which decided not to fund the studies after all. Jonathan Weisberg, a spokesman for Bristol-Myers, would later say that further studies weren't warranted. Instead, Weisberg pointed to another study, one of ten explanted Mêmes, that Bristol-Myers had sponsored, which showed that the "lost" foam in Woodward's study was simply entwined appropriately with tissue. After reviewing that data, Woodward would stick by his own study.

    Besides facing giant holes in its scientific database on the Même, Surgitek was legally ordered to clean up unsanitary conditions in its newly acquired manufacturing plant. Several months before the company acquired the Même, the FDA, reacting to outside pressure, had launched an inspection of the manufacturing facilities that had been expanded from a garage.

    Over a sixteen-day period, beginning on July 11, 1988, FDA agents turned up serious violations of the Federal Food, Drug, and Cosmetic Act, including deficiencies in the process that was used to determine whether the implants were sterile and the lack of an adequate quality-assurance program. The company also had not been training its employees properly. Some were observed blowing into each breast-implant shell for inflation during inflation testing. Inspectors were unable to recover records both of the raw materials used and the established specifications for the implants. But they did find eleven recorded cases of medical problems associated with breast implants, including the Même, which the company had never reported to the FDA as required. The problems included infection, gel leakage, and separation of the foam covering from the shell. Between that inspection and the closing of the plant three years later, about 120,000 additional women received the Même.

    In June 1988, Sybil Niden Goldrich published a short article about her experiences with breast implants in Ms. magazine described how, after her final reconstructive surgery, was determined to find out why she had been a "breast-implant failure." Goldrich had called the FDA for information on breast implants and was informed that every plastic surgeon was provided with a concise manufacturer's warning listing potential complications from and caveats about implants. It was up to the surgeon to properly inform his patient about the pros and cons. She then obtained samples of implant package inserts and was floored by the list of complications mentioned, including leakage of gel, breast hardening, rupture of the implant's shell, infection, blood clots, fluid accumulation, skin decay, and loss of nipple sensation. "I naturally wondered, when I wrote the article, how many other women were out there with breast implants, who had not been advised of the potential risks," she says.

    Within weeks after her article was published, Goldrich began receiving long-distance calls from women around the country who had thought they were alone with their breast-implant problems. Almost all of the callers mentioned how little information about the dangers of implants they had received from their doctors. Then the FDA called. Faced with mounting consumer complaints about breast implants in general, the agency had scheduled a public meeting of its medical-device advisory panel for November to help determine the types of safety and efficacy studies that manufacturers of breast implants would be required to submit for review. Would Goldrich attend to present a consumer's viewpoint?

    By the time Goldrich arrived in Washington, breast implants were hot news. Only days before the meeting, the Washington-based Public Citizen Health Research Group released internal data from Dow Corning, showing that injections of silicone caused malignant tumors in over 23 percent of rats tested. The consumer group also released evidence that FDA scientists were concerned about the manufacturer's experimental findings and that at least one of the reviewers at the agency wanted an alert to be issued immediately to the public, warning of the potential long-term cancer risk of breast implants. One internal FDA memo had stated: "While there is no direct proof that silicone causes cancers in humans, there is considerable reason to suspect that it can do so."

    The FDA's advisory panel took note of the Dow Corning Corp.'s rat study during its deliberations and concluded that the available data did not warrant removal of breast implants from the market. But it did ask the FDA to establish a national information program on the devices so as to assure that patients received balanced information about the surgery. The recommendation pleased Goldrich, who had used up most of her allotted speaking time on that very subject.

 

.   SAFE UNSAFE     Breast implants and the Dalkon Shield IUD may be the most high-profile examples of medical devices gone awry, but there are thousands of other products in use that escape FDA safety checks. Over the last decade, the agency has allowed manufacturers to use loopholes to avoid proper testing; some have neglected to report side effects, including injury and death.     Underregulated medical devices include: respirators for children chin, cartilage, and testicular implants kidney-dialyzing components catheters that are placed in arteries     A federal survey of 112,000 households, released in February 1991, revealed that defects or failure - resulting in pain, infection, bleeding, and blood clots - were associated with a number of implanted devices; for instance, cloudy vision was often associated with lens implants and irregular heartbeat with pacemakers. Nearly 9 percent of the estimated total of fifteen million implants used by Americans were replaced at least once.     The FDA assumes that most of these products are safe because they are claimed by manufacturers to be "substantially equivalent" to older versions of products. The agency relies on manufacturers' legal obligation to report any excessive side effects to the FDA for evaluation, but companies often don't comply. The Washington, D.C.- based Public Citizen Health Research Group recently gained access to FDA files on inspections of thirty-five manufacturers of medical devices between 1985 and 1988. The group discovered that 7 deaths, 109 serious injuries, 265 malfunctions, and 41 other problems had not been reported as required. The unreported casualties included 4 deaths and 4 serious injuries caused by failures of infant respirators, and 2 deaths, 1 serious injury, and 178 malfunctions associated with catheters used during heart surgery. The FDA has taken no action against the companies since this information came to light. - N.R. .

 

    Pierre Blais had realized that the Même's foam was actually intended for industrial use back in 1989 as part of his job at Canada's Health Protection Branch. After evaluating available data, Blais concluded there was a possibility that "women with the Même faced a double cancer threat, one from the silicone gel in the implant and another from its foam." In January of that year, he fired off a memo to David Johnson, a higher-level official, warning that the Même was "unfit for implantation," partly because its chemical products could be released in the body. In a four-page technical report, Blais termed the foam coating a "packaging and general-purpose foam." And he further questioned whether an expert on this type of material "would consider, recommend, or approve the use of such a foam on a device designed to be implanted permanently in a disease-prone area such as the female breast."

    Johnson edited the documents, and Blais was ordered by his immediate boss to eliminate all references to his certainty that the Même was unfit. He complied, but wrote back in a memo, "In my opinion, the content of the original documents is significantly altered." Several days later, Blais was ordered to destroy his original memos and technical report on the Même. The following July, Blais was fired for his insistence that the Même be withdrawn from the market-and for being the likely source of leaks to the media. He was eventually rehired after filing a wrongful - termination suit, but resigned in December 1989.

    One month after his firing, Blais began work with a researcher at Laval University in Quebec City. The research verified under conditions more closely approximating those in the human body that the Même's foam could release TDA. "It was becoming pretty clear that this foam was unstable," he says. Blais reported his progress to scientists, who, after the FDA advisory panel met in December, conducted their own studies. That data, which confirmed Blais's research, was made public one week before Surgitek "voluntarily" withdrew the implant from the market. By that time a total of 200,000 women had the Même.

    Bristol-Myers Squibb closed Surgitek's plastic-surgery unit last September, but that was not an admission of guilt. Surgitek said that its data on the safety and effectiveness of its other product line - silicone-gel breast implants without foam - was deemed insufficient by the FDA, and that, rather than appeal the decision, it was quitting the breast-implant business. In its announcement, Bristol-Myers Squibb said that it remained "committed to completing appropriate research to resolve all outstanding scientific issues" associated with the Même.

    Nearly a decade after the implant's introduction, discovering exactly how much TDA is released by the Même's foam into the body has become a top research priority. Last June, the FDA ordered Surgitek to find out how much TDA might be in the blood, urine, and breast milk of women with the Même. But a dispute over methodology in the studies means that there will likely be a continuing controversy over the issue for years to come, no matter what the findings show.

    The issue of how to quantify the Même's cancer risk is not likely to be settled very soon either. Surgitek claims, on the basis of a recent study it sponsored, that, if there is a cancer risk associated with the Même, it is insignificant, certainly no worse than about one in several million. That would mean, at most, one woman would be affected. The FDA's official worst-case scenario is that the figure may be one in twelve thousand but is far more likely to be one in about a million-which would mean that between one and seventeen women with breast implants are in danger. On that basis, the agency is informing women with the Même that the risks associated with the removal of the implant are likely to be far greater than any cancer risk. But some FDA scientists, as well as Pierre Blais, argue that the cancer risk may actually be between one in 50 and one in 200. According to that estimate, between 1,000 and 4,000 women could contract cancer because of their implants.

    "The FDA is taking absolutely the most conservative stance possible and is, for example, excluding from the risk analysis some early animal studies that show implanted foam similar to the one used in the Même is a strong chemical inducer of tumors," Blais says. "Unfortunately in this case, it appears that time will tell, and this is totally unacceptable. What a time to begin addressing the scientific issues! Thousands of women are waiting for more definitive answers."

    Meanwhile, there is little sign that manufacturers or plastic surgeons feel remorseful about the current dilemma women face. Both Surgitek and Dow Corning insist that what's carcinogenic to rodents is not necessarily translatable to humans. Some doctors, like Hester and Sterling, blame the media for stirring things up. "I might not have implanted quite so many [Mêmes] had I known what I know now," Sterling says, "but I want you to know that my wife and daughters are still doing well." Hester admits that "the controversy will let us get more definitive about the TDA." Even so, he recently published an article that championed the idea of implanting two sets of Mêmes-he called it "stacking"- to achieve a better effect in certain patients.

    As for the American Society of Plastic and Reconstructive Surgeons, the group that referred to small breasts as a disease, it recently voted to collect $1,050 from each of its thirty-seven hundred certified members to finance a campaign to counter bad news about silicone-gel breast implants. Garry Brody, a Los Angeles plastic surgeon and high-profile member of the group, hints at what lies ahead in the controversy when he says, "The whole process [of removing implants from the market] has destroyed the right [of women] to choose."

    Back home in Los Angeles, Sybil Goldrich hopes she can answer that challenge. She is concerned that the four-million-dollar publicity campaign will convince consumer groups to rally around the principle of having access to breast implants-even if they are not proven safe and effective. At the FDA meeting that she attended recently in Washington, a number of women spoke angrily against the idea of removing all implants from the market. "The emotions were pretty high," she says, "especially from those women representing cancer groups." And she adds, "This is something that I understand, but I also don't believe that a breast-cancer patient would knowingly accept a product that might be defective." The FDA subsequently decided to allow breast implants to remain on the market at current availability levels, but will re-evaluate this decision after monitoring recipients for the next year.

    Goldrich recently wrote a letter to Dr. David Kessler, the FDA commissioner, to say how wonderful it would have been if some of that vast amount of money being collected by the plastic surgeons had been designated for independent research to produce a safe and effective breast implant for women who have had breast-cancer surgery.

    She also suggested to Kessler that whatever decision is made about the remaining breast implants on the market, it should be based on science and science alone.

 

For additional information on breast implant issues, visit The Center For Policy Research.

 

 

 

| Premium Subscription |
| Site Philosophy | Columnists | Special Features | Health | Science | Environment |
| Media | Arts | RFW Store | Free Newsletter | Links | Home | E-mail |