Not only are they abusing the judicial system, but they are emotionally abusing the women." Thats what one silicone breast implant recipient told the Boston Herald following the decision of Dow Corning to file for bankruptcy. Dow Corning had contributed about half of a $4.2 billion settlementthe biggest ever for women claiming to suffer various illnesses from their implants.
Earlier this year, however, it became clear that there were far more women trying
Financially, its unclear where the bankruptcy leaves implant claimants. But what has become more and more certain since the settlement was reached back in 1993 is that while both the judicial system and silicone implant recipients have been terribly abused, the villain isnt Dow Corning or any other implant maker.
Indeed, women with breast implants have been nothing more than pawns in a bizarre game involving lawyers, feminists, headline hounds, and super-inflated bureaucratic egos. The stakes, however, go beyond the physical and mental health of women with implants to include the future health of millions of Americans who will need insertable medical devices. Indeed, the multi-million dollar awards against silicone implant manufacturers have already triggered a wave of suits against medical implants made of solid silicone and even some containing no silicone at all.
"We have great concerns that any medical device with silicone in it will not survive," says Elizabeth Connell, a professor of gynecology and obstetrics at Emory University and head of two Food and Drug Administration silicone breast implant panels that unsuccessfully recommended leaving the devices on the market. Since June 1992, most uses of silicone breast implants have been banned by the FDA. Annually, some 1.5 million patients receive silicone eye lenses; another 670,000 get artificial silicone joints. All told, about 7.5 million medical devices are implanted in Americans each year. Many of these devices such as pacemakers, heart valves, and shunts which draw fluid off the brain are life savers.
Hence, the misinformed campaign against silicone breast implants raises issues that go far beyond the not insignificant question of whether women should be able to change their appearance as they see fit. A strange alliance of diverse interests, including FDA bureaucrats interested in broadening their powers, feminists who equate boob jobs with mutilation, and reporters more interested in good copy than relevant medical research, worked together to take implants off the market.
The anti-implant campaign is nothing less than a case study in how medical public policy is often driven by anecdotal rather than epidemiological evidence, formulated by ideologues who have little regard for what individuals might value, and discussed in a consistently one-sided manner.
The use of silicone implants to enlarge the size of the breast dates back to 1963. Somewhere around one million American women have received them. Implants may be used either for "augmentation" making a healthy breast or pair of breasts larger or to replace a breast removed during mastectomy. It appears that about 60 percent of breast implants have been used for augmentation.
As Chung herself later put it, the show "unleashed a torrent of protests and investigations around the country." Soon, women were bombarded with such stories as "Toxic Breasts," "The Hazards of Silicone," and "Time Bombs in the Breasts." The height of hysteria may have been reached when, after the FDA moratorium, two women removed their own implants with razor blades. They said they had no success in getting doctors to remove them.
A new front opened up in December 1991, when a California jury awarded a Marin County woman, Mariann Hopkins, $7.3 million from Dow Corning. She alleged aches, pains, and fatigue caused by her implants without citing any illness more specific than autoimmune disease, a catchall phrase for a variety of connective tissue diseases such as rheumatoid arthritis, scleroderma, lupus, Sjogrens Syndrome, fibromyalgia, and Raynauds Disease.
In January 1992, the FDA declared a voluntary (but strongly recommended) moratorium on the sale and use of silicone breast implants pending review of additional information, saying, "physicians should cease using them and manufacturers should stop shipping them." Four months later, the FDA essentially converted this to a ban, although the agency did allow continued use of the implants for women who had suffered mastectomies and permitted a small number of women who wanted implants for cosmetic purposes to enroll in long-term studies.
Like many health scares, the one over silicone implants is primarily American. Only a few countries besides the United States forbid the devices within their borders. One is Canada, even though the Canadian Independent Advisory Committee review showed no causal link between silicone breast implants and serious illness. While most countries havent even seriously considered removing silicone implants from use, some, such as the United Kingdom, have reviewed the evidence and affirmatively stated that implants should remain available. In June 1994, the 20-member European Committee on Quality Assurance and Medical Devices in Plastic Surgery declared it "does not support any restriction on the use of silicone gel filled implants."
Because of the ban in the United States, American women have gone to other countries, including the United Kingdom, Mexico, France, and Germany, to get implants. One popular package mixing implantation in an English hospital with a trip to Shakespeares birthplace is called "Boobs n Bard." Having to go abroad for implants, of course, prices some women out of the market. Women who do travel for implants face different problems: If something goes wrong with the surgery, the doctor is thousands of miles away. And malpractice suits are difficult to pursue in much of the world and virtually impossible in South and Central America.
The FDA seriously considered pulling saline-filled implants off the market as well. But in late 1994, it decided to allow their continued use pending approval applications due in 1998. Silicone is generally preferred to saline because it gives the breast a more natural feel. To keep saline-filled breasts from swishing like a waterbed, it is necessary to pack them tight with the solution. In breasts that are quite small to begin with, wrinkles or ripples in the implant surface are more easily visible through the skin and the breast may not move or hang as naturally as it would with silicone implants.
Whatever goes into the implant of the future, the silicone implants of today are in the bodies of a million or more women who need to know what risk, if any, these devices pose.
There are two ways that women can be exposed to silicone from an implant. One is when microscopic droplets of silicone fluid "bleed" through the envelope of a gel-filled implant. "Low-bleed" implants have been available since the early 1980s and have reduced the amount of silicone that escapes from the implant. In any event, because scar tissue quickly forms around the implant, the gel usually goes no further than one or two millimeters beyond the implant wall.
The other way women can be exposed is through rupture. According to the FDA, about 4 percent to 6 percent of silicone implants have ruptured, though studies in progress indicate this figure is probably too low.
Nonetheless, again the scar "capsule" that invariably grows around the implant tends to hold any silicone even if it breaks, which explains why so many ruptures are outwardly undetectable. While the gel has gone beyond the pouch, it still usually remains in place, although it has been found in the lymphatic system of some women.
That implants can cause physical problems is beyond doubt. It has long been known, for instance, that the scar capsule can harden and constrict, sometimes painfully so. This hardening can make necessary follow-up treatment to remove the scar tissue. Makers of later model implants claim to have reduced this problem, but its too early to say what success they may have had.
But when critics warn of the dangers of silicone implants, this usually minor problem is seldom what theyre talking about. According to Jack Fisher, a San Diego plastic surgeon and outspoken defender of implants, more than 50 symptoms are alleged to be caused by implants, including memory loss, dry mouth, cancer, bladder problems, difficulty swallowing, joint pain, decreased sex drive, and a host of autoimmune diseases. Some have referred to this broad constellation of symptoms as "silicone-gel syndrome." But if it is a syndrome it appears the proper definition would have to be any illness that any woman with implants ever contracts.
To sympathetic observers, such a wide array of symptoms must seem alarming. But a general rule of epidemiology is that the more diverse the symptoms allegedly related to a single cause are, the less likely it is that the suspected cause is real. This basic precept is, in a sense, the mirror image of snake-oil cures that promise to remedy all sorts of unrelated symptoms. Many of the most com monly cited symptoms of silicone exposure such as fatigue, headaches, and difficulty swallow ingcan be brought on by suggestion. As a result, people who hear that implants may cause certain problems may then develop them. These are the same "side effects" described by participants in drug studies who are actually receiving placebos.
And, in fact, most of the evidence against implants is anecdotal: It is based on reports from women who are sick and have implants and claim the two conditions are related. Thus, if a woman with implants ever develops symptoms that doctors cant readily explain, everyone simply assumes that silicone is the cause. Sometimes this sort of reasoning is expressed in the very titles of the implant scare articles. Consider the headline for the San Francisco Chronicles article about Mariann Hopkins: "After Breast Implant, Horror Began."
While such a loose correlation may be appealing to people looking for quick and easy answers, it is essentially the same logical fallacy that blames black cats for inexplicable illness. Yet, in some cases, the silicone-gel symptoms actually predate the implants. Indeed, such a curious time frame appears to have been the case even in the first big implant settlement.
One of Mariann Hopkinss treating physicians testified that, although her diagnosis of mixed connective-tissue disease did not come until after the implants were put in, she had already displayed symptoms of connective-tissue disease as early as two years before receiving implants. The doctor even testified that another physician was so concerned that he subjected her to a battery of tests for one type of connective-tissue illness called systemic rheumatic disease. Those came back negative, but they were not tests specifically for mixed connective-tissue disease. Had they been and had they come back positive, its unlikely Hopkins would have ever received the $7.3 million award.
But then again, the jury did not seem overly influenced by those most knowledgeable of Hopkinss medical history. At the time of trial, Hopkins was basically free of symptoms, thanks to a low dose of medicine. And none of Hopkinss treating physicians testified at the trial that they believed her illness to be related to the implants. Instead, the jury made its finding on the basis of outside testimony that implants could cause such disease, testimony from professional anti-implant witnesses such as Tampa, Florida, physician Frank Vasey, who makes his living by treating women he says are sick from their implants.
Perhaps the most serious charge against silicone implants is also the weakest that they may cause breast cancer. Although such influential groups as Sidney Wolfes Public Citizen (founded by Ralph Nader) have made the claim, repeated studies have shown no such link. The only cancers ever plausibly attributed to silicone in a study released over 40 years ago were connective-tissue sarcomas that appeared in strains of rodents especially susceptible to cancer.
The simple truth is that no epidemiological studies have linked cancer in people to implants. The largest study is also the most recent: After looking at a group of almost 11,000 women from the Alberta, Canada, area, the Alberta Cancer Board concluded, "The incidence of breast cancer among the women who had breast augmentation could not be said to be either significantly higher or lower than that among the general population."
Polyurethane implants, which make up about 10 percent of implants currently in use, are a special case. Manufactured by Surgitek Inc., a subsidiary of Bristol-Myers Squibb Co., these implants featured a gel-filled pouch with a layer of polyurethane foam coating the silicone envelope. The implants were a special target of Connie Chungs Face to Face report. Under such heat, Surgitek felt it had no choice but to remove them from the market in 1991. (Nevertheless, a USA Today illustration in May 1995 accompanying an anti-implant editorial depicted a polyurethane-coated implant.)
The purpose of the foam was to reduce the chance of scar tissue contracting around the implant. But when the foam breaks down chemically, it produces a substance called 2-toluene diamine (TDA) that is considered a probable animal carcinogen and a possible human one. Although that would seem to be an obvious source of trouble, it turns out that, like all the other serious accusations against breast implants, the charges against polyurethane implants dont hold up under epidemiologi cal scrutiny. The only difference is that in this case the FDA has admitted it.
In late June, Bristol-Myers Squibb concluded an FDA-solicited study to determine how much TDA really ended up in the system of women with polyurethane implants. The amount (when any was found at all) was so small that even assuming it is a definite human carcinogen using the FDAs own rating system the risk of cancer was one in a million. Since only about 110,000 women have had such implants, the FDA stated in a position paper, "FDA estimates it is unlikely that exposure to TDA will cause cancer in even one of the women with these implants." The agency added, "The health risk connected with surgical removal of the implants is far greater than the risk of developing cancer."
Theres another, deeper irony in the whole polyurethane controversy, one the FDA obviously couldnt state: that a product designed to alleviate the only absolutely certain health problem clearly linked to implants was forced off the market because of worries over other unproven health effects.
Since silicone gel from implants is most commonly accused of causing autoimmune disease, or connective-tissue disease, it isnt surprising that a large number of studies on both animals and humans have looked for a link between silicone exposure and autoimmune/connective-tissue disease. When the British Department of Health undertook a review of these studies earlier this year, it found approximately 270 papers published after 1971 alone.
The animal studies, the department concluded, "provide no immunological reason for concern over the use of silicone gels in implants." The report went even further, however: "None of these studies demonstrated that the coexistence of connective-tissue disease with silicone breast implants is any more prevalent than would be expected by chance."
The largest study of connective-tissue disease to date appeared in the New England Journal of Medicine this past June. Conducted by the Harvard School of Public Health and the Brigham and Womens Hospital in Boston, the study looked for evidence of 41 types of connective-tissue disease among 87,501 nurses, of whom 1,183 had implants.
The results were unambiguous. The researchers found no "association between silicone breast implants and connective-tissue diseases, defined according to a variety of standardized criteria." Already anticipating the charge that they knew would be forthcoming from plaintiffs lawyers that silicone implants cause a special kind of autoimmune disease that doesnt show up with standardized criteria the authors added, "or signs or symptoms of these diseases." In fact, they reported that women with silicone implants were significantly less likely to relate symptoms of these diseases or to complain of symptoms or signs of illness resembling connective-tissue disease.
For many health professionals, the NEJM study, added on top of all the others, was the final piece of proof needed. "I think we have enough data to end the moratorium," George E. Erlich, a Philadelphia rheumatologist and head of the FDA arthritis advisory committee, told the New York Times. Erlich emphasized he was speaking for himself and not the FDA committee, but he added that the International League of the Associations of Rheumatology also agreed unanimously there was no evidence linking implants to connective-tissue disease. And long before that, the American College of Rheumatology had already issued its own statement, saying, "There is no convincing evidence that these implants cause any generalized disease."
In December 1991, Kessler called together a panel of physicians, self-styled consumer representatives, and the like to evaluate the evidence of potential harm caused by implants. The verdict of the panel, though by no means unanimous, was that the devices should remain on the market pending collection of further data from studies already underway.
That, however, did not please Kessler, who ordered FDA staffers to solicit case histories from doctors of implant recipients who later claimed to have suffered ills as a possible result. Since lawyers had already begun soliciting women with complaints and sending them on to specially chosen doctors, finding such case histories was probably not difficult. In any event, case histories reveal little because they dont allow for comparison groups. Thats what the epidemiological studies were, but Kessler couldnt wait for them.
In January 1992, Kessler implemented the moratorium, citing the case studies as the reason (and glossing over the fact that he himself solicited them). The next month, he reconvened the panel to ply them with his new "evidence." The panel didnt budge and Kessler once again ignored its advice.
"We still saw no clear evidence of danger, though there were a number of unanswered ques tions," says Emorys Connell, who served as the chair of both panels. "We felt breast implants should stay available to women who, with informed consent, wanted to use them." Three and a half years after the first panel voted to recommend keeping the implants available, Connell says she would clearly do so again. "I think the difference is we could say it this time with a great deal more assurance."
"A whole new literature has been developed since that time," she explains. "We were operating on anecdotal evidence and case history. Now the evidence has been gathered by good people in well-designed studies so its an entirely different situation."
So why did the FDA ban silicone implants despite the lack of evidence that they are harmful? Pressure came from repeated anecdotal reports in both print and television media. The moratorium that became a ban occurred after more than a year of intense media pressure, including Connie Chungs inflammatory show, which was repeated a year later.
Congressional pressure, in the form of the late Rep. Ted Weiss (D-N.Y.), also came down on the FDA. Weiss, who chaired the House committee with jurisdiction over the FDA, accused Dow Corning of possible misconduct in its effort to document the safety of silicone implants and called for both the Justice Department and the FDA to investigate the company. (This May, the Justice Department dropped the investigation for lack of evidence.) He also accused the FDA of dragging its feet over the polyurethane-implant issue.
To be sure, there was pressure to keep implants available, too. It came from the American Medical Association, implant makers, plastic surgeons, and breast-cancer groups. But this was not the sort of public pressure that can embarrass an agency, and the breast cancer groups objections were dealt with by allowing continued use of silicone implants for breast reconstruction following mastectomy.
In an NEJM editorial, Angell noted that nobody questions allowing the use of automobiles, even though they kill over 40,000 Americans a year, because we all have a common understanding of the worth of cars. "In the case of breast implants" though, wrote Angell, "the benefit has to do with the personal judgments about the quality of life, which are subjective and unique to each woman." But given "the difficulty of assessing the benefits, the FDA has acted as though there were none atleast when implants are used for augmentation." The result, said Angell, "is that [FDA Commissioner Kessler] may be holding breast implants to an impossibly high standard: Since there are no benefits, there should be no risks."
The FDAs pseudo-scientific approach lends support to the more obviously ideological attack on breast implants from feminists. To many of the most vocal and influential feminists, a preference for big breasts represents female oppression. Susan K. Brownmiller, in her landmark 1984 book Femininity, opined that "[e]nlarging ones breasts to suit male fantasies" represents the exploitation of women. "Big breasts are one of many factors that have slowed women down in the competitive race of life," she said. "Symbolically, in the conservative Fifties, when American women were encouraged to stay at home, the heavily inflated bosom was celebrated and fetishized as the feminine ideal. In decades of spirited feminist activity such as the Twenties and the present when women advance into untraditional jobs, small, streamlined breasts are glorified in fashion."
If large breasts signal oppression, say these feminists, then the implants used to enlarge ones breasts are tools of oppression. Scarsdale psychologist Rita Freedman, writing in Bound, claims, "Having been taught that feminine beauty means having full, softly rounded breasts, women judge themselves against this standard. Missing the mark, they put on padded bras or suffer silicone implants." Naomi Wolf, in her 1991 bestseller The Beauty Myth, states, "Breast surgery, in its mangling of erotic feeling, is a form of sexual mutilation."
To such polemicists, it doesnt matter that the evidence for negative effects was weak. It was just too fitting that something in their minds so harmful to women as a class should be harmful to them as individuals.
Two women on the FDA panel translated such thoughts into direct action. Vivian Snyder, the panels "consumer representative," told Kessler in a letter that "[t]he federal government now has the power to deliver a profoundly important message to the American public involving basic values, concepts of beauty and health," adding, "it would really be wonderful if the FDA could address such attitude-impacting mental health issues as what is really healthy and normal and maybe even beautiful."
The other panelist was Beauty Bound author Rita Freedman. She sent a letter to Kessler decrying that implants "perpetuate the myth of Barbie Dolls Body" and asked whether breast augmentation will become, "like rhinoplasty [nose surgery], a rite of passage for affluent teens."
Such feminist participation in the anti-implant crusade has proven ironic, since the FDAs virtual ban has denied what feminists have always proclaimed as their goal a womans right to choose for herself. Faludi herself acknowledges that at one time the leading feminist journal, Ms., "deemed plastic surgery a way of reinventing yourself, a strategy for women who dare to take control of their lives."
Writing in NEJM, Angell says, "It is possible to deplore the pressures that women feel to conform to a stereotyped standard of beauty, while at the same time defending their right to make their own decisions." If anything, says Angell, the act of withdrawing implants could be viewed as sexist because "people are regularly permitted to take risks that are probably much greater than the likely risk from breast implants," citing cigarette smoking and excess alcohol consumption.
When the FDA slapped the moratorium on implants, the impact went far beyond prohibiting a single surgical technique. "The widespread fear and the multi-million dollar lawsuit shave dated largely from the FDAs removal of breast implants from the market," says Angell.
One study comparing the attitudes of women with implants before and after the FDA moratorium found that after the moratorium the level of satisfaction dropped markedly, from 98 percent satisfied to 71-79 percent satisfied. The study authors said their findings were similar to those of the American Society for Plastic and Reconstructive Surgery in another poll.
As for prompting the "multi-million dollar lawsuits," one need look no further for evidence than so many of the attorney advertisements soliciting silicone implant recipients. "THE FDA WARNS THAT SILICONE GEL-FILLED BREAST IMPLANTS PRESENT HEALTH RISKS" blared a typical ad of this sort in the Newark, New Jersey, Star-Ledger. Implant critics often cite money as the only concern of Dow Corning and other manufacturers. But few notice that the group which stands to gain the most from liability casestrial lawyershas a love of filthy lucre. In a single case involving three women complaining of implant-related illness, a jury in 1994 awarded $33.5 million, although the judgment was later reversed by an appeals court and then settled. Thirty-three percent of a multi-million dollar award lawyers typically take a third off the top can be a powerful incentive for a law firm.
Its hardly surprising, then, that the American Trial Lawyers Association conducts regular seminars for implant plaintiffs attorneys. It does so using selected data provided by Sidney Wolfe of Public Citizen, the group most identified with criticism of implants. For $750, Public Citizen will also provide trial lawyers a list of medical experts and consultants, FDA reviews and FDA panel testimony, and a variety of other litigation documents. It will also refer clients to those lawyers.
Suing implant manufacturers has become a boom industry in the United States, with lawyers out to convince women that even though they may feel just fine they are really sick and must be properly compensated. With so much money to spread around, it also isnt difficult to get doctors to find patients.
"I get calls from women who say, I have implants. Where do I pick up the money?" says Sandy Finestone of the Womens Implant Information Center in Irvine, California. The center disseminates information on implant safety. "You dangle $4 billion in front of them and it certainly gets their attention." Finestone has two polyurethane-coated implants that she makes clear will not be the subject of litigation.
Indeed, attorneys have not only ignored scientists, theyve attacked them. After Mayo Clinic rheumatologist Sherine E. Gabriel published a study in NEJM in June 1994, a lawyer claiming to represent 2,000-3,000 implant recipients began filing legal demands against her. "The magnitude of the demands is staggering; the burden is staggering," she told the New York Times. "They want over 800 manuscripts from researchers that were here, they want hundreds of databases, dozens of file cabinets and the entire medical records of all Olmsted County [Michigan] women, whether or not they were in the study."
Not surprisingly, Gabriel says the demands have "severely compromised" her ability to do research and made colleagues of hers back off from doing their own implant research, for fear their findings would also infuriate plaintiffs lawyers. "Some," she says, "determined that the price in terms of their own research careers is too high to pay."
The widespread association of silicone implants with various illnesses is largely the result of unsophisticated reporting on the topic. "The media may be portraying a closer link between implants and autoimmune disease than is actually merited because younger women tend to be more prone to autoimmune disease than other groups," explains David Leffell, associate professor of dermatology at the Yale School of Medicine. But the real question, says Leffel, is whether women with silicone implants are getting these diseases at levels higher than expected. All signs point to no.
With silicone implants, the media have managed to make news as much as report it. Clearly, they have had a significant impact on public perceptions, which then fueled both litigation and contributed to the FDA moratorium. This in turn fueled more litigation.
Whatever role sheer confusion and ignorance of scientific data and principles played on the part of the media, it is disturbing to realize that opportunities to present the other side were often ignored. In 1991, for instance, CBS reran the Connie Chung show that did so much to kick off the implant scare. But at the last minute, the network yanked a Dow Corning rebuttal to the programs charges. CBS didnt explain its decision. Apparently it felt its viewers would not benefit from an airing of both sides of the issue.
Unfortunately, the anti-silicone implant crusade has given women something very tangible to fear. Because of the negative publicity, as early as 1991 insurance companies were already denying or restricting medical coverage to women with implants. Now, because some doctors and lawyers have tied various illnesses to implants, women with implants who do eventually get any of those illnesses may find themselves without medical coverage. The founder of the Washington, D.C., chapter of the Y-ME National Breast Cancer Organization told a congressional panel, "In some instances, it is easier for a cancer patient to obtain insurance than one who has implants."
In early June, even before the NEJM connective-tissue disease study, Y-ME Executive Director Sharon Green wrote to Kessler asking him to "make a public statement regarding the most recent epidemiological studiesto stop the current frenzy." The only statement he issued that month was a response to the NEJM study saying yet more evidence was needed.
Emorys Connell says the FDAs actions and the legal professions high-tech ambulance chasing are "costing us not only what we [already] have but the chance for new and better products in the future. I think were in a worse mess in American medicine than weve ever been in. Instead of leading the world, were now a third-rate country in terms of our ability to develop new drugs and devices."
Indeed, J. Donald Hill, chairman of cardiovascular surgery at California Pacific Medical Center, worries that the anti-implant crusade will broaden into an attack against a wide variety of medical aids already on the market. The first device to go down the tubes may be the Norplant contraceptive, which after implantation into the arm releases a tiny amount of silicone into the system. While no suits have yet been filed, lawyers are encouraging women with the devices who have any sort of illness to contact them. Trial lawyer seminars are already being held, using some of the same instructors and same self-styled medical experts who torpedoed breast implants.
In a country so heavily dependent on science to improve the quality of our lives, to defend our shores, to feed our growing population, to prevent and cure illness, the resoundingly anti-scientific and successful crusade against silicone implants portends problems that right now cannot even be guessed.