Silicone Or Bust: Breast Implants And The Abuse Of Science
That the culture has responded angrily to the Mahlum vs. Dow Chemical judgment is without question. Virtually every mainstream media report leading up to and following the decision has been liberally laced with invectives directed at Mahlum, women like her, the attorneys who represent them, the juries who decide in their favor and the judges who allow such decisions to be made. Consider "Silicone: Juries vs. Science," Newsweek's Nov. 13 article on the decision. "The current onslaught of litigation is fueled less by scientific evidence than the vague suspicion that big business is up to no good," Newsweek wrote, after evoking recent epidemiological studies by the Mayo Clinic and Harvard that found no links between women with breast implants and autoimmune diseases. The Wall Street Journal, which has turned its corporate outrage at the "breast implant travesty" into an editorial obsession, has been equally evocative when it comes to the Mayo Clinic and Harvard studies. "The plaintiffs claimed that Dow Corning had unfairly influenced institutions like the Mayo Clinic and Harvard University," said the Journal in its Nov. 8 editorial, "Junk Science v. Judges." "But if that's true, then why haven't the wealthy trial lawyers bought a single peer-reviewed study that supports their claims?" Perhaps "the wealthy trial lawyers" haven't had to "buy" a "single peer-reviewed study that supports their claims" because there are literally hundreds of studies documenting the effects of silicone gel on humans available at no cost, many of which were presented in Mahlum's behalf. But you'll see none of these reports -- not one -- cited in America's most influential print media. Another thing that's missing in these reports is one of the major issues of the trial: studies Dow Chemical performed for Dow Corning documenting that silicone is not an inert substance as far as the human body is concerned. In fact, some of the studies indicated that DC-200 and DC-360, the silicone fluid that constitutes 80 to 85 percent of the gel in Dow Corning implants, was extremely toxic to localized tissue and is a possible immune system stimulant. The jury agreed with Mahlum's attorneys that the results of these studies, which had been conducted since the 1950s, had been purposely kept from the medical community and the public by Dow Chemical. All of this is in the trial transcripts, which large news organizations have ready access to. One possible conclusion, other than the scary thought that an epidemic of bad reporting has struck the Big Apple -- perhaps the large, mainstream media outlets, like their fellow corporations Dow Chemical and Dow Corning, have successfully limited what will be considered "science" in the breast implant debate. Charlotte's Web "Every day is a different day," Charlotte Mahlum is saying via telephone from her home in Elko, Nev. "I never get rid of my headaches; it's like a vise grip squeezing my head. If it would pop off, I would feel better. I never get rid of my crawling." She describes this "crawling" as feeling as though she's in a pine box covered with night crawlers, with worms crawling up and down her arms and legs. "I dig into my skin with my fingernails until I bleed." In 1985, Mahlum was diagnosed with fibrocystic disease, benign lumps in the breast that can lead to cancer, especially in women who have a family history of breast cancer. At the time, the customary treatment for such women was mastectomy -- removal of the fibrous material -- followed by reconstructive surgery utilizing silicone gel implants. This procedure was performed on Mahlum, and she received a pair of Dow Corning gel implants. She was happy with her new, perky breasts, and everything was fine. Until 1990. That's when her symptoms began. They are numerous: "My eyes are so itchy it's like sandpaper scratching my eyeballs." Eventual diagnosis? Sicca syndrome, an autoimmune disease. She gets "big purple blotches, like varicose veins, running all over like a fishnet. I never know where they're going to be." Her husband has sat for hours and watched these violet spider webs -- called livedo reticularis, another autoimmune disease -- play across her body. Then there's the constant fatigue. The terrible aches in her muscles and joints. The headaches. The crawling. The hair loss. All possible signs that Mahlum's immune system was -- is -- attacking her own tissue. That's what autoimmune diseases do. Multiple sclerosis, for instance, is an autoimmune disease in which autoantibodies (just like antibodies, which all of us have to ward off infections, except these get the wrong message and attack the body) go after the brain tissue. All this started in 1990. At the time, the possible dangers caused by silicone leaking from gel implants were beginning to be widely publicized. Dow Corning had already lost a major lawsuit in which a San Francisco jury agreed with a woman's claim that her ruptured gel implants had possibly caused an autoimmune-type reaction. Despite the negative publicity, Mahlum never connected her problems to silicone. Why should she? Her plastic surgeon had told her that silicone could migrate (Mahlum testified she didn't recall this warning), but according to Dow Corning, silicone was inert, so it was no big deal. "I never associated it with my implants," she says. Instead, she delayed treatment. "Who was I going to tell all these symptoms to? Who was going to believe me? They'd send me home and tell me to see a psychiatrist. They tell all us women that we're crazy." Four different doctor visits, four negative test results. Finally, in 1993, one doctor recommended she get an MRI examination of her implants. She did. One of her implants was ruptured. It was recommended that she have both implants removed. She did, and it was discovered that the ruptured implant was missing 60 grams of silicone fluid. It had not been contained by the scar tissue that forms around the implants in most patients. It had disappeared into Mahlum's body. "Go home and live your life the best you can," a doctor who specializes in autoimmune diseases would later tell her. "This may not kill you in a month, but there is nothing I can do for you." Body Control Immunologists call simultaneous multiple symptoms such as Mahlum's a "constellation." Symptoms that would not be noteworthy by themselves take on greater importance when they occur together. In the case of Mahlum and the other women who have had problems with silicone breast implants, this concept of a constellation can be expanded to include not only medical symptoms, but nearly every aspect of their lives: their experiences with doctors, their experiences with men, their experiences with the culture. Mary White Stewart, a professor of social psychology at the University of Nevada, Reno, might describe such a constellation as the "situated reality of women with breast implants," the title of a paper she recently presented at the annual Western Social Science Association meeting in Oakland. She also presented a paper, "Breast Implants As Body Control," to the fifth annual international Social Justice and Research convention in June. Stewart, whose brother is Mahlum's lawyer, Geoffery White, was given a rare opportunity because of her sibling's status as a leading attorney in the nationwide "global settlement" negotiations between the major implant manufacturers and the 100,000 women who have claimed disease from silicone implants. The on-again/off-again settlement recently collapsed when the manufacturers announced they did not have the funds to adequately compensate the women at promised levels. Stewart has interviewed many of the 150 clients her brother represents. She selected eight representatives from the group for more detailed analysis and discovered striking similarities between them. The few sociological studies that have been done on implant patients have focused on those who have had mastectomies, so Stewart concentrated on patients who had chosen breast augmentation for cosmetic reasons. These patients comprise 80 percent of the women who have received implants, and Stewart found that in general, they "are more likely to be white, working-class and lower-middle-class, to be in their early 30s, and to have just gone through a divorce or experiencing a troubled marriage." Many of these women were convinced that their small breasts were "deformities," an assessment encouraged by their boyfriends, their husbands and the culture, as well as the American Society of Plastic Reconstructive Surgeons, which, in 1982, petitioned the Food and Drug Administration to classify small breasts as a disease: "There is a substantial and enlargening body of medical information and opinion ... to the effect that these deformies [small breasts] are really a disease which in most patients results in feelings of inadequacy, lack of self-confidence, distortion of body image and total lack of well-being due to a lack of perceived femininity." This medical sanction, combined with cultural attitudes that equate femininity with bust size, results in the "medicalization of society." As Stewart notes in her heavily footnoted texts, "[T]he combination of medical social control and cultural ideals that emphasize an ideal female form has proved to have far-reaching consequences for women as the aesthetic realm becomes legitimate terrain for the expansion of medical authority." The result? Women are taught to chase an impossible ideal and remain mired in a subordinate socioeconomic class to men, says Stewart. In states like Nevada and California, where the entertainment industry demands that females be able to demonstrate abundant cleavage, implants have become a not-so-unofficial job qualification, according to some plastic surgeons and women in the industry. This impossible cleavage is replicated a million-fold through TV screens and magazines across the nation, and both men and women bow to a false image constructed from Space Age polymers. "If women can be encouraged to focus on finding endless fault with themselves," Stewart writes, "they will not address the structural and economic problems which make it necessary in the first place for them to find their value through men who have the economic and political access and power which they lack." For women with fibrocystic disease, like Mahlum, the consequences were even more dire. Doctors, believing at the time that silicone gel implants were a totally safe form of reconstructive surgery, were more apt to recommend invasive procedures like mastectomy, since the disfiguring aspects of the surgery could be corrected, even improved upon. Today, in part because of the known complications of implant surgery, mastectomy is not necessarily the treatment of choice for fibrocystic disease. In a sense, breast augmentation -- whether for cosmetic or medical reasons -- is an old story. In Asia, the practice of binding women's feet was not abolished until early this century. Clitoridectomy -- the forced circumcision of the female genitalia -- is still a common practice in some Middle Eastern countries. Medicalization, particularly the authority the West has granted physicians on both the institutional and individual levels, merely provides the mask that allows us to condemn the same barbarism abroad that we practice here at home. Silicone Is Not Inert According to Newsweek's account of Mahlum vs. Dow Chemical, "No one denies that Mahlum is ill." The statement is patently false. During the trial, Dow Chemical repeatedly insisted that Mahlum's symptoms were all in her head and continued to assert that silicone gel, including the 60 grams still in Mahlum's body, is an inert substance. If there is one thing scientists and doctors involved in the silicone debate agree on, it is the absurdity of this assertion. Plastic surgeons certainly harbor no such delusions. Because of the FDA's partial ban of silicone implants in 1992, most surgeons are using saline implants today, but the consent form for the patients who qualify for silicone (and some women still choose gel, despite the adverse publicity) contains a long list of known risks associated with silicone gel implants. The most common problem, according to a McGhan implant consent form, is capsular contracture, in which the "body creates a strong layer of scar tissue ['capsule'] around the entire surface of the implant." This results from the classic foreign-body reaction doctors have known about for years, yet when gel implants came on the market in 1964, many surgeons, having been repeatedly told by Dow Corning that silicone was inert, failed to inform their patients that their new breasts could become as hard as a pair of green melons. Studies now show that capsular contraction occurs in an average of 40 percent of all cases. Softening the capsules is no easy task. The procedure formerly used to do this was called closed capsulotomy, or in layman's terms, the "squeeze method." The plastic surgeon literally squeezes the breast, rupturing the scar tissue, decreasing the tension placed on the implant. Often, this only temporarily relieves the hardness, and the procedure must be performed again. It can be brutal, as this description from one of Stewart's interviewees demonstrates: "For the first year or so after the initial implant, she had to be 'popped' every month or so. She is still agitated when she talks about the horrible pain and terrible sounds that accompanied that -- these were closed capsulotomies. After injecting her with Valium, he would exert enough force and pressure to the breast to break apart the hardening capsule. She says you could hear a tearing, then a hot rushing from the breast, as if blood or liquid were oozing from it, 'like you'd been cut badly,' she said. He would sometimes have to do it five times or more to break the hardness, and she cried from the pain and humiliation. She felt degraded by the experience." Closed capsulotomies eventually became a rare practice due to another risk patients will find on the consent form: implant rupture. For a product originally advertised to last forever (one women interviewed for this report says she was told, "You're going to die with perky breasts"), gel implants have demonstrated a disappointingly short life span. Because it is now known that almost all implants will eventually wear out and rupture, some studies place the rupture rate at 100 percent. Surgeons now tell patients they can expect that their implants will need to be replaced every 10 to 15 years, and possibly sooner. In addition to rupture, another known risk of silicone implants is "gel bleed." On the McGhan consent form, this is described as a tendency for "microscopic droplets of silicone gel to 'bleed' through the outer shell of a gel-filled implant. The microscopic droplets, or gel 'bleed,' have been found in both surrounding breast tissue and rarely elsewhere in the body." What are the effects of silicone being released into the body from a rupture or through gel bleed? According to the consent form, "the long-term effects are unknown." What are known are the possible short-term effects of a gel implant rupture: "In some cases this has caused local swelling, inflammation, tenderness, silicone granuloma formation and gel migration. If this happens, you may be able to feel small nodules of gel in the tissues surrounding the implant. Surgery will be required to replace the implant and remove the gel from the tissues. Tissue ingrowth into the outer surface of the shell may result in increased difficulty of removal." Despite these known effects, which have been experienced by hundreds if not thousands of women, Dow Corning and Dow Chemical have continued to insist that silicone is inert. Are they lying? Not necessarily. It depends on how "inert" is defined. Because the human foreign-body response is not completely understood, Dow scientists have been able to claim, with straight faces, that silicone is inert, relatively speaking -- that any foreign object inserted in the body can cause a reaction. At Dow Chemical's trial, Mark Lappe, an experimental pathologist who specializes in bioethical issues, was not so forgiving. Lappe, who has been one of the FDA's main consultants on the breast implant issue, appears frequently at silicone gel trials, for both plaintiffs and defendants. He charges $350 an hour. There is probably no one more familiar with the scientific literature of liquid silicone -- including the documents Dow Chemical and Dow Corning have hidden from the medical community and the public for years -- than Lappe. A Ph.D. with training in biology and immunology, he does not believe that silicone is inert. Nor does he believe that Dow Corning and Dow Chemical believe it. The tests by both corporations which were withheld from public scrutiny clearly demonstrate that such a belief would be difficult to adhere to. A 1956 Dow Chemical found that DC-200, when injected into rats, migrated to various organs of the body, including the brain. The results were never published; the document was discovered in 1991. Another 1956 study in which female rats injected with DC-200 developed heavy livers -- a "red flag that there may be some effect on the immune system," Lappe testified -- was purposely excluded from the final report. And in a 1972 study in which dogs with gel implants developed severe connective tissue inflammation at the implant sites, the final report was altered to show only a mild inflammation. In fact, Lappe's testimony in regard to Dow Corning and Dow Chemical's experiments with silicone indicated that the companies had been withholding information on silicone -- if only for proprietary reasons, if not because they discovered it might be harmful -- for nearly half a century. When asked by Mahlum attorney Frederic Ellis what would have occurred if the corporations had been forthcoming with this information, Lappe replied: "If the full body and work of the data that you just described, including material that I have previous alluded to, were released to the scientific community, there would have been a wholesale clamoring, in my judgment, for a suspension of the continued use of silicone implants until safety testing had established the long-term acceptability of the implant in the human body." Real Science Dr. Eric Gershwin has examined approximately 800 women who have problems associated with silicone gel breast implants. He has published more than 350 peer-reviewed medical articles -- seven on the autoimmune effects of silicone -- and is chief of the division of rheumatic disease, immunology and allergy at the UC Davis Medical Center in Sacramento. One of his patients is Charlotte Mahlum. One of the problems faced by women who claim to be ill from silicone is the stubborn insistence by many doctors, corporations and the culture that the women are malingerers, gold diggers who, in the viewpoint of The Wall Street Journal, will never be convinced that "silicone implants aren't responsible for whatever ails them." It's a convenient setup: The medicalized culture defines what a woman is; women seek to fulfill that definition using methods provided by the culture. When they become sick, they discover that their subjective symptoms -- headaches, fatigue -- do not fall within what the culture defines as objective criteria for illness. Fortunately for Mahlum, Dr. Gershwin provided enough objective evidence to convince the jury that not only is she quite sick, but that the 60 grams of silicone gel from her ruptured implant that are still in her body are, in all likelihood, causing her illness. Far from being inert, silicone, Gershwin and many other researchers believe, is a powerful immune system adjuvant, which is to say it boosts the body's immune response so that "it goes all wacko and it starts to attack itself." Not all women respond to silicone in this manner -- Gershwin was careful to point out that only a minority of the women who have gel implants (the total number nationwide is estimated to be between 500,000 and 2 million) have reported symptoms. For certain individuals like Mahlum, whose immune systems have been exposed to liquid silicone, the human body literally eats itself alive, leaving a trail of objective evidence in its wake. For instance, Gershwin backed up Mahlum's subjective report that she occasionally has bouts with forgetfulness by pointing to her positive GM-1 autoantibody test. GM-1 is a protein that surrounds the nerves in the brain and elsewhere. Mahlum's GM-1 autoantibodies have literally "punched out lesions in her brain and her nerves," lesions verified by an MRI and Mahlum's abnormal nerve conduction studies. One "subjective" symptom, three objective measures of it. "If you have a punched out lesion, a hole," Gershwin explained to the court, "what happens is you get a short circuit in the brain, and it's a bit like having a row of Christmas lights, and if one light goes out ... then all the other lights go out or they tend not to work as well." In addition, Gershwin testified that Mahlum's livedo reticularis (the spider web blotching on her body), sicca symptoms (the dryness in her throat and mouth), her constant fatigue, and the numbness in her extremities -- all of which are symptoms of autoimmune disease he was able to objectively measure -- form a constellation of symptoms that he has seen only in women with silicone gel breast implants. Many of the 800 women he has examined have the same or a similar constellation, and this phenomenon has been reported repeatedly in the literature. Gershwin also pointed out that the recent release of Dow Chemical and Dow Corning documents due to litigation and congressional hearings has only helped confirm his hypothesis that silicone is an extremely powerful autoimmune adjuvant that is affecting hundreds of women, including Charlotte Mahlum. An important word, hypothesis. It's really what the scientific method is all about. Experiment, record the results, experiment again, compare the results, repeat. Essentially, that's what Dow Corning, the other silicone gel implant manufacturers, plastic surgeons and our culture have been doing for 30 years: experimenting on human subjects -- women. Doctors and scientists like Gershwin are just now discovering the results of that experiment: a man-made autoimmune disease that can kill women. This relates directly to the mainstream media's error in relying solely on the epidemiological studies done by Harvard and the Mayo Clinic and published in the New England Journal of Medicine. It's not that such retrospective studies are useless. They are essential for determining risk factors. However, among the many shortcomings that experts have leveled at both studies -- including serious design flaws that would have prevented someone like Mahlum from being included, sample sizes that were too small, the fact that no examinations of women were conducted, and the fact that Dow Corning funneled millions of dollars into both studies -- one criticism stands clear. Neither study looked for a new disease. There is no problem with the ability of the jury to interpret science in this case, as The Wall Street Journal, Newsweek, the New York Times and the rest of the pack have reported. Science -- real science -- is not an immovable object where definitions are fixed in stone, where one study can be taken out of context to overrule hundreds of others. Real science is a process, and the jury in Mahlum vs. Dow Chemical realized that the process is moving toward a consensus that silicone really isn't too good for some people. Unfortunately for Charlotte Mahlum -- who someday, after an endless appeals process, may actually receive some fraction of the $14.1 million awarded to her for the damages caused by her silicone gel implants -- the process didn't move quite fast enough.