There are certain grand historical fights that you think are over, tucked into the quaint Snoopy lunchbox of the past like a Capri Sun or bologna sandwich. Remember the Dalkon Shield I.U.D. uproar of the 1970’s, with its controversial whiff of scientific profit over women’s safety? Or what about the silicone-breast-implant scandals of the early 1990’s? When silicone-boob-makers were all but run out of town as woman after woman came forward with ghoulish tales of ruptured implants and strange autoimmune-style ailments? Those were crazy days.
But sometimes the merry-go-round of culture swoops back around, depositing the old controversies right back in front of you like a stomping, pouty kid. Time slips back, and despite all other indications of social or at least temporal progress, the disgraced, buried past returns. Like Dick Cheney. Or creationism. Or, yes, silicone-boob jobs.
Throughout the last few months, rumors have been whipping through the breast-augmentation world that the Food and Drug Administration is on the verge of returning silicone implants to the open market after a 14-year partial ban on the gel-filled bosom enhancers. The ban, which came down in 1992, had never fully eradicated silicone—women who had endured mastectomies or had a breast “deformity” or agreed to participate in a study could still opt for the gel—but the average Pamela Anderson groupie, the cosmetic breast enhancer, was out of luck. She had to make do with saline.
But last summer, the F.D.A. sent word to two competing implant manufacturers, Inamed and the Mentor Corporation, that their applications to sell a new generation of silicone-filled sacs were “approvable with conditions.” And since then, whispers of an imminent F.D.A. decision date—the most recent centered on July 4—have regularly sifted through the country’s plastic-surgery capitals, from the C-cup-loving streets of New York to the D-cup-worshipping beaches of California and Texas. (Implant size is, apparently, the one area where New Yorkers are more conservative than Texans.)
In a sign of just how confident the manufacturers are in the F.D.A.’s intentions, both Inamed and Mentor have included revenue from silicone implants in their 2006 earnings projections, CNNMoney.com reported.
“We believe that silicone will be approved,” said Dr. Mark Jewell, an Oregon-based plastic surgeon and president of the American Society for Aesthetic Plastic Surgery. “I can’t tell you when, but I think it will be soon.”
A spokesperson for the F.D.A. declined to comment on the rumors, saying only that the applications “are still being reviewed.”
Like the return of all thorny cultural controversies, the news of a potential silicone resurgence has resurrected not just the specter of the gooey sacs, but the old debate around them. And it is as toxic as ever. (And we should emphasize: This is a debate about cosmetic enhancement, not reconstructive surgery.)
In one corner—the corner of the nip-tuckers and implant-makers—the return of silicone has been hailed as everything from the triumph of science over “emotion” to, paradoxically, a victory for women. Cloaking themselves in the velvet mantle of women’s defenders, they have touted silicone not only as safe, but, frequently, as a better product for women than saline: better-looking, better-feeling, the difference between “a zip-lock bag of Jell-o versus a zip-lock bag of water,” said Dr. Jewell.
“I think that we’re the advocates of women who want this operation,” he continued. “These devices should be … available for patients as choice. This is choice.”
That this language skates suspiciously close to the rhetoric of the pro-choice movement makes the whole thing all the more surreal.
And enraging to women’s-rights advocates.
The news of a potential silicone comeback has not gone over well among its historic opponents in the women’s movement. Sounding the old battle hymns feminist, they have grabbed their signs and science Ph.D.’s and argued that, surgeons’ and silicone-makers’ claims to the contrary, silicone has not been proved safe. It wasn’t safe years ago, it isn’t now, and the F.D.A. should not overturn its ban, they say. (Some have also accused the pro-implant warriors of spreading rumors that approval is imminent to create a climate where approval is a done deal.)
“We feel like there are enough warning signs and unanswered questions that women deserve better,” said National Women’s Heath Network director Cynthia Pearson. “This is a disputed product and a disputed body of [scientific] information.”
It is also a deeply symbolic product, one that hovers not just at the intersection of health and sexuality—always a pungent brew—but of women’s health and women’s sexuality.
In today’s America, free-to-be-you-and-me has long since given way to lipo, face-lifts and an ever-wider array of injectables: Botox for the brows, Gore-Tex for the lips, and restylane for those pesky wrinkles around the nose and mouth. In 2005, the American Society of Plastic Surgeons reported nine million cosmetic-surgery procedures on women, up 38 percent from 2000. And while most people acknowledge that you can shave, wax, laser or strut about in pasties and still be a feminist, it’s also no wonder that women’s groups are freaked. Silicone is the stalwart flag of last retreat.
THE HISTORY OF THE BOOB JOB IS LONG and puckered, a Wild West–style tale of experimentation, complications and little regulation. The story begins with a Viennese doctor (of course) who tried injecting paraffin into women’s breasts in the 1890’s, and it continues with tales seedy and strange of doctors experimenting with everything from synthetic sponges to glass balls to industrial-grade silicone (think transformer fluid) injected directly into Vegas showgirls’ breasts, according to Elizabeth Haiken’s Venus Envy. That many of these experiments ended in less than happy results—cysts, gangrene, a few deaths—didn’t stop doctors from experimenting anyway.
The silicone-filled breast implant arrived on the bust-enhancing scene in 1962, to excitement from doctors and enthusiasm from the press. With its handy little protective pouch, this device was to be the solution to all those hapless decades of trial and error, to say nothing of the cruel disease of bustlessness. Once again, however, the big promises went largely unquestioned and unregulated.
But in the late 1980’s, the decades of scientific complacency gave way to scandal. After several critical magazine articles and an F.D.A. study linking silicone gel to cancer in rats, women began coming forward with tales of woe: ruptured implants, free-sloshing silicone (silicone in their breast cavities, their bloodstream, their lymph nodes), and symptoms that ranged from generalized aches, pains and exhaustion to arthritis and lupus.
“[I] was at a rally in Washington, D.C., where women from all over the country came together … and literally every woman had the same story,” recalled Carol Ciancutti-Leyva, whose mother believes that she became ill from ruptured implants, and who is now making a documentary about the subject. “Every woman had the same symptoms.”
Within short order, lawsuits were filed, the media pounced and a debate erupted. Surgeons called the allegations “junk science”—and launched a $2 million counter-campaign—but in 1992, after hemming, hawing and holding three days of hearings, the F.D.A. declared that manufacturers hadn’t done their safety homework and removed the implants from the general-use market. When Dow Corning, the country’s major silicone-implant maker, went bankrupt in 1995, the disgraced polymer seemed officially banished from the cosmetic-implant market.
In fact, it was only in temporary exile.
On Dec. 31, 2002, Inamed filed an application with the F.D.A. to begin marketing a new generation of silicone implants to mammary-challenged Americans—a move that was followed several months later by Mentor. The companies had been emboldened by a series of studies that found no clear link between silicone and serious autoimmune disease, but their move still sparked controversy—nearly three years of it, in fact, including several heated F.D.A. hearings, two rounds of applications (the F.D.A. turned down Inamed’s first attempt) and some serious lobbying (Mentor spent $850,000 on lobbying in 2005 alone).
Such back-and-forth has done little to clarify the burning question of implant safety in the public’s mind.
To listen to its boosters, silicone gel is a decidedly harmless, inert substance, the wonder material behind countless medical innovations, from testicular implants to neurosurgical shunts. “Silicone is everywhere,” said Dr. Helen Colen, a Park Avenue plastic surgeon who supports the return of silicone, though she generally prefers saline. “Your IV lines are silicone, your syringes are silicone. Everything is silicone. And yet only the breast got the raw deal?”
Beyond ubiquity, surgeons and supporters point to a pool of studies, including the much-touted 1999 Institute of Medicine Study, which did not find “statistically significant” links between silicone implants and systemic autoimmune diseases. That some of these studies also warned about an increased incidence of painful or disfiguring local complications—like infection, rupture and a nasty-sounding condition called “capsular contracture”—tends to get less airtime.
“Certainly, there are some local problems. Silicone gel implants got ruptured, and silicone got in the tissues, and that could produce lumps and bumps,” said Dr. Sherrell Aston, the celebrated celebrity plastic surgeon. (Many plastic surgeons dismiss rupture as a minor concern, saying it generally does not lead to serious silicone leakage these days because of sturdier implant shells and gooier silicone gels.) “But the real question is whether they produce any systemic disease, and there’s no evidence in the literature to support that.”
Silicone opponents beg to differ. Not only do they warn that rupture remains a potential problem in today’s new implants—one that can lead to additional surgeries and complications—but, they say, the literature offers a number of noteworthy examples of downright unhealthy silicone side effects, some of the scariest of which are presented in an ongoing National Cancer Institute study. Among its findings: Women with implants were two to three times as likely to die from brain cancer and respiratory cancers, and four times as likely to commit suicide, compared to other plastic-surgery patients.
As for those nasty connective-tissue ailments and autoimmune disorders about which so many women complained, implant opponents aren’t convinced that silicone is innocent there, either. While a number of studies found no observable tie to these diseases, implant critics say the studies are not entirely conclusive or trustworthy. In many cases, the sample size was too small; in other cases, the studies were too short; and frequently they were funded by the implant industry—charges that the groups have also lobbed against Inamed’s and Mentor’s trials of their cohesive-gel implants.
“A lot of this is a data-quality issue,” said Susan Wood, former director of the F.D.A.’s Office of Women’s Health, who resigned last year after the agency refused to approve Plan B despite evidence showing that it was safe. (The agency finally approved it last month.) “I think there needs to be a stand for high-quality data from the companies that has enough people over a long enough period of time …. Because, from what I know of what’s been presented, the studies don’t demonstrate that these products are safe enough for approval.”
THE F.D.A. HAS REMAINED STUBBORNLY MUM on its plans to approve, or not approve, silicone-gel implants, and the reality is that it could as easily give (or deny) its blessing tomorrow as it could over Thanksgiving, after the confirmation of the new F.D.A. commissioner, or during the next eclipse. But one thing is certain: If and when silicone plops back onto the cosmetic-implant market, it will find a ready home in American bosoms.
Between 1992 and 2005, the number of women getting breast augmentation for breast augmentation’s sake bounced an eye-popping 756 percent, from less than 33,000 to more than 279,000, according to the American Society of Plastic Surgeons. If this trend continues, the number of lady augmentees should climb a hefty heap higher next year. And should silicone get the government go-ahead, a good chunk of these women can be expected to choose the gel-filled sacs over saline—in spite of the higher cost, in spite of the hullabaloo. Already, some women have opted to hold off on their Betty Boop dreams until silicone returns, several doctors said.
“I’m trying to find on the Internet what the newest rules on silicone are, and if/when they will be laxer,” one woman wrote on the popular implant message board, BreastImplants411. “I’m looking into a ba”—shorthand for breast augmentation, not Bachelor of Arts—“and only want silicone …. ”
The impulse that drives some women to plump their breasts with silicone or saline—and again, we’re not talking about women who’ve had mastectomies—has long been a source of inter-lady conflict. During the years of hearings, anti-implant crusaders frequently rubbed up against enhancement buffs who accused them of condescension and, yes, suppressing their right to choice—consumer choice, that is.
“I don’t understand the hatred for these products,” said Arlene Nicole Cummings, an implant veteran who runs a Web site, Implantinfo.com, that she said gets more than one million hits a day. “It’s almost like some women feel like you betrayed them, like you have … given in to what society thinks women should look like.”
Ms. Cummings denied that such pesky impulses had anything to do with her desire to boost her bust. “It was not that way at all,” she insisted, pointing instead to an operation she had when younger to remove a breast tumor that left one breast small and underdeveloped, as well as to the vagaries of breast-feeding. “They just felt empty and saggy,” she recalled of her post-baby breasts. Her husband didn’t mind, but she “hated” them.
“For me, it was so much deeper—I just did not feel complete,” she said. “So when I filled them out, I was like, ‘This is great ….’ I could buy clothes; I fit into everything. It just completed me.”
But to one mother, acting student and saline-implant owner, that need for completeness is just the problem. On a recent Thursday, this woman, who gave her name as Foxy, sat perched on a vinyl barstool at Ten’s World-Class Cabaret, where she works evenings to pay her tuition, talking about the decision she now regrets.
“The big deal is men … because you want to be acceptable,” she said of the decision she made six years earlier, when she was just 23. “Unfortunately, in North America, big boobs seem to be a huge factor in our makeup of society these days—to get through doors, or get things open, or get paid, really.
“It’s an American thing,” she concluded with a quick, wry smile. “It’s the American dream—or at least it gets you one.”
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