Breasts (8 page)

While injections were regulated, implants were not. They were
classified as a “medical device,” not a drug, and the FDA did not have authority to regulate medical devices until 1976. Even then, lobbyists ensured the implants were grandfathered in, meaning they did not need to go through an approval process as long as the manufacturer kept the agency updated on any safety problems. It was an eerie parallel to the sixty-two thousand chemicals also grandfathered in that same year under the new Toxic Substances Control Act (for more on that, see chapter 5). In both cases, the lure and power of technology—technology that would alter women’s bodies in wholly unexpected ways—trumped consumer protection.

From the beginning, Cronin and Gerow knew they had some problems on their hands. The sac did not, in fact, prevent the breast from hardening, and the silicone gel proved harder to contain than they’d hoped. The first-generation implants had a ridgelike seam that could be felt on the sides of the breast. Many patients—41 percent, according to a 1979 study—experienced loss of nipple sensation. An enormous percentage of patients—around 25 to 70 percent by ten years—suffered “capsular contracture” in which the body walled off the implant by creating fibrous scar tissue around it. The scar shell then tightened and shrank, contributing to a visual that became known as “the doorknob effect.” If silicone injections came to look like a bag of rocks, the implant resembled one big shriveled stone. A Houston neurologist, who was openly critical of implants, told me he once saw a patient who had been shot. She was a showgirl, and her implants were so hard that the bullet bounced off and saved her life. “They were like doorbells,” he said of her breasts.

Doctors speculated the contracture was a response to contamination and infection. Early dissections of the affected tis
sue revealed that pieces of paper, wood, cotton, talc—essentially pieces of the operating room—had routinely lodged on the implants. The operation itself, initially performed with fairly crude implements like scissors, resulted in a lot of blood and hematomas—gnarly bruises—around the implant. Eventually, surgeons would develop a cleaner, “no-touch” technique with fewer side effects.

Implant makers also attempted to address the problems. Dow Corning created a thinner, seamless bag. That solved the ridge problem, but the bag was so thin the gel freely oozed out of it (this was known as “gel bleed”), and the bags ruptured more easily. Company salesmen were told to wash the leaking implants with soap and water before presenting them to surgeons.

“We had the silicone catastrophe because the implants were made with a not totally impermeable barrier,” Biggs, now a retired plastic surgeon in Houston, told me. “It was a bad product.”

Beginning in 1982, manufacturers introduced a new, polyure-thane-foam-covered implant, called Meme, in hopes it would keep breasts from becoming bulletproof. Patients with these implants did experience lower rates of capsular contracture, and by 1991 this was the most widely used device. But the reason for the success was that the foam was evidently breaking down in the breast, causing a prolonged inflammatory response and “microencapsulations,” in which “multidirectional contractile forces cancel one another.”

In fact, as the implants got better, they were actually getting worse. Despite some sporadic earlier testing, it wasn’t until 1991 that the FDA released a report that the foam was releasing 2,4-toluenediamine, a known carcinogen. Within days, Bristol-Myers Squibb withdrew Meme from the market. But by then, at least 110,000 women had received those implants. Amazingly, the polyurethane
foam being used in the breasts of women was
the same stuff
headed for carpet pads and carburetors. It was never reformulated for medical use, and the manufacturer of the foam was apparently surprised to learn where it was ending up. Many surgeons remember these implants fondly, and foam-covered implants continue to be used in Europe and South America.

(Lest you think the Europeans are making better products, however, a glimpse into the 2011 French implant scandal will set you straight. Jean-Claude Mas, the seventy-two-year-old founder of Poly Implant Prothèse [PIP], is currently facing criminal charges in France for fraud and injury. For nine years, PIP sold implants secretly made with cheap industrial silicone including fuel additives and other chemicals never studied or approved for medical use. The adulterated implants, now installed in a quarter million woman throughout Europe and South America, are believed to be rupturing at higher than expected rates and causing inflammation.)

By the time of the foam revelations in the United States in 1991, another, bigger wave was crashing. Patients whose silicone implants had ruptured were reporting various idiopathic illnesses, everything ranging from fatigue to joint pain to lupus. The stories were all over the media, in the hearing rooms of Congress, and in the mailroom of the FDA. Several multimillion-dollar judgments were awarded to individual patients in juried courtrooms. The agency’s commissioner at the time, David Kessler, stated that “we know more about the life span of automobile tires than we do about the longevity of breast implants.”

In 1992, the FDA issued a moratorium on silicone implants except in women following breast cancer surgery who agreed to participate in clinical studies. (Saline implants were still available.) By 1995, half a million women were suing the makers of implants and
their surgeons. Faced with 20,000 lawsuits and 410,000 impending claims, Dow Corning declared bankruptcy. The company eventually entered into a $3.2 billion settlement with 170,000 women. It was the largest-ever class-action settlement at the time.

A recent college graduate, I clicked into the implant controversy around the time of the moratorium. I’d studied pesticide contamination of farm workers, chemical-plant explosions in Bhopal, and radiation poisoning in Chernobyl. Then an Exxon tanker cracked open in Valdez, Alaska, leaving birds slickened and imperiled. When I saw numerous news reports that plastic implants were rupturing inside women, who then came down with mysterious immunesystem ailments, it seemed to make perfect sense as another example of corporate malfeasance and crimes against nature.

But now, after twenty years of study, science has not backed up most of these claims. Research to date has found that women with silicone implants, even the older versions, do not have more immune-system diseases than their
au naturel peers.
Some research suggests that they have slightly higher rates of immune-related symptoms such as fatigue and arthritis, but other studies contradict that. In 2011, the FDA reported that implant patients have higher rates of a very rare cancer called anaplastic large-cell lymphoma. This cancer grows in the cells of the scar tissue surrounding the implant, but it is distinct from breast cancer. Implant patients do not have statistically higher rates of breast cancer, but they do have higher rates of lung and brain cancer. This is possibly because of migrating silicone, but more likely due to associated lifestyle factors such as smoking.

To be sure, many things are still distressing about the implant story. Doctors and manufacturers profited by introducing a poorly understood substance into women’s bodies. Implants were not engi
neered well at the beginning, they were inadequately tested, and patients were not always informed of the many real risks of the surgery, or of the high failure rates of the devices. Ultimately, the immune-system scare became a distraction from these other issues. As the legal scholar Julie Spanbauer put it in 1997, “The message that never reaches the public is that the majority of women with breast implants, those who received their implants before approximately 1992, have become nonconsenting, de facto participants in these and, unfortunately, in future safety studies.” But the crazy thing about the implant story is that no one comes out looking clean. Everyone was out to exploit everyone else, the media included. The implant patients themselves proved able opportunists; if the medical studies are correct, many more women jumped on the classaction gravy train than had claim to do so.

After 1992, the numbers of women receiving implants in the United States briefly plummeted from a high of 150,000 to about 30,000 annually during the conditional moratorium. But by 2007, a year after the FDA approved the next generation of silicone implants—still based on the original Cronin-Gerow concept of gel in a baggie—that figure had increased nearly 1,000 percent. Despite the recession, the worldwide market for breast implants is roughly $820 million a year and growing at 8 percent a year. Between five and ten million women are walking around with implants.

After a fourteen-year silicone hiatus, the fake-boob industrial complex was fully back in business.

BEFORE I LEFT HOUSTON, I WAS INVITED TO OBSERVE DR. CIAR
avino in action. I was curious to know who his patients were and, I suppose, to bear witness to this visceral alteration of the natural
breast. I steeled myself for the operating room by watching stills and YouTube videos of implant operations. One set of photos showed how the nipples were cut open and tubes placed in them to fill saline sacs. It gave the term
breast-feeding
a whole new visual. This is nurture turned on its head, a gut-churning reversal of lactation.

Fortunately, I would be spared that. Ciaravino prefers to work through a small, neat incision under the breast in what’s called the inframammary fold. He has a kind and compassionate staff, and he uses an experienced anesthesiologist. If you want implants, this seems to be a good place to come. Ciaravino is known for what he calls a “no-bleed” surgery. He cleaves the chest muscle from the rib cage using a pen-sized cauterizing tool that seals the tissue as it goes. He doesn’t want blood because a dry seal around the implant reduces risk of encapsulation and because iron is a primo nutrient for bacteria.

Katye had assured me that implants “are the most studied medical device in history,” and that they are now “100 percent safe.” But are they? The truth is that ongoing studies continue to raise basic health questions, and the FDA and even implant makers acknowledge as much. When the agency approved the new silicone implants in 2006, it was under the condition that manufacturers carry out ten-year follow-up studies. In its fifty-two-page product insert data sheet for MemoryGel implants, the Mentor corporation summarizes the results of the first three years of this study. In addition to finding an eye-raising three-year complication rate of 36 to 50 percent for implant patients (including trickier cancer reconstruction patients), the insert states, “Compared to before having the implants, significant increases were found [in patients] for fatigue, exhaustion, joint swelling, joint pain, numbness of hands, frequent muscle cramps, and the combined categories of fatigue, pain, and
fibromyalgia-like symptoms… These increases were not found to be related to simply getting older over time.”

The Mentor study has found that the three-year reoperation rate for patients (depending on whether they received augmentation or reconstruction procedures) is between 15 and 29 percent. Some reoperations are done because of cosmetic failure. The door-knob effect isn’t the only visual problem. A perusal of “bad boob jobs” on the Internet yields a grim parade of Uniboob (also called “bread-loafing”) in which the implants migrate toward each other; Double Bubble or “bottoming out,” in which the implant drops below the breast fold, creating what looks like a double-decker breast as well as serious asymmetry; Highballing, in which the implant sits too high; and various degrees of wrinkling and dimpling. A woman buying implants today may still be buying into recurrent surgeries, costly, regular MRI screenings (to detect “silent” ruptures), and a reduced ability to detect early breast cancer (the implants can block effective mammography).

Even more troubling, though, is that some women continue to report problems with nipple sensation and breast-feeding because nerves can be damaged during surgery. While Ciaravino says these effects in his practice are rare, a major review of the literature from the Institute of Medicine in 2000 stated that women with either silicone gel–filled or saline-filled breast implants showed lactation insufficiency (not enough milk) at rates ranging from 28 to
64
percent. The FDA’s Breast Implant Consumer Handbook further states, “It is not known if a small amount of silicone may pass from the silicone shell of an implant into breast milk. If this occurs, it is not known what effect it may have on the nursing infant.”

Perhaps few women with implants are interested in nursing,
but one would expect (and hope) that a great number are interested in sexual sensation. Let’s be clear about what these under-sung side effects mean: in a world where breasts are considered purely sexy, we jeopardize the central natural functioning of breasts (lactation and dynamite neural sensation) so that they can be even more sexy, to the point where the improvement actually eliminates the sexual feeling in this allegedly sexy organ. Now we can have hard, lifeless replicas of something sexy. Plastic surgeons understand this: in 1976, a pair of them observed in a trade journal, “Fortunately, patients undergoing plastic surgery of the breast are concerned more with getting rid of a deformity and achieving a desired body image than with maintaining or improving mammary sensation.”

They appear to be correct. When I learned about the continuing problems attributed to implants, what I was most astonished by is that so many women still want them, especially in Texas. Even with their contractures and ruptures and door-knob breasts and lifeless nipples, most women say they are
happy
with their implants. At least over the short term, many implantees report increases in self-esteem and sexual self-confidence, if not actual sensation. As the brain is the body’s largest sex organ, this makes some kind of sense. Mentor’s study to date shows that of 456 new augmentation patients within three years of surgery, 98 percent would have the procedure again. Other studies show that even seasoned patients do it all over again after their old implants have crumpled and died.

Do big breasts really have that much more fun? Or are we, as critics like Naomi Wolf suggest, hopelessly brainwashed by a beauty myth designed to keep our minds distracted by frivolity? That women should feel good about themselves is their right; but that they should
feel so bad about themselves in the first place shows that the modern boob job represents a great failure of the imagination.