Staying abreast of implants

Silicone or saline? Natural or enhanced? In the breast-augmentation wars, nothing less than women’s health, freedom, and empowerment is at stake.
BY DEIRDRE FULTON

THESE DAYS, teenagers get boob jobs as sweet-16 presents, radio stations sponsor "breast giveaway" contests, and ugly ducklings become Swans. On the political stage, Tim Coburn, a doctor and a Republican senator from Oklahoma, said this about breast implants: "If you have them, you’re healthier than if you don’t." Nobody’s really sure what Coburn (a fruitcake to almost anyone but serious right-wingers and Sooner State voters) meant by that, but it is clear he favors breast augmentation, as the procedure is officially known.

Breast implants have been commercially marketed since 1964, but they weren’t officially regulated by the US Food and Drug Administration (FDA) until 1976. In that year, after 17 women died from complications related to their use of IUDs, Congress adopted the Medical Devices Amendments, which regulate all physical implants — from pacemakers and stents to breast implants. In 1992, amid widespread safety concerns, the FDA placed a moratorium on silicone-gel implants. For the next decade, silicone implants were available only through clinical trials, and then only for women who needed breast reconstruction after a mastectomy; who had major deformities; or who needed replacement surgery. Women seeking breast augmentation for cosmetic reasons were stuck with saline implants, an option most people consider somewhat safer but less aesthetically pleasing.

In early April, the FDA will consider lifting the 13-year restriction on silicone implants. The implant industry never gave up on silicone, and manufacturers now feel they have accumulated enough safety data to warrant FDA approval. An expected ruling in March by a Canadian regulatory panel could provide an indication of how the winds will blow here in the United States.

But the implant debate is about more than extreme makeovers or protecting the public’s health. In fact, both sides will tell you that nothing less than women’s freedom and empowerment is at stake. This isn’t particularly comforting, given the FDA’s tendency under the Bush administration to play politics with science. Last year, the FDA weighed in on another women’s-health issue and ignored a committee recommendation to make emergency contraception available over the counter; that decision was widely slammed as being politically motivated. And it didn’t help that, in 2002, Bush named Dr. David Hager, an extreme pro-life obstetrician/gynecologist who penned As Jesus Cared for Women: Restoring Women Then and Now, to head the FDA’s Reproductive Health Drugs Advisory Committee. (The appointment was stymied by vigorous opposition from women’s-rights groups.) More recently, controversies over the agency’s regulation of drugs such as the arthritis medications Vioxx and Celebrex further strained the FDA’s reputation. In this atmosphere, the last thing the agency needs is to foster more doubt about its ability to regulate in the public’s best interests or its treatment of women.

That’s why there’s a good chance silicone implants will be given a thorough evaluation when they go on trial this spring. It’s also likely that, regardless of how well the decision is vetted, the emotional battle waged at the hearings will continue long after the ruling comes down.

ALL IMPLANTS eventually break. In fact, "safer" saline implants have slightly higher rupture rates than their silicone counterparts, according to most studies. But while a woman’s body can quickly and safely absorb leaked saline (salt water), it’s unclear what happens when silicone leaks from an implant, gets past the scarred tissue that surrounds the implant’s outer capsule, and invades a woman’s bloodstream. After all, though silicone is ubiquitous — it’s found in everything from food and beauty products to rubber and cleaning solutions — it’s still a synthetic compound.

Back in the late 1980s and early ’90s, some scientists suggested that silicone could cause various cancers, autoimmune diseases, lupus, and fibromyalgia. Those fears have been largely assuaged, most notably by a 1999 Institute of Medicine study.

It’s also true that breast-implant technology has seen vast improvements. Some early breast implants were made with a coating of polyurethane foam — the same material used to insulate homes. At one point, scientists thought they had found a safe, natural implant-filler in peanut oil — until they remembered that peanut oil, when left out too long, gets rancid. Now, one company is seeking approval to market a new "cohesive-gel implant," whose consistency it compares to that of gummy bears.

But for some women and scientists, questions remain: if a woman has silicone implants in her body for several decades (an increasingly likely scenario, given the growing breast-augmentation trend among younger women), is her health in danger? What happens if she becomes pregnant, or during the natural aging process? Many women can relate horror stories in response to these questions, but it remains unclear whether that adds up to anything more than sickening anecdotal evidence.

The FDA revisited these issues as recently as 2003. Following the typical approval procedure, an FDA advisory committee heard evidence in October 2003, from implant manufacturers and scientists, along with personal testimony from silicone supporters and opponents. That committee voted to approve silicone implants for general use — on condition that doctors and manufacturers provide a long list of safety recommendations — and passed its approval on to the FDA at large. (To read some of their concerns, see "Body of Evidence," page 15.)

Knowing it wouldn’t be able to enforce its panel’s safety recommendations — the FDA has the ability to set rules and provide guidance, but it’s difficult to follow up on each and every regulation — the agency opted to send implant manufacturers back to their labs to collect more safety data. The agency created a new set of guidelines that clearly laid out what it was looking for — most notably, long-term studies. In April, the two primary implant companies, Inamed Corporation and Mentor Corporation, will present to the advisory committee revised data based on those new guidelines.

"We’ve put together new information," says Dan Cohen, Inmed’s vice-president of global corporate and government relations. In addition to researching why implants rupture and where silicone gel goes when it leaves the implant capsule, Inamed collected "over 100 peer-reviewed, epidemiological studies of the safety of breast implants, both domestically and internationally," Cohen says.

They’ll have to bring a truckload of evidence to convince people like Dr. Diana Zuckerman, a Harvard- and Yale-educated researcher who is president of the National Center for Policy Research for Women and Families and an outspoken critic of silicone implants. Zuckerman wonders how Inamed could have collected, in only a year, all the data the FDA requested. She is wary of corporate spin on the evidence. And she worries that the implant discussion in April will be a "political revisiting of an issue," based on the Bush administration’s sympathies to industry.

But most of all, Zuckerman is concerned about the women whose bodies are caught in the middle of yet another FDA debate. Though all products go through a certain amount of testing and trials, Zuckerman thinks too much implant experimentation has gone on inside women’s bodies.

"The history of implants really has been a history of tinkering with a product," she says. "It was never designed with the care that you’d expect from something that’s going in the human body."

ADVOCATES FAMILIAR with the struggle say this debate is about much more than the science of silicone. Reading the testimony and listening to the arguments, it becomes clear that underneath all the talk of statistics and data sets, the discussion has everything to do with women’s rights — on both sides of the table. "It was very clear in the testimony that there was a group that sincerely felt that these devices were responsible for major damage in their lives, and there was also a group that felt similarly at the opposite end," says Dr. Benjamin Anderson, who sat on the 2003 FDA advisory committee, and serves as director of the Breast Health Center at the University of Washington, in Seattle. "It was as polarized a debate as I have seen, in that context."

Take pacemakers, for example: it’s difficult to imagine witnesses becoming so distraught over those devices, Anderson points out. "That’s because no one disputes the value of keeping your heart going," he explains. "But people do dispute and generalize the issues of body image."

"People always make social decisions and moral judgments for others," agrees Dr. James Wells, past president of the American Society of Plastic Surgeons (ASPS) and co-chair of that organization’s Breast Implant Task Force. "The woman who has elected to have her breasts enlarged has always been looked at as an exhibitionist, if you will. The reality is, the woman who seeks out breast augmentation — more often than not — is a woman who’s married, has a satisfactory relationship with her husband, has finished her childbearing years." Often, these are women who have had children and aren’t happy with the way their breasts look after having a baby, he says: "It’s not the 20-year-old who wants to be in a bikini on Southern California beaches."

Statistics back up his claim. In 2003, women between the ages of 35 and 50 accounted for more breast augmentations than any other age group (114,915, or 45 percent), according to the ASPS. However, the procedure appears to be on the rise among younger women: the number of girls under age 18 (3841) who had breast-augmentation surgery grew by 24 percent in just one year (2002-’03) alone.

Wells insists that those who want this cosmetic surgery "have a right to make a judgment about themselves if they know what all the issues of the implant are." Indeed, those who support the implants often frame their argument in "pro-choice" terms — not only should women have the choice to get implants at all; they should also have their choice of implant devices to select from.

On the other side are the unlikely "anti-choicers" — such as the National Organization for Women (NOW) and the National Women’s Health Network — who insist that while they’re not against implants in general, they’re certainly against unsafe ones.

These organizations have serious concerns about women’s health; they worry not just about the long-term ramifications of silicone, but also about whether implants impede mammography readings and what effect silicone has on breast milk. But they also emphasize the social pressures that convince some women to undergo what they consider a dangerous procedure.

"Why are women doing this?" asks NOW president Kim Gandy. "In my opinion, it’s because of the media images that constantly bombard women with the message that ‘you’re not good enough,’ that ‘you have to starve yourself,’ ‘you have to have an unhealthy diet, so you can be a size 0,’ and ‘you have to go and get plastic surgery so that your breasts will be big enough.’ Women — girls — are bombarded with these messages every day."

Even Dr. Wells admits: "Look at the cover of women’s magazines. Look at the cleavage they put on there. Look at the fact that they’re size twos. These images are created, and women are somehow expected to step into that image."

FOR SOME women, the decision to get implants has less to do with body image than with body identity. In other words, putting aside all cultural influences and pressures, sometimes plastic surgery is based simply on a woman’s relationship with her own body.

Plastic surgeons like Dr. Wells are full of stories about introverted patients who became confident and outgoing after surgery. "I’ve seen women change dramatically after having implants done, just in terms of feeling more comfortable about themselves," he says.

And there are more extreme examples, like the coalition of breast-cancer-survivor groups that has emerged as a vocal contingent of the pro-silicone camp. For some mastectomy patients, this debate is about feeling whole again. "Losing a breast is incredibly traumatic," says Fran Visco, president of the National Breast Cancer Coalition (NBCC). "It certainly is physically traumatic, and it’s also psychologically traumatic. While an implant does not in any way replace your breast, it does give you that physical appearance that is extremely important.... Society isn’t ready to accept non-breasted women."

But just because breast-cancer survivors are open and even enthusiastic about implants doesn’t mean they’re ready to embrace silicone. Organizations like the Massachusetts Breast Cancer Coalition and Breast Cancer Action, along with the National Women’s Health Network, have encouraged the FDA to push implant manufacturers for more long-term data.

Still, a growing number of them are vocal fans of silicone. The Chicago-based Y-Me National Breast Cancer Coalition has taken a leading role in supporting the implants. (One health advocate called the organization the "poster children for implant companies.")

"When you lose a part of your body, it’s a very traumatic thing," says Kay Wissman, government relations director for Y-Me. Wissman has been diagnosed with breast cancer three times, and she’s opted for lumpectomies. But from women who have had to lose a breast, Wissman hears that "silicone is superior." That’s because in reconstruction cases, the tissue covering the implant is much thinner than it would be in augmentation surgeries, when a layer of fatty tissue sits between the implant and the breast. Because silicone’s consistency, texture, and appearance can more accurately mimic a natural breast, it’s often a more attractive choice for all women, but especially for breast-cancer patients.

Dr. Anderson, of the Seattle Breast Health Center, offers this way of thinking about what a woman’s breasts mean to her: "What’s interesting is — I think this is less mysterious for women than it is for men — that male partners will often assume that if they’re okay with a mastectomy, then the woman should be as well. Because they assume that the relationship is the main issue. In fact, femininity and sexuality are quite distinct."

SINCE 1992, when silicone implants were taken off the market, the number of women seeking breast augmentation has increased by 593 percent, according to the ASPS statistics. In 2003, 254,140 women had breast-augmentation surgery — and that’s not counting the breast-cancer patients who underwent reconstruction.

"If people didn’t want aesthetic surgery or body-image surgery, there wouldn’t be a product," Dr. Wells acknowledges. "Things are developed in response to a perceived want or need."

"It really is just looking at the data," Visco says. "Sometimes it comes down to risk — how much risk, once you know what the data show and what the risks are, how much risk a woman is willing to accept? After a while, it does just come down to an issue of personal choice."

http://www.bostonphoenix.com/boston/news_features/top/features/documents/04482471.asp

Body of evidence

In October 2003, the FDA’s General and Plastic Surgery Devices Panel heard two long days of testimony from scientists and advocates from both sides of the silicone-implant debate. In a difficult and contentious decision, the committee voted nine to six to approve Inamed’s application to market silicone implants. That approval, however, came with a long list of safety requirements — an indication that some members had significant reservations. Here are some excerpts from an FDA transcript:

"[R]eal autonomy encompasses the right to make foolish decisions and, indeed, I may think it is a foolish decision for a woman to have augmentation surgery.

"The final issue is I have been rather startled today by what I see as the lack of obligation that the sponsor felt to pursue a better product over the decade that I have been engaged in these discussions. I find it strange that this obligation of wise stewardship of the product that they are producing didn’t leave any room for at least attempts to improve it in the last decade."

Nancy Dubler

Director, Division of Bioethics

Montefiore Medical Center, New York

"I am concerned again about the long-term follow-up for local complications, for silent ruptures, and that we just don’t have that data, particularly when maybe we will be looking at these. I am also concerned about the ability to truly provide informed consent without longer-term follow-up, particularly to educate a young woman choosing implants when she may not have a clue about her lactational interests 10 years later, or the importance of breast-cancer screening."

Dr. Emily Conant

Associate professor and chief of breast imaging, Department of Radiology

University of Pennsylvania Medical Center

"I am satisfied with the safety that I have seen in terms of the long-term effects of these implants. I think there are questions that exist but I think that the experience of 40 years, ... the nice analysis of the data, and the published studies that were done by both the FDA and the sponsor summarized the literature very well."

Dr. Michael Miller

Associate surgeon and associate professor, Department of Plastic Surgery

University of Texas MD Anderson Cancer Center

"When the implants were removed from my body, I learned that my right implant was ruptured. I was left with a big gaping hole in my right chest wall. My body would not heal properly. I walked around with this hole in my chest for four months. My scars were open on both sides and would not close. Even the drainage holes where the drainage tubes were took longer than they should have to heal. I dressed these holes in my body twice daily for four months, while green oozing slime came from them.

"I am only one woman in a sea of thousands, all experiencing the same problems, and the only common denominator between us is the fact that we all had silicone breast implants."

Statement submitted by Linda Dinito, who was too ill to attend the hearings. She was 27 when she got silicone-gel implants in 1980, and had them taken out in 1994.

"What does approval mean? If Inamed silicone gel implants are approved, the company might be required to conduct research for another seven or eight years, but the FDA cannot enforce that. They do not have the authority to make sure that those studies are done. If they are approved, the FDA can try to enforce informed consent but they can’t actually enforce it; they don’t have that authority. If they are approved, the women ages 18 and older, 17- and 16-year-old girls, will still have access to them, just as they do to saline breast implants."

Dr. Diana Zuckerman

President, National Center for Policy Research for Women and Families

— Deirdre Fulton