E-Mail This Article to a Friend 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."