A Legacy of Worry
Saline implants have been the only option for many women since 1992, when the FDA banned silicone implants based on concerns that they might be causing autoimmune disorders, such as lupus, arthritis, and body aches.
An Institute of Medicine report last year found no link between silicone implants and autoimmune problems; so did a study reported in the New England Journal of Medicine earlier this month. Yet the controversy over silicone has put pressure on the FDA to take a harder look at saline.
At the recent panel hearings, saline implant maker McGhan Medical acknowledged there were at least minor problems among 60% of patients within four years of implantation and among 84% of breast reconstruction patients. Meanwhile, Mentor said its study of 1,680 saline implant recipients found that up to 27% of the implants were removed within three years, mostly due to infections, pain, or leaking.
In a published report, panel member Stephen Li, M.D., of New York's Hospital for Special Surgery, called Mentor's failure rates "alarmingly high" and said, "it's amazing to me it seems to be tolerated as just something you have to live with."
Nevertheless, implant makers and others will likely take the FDA panel's final decision "as a blessing," says Michael Williams, an attorney who has represented women in lawsuits over silicone implants.
"The medical industry likes to use the FDA as a shield. " They believe that if the FDA has OK'd it, then that should be the end of it."
Increasing Attention on Informed Consent
That's not likely.
Legal experts say a woman will still have grounds to sue if her doctor fails to inform her adequately of the risks involved or if she experiences problems that are worse or different than the ones described in a company's product literature.
And depending on the FDA's final decision, doctors and implant makers may well have to provide additional information on specific risks (see Details of the FDA Panel's Hearings).
Since the early 1990s, many plastic surgeons have required women contemplating implant surgery to sign a special consent form; the content can vary from state to state although the American Society for Aesthetic Plastic Surgery (ASAPS) has published guidelines (see A Guideline to Risks).
Many doctors make it a point to emphasize the downside: "All I do is talk about complications," says Sherwood Baxt, a New Jersey plastic surgeon.
But Diana Zuckerman, Executive Director of the Washington-based National Center for Policy Research for Women and Families, says some doctors aren't so clear. "Many women will tell you that their doctors told them their implants were perfectly safe and nobody told them about the failure rate or that implants could break," she said, adding that consent forms often read like a "mortgage application."
"Everybody knows that there is a huge gap between what a written document says and what the doctor tells a patient," says Zuckerman. "If the doctor says, 'Don't worry, my patients are all very happy,' few women will get up and leave."