Are Implants Really Unsafe?

More and more women aren't waiting for the answer.

March 27, 2000 (San Francisco) -- Forty-year-old Patty Faussett of Las Vegas always thought of herself as the organized type: She balanced a full-time career, taking care of four children and tending to her home. So after her youngest was born, she decided it was time to plan a little something for herself. "My breasts had become unpleasant to look at," she remembers. "So I thought about implants." She had saline-implant surgery in May 1997.

Eight months later, Faussett's vision became blurry and she complained of a "foggy head." "I'd find buckets of cleaning water left all over the house because I'd started something and left it unfinished," she says. "I didn't want to believe that the implants caused my sickness, but I kept saying, 'I want my old self back.' " Just a month later, she had her implants removed.

Faussett was only one of 43,681 women in the United States who had their implants removed in 1998, according to the American Society of Plastic Surgeons (ASPS). They found that 93% of the implants were removed because of physical symptoms, such as deflation, leakage, infection, or capsular contracture -- a hardening of the scar tissue that forms around any type of implant. Still, more women than ever -- some 300% more than in 1992 -- are going under the knife to obtain larger breasts. Plastic surgeons in the United States performed at least 130,000 breast augmentation surgeries last year, the majority of which used saline, or saltwater-filled, implants, says the ASPS.

The FDA Takes a Closer Look

Due in part to the large numbers of women having implants and of stories like Faussett's, a Food and Drug Administration (FDA) advisory committee met in early March to discuss whether saline implant manufacturers have provided sufficient safety data to keep their products on the market. Because these implants were available before the FDA began regulating medical devices in 1976, they've been used without formal FDA approval until now.

Despite emotional testimony from Faussett and other women like her, and despite research that showed 25% of women who received implants needed to have them redone, the panel recommended that saline implants be kept on the market.

Alan Gold, M.D., a plastic surgeon in Great Neck, N.Y., and chairman of the Public Education Committee of the American Society of Aesthetic Plastic Surgery, agrees with that recommendation. While Gold acknowledges that women have complained of symptoms such as memory loss, joint pain, autoimmune disorders, and chronic fatigue from both saline and silicone implants, he counters that "those symptoms are no more common than in women without implants in the same age group." He adamantly challenges the idea that saline, or even silicone, puts women at any greater risk for these serious illnesses.

More Research Needed on Safety

But critics of both types of implants argue that not enough research has been done to assess the risks. Diana Zuckerman, Ph.D., Executive Director of the National Center for Policy Research for Women and Families in Washington, D.C., hopes to see long-term studies of several thousands of women to determine any risks conclusively. Zuckerman cites one 1997 study from Washington University's School of Medicine that found the incidence of infection from breast implants was significant and that more research was warranted. The FDA panel agreed, recommending more long-term studies on women who have had breast implants, as well as testing to see why implants leak or rupture and need to be replaced.

However, Gold is quick to counsel his patients that reoperation is a natural part of an implant. "No implant, not even a heart valve, is permanent. You will almost certainly have to replace it," he says.

Committee Requests Disclosure Form

Although the FDA advisory committee recommended saline's continued presence on the market, it also asked that the FDA devise a standard disclosure form to be given to women before implant surgery. The form would include risks, as well as leakage and reoperation rates. "All possible data on risks and benefits should be given to women," says panelist Nancy Dubler, L.L.B., a bioethicist at the Albert Einstein College of Medicine. "The [disclosure] should be very stark and very informative."

Faussett finds some reassurance in the panel's suggestions. Ironically, just weeks before she spoke in front of the panel, Faussett's stepdaughter called asking for help to pay for her own implants. She didn't know of her stepmother's ordeal, but once she heard Faussett's story, she changed her mind about getting the implants. Spreading the word about both sides of getting implants is just what Faussett's been fighting for.

Priya Giri is a writer in San Francisco.