June 3, 2003 -- Just how safe are silicone gel breast implants? The FDA may soon consider lifting its decade-long ban on sales of the implants, but experts still disagree over their safety.
A plastic surgeon who spoke with WebMD says close to two dozen studies disprove widely publicized reports linking silicone gel implants with various autoimmune diseases, calling the matter "a dead issue." But a women's health advocate who also talked with WebMD counters that the issue is very much alive.
Early findings from a Danish registry that tracks women with breast implants tend to bolster claims of the safety of silicone gel breast implants. Data from the Danish Registry for Plastic Surgery of the Breasts published in the June issue of the journal Plastic and Reconstructive Surgery show a low incidence of serious complications in nearly 1,500 women who got breast implants.
For most of the women, it was their first procedure and most of them did it for cosmetic reasons. Of all implants, 88% were made of silicone gel.
Sixteen percent of these women experienced some adverse effect; mostly women complained of a change in feeling, 4% complained of a hardening of the breast from scarring, and 1% required additional surgery.
'No Link' With Disease
"This is just more evidence substantiating that silicone gel implants are generally safe," plastic surgeon Leroy Young, MD, says.
Young chairs the American Society for Plastic Surgery's National Breast Implant Registry, established in the U.S. three years ago. More than 4,300 women are now included in the U.S. registry, and a report on their health status is scheduled for release late this year.
The FDA banned the sale of silicone gel breast implants in 1992, following reports of high rates of rupture as well as autoimmune diseases such as fibromyalgia, rheumatoid arthritis, and lupus. The legal battle over the implants resulted in one of the largest class-action settlements in history, with implant manufacturer Dow Corning Corp. agreeing to pay $3.2 billion to breast implant recipients who became ill.
Young concedes that silicone implants are associated with more serious local complications than saline implants. But he says the clinical evidence overwhelmingly supports lifting the ban on silicone.
"Over 20 epidemiological studies show no link between silicone gel breast implants and disease," he says.
Critics Beg to Differ
But Diana Zuckerman, PhD, says most of those studies were badly flawed because they included women with new breast implants and follow-up was short. Zuckerman is president of the National Center for Policy Research for Women and Families.
"About half of the women in these studies had their implants for five years or less, and some studies included women who had had their implants for as little as a month," she says. "Someone diagnosed with an autoimmune disease a month after having a breast implant probably already had it."