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."
She cites a 2001 FDA-funded study, which compared women whose silicone gel breast implants ruptured with those who implants remained intact at least six years following surgery. There was a significant increase in fibromyalgia, but not lupus, among the women with leaking implants. Two studies published in 2001 by the National Cancer Institute found a doubling in brain cancer deaths, a tripling in lung cancer, and a quadrupling in suicides in women with breast implants.
"It is certainly not true that there is no evidence linking breast implants and disease," Zuckerman says. "I am not saying the FDA and NCI studies are definitive. But when you have a doubling or tripling in deaths in a relatively young population it shouldn't be ignored."
Zuckerman and Young agree on one thing. Women considering breast implants need to learn all they can about their choices and the potential risks and benefits associated with them. Young says silicone is usually the best choice for very thin women with little breast tissue and women who have had mastectomies, while saline may be preferable for those with more breast tissue. A new type of silicone implant that is more solid than liquid minimizes the risk of leakage, but may be too firm for some women.
"When women lie down their breasts tend to look the same as when they are standing up," he says. "A lot of women don't like that."