As many as 46 percent of women who get silicone-gel breast implants need additional surgery within three years, says research that is key to the government’s reconsideration of an 11-year near-ban on the devices.
Inamed Corp., which manufacturers the implants, wants the ban lifted, arguing that its research shows implants filled with silicone gel are comparable to today’s only option, those filled with salt water — which just as frequently require more surgery too.
That argument promises to be central to the debate as the Food and Drug Administration reopens the emotionally charged issue this week.
The FDA’s independent scientific advisers begin a two-day meeting Tuesday to decide whether Inamed has proven its case. Dozens of women are lined up for a chance to try to sway the decision — some to plead for access to an implant they say feels more natural, others to tell how implants left them permanently scarred.
Last year, 236,000 American women had breast enlargements, over six times more than a decade earlier.
The FDA ended routine sales of silicone-gel implants in 1992 amid fears they could break apart and cause serious disease as the silicone leaked into women’s tissues. While some women seeking breast reconstruction because of cancer or other problems still could get silicone implants in strictly controlled research studies, women wanting larger breasts have had to use saline-filled implants.
Despite thousands of lawsuits that sent one of the largest implant makers, Dow Corning, into bankruptcy, major scientific studies have never proven that silicone-gel implants cause serious diseases like lupus or cancer.
Silicone gel has remained legal in Europe, and Inamed says in countries where women have the option, they far prefer it to saline.
But critics say studies haven’t tracked women for long enough to truly exonerate silicone-gel implants, and contend that local complications like painful scarring and reoperations occur too frequently to warrant their use anyway.
The FDA found one in five women who received silicone implants for breast enlargement in Inamed’s study needed additional surgery within three years. That risk was even larger — 46 percent — for breast cancer survivors who received the implants.
Both rates are similar to reoperations seen with saline-filled implants, which the FDA allows to sell as long as women are forewarned.
Proponents had hoped the silicone implants would not cause as many return trips to the operating room. Sometimes the additional surgeries were done to treat painful scarring. In 7.5 percent of enlargement cases and a quarter of cancer survivors, implants were removed or replaced, because of pain, improper position, breakage or, sometimes, patient desire for a different size.
What about long-term effects? FDA research suggests implants are more likely to break later, after about seven years.
While the FDA agrees there’s little proof that implants cause serious disorders such as lupus, agency scientists say rare diseases aren’t completely ruled out. Additionally, they plan to tell the meeting, a possible increase in lung cancer and brain tumors found in a handful of studies requires more research.
The FDA’s advisers will issue recommendations Wednesday. The FDA isn’t bound by the advice but usually follows it; it hasn’t set a deadline for deciding the fate of Inamed’s appeal.