Silicone breast implants back after 11-year ban
October 21, 2003
Despite reported risks associated with silicone breast implants in the past, some local plastic surgeons welcomed the Food and Drug Administration’s decision to allow the implants back on the market.
The FDA gave conditional approval to use silicone gel breast implants for cosmetic use after reviewing safety data from a silicone gel implant manufacturer.
Before the 9-6 vote, the FDA’s advisers spent two days hearing stories from dozens of women who blamed silicone gel implants for permanent disfigurement and women who wanted more options to repair cancer-damaged breasts or enlarge healthy ones.
Saline breast implants are used in cosmetic surgery, said Lester J. Yen, staff physician at Cosmetic & Reconstructive Surgery in Des Moines. Since 1992, silicone gel breast implants were only allowed in reconstructive surgery, primarily in breast cancer patients.
Inamed Corp., the manufacturer seeking an end to the ban, will be required to track the health of all implant recipients. Women with silicone implants would need annual exams to make sure the implants aren’t leaking.
Women will also need detailed information about the implants’ known risks before an operation, the advisers to the FDA said. This includes information about high rates of repeated surgeries and lingering safety questions.
The decision disappointed women who told the FDA about disabling pain and silicone oozing through their skin — even after leaky implants were removed.
“It’s a black day for the women of this country when our government doesn’t protect us from such dangerous products,” said Lynda Roth, who heads the Coalition of Silicone Survivors.
Others welcomed the news.
Eugene Cherny, medical director and senior surgeon at Heartland Plastic and Reconstructive Surgery in Des Moines, called it “vindication.”
Most leakage problems with silicone gel breast implants had been addressed by 1992, when the FDA banned them, he said.
Having silicone gel back on the cosmetic market can have many benefits, Cherny said. Having more options will allow doctors to do a better job.
“On the appropriate patient, [silicone] looks and feels more natural,” Cherny said.
The same issues occur with saline implants, Cherny said. More than 10 percent deflate or rupture.
When used correctly, Yen said, both silicone gel and saline implants have good results. Doctors must tell people about options and possible detrimental effects, he said.
“What is completely acceptable to one [patient] my not be acceptable to another,” Yen said.
However, silicone’s past may have left the substance with a bad reputation.
“I think it is going to take some time to get [negative opinions] out of the public’s memory,” Cherny said.
— The Associated Press contributed to this article.