FDA rejects lifting ban on silicone breast implants

? The government will continue its decade-plus ban on most silicone gel breast implants for now, health officials announced Thursday, saying they still have serious questions about how often the devices break apart and the damage that can result.

The Food and Drug Administration rejected Inamed Corp.’s bid to bring back silicone implants, and outlined new guidelines for all manufacturers on the scientific issues that must be settled if the devices ever are to return to the market.

Key is answering questions about the gel that can ooze into a woman’s breast, and sometimes beyond, when the implant breaks.

“We’re quite convinced that there are women who have these products and get a very satisfactory result,” said FDA medical device chief Dr. David Feigal. “The point isn’t to talk about how many have a good result and how many have a rupture. What you really need to know is, for someone who has a rupture, what are the consequences of that?”

The FDA’s move doesn’t end strictly controlled research studies that make the once highly popular implants available to some women with breast cancer and a few other conditions.

But it could delay for several more years the return of silicone implants, meaning the main option for most women, especially those who want bigger breasts, will remain implants filled with salt water. Some 236,000 U.S. women underwent breast enlargement in 2002.

Inamed expressed disappointment but pledged to seek FDA approval again.

“We see this as a setback but by no means do we see this as the end of the road,” Inamed chief executive Nick Teti told financial analysts late Thursday. “We are confident we can provide the information,” but he wouldn’t estimate how long it would take.

The decision delighted women’s and consumer advocacy groups that had intensely lobbied the FDA to keep the implants banned.

“At last they’ve heard us,” said Sybil Goldrich, a breast cancer survivor who first complained about implants to the FDA 15 years ago. Goldrich went through four sets of broken implants in the 1980s.

Now that FDA has provided explicit advice to manufacturers, “I really hope they’ll be able to make a product that works,” she said. “If we can put a man on the moon and get a little machine to explore Mars, it seems to me you could make a good breast implant.”