Home > News

THURSDAY, Jan. 8 (HealthDayNews -- The controversy over silicone breast implants took a surprising new turn Thursday with the announcement that the Food and Drug Administration would not follow an advisory panel's recommendation to allow the devices back on the market.

Inamed Corp. of Santa Barbara, Calif., which makes the implants, said that it had received a "not approvable" letter from the FDA.

"The letter outlines the additional information that Inamed must provide prior to the FDA's further review of its premarket approval application (PMA) for silicone gel-filled breast implants," a company statement said. "According to the letter, submission of this requested information and data will place the PMA in approvable form and allow the FDA to conduct further review of Inamed's PMA."

Nick Teti, Inamed's chairman, CEO, and president said in a statement, "Although we are disappointed with the current outcome, we appreciate the serious and thorough review of our PMA by the Food and Drug Administration. The FDA letter that we received provides directions for us to follow, and we intend to work cooperatively with the agency to place the PMA in approvable form."

Silicone gel implants were taken off the market in 1992 amid fears that leaking might be responsible for autoimmune diseases and even cancer. Other problems included the fact that many women needed repeat operations to deal with painful scar tissue. Inamed was seeking approval to start selling the devices again for aesthetic purposes.

On Oct. 15, the FDA's General and Plastic Surgery Devices Advisory Panel of the FDA's Medical Device Advisory Committee voted to allow the devices back on the market, albeit with a series of strict conditions. These included warnings to users and more safety tests.

Soon after, however, Dr. Thomas Whalen, the panel chairman, publicly disagreed with his own panel's decision by sending a letter to FDA Commissioner Mark McClellan and five members of Congress citing his "strong reservations" about the vote and "imploring" them not to approve the product.

"What was most troubling is that here we had this device pulled for lack of long-term safety data and we were sitting in a room for a day and a half without any long-term safety data," Whalen said in an interview in early November. "Without that long-term safety data, we shouldn't be approving this."

In fact, the committee vote was far from unanimous, with nine voting for letting the implants back on the market and six voting no. Even among the "yes" voters, however, there were considerable reservations. "This was a relatively closely voted panel," said Whalen in early November. "One person had to leave early and I don't know what they would have voted. It is suspected it would have been against. It might have been 9-8 if I had been able to vote."

Whalen felt that Dr. David Feigal, director of the FDA's Center for Devices and Radiological Health, was "fairly skeptical of what was going on."

The recent FDA move set off a new flurry of responses.

Public Citizen commended the FDA. "As the group that petitioned the U.S. Food and Drug Administration in 1988 to ban silicone gel breast implants, we commend the FDA for the non-approvable letter it released today, concerning Inamed silicone gel breast implants," Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a prepared statement.

Dr. Nolan Karp, associate professor of plastic surgery at New York University School of Medicine in New York City, expressed disappointment. "We all hoped that these would be approved but that's not what's going to happen," he says. "It means a lot of time, a lot of money, a lot of effort if [Inamed] wants to get these things back on the market."

Karp uses the implants as part of a study involving women who need reconstruction after breast cancer surgery. "I think the implants are really terrific. For certain people they allow them to live a normal life," he says. "I wish they would loosen it up a little for the people who have cancer and need reconstruction."

More information

The FDA has more on breast implants, as does the British Department of Health.

(SOURCES: Thomas Whalen, M.D., professor of surgery and pediatrics, Robert Wood Johnson Medical School, New Brunswick, N.J.; Nolan Karp, M.D., associate professor of plastic surgery, New York University School of Medicine, New York; Public Citizen statement; Inamed Corp. statement)

Copyright © 2004 ScoutNews, LLC. All rights reserved.