News Center Home > Breast

11/06/03 - Panel Chair Opposes Advice on Breast Implants - Washington Post

By Ceci Connolly
Washington Post Staff Writer

The chairman of the federal advisory panel that voted last month to allow silicone breast implants back on the market after an 11-year absence is urging the Food and Drug Administration to override the recommendation because of lingering long-term safety concerns.

Thomas V. Whalen, a professor of surgery at the Robert Wood Johnson Medical School, said he decided to take the unusual step of speaking out against his own panel's action because "to approve this device poses threats to women that are clearly unknown."

The palm-size gel implants were pulled from U.S. markets in 1992 because of fears that ruptures and leakage could cause complications such as neurological and tissue damage.

In a letter to FDA Commissioner Mark McClellan, Whalen said the questions remain unanswered.

"It is incumbent upon the FDA to demand that the manufacturer establish in a rigorous, prospective, controlled study that these devices, despite their established breakage and leakage rates, are safe in the long term," he wrote.

Calling last month's 9 to 6 recommendation "misguided," Whalen said it was tainted because every plastic surgeon on the panel voted to approve the implants.

FDA would not comment on Whalen's letter or the application by Inamed Corp. of Santa Barbara, Calif., to market the devices.

The Oct. 31 letter, released to a few news organizations, reignited passions on both sides of the emotional debate. Since regulators prohibited the use of silicone implants, physicians have used saline implants for breast augmentation. The silicone model has been available only for reconstructive surgery and as part of clinical trials. Last year, more than 225,000 women sought cosmetic breast enlargement.

A growing contingent of women and physicians have clamored for the silicone gel implants, saying they look and feel more natural.

"For me, it's all about choice," said Michael Olding, chief of plastic surgery at George Washington University and a panel member who supported approval. "Those women deserve to have that choice, particularly when we have no scientific evidence that there's any connection between silicone gel breast implants and systemic long-term complications."

After two days of testimony last month, the panel recommended approval with certain conditions, such as educating surgeons and patients about the use of the implants and continuing to track the health of women who have them.

According to several panel members, the turning point in the deliberations came during a lunch break Oct. 15 when Inamed representatives proposed eight conditions for FDA approval.

"It was a divided panel," said member Nancy Neveloff Dubler, a bioethicist at Montefiore Medical Center in New York. "Even those members of the panel like I, who voted for this, did so with a bit of fear and trembling."

Following FDA rules, Whalen, as chairman, did not vote. He did, however, say at the hearing that he was "flabbergasted" the FDA had not required -- and Inamed had not offered -- safety data with more than two years of follow-up. "We didn't have the tools to judge if it was safe and effective," he said in an interview.

"The FDA required two years' minimum follow-up, and that's what we provided," Inamed spokesman Peter Nicholson replied.

Plastic surgeons said they were offended by Whalen's observation that "it serves the reputation of the FDA . . . exceedingly poorly to have had all of the plastic surgeons vote for approval" on such a close vote.

"He's suggesting the possibility of financial gain eclipses in my mind the issue of safety for the patient and honest objective analysis of the data," said Michael Miller, a plastic surgeon at the University of Texas M.D. Anderson Cancer Center in Houston. "My personal income has absolutely no reflection on whether I use these devices or do any surgery."

Opponents of silicone implants, however, called Whalen "gutsy."

"This will really be a wake-up call for the FDA to scrutinize not just this panel's recommendation but also their whole process, particularly for medical devices," said Diana Zuckerman of the National Center for Policy Research for Women and Families.