Implant doubts

OB/GYN News, Dec 15, 2003 by Mary Ellen Schneider

The FDA should ignore its advisory panel's recent recommendation to approve silicone gel breast implants, says the panel's own chairman, Dr. Thomas V. Whalen, professor of surgery and pediatrics at Robert Wood Johnson Medical School in New Brunswick, N.J. The panel voted 9-6 in favor of recommending the approval of the implants with strict conditions.

The decision is now under consideration at FDA. But Dr. Whalen--who, as chairman, can only vote to break a tie--says he has reservations about the product's safety and the ability of the FDA to compel the company to meet approval conditions for demonstrating long-term safety. "Long-term safety, the concern that prompted the removal from the market 11 years ago, was clearly not demonstrated and to approve this device poses threats to women that are clearly unknown," Dr. Whalen said in a letter to Dr. Mark McClellan, FDA commissioner. FDA is reviewing the letter.