FDA Process Could be Sabotaged by Panel Chair, Says American Society for Aesthetic Plastic Surgery

11/6/2003

From: Leida Snow or Adeena Colbert, 212-921-0500, both of the American Society for Aesthetic Plastic Surgery

NEW YORK, Nov. 6 -- The American Society for Aesthetic Plastic Surgery (ASAPS) today voiced its strong objection to criticisms of the FDA advisory process expressed in a letter written by Thomas Whalen, MD, chair of the Food and Drug Administration's General and Plastic Surgery Devices Panel, to the FDA Commissioner and selected members of Congress. Dr. Whalen, in his letter, urged FDA Commissioner Mark McClellan, MD, to disregard the advisory panel's October 15 recommendation to conditionally approve silicone gel-filled breast implants for general use, in part because of the favorable votes cast by four plastic surgeons invited by the FDA to serve on the panel. "Dr. Whalen knew that plastic surgeons were included on the advisory panel when he agreed to chair it, and he had ample opportunity before and during the hearings to voice any objections," said ASAPS President Robert Bernard, MD, of White Plains, NY. "It is unfortunate that his comments now may serve to politicize an issue that the FDA has appropriately considered a scientific inquiry."

Dr. Whalen, in his letter, acknowledged "it was essential to include board-certified plastic and reconstructive surgeons when considering a PMA (pre-market approval) on breast implants," but then disparaged the contributions of these invited physicians to the advisory process by questioning their objectivity.

Representatives of the American Society for Aesthetic Plastic Surgery testified as patient advocates at the FDA advisory panel hearings on silicone gel-filled breast implants. The 2000-member organization of board-certified plastic surgeons presented data on patient outcomes from breast augmentation, but it took no position on whether silicone gel implants should be permitted on the market. "ASAPS encourages the ongoing review of breast implant safety and efficacy, including the establishment of a national breast implant registry," said Dr. Bernard. "As plastic surgeons, our commitment is to scientific research and to the welfare of our patients."

"ASAPS members will continue to support the FDA's regulatory process," Dr. Bernard said.