Silicone Implant Panel Chair Raises Surprising Objections to FDA Panel
New York, NY (November 13, 2003) — The American Society for Aesthetic Plastic Surgery (ASAPS) strongly objects to criticisms of the FDA advisory process expressed in a letter recently 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.
"Our disappointment with Dr. Whalen's letter is not directed at the personal opinions he holds regarding the safety and effectiveness of silicone gel implants," adds Dr. Bernard. "We simply are surprised, and disturbed, that he would question the integrity of the advisory panel process after-the-fact and in this highly unusual manner."
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 2100-member organization of board-certified plastic surgeons presented data on patient outcomes from breast augmentation, but 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," said Dr. Bernard.
The American Society for Aesthetic Plastic Surgery (ASAPS), is recognized as the world’s leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. ASAPS is comprised of over 2,600 Plastic Surgeons; active members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and non-surgical aesthetic procedures. International active members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.
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