The American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS) applauded the US Food and Drug Administration’s (FDA) decision to approve silicone breast implants and return them to the US market.
“This is a great day for American women and the plastic surgeons who care for them,” says Roxanne Guy, MD, ASPS president. “Silicone breast implants have been scrutinized more than any medical device, and we applaud the FDA for making its well thought-out decision and allowing American women to make informed choices about their health care.”
FDA’s decision follows a lengthy process, during which the agency sent “approvable with conditions” letters to the two silicone breast implant manufacturers in the second half of 2005. The letter stipulated several conditions that the manufacturers had to satisfy to receive final FDA approval to market and sell the implants in the United States. These letters followed an FDA advisory panel hearing in April 2005, in which the panel heard more than 20 hours of data presentations from the manufacturers and comments from the public.
“Plastic surgeons are committed to patient safety and education,” says James Stuzin, MD, ASAPS president. “It is clear that the agency has carefully evaluated the data presented by the manufacturers, as well as the testimony of physicians, patients, and advocacy groups and has made a thoughtful decision to give our patients the access to silicone gel breast implants that women in 60 countries around the world have.”
ASPS and ASAPS will continue to offer their assistance to the manufacturers regarding the conditions set forth by the FDA related to physician and patient education. One example of such assistance is the establishment of a joint Web site, breastimplantsafety.org, which offers objective science-based information regarding saline and silicone implants.
[www.plasticsurgery.org, November 17, 2006]