Silicone Implant History - FDA: 2005 Silicone Breast Implants FDA Hearings - BreastImplantsUSA.com Articles
Plastic Surgery Societies Applaud FDA Panel Recommendation That Mentor's Silicone Breast Implants Be Approved With Conditions
For Immediate Release: April 13, 2005
Press Release
GAITHERSBURG, MD – The FDA advisory panel’s 7-2 vote on April 13, 2005 to recommend to the FDA that Mentor’s silicone breast implants be approved with conditions is applauded by the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS), the two largest plastic surgery membership organizations. This recommendation comes 13 years after the FDA restricted access to the silicone implants because of safety concerns.
“We are pleased that the panel based its decision on scientific evidence, not on special interests, emotion or anecdotes,” said James Wells, MD, ASPS past president. “The comments by Josh Levine, Mentor’s CEO, during his summation confirm Mentor’s long-term commitment to safety. This should go a long way to assure the FDA and the public that the panel’s recommendation is prudent and sound...”
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