Mentor Silicone Breast Implant

On April 13, 2005, Mentor Corporation presented a summary of their Silicone Gel-Filled Breast Implant PMA data and FDA presented their review of the data. The presentations highlighted the results of preclinical testing and clinical testing. The preclinical testing included chemical, toxicological and mechanical characterizations. The clinical testing summary included safety and effectiveness data. With respect to the clinical trial data, both the sponsor and the FDA focused their presentations on the clinical data provided in the Core Study, which is a 10-year open label, prospective study involving augmentation, reconstruction and revision patients that has completed 2-year follow-up and has collected some 3-year follow-up data. Safety was assessed by looking at rates of complications for all subjects and MRI data on a limited cohort of patients to evaluate asymptomatic device rupture. The study enrolled 551 patients undergoing breast augmentation, 252 patients undergoing breast reconstruction and 226 patients undergoing implant revision.

The discussion of the data and FDA questions was followed by approximately an hour of public participation during which 11 individual consumers, consumer groups, and professional societies provided testimony before the panel. Following the public testimony, the panel heard a brief summation by Mentor Corporation and then voted. In the first vote, the motion for “not approvable” was defeated by a 7 to 2 vote. In a second vote, the Mentor Corporation PMA for Silicone Gel-Filled Breast Implants (P030053) was recommended as “approvable with conditions” by a 7 to 2 vote.

Among the conditions of approval were, a requirement for training and certification of Board Certified and Board Eligible Plastic Surgeons before they could receive devices to implant, a requirement for Mentor Corporation to complete their 10-year core study and for the FDA to convene a panel meeting in 5 years to review the post-approval study data, the requirement for Mentor Corporation to establish an independent Data Safety Monitoring Committee as outlined in the FDA guidance document to periodically review the post-approval data collection and results, and the requirement that the company attempt to obtain follow-up information on patients that had their implants taken out and not replaced.