The General and Plastic Surgery Devices Panel met on October 14 and 15, 2003 at the Gaithersburg Marriott Hotel located at 9751 Washingtonian Boulevard in Gaithersburg, Maryland. The panel met in order to provide advice and recommendations to the Agency for a premarket approval application for Inamed Corporation’s McGhan Silicone Gel-Filled Breast Implants.
The meeting began with introductory remarks by CDR Stephen P. Rhodes (Branch Chief, Plastic and Reconstructive Surgery Devices Branch) and by Dr. David W. Feigal, Jr. (Director, Center for Devices and Radiological Health). Dr Feigal presented information on a new web-based Breast Implants Listserv designed to provide consumers with updated information about breast implants. The remainder of the morning session consisted of public testimony from individual consumers, consumer groups, and professional societies.
In the afternoon, following the public testimony, Dr. Celia Witten (Director, Division of General Restorative & Neurological Devices) presented the regulatory history of silicone gel-filled breast implants.
The sponsor presented a summary of their PMA and FDA presented their review of the data in the PMA application for Inamed Corporation’s Silicone Gel-Filled Breast Implants. The presentations highlighted the results obtained from preclinical and clinical studies performed by the sponsor, information from the published literature on the long-term health effects of gel-filled breast implants, and data from FDAs medical device surveillance system. 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. Effectiveness was assessed by the examination of breast dimensions, patient satisfaction and Quality of Life measures. The study enrolled 494 patients undergoing breast augmentation with 987 devices, 221 patients undergoing breast reconstruction with 361 devices and 226 patients undergoing implant revision with 432 devices.
During the evening session, the panel engaged in an in-depth discussion of the PMA data and the FDA questions, which included inquiries regarding the adequacy of the asymptomatic rupture data, the adequacy of the data to evaluate the long-term health effects, the adequacy of the sponsor’s proposal for a post-approval study and recommendations for patient management.
On the morning of the second day of the meeting, the panel heard additional public testimony. The panel engaged several of the public speakers as well as the sponsor and FDA representatives in additional discussion, following which the panel completed its own discussion of the PMA and voted on what its recommendation to the agency regarding this marketing application should be. The PMA was recommended for “approval with conditions” by a 9 to 6 vote. Among the conditions of approval were the development of patient education media, a professional training program, and a patient registry. The panel recommended that these efforts be designed and accomplished in collaboration with FDA and professional societies. Another condition was that patients in the Core Study complete their 10 year follow-up as a post-approval study with annual follow-up visits and the MRI screening that should continue at least through year 9.
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