• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Advisory Committees

  • Print
  • Share
  • E-mail

General and Plastic Surgery Devices Panel - April 11-13, 2005

The General and Plastic Surgery Devices Advisory Panel met on April 11-13, 2005 at the Hilton Washington DC North/Gaithersburg Hotel located at 620 Perry Parkway in Gaithersburg, Maryland. The panel met in order to provide advice and recommendations to the Agency for premarket approval applications for Inamed Corporation’s Silicone-Filled Breast Implants and Mentor Corporation’s Silicone Gel-Filled Breast Implants.

The meeting began on April 11, 2005 with CDR Stephen P. Rhodes (Acting Deputy Director, Division of General, Restorative & Neurological Devices) giving the panel an update since the last panel meeting and Dr. Miriam Provost (Acting Director, Division of General, Restorative & Neurological Devices) summarizing the history of the regulation of silicone gel-filled breast implants. The remainder of the April 11 session consisted of public testimony from over 140 individual consumers, consumer groups, and professional societies.

On April 12, 2005, Inamed Corporation presented a summary of their amended Silicone-Filled Breast Implant PMA data, which was reviewed previously by the panel on October 13-14, 2003, and FDA presented their review of the data. The presentations highlighted the results obtained from an explanted implant retrieval study and an additional year of patient follow-up data on silent rupture. 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 3-year follow-up and has collected some 4-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. The panel engaged in an in-depth discussion of the PMA data and the FDA questions, which included inquiries regarding the adequacy of the characterization of the rupture data, the adequacy of the data to evaluate the consequences of rupture, the adequacy of Inamed Corporation’s labeling in the discussion of methods for screening silent rupture, intracapsular and extracapsular rupture and consequences of extracapsular gel.

The discussion of the data and FDA questions was followed by approximately an hour of public participation during which 14 individual consumers, consumer groups, and professional societies provided testimony before the panel. Following the public testimony, the panel heard a brief summation by Inamed Corporation and then voted. The Inamed Corporation PMA for Silicone-Filled Breast Implants (P020056) was recommended as “not approvable” by a 5 to 4 vote. Among the reasons given by the panel for their vote was the need for additional patient follow-up data and the inadequate performance of the Style 153 device.

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. Also, 420 of the total patient enrollment were also enrolled into the MRI screening for silent rupture. The panel engaged in an in-depth discussion of the PMA data and the FDA questions, which included inquiries regarding the adequacy of the characterization of the rupture data (including silent rupture), the adequacy of the data to adequately evaluate the consequences of rupture, the adequacy of Mentor Corporation’s labeling in the discussion of methods for screening silent rupture, intracapsular and extracapsular rupture and consequences of extracapsular gel.

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.


Contact: David Krause, Ph.D., Executive Secretary, 301-594-3090, x141


Transcripts may be purchased from:
Neal R. Gross & Company
1323 Rhode Island Avenue, NW
Washington, DC 20005
(202) 234-4433
Or
The Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
301-827-6500 (voice) or 301-443-1726 (FAX)