Fw: Summary from the FDA Meeting on silicone gel implants

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----- Original Message ----- From: ilena rose

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Sent: Wednesday, October 22, 2003 11:57 AM

Subject: Summary from the FDA Meeting on silicone gel implants

http://www.fda.gov/cdrh/panel/summary/gpsd101403.html

Summary from the General and Plastic Surgery Devices Panel Meeting -October 14 and 15, 2003

The General and Plastic Surgery Devices Panel met on October 14 and15, 2003 at the Gaithersburg Marriott Hotel located at 9751Washingtonian Boulevard in Gaithersburg, land. The panel met inorder to provide advice and recommendations to the Agency for apremarket approval application for Inamed Corporation's McGhanSilicone Gel-Filled Breast Implants.

The meeting began with introductory remarks by CDR P. (Branch Chief, Plastic and Reconstructive Surgery Devices Branch) andby Dr. W. al, Jr. (Director, Center for Devices andRadiological Health). Dr al presented information on a newweb-based Breast Implants Listserv designed to provide consumers withupdated information about breast implants. The remainder of themorning session consisted of public testimony from individualconsumers, 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 breastimplants.

The sponsor presented a summary of their PMA and FDA presented theirreview of the data in the PMA application for Inamed Corporation'sSilicone Gel-Filled Breast Implants. The presentations highlighted theresults obtained from preclinical and clinical studies performed bythe sponsor, information from the published literature on thelong-term health effects of gel-filled breast implants, and data fromFDAs medical device surveillance system. With respect to the clinicaltrial data, both the sponsor and the FDA focused their presentationson the clinical data provided in the Core Study which is a 10 yearopen label, prospective study involving augmentation, reconstructionand revision patients that has completed 2-year follow-up and hascollected some 3-year follow-up data. Safety was assessed by lookingat rates of complications for all subjects and MRI data on a limitedcohort 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 enrolled494 patients undergoing breast augmentation with 987 devices, 221patients undergoing breast reconstruction with 361 devices and 226patients undergoing implant revision with 432 devices.

During the evening session, the panel engaged in an in-depthdiscussion of the PMA data and the FDA questions, which includedinquiries regarding the adequacy of the asymptomatic rupture data, theadequacy of the data to evaluate the long-term health effects, theadequacy of the sponsor's proposal for a post-approval study andrecommendations for patient management.

On the morning of the second day of the meeting, the panel heardadditional public testimony. The panel engaged several of the publicspeakers as well as the sponsor and FDA representatives in additionaldiscussion, following which the panel completed its own discussion ofthe PMA and voted on what its recommendation to the agency regardingthis marketing application should be. The PMA was recommended for"approval with conditions" by a 9 to 6 vote. Among the conditions ofapproval were the development of patient education media, aprofessional training program, and a patient registry. The panelrecommended that these efforts be designed and accomplished incollaboration with FDA and professional societies. Another conditionwas that patients in the Core Study complete their 10 year follow-upas a post-approval study with annual follow-up visits and the MRIscreening that should continue at least through year 9.

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

Transcripts may be purchased from: Reporting735 Eighth Street, SEWashington, DC 20003-2802Phone: 202-546-6666; FAX: 202-546-1502OrThe Food and Drug AdministrationFreedom of Information Staff (FOI)5600 Fishers Lane, HFI-35Rockville, MD 20852301-827-6500 (voice) or 301-443-1726 (FAX)

Under normal circumstances, panel summary minutes are available 60-90days post meeting. Summaries are also available on the CDRH web site:http://www.fda.gov/cdrh/panel/index.html

CDRH Advisory Committee Database

Updated 10/21/2003

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For more information on this meeting and the campaign against FDAapproval for silicone gel implants ... please visit:

www.BreastImplantAwareness.org

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