of the



Grand Ballroom, Gaithersburg Marriott Hotel

9751 Washingtonian Blvd., Gaithersburg, Maryland

October 14 and 15, 2003


Panel Acting Chair:                                                                            Executive Secretary:

Thomas V. Whalen, MD                                                                                                         David Krause, PhD


October 14, 2003


8:00 am                 Call to Order


Conflict of Interest and Opening Remarks

David Krause, PhD, Executive Secretary


Panel Introductions

Thomas V. Whalen, MD, Acting Chairman


Welcome Remarks

CDR Stephen P. Rhodes, USPHS, Branch Chief, Plastic and Reconstructive Surgery Devices Branch, Division of General, Restorative & Neurological Devices (DGRND), Office of Device Evaluation (ODE)


8:15 am                 Open Public Comment

10:15 am               Break


10:30 am               Open Public Comment Continued


12:30 pm               Lunch


1:25 pm                 Regulatory Overview of Silicone Gel-Filled Breast Implants

Celia M. Witten, Ph.D., M.D., Director, DGRND, ODE


1:30 pm                 Applicant Presentation, Inamed Corporation, McGhan Silicone-Filled Breast Implants



Ronald J. Ehmsen, Sc.D., Senior Vice President, Clinical and Regulatory Affairs


Preclinical Studies Review

Thomas E. Powell, Director, Technologies


Clinical Studies

JoAnn M. Kuhne, M.S.N., R.A.C., Senior Director, Regulatory and Clinical Affairs


3:00 pm                 Break



3:15 pm                 FDA Presentation

ODE and Office of Surveillance and Biometrics (OSB)


Introduction and Mechanical Testing

CDR Samie Allen, DGRND, ODE


Chemical Testing

Sam Arepalli, Ph.D., DGRND, ODE


Toxicology Testing

David B. Berkowitz, Ph.D, V.M.D., DGRND, ODE


Clinical Data Overview

Sahar M. Dawisha, M.D., DGRND, ODE


Statistical Review

Telba Z. Irony, Ph.D., Division of Biostatistics, OSB


Medical Device Surveillance and Literature Review

S. Lori Brown, Ph.D., M.P.H., Division of Postmarket Surveillance, OSB

Postapproval Study and Labeling
CDR Samie Allen, DGRND, ODE


4:45 pm                 Open Panel Discussion


6:00 pm                 Dinner


7:00 pm                 Open Panel Discussion and FDA Questions


 10:00 pm              Day 1Adjournment

October 15, 2003


7:30 am                 Call to Order


Panel Introductions

Thomas V. Whalen, MD, Acting Chairman


7:45 am                 Open Public Comment


9:45 am                 Break


10:00 am               Open Public Comment Continued


12:00 am               Lunch


12:45 pm               FDA Summation


Sponsor Summation


Concluding Panel Deliberations and Vote


5:00 pm                 Concluding Remarks and Adjournment