AGENDA

GENERAL AND PLASTIC SURGERY DEVICES PANEL

of the

MEDICAL DEVICES ADVISORY COMMITTEE

 

Grand Ballroom, Hilton Washington DC North/Gaithersburg

620 Perry Parkway, Gaithersburg, Maryland

April 11-13, 2005

 

 

Panel Chair:                                                                                                                         Executive Secretary:

Michael Choti, M.D.                                                                                                           David Krause, Ph.D.

 

 

April 11, 2005

 

8:00 am                                 Call to Order

 

Conflict of Interest and Opening Remarks

David Krause, Ph.D., Executive Secretary

 

Panel Introductions

Michael Choti, M.D., Chairman

 

                Panel Update

                CDR Stephen P. Rhodes, USPHS, Acting Deputy Director, Division of General, Restorative, and Neurological Devices (DGRND), Office of Device Evaluation (ODE)

 

Welcoming Remarks

                                                Miriam Provost, Ph.D., Acting Director, DGRND, ODE

 

8:15 am                                 Open Public Comment

10:15 am                               Break

 

10:30 am                               Open Public Comment Continued

               

12:30 pm                               Lunch

 

1:30 pm                                 Open Public Comment Continued

 

3:30 pm                                 Break

 

3:45 pm                                 Open Public Comment Continued

 

6:30 pm                                 Break

 

7:30 pm                                 Open Public Comment Continued

 

~11:00 pm                             Adjournment Day 1


April 12, 2005

 

8:00 am                                 Call to Order

 

Panel Introductions

Michael Choti, M.D., Chairman

 

8:15-9:15 am                        Applicant Presentation, Inamed Corporation, Silicone-Filled Breast Implants

 

Introduction

Dan Cohen, Vice President of Global Government and Corporate Affairs

 

Preclinical Studies Overview and Clinical Studies Overview

Patricia Walker, M.D., Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer (CSO)

 

                                                Closing Remarks

                                                Scott Spear, M.D., Professor and Chief, Division of Plastic Surgery, Georgetown University Hospital; President of the American Society of Plastic Surgeons (ASPS); consultant to Inamed

 

9:15-9:45 am                        Panel Questions to Inamed Presenters

 

9:45 am                                 Break

 

9:45-10:45 am                     FDA Presentation

 

Introduction, Device Description, and Preclinical Testing Overview

CDR Samie Allen, DGRND, ODE

 

Rupture Overview

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

 

Long-Term Probability of Rupture

Pablo Bonangelino, Ph.D., Division of Biostatistics, Office of Surveillance and Biometrics (OSB)

 

10:45-11:15 am                   Panel Questions to FDA Presenters

 

11:15 am                               Open Panel Discussion and FDA Questions

 

12:00 pm                               Lunch

 

12:45 pm                               Open Panel Discussion and FDA Questions Continued

 

2:30 pm                                 Break

 

2:45 pm                                 Open Public Comment

 

3:45 pm                                 FDA Summation

Sponsor Summation

Concluding Panel Deliberations and Vote

 

6:00 pm                                 Adjournment Day 2


April 13, 2005

 

8:00 am                                 Call to Order

 

Panel Introductions

Michael Choti, M.D., Chairman

 

8:15-9:45 am                        Applicant Presentation, Mentor Corporation, Silicone Gel-Filled Breast Implants

 

Introduction
Josh Levine, President and CEO 

Preclinical Summary
Jerry Barber, Ph.D. Vice President Corporate Research
 
Clinical Safety
Bruce Cunningham, M.D., Professor and Chair, Dept of Plastic Surgery, University of Minnesota

Clinical Effectiveness and Benefits
Rebecca Anderson, Ph.D. Associate Professor/Psychologist, Medical College of Minnesota

Summation
Bruce Cunningham, M.D., Professor and Chair, Dept of Plastic Surgery, University of Minnesota

 

9:45-10:15 am                     Panel Questions to Mentor Presenters

 

10:15 am                               Break

 

10:30 am-12:00 pm           FDA Presentation

 

Introduction, Device Description, and Preclinical Testing Overview

CDR Samie Allen, DGRND, ODE

 

Chemical Data Overview

Sam Arepalli, Ph.D., DGRND, ODE

 

Toxicological Data Overview

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

 

Clinical Data Overview

Herbert Lerner, M.D., DGRND, ODE

 

Rupture Overview

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

 

Statistical Overview

Phyllis Silverman, M.S., Division of Biostatistics, OSB

 

12:00-12:30 pm                   Panel Questions to FDA Presenters

 

12: 30 pm                              Lunch

 

1:15 pm                                 Open Panel Discussion and FDA Questions

 

2:30 pm                                 Break

 

2:45 pm                                 Open Public Comment

 

3:45 pm                                 FDA Summation

Sponsor Summation

 

Concluding Panel Deliberations and Vote

 

6:00 pm                                 Concluding Remarks and Meeting Adjournment

                                                Michael Choti, MD, Chairman