ATDEPARTMENT OF HEALTH AND HUMAN SERVICES

 

FOOD AND DRUG ADMINISTRATION

 

CENTER FOR DEVICES AND RADIOLOGIC HEALTH

 

 

 

 

 

 

 

 

 

 

 

GENERAL AND PLASTIC SURGERY DEVICES PANEL

 

OF THE MEDICAL DEVICES ADVISORY COMMITTEE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tuesday, October 14, 2003

 

8:00 a.m.

 

 

 

 

 

 

 

 

 

Grand Ballroom

Gaithersburg Marriott Hotel

9751 Washingtonian Boulevard

Gaithersburg, Maryland

 

 

PARTICIPANTS

 

Thomas V. Whalen, M.D., Acting Chair

David Krause, Ph.D., Executive Secretary

 

VOTING MEMBERS

 

    Brent A. Blumenstein, Ph.D.

    Phyllis Chang, M.D.

    Michael A. Choti, M.D.

    Ann Marilyn Leitch, M.D.

    Michael J. Miller, M.D.

    Amy E. Newberger, M.D.

 

CONSUMER REPRESENTATIVE

 

    Alisa M. Gilbert

 

INDUSTRY REPRESENTATIVE

 

    Debera M. Brown

 

TEMPORARY VOTING MEMBERS

 

    Benjamin O. Anderson, M.D.

    Dennis W. Boulware, M.D.

    Emily F. Conant, M.D.

    Nancy A. Dubler, LLB

    Ruth A. Lawrence, M.D.

    Stephen Li, Ph.D.

    Ellice S. Lieberman, M.D., DR PH

    Barbara R. Manno, Ph.D.

    Mary H. McGrath, M.D., MPH

    Michael J. Olding, M.D.

 

FDA

 

    Celia Witten, Ph.D., M.D.

C O N T E N T S

 

PAGE

 

Conflict of Interest and Opening Remarks:

   David Krause, Ph.D.    7

 

Panel Introductions:

   Thomas V. Whalen, M.D.    10

 

Welcome Remarks:

 

    CDR Stephen P. Rhodes    16

    Dr. David Feigal    18

 

Open Public Comment

   Introductory Remarks:  Thomas V. Whalen, M.D.    20

 

Public Speakers

   Susan Scherr, National Coaltion

      for Cancer Survivorship    23

 

   Shery Henderson, Silicone Solutions Outreach    28

 

   Carolyn Kittle    31

 

   Elizabeth Anderson    34

 

   Arlene Nicole Cummings    37

 

   Michelle Colombo    40

 

   Dr. Thomas Joiner    42

 

   Susan Cunningham    45

 

   Anne Stansell    49

 

   Rosella Rust    51

 

   Kathy Pate    54

 

   Nancy Bruning    57

 

   Jill Fallows    63

 

   Elizabeth Santoro    65

 

   Evon Peterson    69

 

   Elizabeth Weber    72

 

   Ed Brent    73

 

   Dr. Bruce Cunningham    76

C O N T E N T S (Continued)

 

PAGE

 

Open Public Comment (Continued)

 

   Margaretha McGrail    78

 

   Gail Hamilton    80

 

   Audrey Moritz-Ciancutti    84

 

   Cynthia Teague    87

 

   Pamela Dowd    89

 

   Lisa Bordelon    92

 

   Jessica Forman    94

 

   Diane Fjelstad    98

 

   Dr. Frank Vasay    101

 

   Marcy Gross    104

 

   Dr. Marga Massey    109

 

   Carolyn Wolf    113

 

   Dr. Vicki Hofnagel, (by conference call)    117

 

   Virginia Gallagher, (by conference call)    121

 

   Dr. Mark Jewel          124

 

   Mary Ann Richards    127

 

   Lisa Bancarz    129

 

   Eileen Wright    132

 

   Lisa Lowenstein    134

 

   Kathleen V.F. Nye    138

 

   Betty Buikema    140

 

   Dr. Caroline Glicksman    143

 

   Dr. Edward Melmed    147

 

   Dr. Paul H. Wooley    152

 

   Nancy Gertner    157

C O N T E N T S (Continued)

 

PAGE

 

Open Public Comment (Continued)

 

   Dr. Eugene Goldberg    160

 

   Mindy Tapscott    164

 

   Kim Gandy, National Association for Women     168

 

   Mary Ann Ward    175

 

   Marlene Keeling, Chemically Associated

      Neurological Disorders    180

 

   Vanessa Rose Ferelli    183

 

   Connie Wasserman    190

 

   Dr. Sidney Wolfe, Public Citizen    193

 

   Judy Norsigian, Our Bodies, Ourselves    203

 

   Dr. Deborah Bash    208

 

   Kathy Keithley Johnson, Toxic Discovery    212

 

   Dr. Paul Weiss, National Endowment

      for Plastic Surgery    218

 

   Dr. Laurie Casas, American Society

      for Aesthetic Plastic Surgery     223

 

   Dr. Leroy Young, Aesthetic Surgery

      and Research Foundation    229

 

   Dr. Martha Burke, National Council

      of Women's Organizations    233

 

   Dr. Laurie Young, Older Women's League    237

 

   Christine Lozier    241

 

   Anne S. Kasper, Finding My Way    244

 

   Dr. Shawna Willey, American College

      of Surgeons    249

 

   Margaret Volpe, Y-Me    252

 

Regulatory Overview of Silicone Gel-Filled

   Breast Implants:

    Cilia M. Witten, Ph.D., M.D.    257

C O N T E N T S (Continued)

 

PAGE

 

Applicant Presentation

Inamed Corporation

McGhan Silicone-Filled Breast Implants

 

Introduction:

   Ronald J. Ehmsen, Sc.D.    264

 

Preclinical Studies Review:

   Thomas E. Powell    267

 

Clinical Studies:

   JoAnn M. Kuhne, MSN, RAC    295

 

FDA Presentation

ODE and Office of Surveillance and Biometrics (OSB)

 

   Introduction and Mechanical Testing:

        CDR Samie Allen    393

 

   Chemical Testing:

        Sam Arepalli, Ph.D.    399

 

   Toxicology Testing:

        David B. Berkowitz, Ph.D., VMD    405

 

   Clinical Data Overview:

       Sahar M. Dawisha, M.D.    413

 

   Statistical Testing:

        Telba Z. Irony, Ph.D.    439

 

   Medical Devices Surveillance and

      Literature Review:

        S. Lori Brown, Ph.D., MPH    448

 

   Postapproval Study and Labeling:

        CDR Samie Allen    465

 

Open Panel Discussion    489

 

Open Panel Discussion and FDA Questions    551

P R O C E E D I N G S

Conflict of Interest and Opening Remarks

    DR. KRAUSE:  Good morning, everybody.  We are ready to begin this, the 63rd meeting of the General and Plastic Surgery Devices Panel.  My name is David Krause.  I am the Executive Secretary of this panel and I am also a biologist and a reviewer in the Plastic and Reconstructive Surgery Devices Branch.

    I would like to remind everyone that we request that you sign in on the attendance sheets which are just outside the door.  You can also pick up an agenda, a panel-member roster and information about today's meeting out there on the table.  The information includes how to find out about future meetings, future-meeting dates, through the advisory panel phone line and how to obtain meeting minutes or transcripts.

    Before I turn the meeting over to Dr. Whalen, I am required to read two statements into the record.  One is the deputization to temporary voting status and the other is the conflict-of-interest statement.

    "Pursuant to the authority granted under the Medical Devices Advisory Committee Charter, dated October 27, 1990, and as amended August 18, 1999 I appoint Benjamin Anderson, Dennis Boulware, Emily Conant, Nancy Dubler, Ruth Lawrence, Stephen Li, Ellice Liberman, Barbara Manno, Mary McGrath and Michael Olding as deputized voting members of the General and Plastic Surgery Devices Panel for this meeting on October 14 and 15, 2003.