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FDA Releases Information from Mentor's Silicone Gel Breast Implant Approval Application

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=593

SANTA BARBARA, Calif.--(BUSINESS WIRE)--April 6, 2005--Mentor Corporation (NYSE:MNT):

-- General And Plastic Surgery Devices Advisory Panel Meeting Scheduled for April 11-13, 2005 at the Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy, Gaithersburg, MD

-- Mentor To Present Data From Pivotal Core Gel Study On Wednesday, April 13, 2005

Mentor Corporation (NYSE:MNT), a leading supplier of medical products in the United States and internationally, today announced that the U.S. Food and Drug Administration (FDA) has posted information related to Mentor's silicone gel breast implant pre-market approval (PMA) application, scheduled to be reviewed at a General and Plastics Surgery Devices Advisory Panel meeting April 11-13, 2005, on its web site. The information can be viewed by accessing a link on Mentor's web site, www.mentorcorp.com, or by accessing the FDA web site directly, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfAdvisory/details.cfm?mtg=593. (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.)

Mentor's pivotal Core Gel Study followed 1,007 women who were implanted with silicone gel-filled breast implants for either augmentation, reconstruction or revision surgery. The data submitted to the FDA includes information from the 3-year follow-up period as well as longer-term clinical data specific to the integrity of Mentor's silicone gel-filled breast implants.

The FDA General and Plastic Surgery Devices Advisory Panel meeting is scheduled for April 11-13, 2005. Mentor is scheduled to present its data on Wednesday, April 13th.

Founded in 1969, Mentor Corporation is a leading supplier of medical products for the global healthcare market. The Company develops, manufactures and markets innovative, science-based products for the aesthetics, urologic specialties and clinical and consumer healthcare markets around the world.

CONTACT: Mentor Corporation

Peter R. Nicholson, 805-879-6082 (Investors)

Sara Allison DeRousse, 805-879-6346 (Media)

SOURCE: Mentor Corporation

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Name of Committee General and Plastic Surgery Devices Panel

Date and Time The meeting will be held on the following dates:

Apr 11, 2005 8:00 AM - 5:30 PM

Apr 12, 2005 8:00 AM - 6:00 PM

Apr 13, 2005 8:00 AM - 6:00 PM

Location Hilton Washington DC North/Gaithersburg, Grand Ballroom

620 Perry Parkway

Gaithersburg , MD

Hotel Accommodations A block of sleeping rooms has been reserved at the Hilton Washington, DC North - Gaithersburg, 620 Perry Parkway, Gaithersburg, MD (phone: 301-977-8900) for arrival on April 10, 2005 and departure on April 13, 2005. Rooms not reserved by March 21, 2005 will be released back to the hotel. Please reference FDA’s General and Plastic Surgery Devices Panel when making your reservation.

Disability Accommodations FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, Conference Management Staff, at 240-276-0450, ext. 113, at least 7 days in advance of the meeting.

Contact Information David Krause, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 141, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512519. Please call the Information Line or access the Internet address of http://www.fda.gov/cdrh/panelmtg.html for up-to-date information on this meeting. Information can be found on the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512519. Please call the Information Line or access this Internet page for up-to-date information on this meeting.

On April 11, 2005, the committee will hear oral presentations from the public. On April 12 and 13, 2005, the committee will discuss, make recommendations, and vote on two premarket approval applications for Silicone Gel-Filled Breast Prostheses. Background information, including the agenda and questions for the committee, will be available to the public on April 8, 2005, on the Internet at http://www.fda.gov/cdrh/panelmtg.html

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by March 28, 2005. Oral presentations from the public will be scheduled on April 11, 2005, between approximately 8 a.m. and 5:30 p.m., and on April 12 and 13, 2005, between approximately 2:45 p.m. and 3:45 p.m. Time allotted for each presentation is limited. Those desiring to make formal oral presentations should notify the contact person before March 28, 2005, and submit a brief statement of the general nature of the comments they wish to present, and the names and addresses of proposed participants.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

AGENDA

GENERAL AND PLASTIC SURGERY DEVICES PANEL

of the

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

David Krause, Ph.D., Executive Secretary

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)

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

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

CDR Samie Allen, DGRND, ODE

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

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

6:00 pm Adjournment Day 2

April 13, 2005

8:00 am Call to Order

Michael Choti, M.D., Chairman

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

Josh Levine, President and CEO

Jerry Barber, Ph.D. Vice President Corporate Research

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

Rebecca Anderson, Ph.D. Associate Professor/Psychologist, Medical College of Minnesota

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

CDR Samie Allen, DGRND, ODE

Sam Arepalli, Ph.D., DGRND, ODE

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

Herbert Lerner, M.D., DGRND, ODE

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

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

6:00 pm Concluding Remarks and Meeting Adjournment

Michael Choti, MD, Chairman

April 11, 2005

Briefing Information

http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1.htm

April 11 to 13, 2005

General and Plastic Surgery Devices Panel

Panel Chairperson:

Michael A. Choti, MD

Associate Professor

Department of Surgical Oncology

Johns Hopkins School of Medicine

Baltimore, Maryland

________________________________________

Voting Members:

Brent A. Blumenstein, PhD

TriArc Consulting

Seattle, Washington

________________________________________

Cheryl A. Ewing, MD

Assistant Professor in Clinical Surgery,

Carol Buck Breast Care Center

University of California San Francisco

San Francisco, California

________________________________________

A. Marilyn Leitch, MD

Professor of Surgery

Department of Surgery

University of Texas Southwestern Medical Center

Dallas, Texas

________________________________________

Joseph LoCicero, III, MD

Professor and Chair

Department of Surgery

University of South Alabama

Mobile, Alabama

________________________________________

Michael J. Miller, MD

Professor and Deputy Chairman

Department of Plastic Surgery

University of Texas, MD Anderson Cancer Center

Houston, Texas

________________________________________

Amy E. Newburger, MD

Dermatology Consultants of Westchester, PLLC

2 Overhill Road

Scarsdale, NY 10583

________________________________________

LeeLee Doyle, PhD

Assistant Dean for Faculty Development

University of Arkansas for Medical Sciences

College of Medicine

Little Rock, Arkansas

________________________________________

Industry Representative:

Grace T. Bartoo, PhD, RAC

General Manager

Decus Biomedical, LLC

San Carlos, California

________________________________________

Temporary Voting Members:

Leigh F. Callahan, PhD

Associate Professor of Orthopedics, Medicine and Social Medicine

Thurston Arthritis Research Center

University of North Carolina

Chapel Hill, North Carolina

________________________________________

Stephen Li, PhD

President

Medical Device Testing and Innovations, LLC

Sarasota, Florida

________________________________________

Barbara R. Manno, PhD

Professor

Department of Psychiatry

Louisiana State University Health Sciences Center Shreveport

School of Medicine

Shreveport, Louisiana

________________________________________

Michael J. Olding, MD

Chief, Division of Plastic Surgery

Department of Surgery

George Washington University School of Medicine

Washington, DC