Food and Drug Administration

General and Plastic Surgery Devices Panel

April 11, 2005

Briefing Information

Silicone Gel-Filled Breast Implants

FDA

Mentor Corporation P030053

Tab 1. FDA Summary Panel Memorandum (PDF)

Tab 2. Draft Panel Questions (PDF)

Tab 3. Package Insert (PDF)

Patients Insert Labeling (PDF)

Tab 4. Mentor Corp.'s Silicone Gel-Filled Breast Implants

Table of Contents (PDF)

Design and Manufacturing Changes

Response to FDA Question 27 (PDF)

Biological/Toxicology Data

PMA M020018 Mentor Low-Bleed Gel-Filled Mammary Prosthesis: Module #1 Toxicology Part 1 (PDF), Part 2 (PDF)

Amendment to PMA M020018/M1 Mentor Gel-Filled Mammary Prosthesis Biocompatibility Module: Response to FDA Deficiency Letter dated March 11, 2003 (PDF)

Appendix 1. Chemistry Testing Summary (PDF)

Appendix 3. Carcinogenicity Study (PDF)

Appendix 4. Mouse Lymphoma and Micronucleus Assay Data (PDF)

PMA M020018/M5 Mentor Low-Bleed Gel-Filled Mammary Prosthesis: Final Report (PDF)

Response to FDA Toxicology/Biological Questions 23-26 (PDF)

Dr. Rodricks' Expert Review - Attachment 26 (PDF)

Chemistry Data

PMA M020018/M3 Mentor Low-Bleed Gel-Filled Mammary Prosthesis: Module #3 Chemistry Data (PDF)

Response to FDA Chemistry Questions 20-22 (PDF)

Attachment 24. Report CP 368 (PDF)

Attachment 25. Report M 043 (PDF)

Physical/Mechanical Data

Submission Narrative (PDF)

Product Performance Qualification Summary report for the Silex® Moderate Profile Round Gel-Filled Mammary Prosthesis (PDF)

M020018/M4 Attachment: Report M 028 (PDF)

P030053 Attachment 10: Report M016 (PDF)

P030053 Attachment 11: Report M 028 (PDF)

Crease Fold Testing - Attachment 17 (PDF)

Email Dated October 11, 2004 Regarding Mentor's Crease Fold Testing Study (PDF)

Gel Bleed Test Report (PDF)

Gel Bleed Test Report Addendum (PDF)

Response to FDA Question on Gel Bleed #26 (PDF)

Attachment 28. Report CP 246 Gel Bleed (PDF)

Attachment 29. Final Report CP 411 (PDF)

Attachment 30. Updated Gel Loss Report M 054 (PDF)

Modes and Causes Rupture Data

Attachment 3. M050 SEM Brandon Study (PDF)

Attachment 4. M051 SEM Brandon Study (PDF)

Attachment 5. M052 Optical Microscopy (PDF)

Attachment 6. Retrieval - Addendum (PDF)

Attachment 15. M053 Surgical Techniques (PDF)

Attachment 16. Dr. Brandon's Expert Report (PDF)

November 10, 2004 Email Clarification of Failure Modes in the SEM and Optical Microscopy Studies (PDF)

November 11, 2004 Email Clarification of Iatrogenic Failures and Fatigue Testing as a Prediction for Long-term Failures (PDF)

Attachment 7. M048 Physical Testing (PDF)

Attachment 8. M049 Rupture Failure Analysis (PDF)

Attachment 9. M044 In Vitro Biodegradation (PDF)

Attachment 12. Engineering Study: HTV Particle Specification Analysis (PDF)

Attachment 13. Laboratory Study Report: HTV Bubble Specification Analysis (PDF)

Attachment 14. M041 Iatrogenic Effects (PDF)

Clinical Data - Core Study

Core Gel Study (PDF)

Core Protocol (PDF)

Response to FDA Questions 1-2 (PDF)

Response to FDA Question 4 (PDF)

Response to FDA Question 5 (PDF)

Response to FDA Questions 6-8 (PDF)

Response to FDA Questions 9-16 (PDF)

Response to FDA Question 17 (PDF)

Response to FDA Question 18 (PDF)

Response to FDA Questions 29-31 (PDF)

Attachment A. Reason for Explant (PDF)

Attachment B. Complications and Resolution for Those Patients Who Have Been Explanted (PDF)

Attachment C. Reoccurrence of Malignant Breast Disease (PDF)

Attachment D. Details on Patients Who Said No to Global Satisfaction Question (PDF)

Updated 3-Year Core Study Report: Part 1 (PDF), Part 2 (PDF), Part 3 (PDF), Part 4 (PDF), Part 5 (PDF), Part 6 (PDF), Part 7 (PDF), Part 8 (PDF), Part 9 (PDF), Part 10 (PDF), Part 11 (PDF), Part 12 (PDF), Part 13 (PDF), Part 14 (PDF), Part 15 (PDF), Part 16 (PDF), Part 17 (PDF), Part 18 (PDF), Part 19 (PDF), Part 20 (PDF), Part 21 (PDF), Part 22 (PDF)

Attachment 18. MRI Patient Histories (PDF)

Attachment 19. Kaplan Meier Rates for Complications (PDF)

Attachment 20. CTD Patient Data (PDF)

Attachment 21. CTD - Rheumatological Symptoms Tables (PDF)

Attachment 22. GEE - GEE Model Testing of the Effect of Age (PDF)

October 4, 2004 Email Regarding K-M 2 to 3 Year Complication Rate Comparison (PDF)

November 8, 2004 Email Regarding Statistical Questions and Updated GEE Tables (PDF)

November 19, 2004 Email Regarding MRI Tables 13.1 and 13.3.1 Clarification (PDF)

November 29, 2004 Email Regarding MRI Tables 13.1 and 13.3.1 Clarification (PDF)

December 1, 2004 Email Regarding MRI Tables 13.1 and 13.3.1 Clarification (PDF)

December 17, 2004 Email Regarding Updated CTD Tables (PDF)

December 23, 2004 Email Regarding CTD and GEE Updated Tables (PDF)

January 3, 2005 EMail Regarding Updated Reoperation Tables (PDF)

January 3, 2005 Letter Regarding Mentor's Submission of Amendment 6 (PDF)

Clinical Data

Adjunct Study Protocol (PDF)

Supplemental Clinical Data

Long-Term Rupture Rates From a UK Clinical Study (PDF)

Literature Section Submission (PDF)

Response to FDA Question 32-33 (PDF)

Complaint Analysis (PDF)

Post Aproval Conditions

Response to FDA Question 37 Pertaining to Post Approval Conditions (PDF)

September 30, 2004 Email Regarding Post Approval Study (PDF)

October 5, 2004 Email Regarding Post Approval Study (PDF)

Attachment 35. Focus Group Protocol (PDF)

Attachment 36. Patient Registry (PDF)

Attachment 38. Physician Training File 1 (PDF), File 2 (PDF), File 3 (PDF), File 4 (PDF), File 5 (PDF), File 6 (PDF), File 7 (PDF), File 8 (PDF), File 9 (PDF), File 10 (PDF), File 11(PDF), File 12 (PDF), File 13-A (PDF), File 13 B (PDF), File 14 (PDF), File 15 (PDF)

November 30, 2004 Email Regarding Physicial Training (PDF)

Labeling

Labeling - Physician Labeling/Package Insert (PIDS) (PDF)

Labeling - Patient Brochure (PDF)

Summary of Safety and Effectiveness (SSED)

Silicone Gel-Filled Breast Implant Surgery: Making an Informed Decision (August 2004) (PDF)

Adjunct Study Annual Report for Low-Bleed Gel Mammary Prostheses Year 10 (September 1992 - November 2002) Part 1 (PDF), Part 2 (PDF)

Mentor Corporation

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Panel Package Supplement - Sponsor Briefing Document (HTM) (PDF) (Word)

FDA

Inamed Corporation P020056

Tab 1. FDA Summary Panel Memorandum (PDF)

Tab 2. Draft Panel Questions (PDF)

Tab 3. Attachment 9-1. Package Insert (PDF)

Attachment 9-2. Augmentation Patient Labeling (PDF)

Attachment 9-3. Reconstruction Patient Labeling (PDF)

Attachment 9-4. Revision Patient Labeling (PDF)

Tab 4. Inamed Corp.'s Silicone Gel-Filled Breast Implants (PDF)

Tab 5. Reference Information From October 2003 Panel Meeting (HTM)

Inamed Corporation

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Panel Package Supplement - Sponsor Briefing Document (PDF)