MENTOR MEMORYGEL BREAST IMPLANT
Report
- Report Number
- 1645337-2024-04761
- Event Type
- Injury
- Date Received
- April 22, 2024
- Date of Event
- April 5, 2024
- Manufacturer
- MENTOR TEXAS
- Product Code
- FTR
- UDI-DI
- 00081317000327
- PMA / PMN Number
- P030053
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ON 10-MAY-2024, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. INFORMATION ABOUT TWO DEVICES WAS REPORTED: DEVICE #1: MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESIS, CATALOG #3504001BC, LOT #6883758, UDI #(B)(4) PMA #P030053 DEVICE #2: MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL BREAST PROSTHESIS, CATALOG #3504001BC, LOT #6781100, UDI #(B)(4) PMA #P030053 IT WAS NOT SPECIFIED WHICH OF THESE TWO DEVICES IS THE PATIENT¿S RUPTURED RIGHT BREAST PROSTHESIS. IF CLARIFICATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONALLY, S MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED ON LOT #6883758 AND LOT #6781100, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. ON 23-MAY-2024, THE MENTOR FAILURE ANALYSIS LAB RECEIVED TWO DEVICES FOR EVALUATION, ONE FROM LOT #6883758 AND ONE FROM LOT #6781100. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: IMPLANT REMOVAL SURGERY. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 24-APR-2024, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. THE PATIENT¿S RACE IS WHITE AND HER ETHNICITY IS NOT HISPANIC/LATINO. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 23-MAY-2024, MENTOR BECAME AWARE THAT THE PATIENT DEVELOPED BREAST IMPLANT ILLNESS AND BREAST PAIN POST IMPLANTATION. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2024-06436 FOR THE REPORT FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. ADDITIONALLY, MENTOR BECAME AWARE THAT THE LOT NUMBER FOR THE RUPTURED RIGHT BREAST PROSTHESIS IS 6883758. ON 28-MAY-2024, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT PRESENTED BREAST PAIN AND BREAST IMPLANT ILLNESS. IN ADDITION, THE PATIENT EXPERIENCED A RUPTURE IN THE BREAST IMPLANT. THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE BREAST IMPLANT WAS RUPTURED AND RECEIVED IN TWO PARTS. IN ADDITION, SHELL ABRASION WAS OBSERVED AT THE EDGES OF THE RUPTURE. THE EVALUATION DETERMINED THAT THE POSSIBLE CAUSE OF THE RUPTURE IS CONSISTENT WITH NORMAL WEAR. SHELL ABRASION SUGGESTS IN-VIVO FOLDING OR CREASING OF THE DEVICE. THIS MAY BE THE RESULT OF THE FOLLOWING FACTORS: CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE SUCH AS TOO SMALL BREAST POCKET AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET. IN SOME CASES, THE BREAST IMPLANTS MAY ALSO WEAR OUT OVER TIME. AT THE PRESENT TIME, THERE IS NO SUFFICIENT EVIDENCE TO SHOW AN ASSOCIATION BETWEEN BREAST IMPLANTS AND GENERALIZED ILLNESS (ASSESSING THE RISKS OF BREAST IMPLANTS AND FDA¿S VISION FOR THE NATIONAL BREAST IMPLANT REGISTRY). AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. H6 HEALTH EFFECT - CLINICAL CODE E2402: BREAST IMPLANT ILLNESS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH AN UNSPECIFIED MENTOR SMOOTH GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS OBSERVED DURING A BILATERAL EXPLANTATION SURGERY ON (B)(6) 2024. THE EXPLANTED BREAST PROSTHESES WERE NOT REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1696081 | MENTOR MEMORYGEL BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | MENTOR TEXAS | 6883758 | 00081317000327 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female | Required Intervention |