MENTOR MEMORYGEL BREAST IMPLANT
Report
- Report Number
- 1645337-2025-00493
- Event Type
- Injury
- Date Received
- January 19, 2025
- Date of Event
- December 13, 2024
- Manufacturer
- MENTOR TEXAS
- Product Code
- FTR
- UDI-DI
- 00081317000471
- PMA / PMN Number
- P030053
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ON FEBRUARY 10, 2025, MENTOR RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: MATERIAL RUPTURE.
ON MARCH 27, 2025, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ON MARCH 28, 2025, MENTOR RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE PATIENT'S IMPLANT WAS REPLACED WITH THE FOLLOWING DEVICES: (LEFT) 325CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3503254BC LOT: 2036632 SN: (B)(6) AND (RIGHT) 275CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3502754BC LOT: 2040631 SN: (B)(6). ON APRIL 10, 2025, MENTOR RECEIVED CLARIFYING INFORMATION INDICATING THAT THE CORRECT SUSPECT MEDICAL DEVICE IS A 325CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG: 3503254BC LOT: 6593389 SN: (B)(6)). IN ADDITION, THE PATIENT INITIALLY EXPERIENCED LEFT BREAST AXILLARY PAIN. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE AND EXPIRATION DATE FIELDS HAVE BEEN UPDATED. THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, 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 APRIL 25, 2025, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SMOOTH HPG, 325CC BREAST IMPLANT WAS FOUND TO BE RUPTURED AND RECEIVED IN TWO PARTS. IN ADDITION, AN AREA OF SHELL ABRASION WAS OBSERVED ON THE EDGES OF THE TEAR. THESE FINDINGS ARE CONSISTENT WITH NORMAL WEAR OF THE DEVICE. SHELL ABRASION SUGGESTS IN-VIVO FOLDING OR CREASING OF THE DEVICE, WHICH MAY BE CAUSED BY CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE, SUCH AS AN EXCESSIVELY SMALL BREAST POCKET OR THE FOLDING OR WRINKLING OF THE SHELL WITHIN THE BREAST POCKET. IN SOME CASES, BREAST IMPLANTS MAY ALSO EXPERIENCE NORMAL WEAR OVER TIME. MOST WOMEN UNDERGOING AUGMENTATION OR RECONSTRUCTION WITH A MAMMARY PROSTHESIS WILL EXPERIENCE SOME PAIN POSTOPERATIVELY. WHILE PAIN NORMALLY SUBSIDES IN MOST WOMEN AS THEY HEAL FROM SURGERY, IT CAN BECOME A CHRONIC PROBLEM IN OTHER WOMEN. CHRONIC PAIN CAN BE ASSOCIATED WITH A VARIETY OF FACTORS. PAIN IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. THE CONTRALATERAL DEVICE WAS ALSO RECEIVED (LOT NUMBER 6554578). THE PATIENT DID NOT REPORT ANY ISSUE WITH THIS DEVICE. THEREFORE, NO FURTHER ANALYSIS OF THE CONTRALATERAL DEVICE IS REQUIRED. AS PART OF MENTOR'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED ACCORDING TO APPROVED SPECIFICATIONS. BASED ON THE RESULTS OF THIS INVESTIGATION, IT WAS DETERMINED THAT THE PRODUCT MET THE MANUFACTURING RELEASE CRITERIA, AND THAT NORMAL WEAR MAY HAVE CAUSED THE OBSERVED DEFECT. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW.
AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: 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).
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 275CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH LEFT BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 908359 | MENTOR MEMORYGEL BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | MENTOR TEXAS | 6593389 | 00081317000471 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Female | Required Intervention| O |