MENTOR MEMORYGEL BREAST IMPLANT
Report
- Report Number
- 1645337-2022-14516
- Event Type
- Injury
- Date Received
- December 14, 2022
- Date of Event
- October 6, 2022
- Manufacturer
- MENTOR TEXAS
- Product Code
- FTR
- UDI-DI
- 00081317004172
- PMA / PMN Number
- P030053
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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 COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: LEFT RUPTURE, AND CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON FEBRUARY 16, 2023, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE TWO 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. AS PER CLARIFICATION RECEIVED ON MARCH 2, 2023, THE FOLLOWING INFORMATION HAS BEEN UPDATED ON THIS FORM: FIELD D4 FOR CATALOG NUMBER HAS BEEN UPDATED FROM "3504501BC" TO "3507360MC" FIELD D4 FOR LOT NUMBER HAS BEEN UPDATED TO FROM "6980097" TO "6812059" FIELD D4 FOR UNIQUE IDENTIFIER( UDI) HAS BEEN UPDATED TO (B)(4). 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
AS PER ADDITIONAL INFORMATION RECEIVED ON DECEMBER 27, 2022, THE FOLLOWING INFORMATION HAS BEEN UPDATED ON THIS FORM: PATIENT'S AGE UNDER FIELD A2 HAS BEEN UPDATED TO "61". EVENT DATE UNDER FIELD B3 HAS BEEN UPDATED TO OCTOBER 6, 2022. UPDATED CLINICAL CODE UNDER FIELD H6 FROM "CAPSULAR CONTRACTURE" TO " DEFORMITY/ DISFIGUREMENT " DUE THE EVENT IS LEFT RUPTURE LEFT SIDE AND CAPSULECTOMY WAS PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: LEFT RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON MARCH 9, 2023, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: MENTOR CONDUCTED A VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SM MOD CLASSIC GEL, 360CC BREAST IMPLANT WAS FOUND TO BE RUPTURED. IN ADDITION, SHELL ABRASION WAS OBSERVED AT THE EDGES OF THE RUPTURE. A MICROSCOPIC EXAMINATION WAS PERFORMED AND NO INSTRUMENT DAMAGE 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. A SECOND PRODUCT WAS RECEIVED (LOT-6980097). NO ADVERSE EVENTS WERE REPORTED FOR THIS CONCOMITANT (CONTRALATERAL) DEVICE, THEREFORE NO FURTHER ANALYSIS IS REQUIRED. IT SHOULD BE NOTED THAT AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON JANUARY 27, 2023, MENTOR BECAME AWARE OF THE IMPACTED DEVICE INFORMATION. HENCE, FOLLOWING FIELDS HAVE BEEN UPDATED ON THIS FORM: - FIELD D1 FOR BRAND NAME HAS BEEN UPDATED TO "MENTOR MEMORYGEL BREAST IMPLANT" - FIELD D4 FOR CATALOG NUMBER HAS BEEN UPDATED TO "3504501BC" - FIELD D4 FOR LOT NUMBER HAS BEEN UPDATED TO "6980097" - FIELD D4 FOR UNIQUE IDENTIFIER( UDI) HAS BEEN UPDATED TO (B)(4). - FIELD G4 FOR PMA/ 510(K) HAS BEEN UPDATED TO "P030053" A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 450CC UNKNOWN GEL IMPLANTS SMOOTH AND EXPERIENCED BREAST IMPLANT RUPTURE, AND CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ONLY SURGERY ON (B)(6) 2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2141794 | MENTOR MEMORYGEL BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | MENTOR TEXAS | 3504501BC | 6812059 | 00081317004172 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Female | Required Intervention |