MENTOR MEMORYGEL BREAST IMPLANT
Report
- Report Number
- 1645337-2020-16575
- Event Type
- Injury
- Date Received
- January 4, 2021
- Date of Event
- October 30, 2020
- Report Date
- December 11, 2020
- Manufacturer
- MENTOR TEXAS
- Product Code
- FTR
- PMA / PMN Number
- P030053
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
ON (B)(6) 2021, MENTOR BECAME AWARE OF THE IMPACTED DEVICE INFORMATION. HENCE, FOLLOWING FIELD 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 "3507300BC" - FIELD D4 FOR LOT NUMBER HAS BEEN UPDATED TO "5930351" - FIELD D4 FOR UNIQUE IDENTIFIER( UDI) HAS BEEN UPDATED TO (B)(4). ON (B)(6) 2021, MENTOR BECAME AWARE THAT SERIAL NUMBER FOR THE REPLACEMENT LEFT SIDE DEVICE WAS MISTAKENLY NOT LISTED UNDER FIELD H10 OF THE PREVIOUS SUBMISSION. THE SERIAL NUMBER FOR THE LEFT SIDE REPLACEMENT DEVICE IS (B)(6). A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON JUNE 23, 2021, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: MENTOR CONDUCTED A VISUAL INSPECTION, MICROSCOPIC EXAMINATION, AND THICKNESS MEASUREMENT OF THE RETURNED DEVICE. THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE GEL MOD-RND 300CC BREAST IMPLANT WAS FOUND TO BE RUPTURE AND RECEIVED IN TWO PARTS. A MICROSCOPIC EXAMINATION WAS PERFORMED, AND THE CAUSE OF THE TEAR COULD NOT BE IDENTIFIED. THEREFORE A THICKNESS MEASUREMENT WAS CONDUCTED ON THE SHELL AT THE TEAR, AND THE THICKNESS WAS WITHIN MANUFACTURING SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ALTHOUGH NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION BUT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. THE FOLLOWING MAY CAUSE THE IMPLANT TO RUPTURE: STRESSING THE IMPLANT DURING IMPLANTATION AND WEAKENING IT; FOLDING OR WRINKLING OF THE IMPLANT SHELL; EXCESSIVE FORCE TO THE CHEST (E.G. DURING CLOSED CAPSULOTOMY); TRAUMA; COMPRESSION DURING MAMMOGRAPHIC IMAGING; AND SEVERE CAPSULAR CONTRACTURE. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT 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. SURGEONS SHOULD INSTRUCT THEIR PATIENTS TO INFORM THEM IF THERE IS SIGNIFICANT PAIN OR IF PAIN PERSISTS. PAIN IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2021, 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. ON (B)(6) 2021, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON JANUARY 5, 2021, MENTOR BECAME AWARE THAT UNKNOWN SILICONE GEL BREAST IMPLANT WAS USED AS REPLACEMENT ON (B)(6) 2020. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2021, MENTOR BECAME AWARE THAT THE REPLACEMENT DEVICES USED ON (B)(6) 2021 WERE CATALOG NUMBER 3507320MC; SERIAL NUMBER 9450843-039 ON THE RIGHT SIDE, AND CATALOG NUMBER 3507300MC; SERIAL NUMBER ON THE LEFT SIDE. 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 COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: LEFT SIDE PAIN AND BREAST IMPLANT RUPTURE. (B)(4).
IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH AN UNKNOWN GEL IMPLANT AND EXPERIENCED LEFT SIDE PAIN AND BREAST IMPLANT RUPTURE POSTOPERATIVELY. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2020.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5189 | MENTOR MEMORYGEL BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | MENTOR TEXAS | 5930351 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |