MENTOR MEMORYGEL XTRA BREAST IMPLANT
Report
- Report Number
- 1645337-2024-08798
- Event Type
- Injury
- Date Received
- July 26, 2024
- Date of Event
- June 10, 2024
- Manufacturer
- MENTOR TEXAS
- Product Code
- FTR
- PMA / PMN Number
- P030053
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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. 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: UNSPECIFIED, BUBBLES 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 AUGUST 7, 2024, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. ON AUGUST 12, 2024, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR THEN CONDUCTED A VISUAL INSPECTION, LEAK TEST, AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SMOOTH HIGH PROFILE XTRA 490CC BREAST IMPLANT WAS FOUND TO HAVE SOME BUBBLES WITHIN THE GEL. LEAK TESTING WAS PERFORMED, ACCORDING TO THE MENTOR PROCEDURE, AND IT REVEALED A PUNCTURE ON THE POSTERIOR VIEW, MEASURING APPROXIMATELY 0.1 CM. THE BUBBLES CAN BE ORIGINATED BY THE PUNCTURE FOUND. MICROSCOPIC EXAMINATION WAS PERFORMED ON THE EDGES OF THE PUNCTURE, AND PARALLEL STRIATIONS WERE FOUND IN THE WHOLE AREA OF THE PUNCTURE. PARALLEL STRIATIONS ARE CONSISTENT WITH MARKINGS MADE BY A SHARP OBJECT PERFORATING THE IMPLANT SHELL. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A MICROSCOPIC EXAMINATION OF THE RETURNED PRODUCT INDICATES THAT THE IMPLANT COULD HAVE BEEN DAMAGED DURING OR SUBSEQUENT TO IMPLANTATION. THE PRODUCT INSERT DATA SHEET CAUTIONS TO NOT ALLOW CAUTERY DEVICES OR SHARP INSTRUMENTS, SUCH AS SCALPELS, SUTURE NEEDLES, HYPODERMIC NEEDLES, HEMOSTATS, ADSON FORCEPS, OR SCISSORS TO CONTACT THE DEVICE DURING THE IMPLANTATION OR OTHER SURGICAL PROCEDURES. 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.
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 490CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT UNDERWENT BREAST IMPLANT REVISION SURGERY ON (B)(6) 2024, FOR UNSPECIFIED REASONS. DURING THE SURGERY, IT WAS NOTICED THAT THE LEFT BREAST IMPLANT HAD BUBBLES INSIDE OF IT. SUBSEQUENTLY, THE IMPLANT WAS REPLACED WITH A 490CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (CATALOG: SHPX490 LOT: 9981222 SN: (B)(6)).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 561831 | MENTOR MEMORYGEL XTRA BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | MENTOR TEXAS | 9923484 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female | Required Intervention |