MENTOR MEMORYGEL XTRA BREAST IMPLANT
Report
- Report Number
- 1645337-2025-13860
- Event Type
- Injury
- Date Received
- December 12, 2025
- Date of Event
- November 14, 2025
- Manufacturer
- MENTOR TEXAS
- Product Code
- FTR
- UDI-DI
- 00081317025351
- PMA / PMN Number
- P030053
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ON MARCH 16, 2026, MENTOR RECEIVED CLARIFICATION THAT A RECEIVED DEVICE WAS ASSOCIATED WITH THIS FILE. THE PRODUCT IDENTITY WAS UPDATED AS THE FOLLOWING: LOT: 9894911. SERIAL: (B)(6). ON MARCH 28, 2026, MENTOR COMPLETED AN EVALUATION ON THE RETURNED DEVICE. DEVICE EVALUATION: MENTOR CONDUCTED A VISUAL INSPECTION OF THE DEVICE. DURING VISUAL EVALUATION, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE RETURNED DEVICE. REGARDING THE REPORTED CAPSULAR CONTRACTURE CONDITION, THERE ARE NOT ENOUGH DETAILS TO DETERMINE THE FACTORS THAT MAY HAVE CAUSED THIS CONDITION. CAPSULAR CONTRACTURE IN THE PATIENT¿S BREAST MIGHT BE THE RESULT OF THE BODY¿S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. FURTHER, CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR LOT 9894911, 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).
ON JANUARY 28, 2026, MENTOR WAS NOTIFIED THAT THE PATIENT WAS SCHEDULED FOR LEFT-SIDED IMPLANT EXCHANGE ON (B)(6) 2026. DATE OF EXPLANTATION: (B)(6) 2026. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE. ON FEBRUARY 04, 2026, MENTOR WAS NOTIFIED THAT THE REPLACEMENT DEVICE WAS A MENTOR GEL IMPLANT. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
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: THE PATIENT HAS NOT UNDERGONE EXPLANTATION OR REOPERATION AT THIS TIME. 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 A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 700CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37 | MENTOR MEMORYGEL XTRA BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | MENTOR TEXAS | 9894911 | 00081317025351 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |