MENTOR MEMORYGEL BREAST IMPLANT
Report
- Report Number
- 1645337-2025-13019
- Event Type
- Injury
- Date Received
- November 24, 2025
- Date of Event
- October 24, 2025
- Manufacturer
- MENTOR TEXAS
- Product Code
- FTR
- UDI-DI
- 81317006978
- PMA / PMN Number
- P030053
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ON JANUARY 20, 2026, MENTOR BECAME AWARE THAT THE FOLLOW UP:#1MISSED REPORTING THE FOLLOWING: THE PATIENT EXPERIENCED BILATERAL PAIN, AND WORST ON THE LEFT SIDE AND IT CAUSED NIPPLE HYPERSENSITIVITY. THE BILATERAL RUPTURES THAT THE PATIENT EXPERIENCED WERE SYMPTOMATIC. AS A RESULT, THE PATIENT UNDERWENT BILATERAL NEAR CAPSULECTOMIES AND BILATERAL REPLACEMENTS PER FOLLOWING: LEFT SERIAL#: (B)(6), RIGHT SERIAL #: (B)(6). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
PER ADDITIONAL INFORMATION RECEIVED ON JANUARY 12, 20256, THE PATIENT DIDN'T HAVE ANY CAPSULAR CONTRACTURE. 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. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: SILENT RUPTURE. 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).
SUSPECT DEVICE RECEIVED ON JANUARY 05, 2026. DEVICE EVALUATION COMPLETED ON JANUARY 12, 2026: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION, MICROSCOPIC EXAMINATION, AND THICKNESS MEASUREMENT OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE BREAST IMPLANT WAS FOUND TO BE RUPTURED AND RECEIVED IN THREE (3) PARTS. 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. MENTOR ALSO PERFORMED A MANUFACTURING RECORD EVALUATION RELATED TO THE REPORTED COMPLAINT FOR THE FINISHED DEVICE LOT NUMBER. NO MANUFACTURING NON-CONFORMANCES RELATED TO THE ISSUE REPORTED WERE IDENTIFIED AS PART OF THIS EVALUATION. 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 IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. THE FOLLOWING THINGS MAY CAUSE IMPLANT TO RUPTURE: DAMAGE BY SURGICAL INSTRUMENTS; 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 ACCORDING TO APPROVED SPECIFICATIONS. THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. PER ADDITIONAL INFORMATION RECEIVED ON JANUARY 07, 2026, THE PATIENT ALSO EXPERIENCED LEFT SIDED CAPSULAR CONTRACTURE UNKNOWN GRADE, NIPPLE SENSATION AND BILATERAL BREAST PAIN. THIS PATIENT HAS HAD BILATERAL BREAST PAIN FOR ABOUT TWO MONTHS AND SAYS THAT IT IS GETTING WORSE EVERY WEEK. SHE DESCRIBES IT WORSE ON THE LEFT SIDE AND SAYS IT HAS CAUSED NIPPLE HYPERSENSITIVITY AND AN ICY HOT FEELING ESPECIALLY LATERALLY AND INTO THE LEFT SHOULDER AND ALONG HER LEFT FLANK. BILATERAL MAMMOGRAMS, ULTRASOUNDS, AND MRI SHOWED BILATERAL RUPTURES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL NEAR CAPSULECTOMIES AND BILATERAL REPLACEMENTS PER FOLLOWINGS; LEFT SERIAL#: (B)(6), RIGHT SERIAL #: (B)(6). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL, 480CC SILICONE PROSTHESIS EXPERIENCES BILATERAL SILENT RUPTURES POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH AN OFFICE EXAMINATION, CONFIRMED BY MRI EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL SURGERY ON (B)(6) 2025. THIS REPORT RELATES TO THE RIGHT SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2556259 | MENTOR MEMORYGEL BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | MENTOR TEXAS | 6950275 | 81317006978 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Female | Required Intervention |