MENTOR MEMORYGEL BREAST IMPLANT
Report
- Report Number
- 1645337-2020-06677
- Event Type
- Injury
- Date Received
- May 29, 2020
- Date of Event
- January 1, 2020
- Manufacturer
- MENTOR TEXAS
- Product Code
- FTR
- UDI-DI
- 00081317000310
- PMA / PMN Number
- P030053
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 6974321, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON JULY 7, 2020. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATION AND ANALYSIS HAVE BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON JULY 28, 2020. DEVICE EVALUATION SUMMARY: DURING THE VISUAL EVALUATION, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE RETURNED DEVICE. MENTOR CONCLUDED THAT THE CAPSULAR CONTRACTURE IN THE PATIENT´S BREAST WAS THE RESULT OF THE BODY´S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. THE AMERICAN SOCIETY OF PLASTIC SURGEONS RECOMMENDS AND ENCOURAGES MEMBER SURGEONS TO ALWAYS SUBMIT BREAST IMPLANTS, CAPSULE, AND EFFUSION TO PATHOLOGY FOR EXAMINATION. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 3, 2020. IN ADDITION TO THE ISSUES REPORTED PREVIOUSLY, THE FORMATION OF CYSTS WAS REVEALED THROUGH MAGNETIC RESONANCE IMAGING. THE FOLLOWING STATEMENT WAS ADDED TO THE DEVICE EVALUATION SUMMARY REPORTED PREVIOUSLY: A BREAST CYST IS A FLUID-FILLED SAC WITHIN THE BREAST. ONE BREAST CAN HAVE ONE OR MORE BREAST CYSTS. THEY ARE OFTEN DESCRIBED AS ROUND OR OVAL LUMPS WITH DISTINCT EDGES. BREAST CYSTS ARE USUALLY AND TYPICALLY DO NOT REQUIRE TREATMENT, BUT THEY CAN BE DRAINED USING FINE NEEDLE ASPIRATION IF THE CYST IS LARGE OR UNCOMFORTABLE. 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: CAPSULAR CONTRACTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 375CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED SILENT RIGHT SIDED RUPTURE AND BILATERAL CAPSULAR CONTRACTURE POST PROCEDURE. THE RIGHT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE IV. THE LEFT SIDED CAPSULAR CONTRACTURE WAS BAKER GRADE III. THE RUPTURE WAS DIAGNOSED THROUGH MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT HAD BILATERAL PROSTHESIS REPLACEMENT WITH 450CC MENTOR MEMORYGEL BREAST IMPLANTS PERFORMED ON (B)(6) 2020. SEE 1645337-2020-06678 FOR CONTRALATERAL PROSTHESIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 566193 | MENTOR MEMORYGEL BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | MENTOR TEXAS | 3503751BC | 6974321 | 00081317000310 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention |