BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMM GEL/SAL5000 275/300

    MDR report key: 19652478 · Received July 1, 2024

    Report

    Report Number
    1645337-2024-07856
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    May 28, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D 6B. EXPLANTATION DATE: (B)(6) 2024. 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 VALID LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: MATERIAL RUPTURE, CAPSULAR CONTRACTURE 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).

    Additional Manufacturer Narrative · 0

    ON JULY 22, 2024, MENTOR RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE PATIENT'S IMPLANTS WERE REPLACED WITH THE FOLLOWING DEVICES: (LEFT) 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMPB320 LOT: 9990411 SN: (B)(6) AND (RIGHT) 320CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMPB320 LOT: 9990411 SN: (B)(6). A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE FIELD HAS BEEN UPDATED. THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, 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.

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. ON AUGUST 7, 2024, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. IN ADDITION, THE CORRECT DATE OF EXPLANTATION WAS ALSO PROVIDED AS (B)(6) 2024. ON AUGUST 9, 2024, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE MAMM GEL/SAL5000 275/300 BREAST IMPLANT WAS FOUND TO HAVE A TEAR ON THE POSTERIOR VIEW, MEASURING APPROXIMATELY 0.2 CM. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. BECAUSE OF THE NOW SETTLED U.S. CLASS ACTION THAT APPLIED, IN PART, TO IMPLANTS MANUFACTURED IN TEXAS, USA THAT WERE IMPLANTED ON OR BEFORE (B)(6) 1993, TO AVOID ANY POTENTIAL ALLEGATION OF SPOLIATION OF EVIDENCE, MENTOR IS PROHIBITED FROM CONDUCTING A FURTHER PHYSICAL EVALUATION OF THIS COVERED DEVICE. MENTOR PERFORMS 100% INSPECTION OF ALL DEVICES PRIOR TO RELEASE, PRODUCT EVALUATION CONCLUDED THAT THE TEAR OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. 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 THE 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. 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR MAMM GEL/SAL5000 275/300 IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST IMPLANT RUPTURES AND BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV ON THE LEFT AND BAKER GRADE III ON THE RIGHT). AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526639 MAMM GEL/SAL5000 275/300 PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 44138

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention