BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 13366886 · Received January 27, 2022

    Report

    Report Number
    1645337-2022-00755
    Event Type
    Injury
    Date Received
    January 27, 2022
    Date of Event
    May 19, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: LEFT DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON JANUARY 30, 2022, MENTOR BECAME AWARE REGARDING THE DEVICE INFORMATION. HENCE, THE FOLLOWING FIELDS HAVE BEEN UPDATED ON THIS FORM: FIELD D1 FOR BRAND NAME HAS BEEN UPDATED TO "MENTOR MEMORYGEL BREAST IMPLANT". FIELD D4 FOR CATALOG NUMBER HAS BEEN UPDATED TO "3507350BC". FIELD D4 FOR LOT NUMBER HAS BEEN UPDATED TO "5883991". FIELD D4 FOR UNIQUE IDENTIFIER( UDI) HAS BEEN UPDATED TO (B)(4). A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 11, 2022, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PAPERWORK RECEIVED WITH THE DEVICE INDICATED THE FOLLOWING AND INFORMATION HAS BEEN UPDATED ON THIS FORM: THE IMPACTED SIDE WAS "RIGHT" AS IT WAS REPORTED THAT THE RIGHT SIDE IMPLANT HAD INTRACAPSULAR RUPTURE AND LEFT WAS INTACT. SERIAL NUMBER UNDER FIELD D4 HAS BEEN UPDATED TO (B)(6). DATE OF IMPLANT FIELD D6A HAS BEEN UPDATED TO (B)(6) 2009. NON-MENTOR (SIENTRA) DEVICE WAS USED AS REPLACEMENT PRODUCT. ON FEBRUARY 28, 2022, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE GEL MOD-RND 350CC BREAST IMPLANT WAS FOUND TO BE RUPTURED. IN ADDITION, AN AREA OF SHELL ABRASION WAS OBSERVED ON THE EDGES OF THE TEAR. THE EVALUATION DETERMINED THAT THE CAUSE OF THE RUPTURE IS CONSISTENT WITH NORMAL WEAR. SHELL ABRASION SUGGESTS IN-VIVO FOLDING OR CREASING OF THE DEVICE. THIS MAY BE THE RESULT OF THE FOLLOWING FACTORS: CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE SUCH AS TOO SMALL BREAST POCKET AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET. IN SOME CASES, THE BREAST IMPLANTS MAY ALSO WEAR OUT OVER TIME. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH UNKNOWN SIZE UNKNOWN GEL IMPLANTS AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER LEFT SIDE POSTOPERATIVELY, DIAGNOSED AT AN OFFICE VISIT. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297436 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5883991

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention