BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8731824 · Received June 25, 2019

    Report

    Report Number
    1645337-2019-14253
    Event Type
    Injury
    Date Received
    June 25, 2019
    Date of Event
    May 13, 2019
    Report Date
    May 30, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000365
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ON (B)(6), 2019, MENTOR RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT ALSO EXPERIENCED BILATERAL CAPSULAR CONTRACTION AND PTOSIS ON THE RIGHT SIDE POST-OPERATIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANTS 600CC, CATALOG NUMBER 3506004BC, SERIAL NUMBERS (B)(4) ON THE RIGHT SIDE AND (B)(4) ON THE LEFT SIDE ON (B)(6) 2019. DEVICE EVALUATION SUMMARY: DURING ANALYSIS OF THE SAMPLE WAS FOUND RUPTURED. SHELL ABRASION WAS FOUND IN THE EDGES OF THE TEAR. NO OTHER ANOMALIES WERE DISCOVERED. THE MANUFACTURING RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. SHELL ABRASION SUGGESTING IN-VIVO FOLDING OR CREASING OF THE DEVICE. A CREASE/FOLD FAILURE MAY BE THE RESULT OF THE CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE. POSTOPERATIVE FORMATION OF A FIBROUS TISSUE CAPSULE AROUND A MAMMARY PROSTHESIS IS A NORMAL PHYSIOLOGIC RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT AND OCCURS IN ALL PATIENTS IN VARYING DEGREES. IN SOME CASES, CONTRACTURE OF THE FIBROUS CAPSULE MAY OCCUR. THIS PHENOMENON IS REFERRED TO AS CAPSULAR CONTRACTURE. ASYMMETRY MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: CONTRACTURE OF THE FIBROUS CAPSULE, SEROMA OR HEMATOMA, DEVELOPMENT OF POSTOPERATIVE BREAST DYSPLASIA, UNILATERAL DISCREPANCY IN MUSCLE DEVELOPMENT, DEFLATION OF THE IMPLANT, INCORRECT CHOICE OF IMPLANT SHAPE OR SIZE, AND SURGICAL TECHNIQUE. ASYMMETRY IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. RUPTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. BASED ON THE INFORMATION REPORTED AND/OR THE PRODUCT INVESTIGATION, THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH THE MANUFACTURING PROCESS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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: RUPTURE. CONCOMITANT PRODUCTS: MENTOR MEMORYGEL BREAST IMPLANT 600CC, CATALOG # 3506001BC, SERIAL # (B)(4), LOT # 5944124. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 600CC AND EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIONAL. THE RUPTURE WAS CONFIRMED WITH AN MRI. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523725 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5969396 00081317000365

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention