BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 17801084 · Received September 22, 2023

    Report

    Report Number
    1645337-2023-11274
    Event Type
    Injury
    Date Received
    September 22, 2023
    Date of Event
    June 27, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000464
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON OCTOBER 13, 2023, THE MENTOR ANALYSIS LAB RECEIVED THE SUSPECT MEDICAL DEVICE FOR EVALUATION. WITH THE RETURNED DEVICE, THE PRODUCT IDENTITY WAS DETERMINED AS THE FOLLOWING: SIZE: 300CC. BRAND NAME: MENTOR MEMORYGEL BREAST IMPLANT.  CATALOG: 3503004BC. LOT: 6936156. THE FOLLOWING ADDITIONAL INFORMATION WAS ALSO RECEIVED. THE PATIENT WAS NOTED TO HAVE BILATERAL BREAST ASYMMETRY BY A MEDICAL PROFESSIONAL. ADDITIONALLY, MAMMOGRAM RESULTS INDICATED BENIGN-APPEARING CALCIFICATIONS IN THE BREASTS. AS THE MAMMOGRAM WAS PERFORMED ON (B)(6) 2023, THE DATE OF EVENT HAS BEEN UPDATED TO (B)(6) 2023. AS AN EVENT WAS REPORTED FOR THE CONTRALATERAL SIDE, ANOTHER FILE WAS GENERATED TO DOCUMENT THE EVENT. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-12683 FOR THE CONTRALATERAL EVENT. ON OCTOBER 19, 2023, MENTOR BECAME AWARE THAT OF THE SERIAL NUMBER OF THE DEVICE. SERIAL: (B)(6). ON OCTOBER 20, 2023, MENTOR COMPLETED AN EVALUATION ON THE RETURNED DEVICE. MENTOR CONDUCTED A VISUAL INSPECTION, MICROSCOPIC EXAMINATION, AND THICKNESS MEASUREMENT OF THE DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE BREAST IMPLANT WAS FOUND TO BE RUPTURED AND RECEIVED IN THREE PARTS. A 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. 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.   CALCIFICATION AND BREAST IMAGING CALCIFICATION OF A BIOMATERIAL OCCURS WHEN CALCIUM SALTS ARE DEPOSITED IN THE TISSUE CAPSULE SURROUNDING THE IMPLANTED DEVICE. CALCIFICATION OCCURS IN ASSOCIATION WITH A WIDE VARIETY OF IMPLANTED PROSTHESES, INCLUDING BREAST IMPLANTS, HEART VALVES, VASCULAR GRAFTS, AND SOFT CONTACT LENSES, AS WELL AS IN THE MATURE BREAST TISSUE OF WOMEN WHO HAVE NOT UNDERGONE BREAST SURGERY. CALCIFICATION OF THE FIBROUS CAPSULE THAT MAY OCCUR FOLLOWING IMPLANTATION OF BREAST PROSTHESES IS GENERALLY NOT OF CLINICAL SIGNIFICANCE, ALTHOUGH IT MAY EXACERBATE SYMPTOMS OF CAPSULAR CONTRACTURE. CONCERN HAS BEEN RAISED, HOWEVER; THAT CALCIFICATION MAY INTERFERE WITH TUMOR DETECTION BECAUSE MICROCALCIFICATIONS ARE CONSIDERED A HALFMARK OF MALIGNANT BREAST DISEASE. ALTHOUGH CLINICIANS HAVE RECOMMENDED PRE- AND POST-SURGICAL MAMMOGRAMS FOR AUGMENTATION PATIENTS TO ASSIST IN DISTINGUISHING POST-OPERATIVE FINDINGS FROM CALCIFICATION ASSOCIATED WITH MALIGNANCY, BENIGN CALCIFICATION RESULTING FROM SURGERY IS GENERALLY CONSIDERED DISTINGUISHABLE FROM MALIGNANT-TYPE CALCIFICATION. FURTHER, NO PUBLISHED REPORTS WERE IDENTIFIED THAT DOCUMENT ANY ACTUAL OCCURRENCES OF MISSED OR DELAYED DIAGNOSES ATTRIBUTABLE TO CAPSULAR CALCIFICATION. CALCIFICATION IS NOT A PHENOMENON UNIQUE TO BREAST IMPLANTS. IT OCCURS IN 11 TO 53 PERCENT OF WOMEN WHO UNDERWENT BREAST REDUCTION PROCEDURES (ABBOUD ET AJ. 1995, M&NICK ET AL. 1990, BROWN ET AL. 1987). IN THE BREASTS OF WOMEN WHO HAVE NOT UNDERGONE ANY BREAST SURGERY, THE PREVALENCE OF BENIGN CALCIFICATIONS INCREASES PROGRESSIVELY WITH AGE FROM 8 PERCENT IN WOMEN 25 TO 29 YEARS OLD UP TO 86 PERCENT IN WOMEN 75 TO 79 YEARS OLD (STOMPER ET AL. 1996). 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: ANISOMASTIA, IMPLANT SITE CALCIFICATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    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. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF AN UNDISCLOSED MENTOR SMOOTH GEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT USING MAMMOGRAM IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 450CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2023. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1835517 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6936156 00081317000464

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention