BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA IMPLANTS

    MDR report key: 20787687 · Received November 26, 2024

    Report

    Report Number
    3012883202-2024-00156
    Event Type
    Injury
    Date Received
    November 26, 2024
    Report Date
    November 26, 2024
    Manufacturer
    MOTIVA USA LLC
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A CLINICAL EVALUATION OF THE REPORT AND THE PROVIDED EVIDENCE WAS CONDUCTED; HOWEVER, THE CLINICAL EVIDENCE WAS INSUFFICIENT, AND THE DEVICES WERE NOT RETURNED. AS A RESULT, THE CONDITION COULD NOT BE CONFIRMED. · A COMPLETE REVIEW OF THE DHR FOR LOTS 22101232/ 22111570 WERE CARRIED OUT, NO DEVIATION WAS FOUND IN THE MANUFACTURING PROCESS. THE REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER AND STERILIZATION RUN FOUND NO OTHER SIMILAR COMPLAINTS REPORTED IN THE PAST. THE INSTRUCTIONS FOR USE IN THE DIRECTIONS FOR USE WERE REVIEWED, TO DETERMINATE IF THERE ARE INDICATIONS THAT ENSURE THE PREVENTION AND GOOD HANDLING OF THE PRODUCT. FOR THIS EVENT, IT IS CONSIDERED THAT THE INFORMATION IS SUITABLE FOR THE SECTION OF SURGICAL PRECAUTIONS AS FOLLOWS: RUPTURE¿ BREAST IMPLANTS CAN RUPTURE WHEN THE SHELL DEVELOPS A TEAR OR HOLE. RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO HAPPEN WHEN THE IMPLANT HAS BEEN IN PLACE FOR A LONG TIME. RUPTURE OF A SILICONE GEL-FILLED BREAST IMPLANT IS MOST OFTEN SILENT (THE PATIENT DOES NOT EXPERIENCE ANY SYMPTOMS AND THERE ARE NO PHYSICAL SIGNS OF CHANGES WITH THE IMPLANT) RATHER THAN SYMPTOMATIC. THEREFORE, PATIENTS SHOULD BE ADVISED TO HAVE REGULAR MRIS OVER THEIR LIFETIME TO SCREEN FOR SILENT RUPTURE EVEN IF THEY ARE NOT HAVING ANY APPARENT PROBLEMS. THE FIRST MRI SHOULD BE PERFORMED AT 3 YEARS POSTOPERATIVELY, THEN REGULARLY AT 2-YEAR INTERVALS, AND THE IMAGES SUBMITTED TO THE TREATING SURGEON. PATIENTS SHOULD BE PROVIDED WITH A LIST OF RADIOLOGY CENTERS WITH EXPERIENCE WITH BREAST IMPLANT MRI TO SCAN FOR SIGNS OF RUPTURE. THE IMPORTANCE OF THESE MRI EVALUATIONS SHOULD BE EMPHASIZED. IF RUPTURE IS NOTED ON AN MRI, THE PATIENT SHOULD BE STRONGLY ENCOURAGED TO HAVE HER IMPLANT REMOVED. AS NO MANUFACTURING, MATERIAL OR DESIGN ISSUES WERE IDENTIFIED, NO FURTHER INVESTIGATION OR ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME. ·-ESTABLISHMENT LABS WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS/TRENDS.

    Additional Manufacturer Narrative · 0

    AS STATED IN THE LITERATURE, ¿A NUMBER OF RISK FACTORS FOR RUPTURE HAVE BEEN IDENTIFIED; THE MOST COMMON CAUSE IS SURGICAL INSTRUMENT DAMAGE.¿ (HANDEL, GARCÍA AND WINXTROM, 2013. BREAST IMPLANT RUPTURE: CAUSES, INCIDENCE, CLINICAL IMPACT, AND MANAGEMENT. PLAST. RECONSTR. SURG. 132: 1128.) ADITTIONALLY, RUPTURE IS A COMMON AND KNOWN REASON FOR COMPLAINTS, AND IT IS CLEARLY CHARACTERIZED IN THE PRODUCT DFU INCLUDED WITH THE IMPLANT, AS STATED ABOVE. ADDITIONALLY, NO CASES OF RUPTURE BECAUSE OF PRODUCT FAILURE HAVE BEEN REPORTED TO ESTABLISHMENT LABS EVER. PER OUR DIRECTIONS FOR USE, EACH PATIENT MUST RECEIVE THE ESTABLISHMENT LABS S.A. ¿MOTIVA IMPLANTS®: INFORMATION FOR THE PATIENT¿ DURING HER SURGICAL CONSULTATION, IT IS THE SURGEONS´ RESPONSIBILITY TO ENSURE THAT THE PATIENT COMPLETELY UNDERSTANDS THE INFORMATION REGARDING THE RISKS, BENEFITS, AND RECOMMENDATIONS ASSOCIATED WITH SILICONE GEL-FILLED BREAST IMPLANT SURGERY, AS WELL AS THE COMPLICATIONS TYPICAL OF ANY TYPE OF SURGERY. THIS DOCUMENT IS AVAILABLE IN MOTIVA® WEBSITE: IFU.MOTIVA.HEALTH THE INSTRUCTIONS FOR USE IN THE DIRECTIONS FOR USE WERE REVIEWED, TO DETERMINATE IF THERE ARE INDICATIONS THAT ENSURE THE PREVENTION AND GOOD HANDLING OF THE PRODUCT. FOR THIS EVENT, IT IS CONSIDERED THAT THE INFORMATION IS SUITABLE FOR THE SECTION OF SURGICAL PRECAUTIONS AS FOLLOWS: ¿BREAST IMPLANTS CAN POTENTIALLY REMAIN INTACT FOR DECADES IN THE BODY, BUT ALL SUCH DEVICES WILL FAIL AT SOME POINT. BREAST IMPLANTS RUPTURE WHEN THE SHELL DEVELOPS A TEAR OR HOLE. RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MOST LIKELY TO OCCUR; THE LONGER THE IMPLANT IS IN PLACE. THE FOLLOWING MAY CAUSE IMPLANTS TO RUPTURE: DAMAGE BY SURGICAL INSTRUMENTS, IMPLANT STRESS, AND WEAKENING DURING IMPLANTATION, AGE AND DESIGN OF THE IMPLANT, SUBMUSCULAR RATHER THAN SUB-GLANDULAR LOCATION, THE OCCURRENCE OF POST-OPERATORY HEMATOMAS OR SEROMAS, FOLDING OR WRINKLING OF THE IMPLANT SHELL, EXCESSIVE FORCE TO THE CHEST, TRAUMA, COMPRESSION DURING MAMMOGRAPHIC IMAGING, AND SEVERE CAPSULAR CONTRACTURE¿. ESTABLISHMENT LABS NEEDS TO CONDUCT THE NECESSARY TESTS, WHICH INCLUDE, BUT ARE NOT LIMITED TO, A MICROSCOPIC EXAMINATION AND CHARACTERIZATION OF THE RUPTURE SECTION, ALONG WITH MECHANICAL TESTING IN COMPLIANCE WITH APPROVED STANDARDS. IN ADDITION, A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED, AND IT WAS CONCLUDED THAT THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS OF THIS DEVICE THAT WOULD HAVE CAUSED OR CONTIBUTED TO THIS INCIDENT. WHEN THE INVESTIGATION PROCESS IS COMPLETED, THE APPLICABLE FINDINGS WILL BE INCLUDED IN A SUPPLEMENTAL MEDWATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST AUGMENTATION IN (B)(6) 2023, RECEIVING MOTIVA IMPLANTS IDENTIFIED AS RIGHT SIDE 22101232-34 AND LEFT SIDE 22111570-08. SUBSEQUENTLY, IT WAS DETERMINED THAT ONE OF THE IMPLANTS HAD RUPTURED; HOWEVER, THE SPECIFIC SIDE AFFECTED WAS NOT DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2384320 MOTIVA IMPLANTS ERGONOMIX ROUND SILKSURFACE FTR MOTIVA USA LLC 22101232/ 22111570

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Required Intervention