BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA IMPLANTS

    MDR report key: 24168357 · Received January 23, 2026

    Report

    Report Number
    3012883202-2026-01787
    Event Type
    Injury
    Date Received
    January 23, 2026
    Date of Event
    November 22, 2025
    Report Date
    January 23, 2026
    Manufacturer
    ESTABLISHMENT LABS S.A.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALLEGED EVENT IS A RISK ASSOCIATED WITH BREAST SURGERY AND THERE IS NO EVIDENCE TO SUGGEST A LINK BETWEEN THIS PARTICULAR IMPLANT AND/OR ITS MANUFACTURING PROCESS AND A HIGHER RISK OF OCCURRENCE. AS STATED IN THE LITERATURE, ¿A NUMBER OF RISK FACTORS FOR RUPTURE HAVE BEEN IDENTIFIED; THE MOST COMMON CAUSE IS SURGICAL INSTRUMENT DAMAGE.¿ (HANDEL ET AL., 2013). ADDITIONALLY, 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: RUPTURE: ¿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 REQUESTS THE UNIT TO CONFIRM THE EVENT AND TO PERFORM THE CORRESPONDING TESTING (INCLUDING BUT NOT LIMITED TO: REVISION AND CHARACTERIZATION UNDER THE MICROSCOPE OF THE RUPTURE SECTION, MECHANICAL TESTING ACCORDING TO APPROVED STANDARDS, ETC.). BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES, AND IMPLANT RUPTURE IS A RISK ASSOCIATED WITH BREAST SURGERY, WHICH CAN OCCUR AT ANY TIME. A COMPLETE REVIEW OF THE DHR FOR LOT INVOLVED WAS CARRIED OUT, NO DEVIATION WAS FOUND IN THE MANUFACTURING PROCESS. ADDITIONALLY, THERE WERE NO INDICATIONS OF ABNORMALITIES IN RAW MATERIALS OR MANUFACTURING PROCESSES WHICH MAY HAVE AFFECTED THIS PARTICULAR BATCH. ESTABLISHMENT LABS WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS/TRENDS. AS PART OF THE POST MARKET SURVEILLANCE PROCESS, MONITORING OF THE PRIMARY ENDPOINTS REPORTED IS PERFORMED TO DETERMINE UNFAVORABLE TRENDS. PER OUR CURRENT COMPLAINT DATA REPORT, NO UNFAVORABLE TRENDS WERE DETECTED ON THIS PRODUCT. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    KOREA. ALLEGEDLY, A RUPTURE OF THE LEFT BREAST IMPLANT WAS IDENTIFIED (SN: (B)(6)). A REVISION SURGERY WAS PERFORMED. NO PATIENT DEMOGRAPHICS, SUCH AS WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232444 MOTIVA IMPLANTS ERGONOMIX ROUND SILKSURFACE WITH QID FTR ESTABLISHMENT LABS S.A. 16100053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention