BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA ERGONOMIX ROUND SILKSURFACE WITH QID

    MDR report key: 20690964 · Received November 14, 2024

    Report

    Report Number
    3012883202-2024-00124
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    September 12, 2024
    Report Date
    September 2, 2025
    Manufacturer
    MOTIVA USA LLC
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 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. 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 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¿. GEL FRACTURE: "GEL FRACTURE IS DEFINED AS A FISSURE OR CRACKS IN THE IMPLANT¿S GEL WHEN EXCESSIVE INTRINSIC FORCES FORCIBLY SEPARATE THE SILICONE GEL FILLING. AS A RESULT, THE IMPLANT¿S SHAPE IS IRREVOCABLY LOST, LEADING TO THE NEED FOR IMPLANT REPLACEMENT. IT CAN OCCUR WITH COHESIVE SILICONE GEL AND MOST FREQUENTLY DUE TO EXPOSING THE IMPLANT TO EXCESSIVE COMPRESSION FORCES APPLIED TO A SMALL SHELL AREA DURING IMPLANT INSERTION. GEL FRACTURE CAN ALSO OCCUR DUE TO THE DEVELOPMENT OF CAPSULAR CONTRACTURE AND MAY RESULT IN DEVICE DISTORTION". LUMPS: "SOMETIMES THERE ARE SYMPTOMS ASSOCIATED WITH GEL IMPLANT RUPTURE, SUCH AS LUMPS SURROUNDING THE IMPLANT OR IN THE ARMPIT". "THE PATIENT SHOULD BE ADVISED THAT THE PRESENCE OF LUMPS, PERSISTENT PAIN, SWELLING, HARDENING, OR CHANGE IN THE IMPLANT SHAPE COULD SUGGEST SYMPTOMATIC RUPTURE OF THE IMPLANT". ESTABLISHMENT LABS REQUESTED 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.).

    Additional Manufacturer Narrative · 0

    A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE HAS BEEN ESTABLISHED. LABORATORY EVALUATION WAS CONDUCTED IN ACCORDANCE WITH INTERNAL PROCEDURES. KEY FINDINGS INCLUDE: VISUAL INSPECTION: MACROSCOPIC EXAMINATION OF THE RETURNED DEVICE REVEALED CLEAR EVIDENCE OF SHELL RUPTURE. MICROSCOPIC ANALYSIS: UNDER MAGNIFICATION, THE SHELL EXHIBITED TRACE MARKS INDICATIVE OF INTERACTION WITH A SHARP INSTRUMENT. THE MORPHOLOGY OF THESE MARKS CLOSELY MATCHED THOSE REPRODUCED UNDER CONTROLLED LABORATORY CONDITIONS SIMULATING INSTRUMENT-RELATED DAMAGE. THESE FINDINGS DIFFER SIGNIFICANTLY FROM PATTERNS ASSOCIATED WITH SPONTANEOUS RUPTURE (E.G., FATIGUE OR SHELL DEGRADATION). SHELL COMPLIANCE TESTING: MECHANICAL AND MATERIAL INTEGRITY TESTING CONFIRMED THAT THE IMPLANT SHELL MET ALL APPLICABLE INTERNATIONAL SPECIFICATION STANDARDS. BASED ON THE TESTING RESULTS, THE MOST PROBABLE ROOT CAUSE OF THE IATROGENIC RUPTURE IS A DAMAGE FROM A SHARP SURGICAL INSTRUMENT. SUCH DAMAGE MAY HAVE COMPROMISED THE SHELL¿S INTEGRITY, PREDISPOSING IT TO FAILURE DURING CLINICAL PROCEDURE. ADDITIONALLY, THE REPORTED GEL FRACTURE WAS NOT CONFIRMED SINCE THE EXPLANT DID NOT SHOW ANY SIGNS OF IT. A COMPREHENSIVE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE AFFECTED LOT WAS COMPLETED. NO DEVIATIONS, NON-CONFORMANCES, OR ANOMALIES WERE IDENTIFIED DURING MANUFACTURING. ALL RAW MATERIALS AND PROCESS PARAMETERS CONFORMED TO SPECIFIED QUALITY REQUIREMENTS. REFERENCE: PHR SECTION OF THE MANUFACTURING DOCUMENTATION. THE EVENT HAS BEEN EVALUATED AS PART OF ONGOING TREND ANALYSIS ACTIVITIES WITHIN THE PMS PROGRAM. PER THE CURRENT COMPLAINT DATA REPORT: -NO ADVERSE OR UNEXPECTED TRENDS RELATED TO THE ALLEGED EVENT HAVE BEEN IDENTIFIED. -NO FURTHER CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED AT THIS TIME. ESTABLISHMENT LABS WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS AS PART OF ROUTINE PMS SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT FELT A LUMP IN HER CHEST, WHICH CAUSED SIGNIFICANT DISCOMFORT. A SUBSEQUENT CT SCAN REVEALED A RUPTURE OF THE RIGHT BREAST IMPLANT AND ALSO A GEL FRACTURE WAS REPORTED TO US. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION. NO PATIENT DEMOGRAPHICS, SUCH AS AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENT HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

    Description of Event or Problem · 0

    KAZAKHSTAN. IT WAS REPORTED THAT A PATIENT FELT A LUMP IN HER CHEST, WHICH CAUSED SIGNIFICANT DISCOMFORT. A SUBSEQUENT CT SCAN REVEALED A RUPTURE OF THE RIGHT BREAST IMPLANT AND ALSO A GEL FRACTURE WAS REPORTED TO US. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION. NO PATIENT DEMOGRAPHICS, SUCH AS AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENT HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION WERE MADE, AND THE INVESTIGATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349686 MOTIVA ERGONOMIX ROUND SILKSURFACE WITH QID MOTIVA ERGONOMIX FTR MOTIVA USA LLC 16080212

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention