BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA IMPLANTS

    MDR report key: 21019185 · Received December 26, 2024

    Report

    Report Number
    3012883202-2024-00242
    Event Type
    Injury
    Date Received
    December 26, 2024
    Report Date
    January 26, 2026
    Manufacturer
    MOTIVA USA LLC
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. COMPLAINT REASON: NERVOUS SYSTEM AFFECTIONS.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINT EVIDENCE, THERE WAS A RELATIONSHIP BETWEEN THE REPORTED (DEVICE RUPTURE) EVENT AND THE DEVICE INVOLVED. AFTER ANALYZING THE UNIT RECEIVED AND TEST PERFORMED, A DEVICE RUPTURE WAS CONFIRMED. ADDITIONAL SYMPTOMS CAN BE RELATED TO THE RUPTURE CONFIRMED, NEVERTHELESS IT WAS NO POSSIBLE TO BE CONFIRMED DUE TO NO CLINICAL EVIDENCE WAS RECEIVED. DHR REVIEW: A COMPLETE REVIEW OF THE DHR FOR LOT 24050192 WAS CARRIED OUT, NO DEVIATION WAS FOUND IN THE MANUFACTURING PROCESS. 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. NEUROLOGICAL SIGNS AND SYMPTOMS ¿ SOME WOMEN WITH BREAST IMPLANTS HAVE EXPERIENCED NEUROLOGICAL DISTURBANCES (E.G., VISUAL SYMPTOMS OR ALTERATIONS IN SENSATION, MUSCLE STRENGTH, WALKING, BALANCE, THINKING OR MEMORY) OR DISEASES (E.G., MULTIPLE SCLEROSIS), AND THEY BELIEVE THOSE SYMPTOMS ARE RELATED TO THEIR IMPLANTS. HOWEVER, THERE IS NO EVIDENCE IN THE PUBLISHED LITERATURE OF A CAUSAL RELATIONSHIP BETWEEN BREAST IMPLANTS AND NEUROLOGICAL DISEASE. IN CONCLUSION, IT WAS DETERMINED THAT A PROBABLE CAUSE FOR THE RUPTURE REPORTED WAS A CUT RESULTING FROM A SHARP INSTRUMENT USED WHICH COULD HAVE WEAKENED THE SHELL. ESTABLISHMENT LABS WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS/TRENDS.

    Description of Event or Problem · 0

    ALLEGEDLY, "DURING THE SURGERY, THERE WERE NO INCIDENTS AND (B)(6) CONFIRMED THAT EVERYTHING HAD BEEN PERFORMED CORRECTLY ACCORDING TO THE COMPANY'S RECOMMENDATIONS. THEN THE PATIENT REPORTED HYPOESTHESIA IN THE ARM AND WEAKNESS IN IT. AFTER 8 HOURS THE PATIENT WAS REEVALUATED, WITHOUT EVIDENCE OF HEMATOMA OR SYMPTOMS OF LOCAL COMPRESSION IN THE AXILLA. COMPLETE MOTOR PARALYSIS OF THE RADIAL NERVE WAS EVIDENCED: THE IMPOSSIBILITY OF DORSAL FLEXION OF THE WRIST, THE IMPOSSIBILITY OF EXTENSION OF THE FINGERS, IN ADDITION TO COMPLETE PARALYSIS OF THE TRICEPS."

    Description of Event or Problem · 0

    ON ADDITIONAL COMMUNICATIONS WITH THE COMPLAINT SUBMITTER, IT WAS INDICATED THAT THE DEVICE WAS FOUND RUPTURE DURING THE IMPLANTATION SURGERY. REGARDING THE NEUROLOGICAL SYMPTOMS THERE WAS NO INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1890304 MOTIVA IMPLANTS MOTIVA SMOOTHSILK FTR MOTIVA USA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other