BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA IMPLANTS

    MDR report key: 21982155 · Received May 7, 2025

    Report

    Report Number
    3012883202-2025-00608
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    August 10, 2024
    Report Date
    May 7, 2025
    Manufacturer
    ESTABLISHMENT LABS S.A.
    Product Code
    FTR
    UDI-DI
    07445161010582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MOST COMMON OVERALL INDICATION FOR REOPERATION IS CAPSULAR CONTRACTURE (HANDEL, 2006). BREAST PROSTHESES ARE NO DIFFERENT FROM ANY FOREIGN MATERIAL IMPLANTED INTO THE HUMAN BODY IN THE SENSE OF TRIGGERING A PROTECTIVE IMMUNE REACTION FROM THE HOST. THIS ¿FOREIGN BODY RESPONSE¿ (FBR) IS UNIVERSAL AND IDEALLY REMOVES OR OTHERWISE SURROUNDS THE ¿IRRITANT MATERIAL¿ WITH FIBROUS TISSUE TO PREVENT UNWANTED IMMUNE SEQUELAE. A CAPSULE AROUND A BREAST IMPLANT IS, THEREFORE, A NECESSARY MECHANISM OF BODY DEFENSE, BUT IF EXCESSIVE IT CAN LEAD TO PAIN AND DEFORMITY OF THE BREAST (STEIERT, ET AL., 2013). 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: ¿CAPSULAR CONTRACTURE OCCURS WHEN THE CAPSULE TIGHTENS AND SQUEEZES THE IMPLANT. THIS CAN CAUSE THE IMPLANT TO TURN RIGID (FROM SLIGHTLY FIRM TO QUITE HARD) AND THE FIRMEST ONES CAN CAUSE VARYING DEGREES OF DISCOMFORT, PAIN, AND PALPABILITY. IN ADDITION TO THE FIRMNESS, CAPSULAR CONTRACTURE CAN RESULT IN A DEFORMED BREAST, VISIBLE SURFACE WRINKLING AND/OR DISPLACEMENT OF THE IMPLANT. DETECTION OF BREAST CANCER BY MAMMOGRAPHY MAY ALSO BE A MORE DIFFICULT. CAPSULAR CONTRACTURE MAY BE MORE COMMON FOLLOWING INFECTION, HEMATOMA, AND SEROMA, AND THE CHANCE OF IT HAPPENING MAY INCREASE OVER TIME. CAPSULAR CONTRACTURE IS A RISK FACTOR FOR IMPLANT RUPTURE, AND IT IS THE MOST COMMON REASON FOR REOPERATION IN AUGMENTATION AND RECONSTRUCTION PATIENTS. PATIENTS SHOULD ALSO BE ADVISED THAT ADDITIONAL SURGERY MIGHT BE NEEDED IN CASES WHERE PAIN AND/OR FIRMNESS ARE SEVERE (BAKER GRADES III OR IV) AND THAT CAPSULAR CONTRACTURE MAY HAPPEN AGAIN AFTER ADDITIONAL SURGERIES. "CORRECTION OF CAPSULAR CONTRACTURE MAY REQUIRE SURGICAL REMOVAL OR RELEASE OF THE CAPSULE, OR REMOVAL AND POSSIBLE REPLACEMENT OF THE IMPLANT ITSELF¿. GENERAL CONCLUSION: ¿ THE ALLEGED UNILATERAL CAPSULAR CONTRACTURE BAKER GRADE III WAS CONFIRMED ACCORDING TO THE CLINICAL EVIDENCE PROVIDED. THE AETIOLOGY OF CAPSULAR CONTRACTURE IS MULTIFACTORIAL AND CONSISTING OF PATIENT, TYPE OF SURGERY, PROSTHETIC MATERIAL USED, THE IMPLANT POCKET PLACEMENT, THE INCISION TYPE AND THE DURATION OF FOLLOW-UPS (LIU ET AL., 2015) (HEADON, KASEM & MOKBEL, 2015). ¿ CAPSULAR CONTRACTURE IS A RISK ASSOCIATED WITH BREAST SURGERY (HANDEL, 2006) AND THERE IS NO EVIDENCE TO SUGGEST A LINK BETWEEN THIS PARTICULAR IMPLANT AND/OR ITS MANUFACTURING PROCESS AND A HIGHER RISK OF CAPSULAR CONTRACTURE OCCURRENCE. ¿ POTENTIAL FACTORS UNRELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE THAT MAY LEAD TO CAPSULAR CONTRACTURE, INCLUDE BUT ARE NOT LIMITED TO: (1) PATIENT UNDERGOING REVISION SURGERY. (2) PREVIOUS INFECTION, HEMATOMA AND/OR SEROMA. (3) PATIENT HAS PREVIOUS HISTORY OF CAPSULAR CONTRACTURE. (4) SURGICAL FACTORS. ¿ AS NO MANUFACTURING, MATERIAL OR DESIGN ISSUES WERE IDENTIFIED, NO FURTHER INVESTIGATION OR ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME. ¿ THE DEVICE RETURNED FOR EVALUATION PRESENTED NO DAMAGE. ¿ ESTABLISHMENT LABS WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS/TRENDS.

    Description of Event or Problem · 0

    SOUTH KOREA. IT WAS REPORTED THAT A PATIENT WHO HAD SURGERY IN (B)(6) 2023 CONSULTED WITH HER SURGEON EIGHT MONTHS AFTER SURGERY DUE TO LEFT BREAST FIRMNESS. SHE WAS DIAGNOSED WITH A CAPSULAR CONTRACTURE BAKER GRADE III AND REQUIRED A REVISION SURGERY. THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794962 MOTIVA IMPLANTS MOTIVA ERGONOMIX ROUND SILKSURFACE FTR ESTABLISHMENT LABS S.A. 22101380 07445161010582

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention