BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA IMPLANTS

    MDR report key: 21922071 · Received April 28, 2025

    Report

    Report Number
    3012883202-2025-00616
    Event Type
    Injury
    Date Received
    April 28, 2025
    Date of Event
    May 31, 2024
    Report Date
    April 28, 2025
    Manufacturer
    ESTABLISHMENT LABS S.A.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CLINICAL EVALUATION OF THE REPORT AND EVIDENCE PROVIDED WAS EXECUTED AND A CAPSULAR CONTRACTURE BAKER GRADE III/IV WAS CONFIRMED. THERE WAS A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE. · A COMPLETE REVIEW OF THE DHR FOR LOT 17010397 WAS CARRIED OUT, NO DEVIATION WAS FOUND IN THE MANUFACTURING PROCESSES. REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER AND STERILIZATION RUN FOUND NO OTHER SIMILAR COMPLAINTS REPORTED IN THE PAST. · A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. · POTENTIAL FACTORS RELATED TO THE 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. · 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 - NORMALLY, CAPSULES OF COLLAGEN FIBERS FORM AS AN IMMUNE RESPONSE AROUND A FOREIGN BODY, SUCH AS A BREAST IMPLANT, TENDING TO ISOLATE IT. 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 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 OCCURS MORE COMMONLY IN PATIENTS UNDERGOING REVISION SURGERY THAN IN PATIENTS UNDERGOING PRIMARY IMPLANTATION SURGERY. CAPSULAR CONTRACTURE IS A RISK FACTOR FOR IMPLANT RUPTURE, AND IT IS THE MOST COMMON REASON FOR REOPERATION IN AUGMENTATION AND RECONSTRUCTION PATIENTS. CAPSULAR CONTRACTURE IS GRADED INTO 4 LEVELS DEPENDING ON ITS SEVERITY. BAKER GRADE I: THE BREAST IS NORMALLY SOFT AND LOOKS NATURAL; BAKER GRADE II: THE BREAST IS A LITTLE FIRM BUT LOOKS NORMAL; BAKER GRADE III: THE BREAST IS FIRM AND LOOKS ABNORMAL; BAKER GRADE IV: THE BREAST IS HARD, PAINFUL, AND LOOKS ABNORMAL. 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. CLOSED CAPSULOTOMY (EXTERNAL MANIPULATION OF THE CAPSULE IN ORDER TO ¿POP¿ THE TISSUE CAPSULE AND OPEN IT UP) USED TO BE A COMMON PROCEDURE FOR TREATING CAPSULAR CONTRACTURE, BUT MOST MANUFACTURERS, INCLUDING ESTABLISHMENT LABS, CONTRAINDICATE IT BECAUSE IT CAN CAUSE IMPLANT RUPTURE. · 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.

    Description of Event or Problem · 0

    KOREA- IT WAS REPORTED THAT A PATIENT PRESENTS BREAST FIRMNESS SIX YEARS AGO HER FIRST BREAST AUGMENTATION SURGERY. IMPLANT REPLACEMENT WAS PERFORMED WITH BILATERAL CAPSULECTOMY ON (B)(6) 2024. LEFT SIDE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222098 MOTIVA IMPLANTS ERGONOMIX ROUND SILKSURFACE WITH QID FTR ESTABLISHMENT LABS S.A. ERSF 275Q 17010397

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention