BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA IMPLANTS

    MDR report key: 20921437 · Received December 12, 2024

    Report

    Report Number
    3012883202-2024-00212
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    September 5, 2024
    Report Date
    December 12, 2024
    Manufacturer
    MOTIVA USA LLC
    Product Code
    FTR
    UDI-DI
    07445161002921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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). IT HAS BEEN IDENTIFIED SEVERAL SIGNIFICANT RISK FACTORS FOR CAPSULAR CONTRACTURE, INCLUDING DEVICE FEATURES (SURFACE, SIZE), SURGICAL FACTORS (PERIAREOLAR INCISION, SUBGLANDULAR PLACEMENT, ANTIBIOTIC IRRIGATION), THE DEVELOPMENT OF HEMATOMA/SEROMA, AND THE USE OF A SURGICAL BRA. (CALOBRACE, 2018). PERIPROSTHETIC CAPSULES BECOME PATHOLOGICALLY ACTIVE AND UNDERGO A ¿CONSTRICTIVE FIBROSIS¿ DUE TO RETRACTION OF THE FIBROUS TISSUE, WHICH DEFORMS THEIR CONTENTS AND IMPAIRS THE AESTHETIC OUTCOME, MANIFESTED BY HARDENING OF VARIABLE DEGREE AND, IN ADVANCED CASES, BY DEFORMITY OF THE BREAST. (BAKER ET AL., 1990). 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¿. IN ADDITION, A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED, AND IT WAS CONCLUDED THAT THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS OF THIS DEVICE THAT WOULD HAVE CAUSED OR CONTIBUTED TO THIS INCIDENT. WHEN THE INVESTIGATION PROCESS IS COMPLETED THE APPLICABLE FINDINGS WILL BE INCLUDED IN A SUPPLEMENTAL MEDWATCH. AT ESTABLISHMENT LABS, WE ARE COMMITTED TO PATIENT SAFETY AND CONTINUALLY EVALUATE THE PERFORMANCE OF OUR DEVICES THROUGH POST-MARKET SURVEILLANCE OF REPORTED COMPLAINTS & ADVERSE EVENTS.

    Additional Manufacturer Narrative · 0

    A CLINICAL EVALUATION OF THE REPORT AND EVIDENCE PROVIDED WAS EXECUTED AND A CAPSULAR CONTRACTURE BAKER GRADE IV WAS CONFIRMED. A COMPLETE REVIEW OF THE DHR FOR LOT 23100061 WAS CARRIED OUT, NO DEVIATION WAS FOUND IN THE MANUFACTURING PROCESS. ADDITIONALLY, THE 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: "A CAPSULAR CONTRACTURE PERTAINS TO HYPERTROPHIC SCAR TISSUE INVESTING IN A FOREIGN BODY OR SURGICALLY IMPLANTED DEVICE, COMPROMISING THE AESTHETIC OUTCOME, RESULTING IN PAIN, BREAST DEFORMITY, AND OFTEN NECESSITATING FURTHER OPERATIONS4 . DETECTION OF BREAST CANCER BY MAMMOGRAPHY MAY ALSO BE CHALLENGING. 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 THE MOST COMMON COMPLICATION FOLLOWING IMPLANT- BASED BREAST SURGERY AND IS ONE OF THE MOST COMMON REASONS FOR REOPERATION" 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. ESTABLISHMENT LABS WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS/TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV, ACCOMPANIED BY PERSISTENT DAILY PAIN. RIGHT SIDE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2417401 MOTIVA IMPLANTS ROUND SILKSURFACE PLUS WITH QID FTR MOTIVA USA LLC 23100061 07445161002921

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female Required Intervention