BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA SILKSURFACE PLUS WITH QID

    MDR report key: 20832872 · Received December 3, 2024

    Report

    Report Number
    3012883202-2024-00173
    Event Type
    Injury
    Date Received
    December 3, 2024
    Date of Event
    September 30, 2024
    Report Date
    December 3, 2024
    Manufacturer
    MOTIVA USA LLC
    Product Code
    FTR
    UDI-DI
    07445161003041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CLINICAL EVALUATION OF THE REPORT WAS EXECUTED AND IT WAS NOT POSSIBLE TO CONFIRM THE REPORTED CAPSULAR CONTRACTURE BAKER GRADE III DUE TO INSUFFICIENT CLINICAL EVIDENCE. THERE WAS NOT A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE. A COMPLETE REVIEW OF THE DHR FOR LOT 23063237 WAS CARRIED OUT, NO DEVIATION WAS FOUND IN THE MANUFACTURING PROCESSES. THE 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. 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.

    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 DETERMINE 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 ON 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." ALSO, A COMPLETE REVIEW OF THE DHR WAS CARRIED OUT, NO DEVIATION WAS FOUND IN THE PROCESS, SO IT IS ESTABLISHED THAT THERE IS NO EVIDENCE OF A RELATIONSHIP BETWEEN THE EVENT AND THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    PATIENT UNDERGOING POST-OPERATIVE MASTOPEXY WITH PROSTHESIS ON (B)(6) 2024 EVOLVED WITH PAIN AND CHANGE IN SHAPE OF RIGHT BREAST, ON CLINICAL EXAMINATION COMPATIBLE WITH GRADE 3 CAPSULAR CONTRACTURE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209969 MOTIVA SILKSURFACE PLUS WITH QID MOTIVA IMPLANTS FTR MOTIVA USA LLC 23063237 07445161003041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other