BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA ERGONOMIX2 SMOOTHSILK WITH QID

    MDR report key: 20945182 · Received December 16, 2024

    Report

    Report Number
    3012883202-2024-00221
    Event Type
    Injury
    Date Received
    December 16, 2024
    Date of Event
    April 25, 2024
    Report Date
    December 16, 2024
    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

    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¿ . 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 CONTRIBUTED TO THIS INCIDENT.

    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. A COMPLETE REVIEW OF THE DHR FOR LOT 23092753 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. ¿ 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

    A PATIENT REPORTED EXPERIENCING DEFORMATION AND PAIN IN HER RIGHT BREAST. PHYSICAL EXAMINATION AN ULTRASOUND REPORT REVEALED CAPSULAR CONTRACTURE BAKER GRADE III. THE PATIENT WAS ADVISED TO UNDERGO BREAST IMPLANT REMOVAL SURGERY. NO PATIENT DEMOGRAPHICS, 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.

    Description of Event or Problem · 0

    THAILAND. A PATIENT REPORTED EXPERIENCING DEFORMATION AND PAIN IN HER RIGHT BREAST. PHYSICAL EXAMINATION AN ULTRASOUND REPORT REVEALED CAPSULAR CONTRACTURE BAKER GRADE III. THE PATIENT WAS ADVISED TO UNDERGO BREAST IMPLANT REMOVAL SURGERY. NO PATIENT DEMOGRAPHICS, 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
    2327229 MOTIVA ERGONOMIX2 SMOOTHSILK WITH QID MOTIVA IMPLANTS FTR MOTIVA USA LLC 23092753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention