BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA IMPLANTS

    MDR report key: 20920979 · Received December 12, 2024

    Report

    Report Number
    3012883202-2024-00215
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    September 30, 2024
    Report Date
    December 12, 2024
    Manufacturer
    ESTABLISHMENT LABS S.A
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL ASSESSMENT: SEROMA: SEROMA IS RECOGNIZED AS AN EARLY COMPLICATION OF BREAST IMPLANT SURGERY AND ITS INCIDENCE IS REPORTED TOGETHER WITH HEMATOMAS IN 6.6% FOR PRIMARY SURGERY. FOR OTHER AUTHORS THE INCIDENCE OF EARLY-STAGE SEROMA IS 0.1%. EARLY SEROMA FORMATION IS DEFINED AS PERIPROSTHETIC FLUID ACCUMULATION WITHIN THE FIRST POSTOPERATIVE YEAR, WHEREAS THE LATE FORM IS ANY MOMENT BEYOND THAT TIME.¿ SFORZA, M., HUSEIN, R., ATKINSON, C., & ZACCHEDDU, R. (2017). UNRAVELING FACTORS INFLUENCING EARLY SEROMA FORMATION IN BREAST AUGMENTATION SURGERY. AESTHETIC SURGERY JOURNAL, 37(3), 301¿307. HTTPS://DOI.ORG/10.1093/ASJ/SJW196. 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: HTTP://MOTIVAIMPLANTS.COM/INFORMATION-FOR-THE-PATIENT/ MCARDLE B, LAYT C. A CASE OF LATE UNILATERAL HEMATOMA AND SUBSEQUENT LATE SEROMA OF BREAST AFTER BILATERAL BREAST AUGMENTATION. AESTH PLAST SURG 2009; 33: 669-670. SCOTT L. BREAST AUGMENTATION. CLIN PLAST SURG 2009; 36(1): 105-115. OLIVEIRA VM, ROVEDA D JR, LUCAS FB ET AL. LATE SEROMA AFTER BREAST AUGMENTATION WITH SILICONE PROSTHESES: A CASE REPORT. BREAST J 2007; 13(4): 421-423. DFU REVISION: 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 SEROMA IS A BUILD-UP OF FLUID AROUND THE IMPLANT. HAVING A HEMATOMA AND/ OR SEROMA FOLLOWING SURGERY MAY RESULT IN INFECTION AND/OR CAPSULAR CONTRACTURE LATER ON. SYMPTOMS FROM SEROMA MAY INCLUDE SWELLING, PAIN, AND BRUISING. IF A SEROMA OCCURS, IT WILL USUALLY BE SOON AFTER SURGERY. HOWEVER, THEY CAN ALSO OCCUR AT ANY TIME AFTER INJURY TO THE BREAST. WHILE THE BODY ABSORBS SMALL SEROMAS, SOME WILL REQUIRE SURGERY, TYPICALLY INVOLVING DRAINING, AND POTENTIALLY PLACING A SURGICAL DRAIN IN THE WOUND TEMPORARILY FOR PROPER HEALING. A SMALL SCAR CAN RESULT FROM SURGICAL DRAINING. IMPLANT RUPTURE ALSO CAN OCCUR FROM SURGICAL DRAINING IF THERE IS DAMAGE TO THE IMPLANT DURING THE PROCEDURE". CASE REPORTED WITH MFR REPORT # 3012883202-2024-00067.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A CLINICAL EVALUATION OF THE REPORT AND EVIDENCE PROVIDED WAS PERFORMED AND SEROMA IS NOT CONFIRMED DUE TO LACK OF EVIDENCE. THE REPORTED DEVICE WAS RETURNED FOR EVALUATION, AND THERE WAS NO RELATIONSHIP BETWEEN THE REPORTED EVENTS AND THE DEVICE. A FULL REVIEW OF THE DHR FOR THE LOT 23070695 WAS CONDUCTED AND NO DEVIATION IN THE MANUFACTURING PROCESSES WAS FOUND. REVIEW OF THE CLAIMS HISTORY FOR THE REPORTED LOT NUMBER AND STERILIZATION SERIES FOUND NO OTHER SIMILAR CLAIMS 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 THE SEROMA INCLUDE, BUT ARE NOT LIMITED TO: SEROMA: PREVIOUS INFECTION, HEMATOMA AND/OR SEROMA. PATIENT'S UNDERLYING CONDITION. SURGICAL TECHNIQUE/ENVIRONMENT. THE INSTRUCTIONS FOR USE IN THE INSTRUCTIONS FOR USE WERE REVIEWED TO DETERMINE IF THERE ARE INDICATIONS TO ENSURE PREVENTION AND PROPER HANDLING OF THE PRODUCT. FOR THIS EVENT, IT IS CONSIDERED THAT THE INFORMATION IS ADEQUATE FOR THE SURGICAL PRECAUTIONS SECTION AS FOLLOWS: SEROMA ¿ SEROMA IS AN ACCUMULATION OF FLUID THAT RESULTS FROM TISSUE INFLAMMATION. THE ETIOLOGY OF SEROMA IS KNOWN IN BREAST SURGERY AND IS CONNECTED TO A HYPOVASCULAR MILIEU OR TRAUMA FOLLOWING THE SURGERY. OFTEN, SEROMAS ARE REABSORBED BY THE BODY OVER SEVERAL WEEKS, BUT NEEDLE DRAINAGE IS SOMETIMES NEEDED TO REMOVE THE FLUID. WHILE SEROMAS DO NOT INCREASE BREAST CANCER RISK, THEY SOMETIMES HEAL WITH SCAR TISSUE OR CALCIFICATIONS THAT CAN RAISE A CONCERN ABOUT MAMMOGRAMS IN THE FUTURE. SEROMA SYMPTOMS MOST OFTEN APPEAR A WEEK TO 10 DAYS AFTER SURGERY; THE AREA MAY FEEL TENDER AND SWOLLEN, WITH A DISCRETE LUMP AND REDNESS ARISING WITHIN A DAY OR TWO. EARLY SEROMA FORMATION IS DEFINED AS PERIPROSTHETIC FLUID ACCUMULATION WITHIN THE FIRST POSTOPERATIVE YEAR, WHEREAS THE LATE FORM IS ANY MOMENT BEYOND THAT TIME. IN ADDITION TO CAUSING PAIN, A SEROMA INCREASES THE RISK OF DEVELOPING AN INFECTION IN THE BREAST. DEPENDING ON THE LOCATION, IT MAY ALSO INCREASE PRESSURE OVER THE SURGICAL SITE AND SOMETIMES CAUSE WOUND DEHISCENCE. 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

    EARLY SEROMA REQUIRED REMOVAL OF THE PROSTHESES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856987 MOTIVA IMPLANTS ERGONOMIX ROUND SILKSURFACE PLUS WITH QID FTR ESTABLISHMENT LABS S.A ERSM 260Q 23070695

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention