BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA IMPLANTS

    MDR report key: 21681112 · Received March 24, 2025

    Report

    Report Number
    3012883202-2025-00521
    Event Type
    Injury
    Date Received
    March 24, 2025
    Date of Event
    February 18, 2025
    Report Date
    August 4, 2025
    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". CONCLUSION: ADDITIONALLY, REGARDING TO THE CONDITION REPORTED, ESTABLISHMENT LABS REQUESTED CLINICAL INFORMATION LIKE THE PATIENT'S CLINICAL HISTORY, LAB CULTURES, IMAGING REPORTS AND PHOTOGRAPHS WHERE THE CONDITION REPORTED CAN BE CONFIRMED. ONCE THIS INFORMATION IS PROVIDED, A COMPLETE REVISION WILL BE PERFORMED IN ORDER TO CONFIRM THE CONDITION AND DEFINE FURTHER ACTIONS.

    Additional Manufacturer Narrative · 0

    GENERAL CONCLUSION: -EVENT ANALYSIS: SEROMA. AFTER AN ANALYSIS OF THE REPORT, IT WAS NOT POSSIBLE TO CONFIRM THE ALLEGED EVENT DUE TO INSUFFICIENT CLINICAL EVIDENCE. THE ALLEGED EVENT IS A RISK ASSOCIATED WITH BREAST SURGERY AND THERE IS NO EVIDENCE TO SUGGEST A LINK BETWEEN THIS PARTICULAR IMPLANT AND/OR ITS MANUFACTURING PROCESS AND A HIGHER RISK OF OCCURRENCE. THE CAUSE OF THIS EVENT IS MULTIFACTORIAL, AND WE CANNOT CONCLUDE THAT THE REPORTED EVENT WAS CAUSED BY THE MANUFACTURING PROCESS AND/OR THE PRODUCT ITSELF. DHR REVIEW: A COMPLETE REVIEW OF THE DHR FOR LOT INVOLVED WAS CARRIED OUT, NO DEVIATION WAS FOUND IN THE MANUFACTURING PROCESS. ADDITIONALLY, THERE WERE NO INDICATIONS OF ABNORMALITIES IN RAW MATERIALS OR MANUFACTURING PROCESSES WHICH MAY HAVE AFFECTED THIS PARTICULAR BATCH. ESTABLISHMENT LABS WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS/TRENDS. AS PART OF THE POST MARKET SURVEILLANCE PROCESS, MONITORING OF THE PRIMARY ENDPOINTS REPORTED IS PERFORMED TO DETERMINE UNFAVORABLE TRENDS. PER OUR CURRENT COMPLAINT DATA REPORT, NO UNFAVORABLE TRENDS WERE DETECTED ON THIS PRODUCT. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    FRANCE. IT WAS REPORTED THAT, AFTER IMPLANTATION IN (B)(6) 2025, THE PATIENT HAD A RECURRENCE OF INFLAMMATORY SEROMA WITH PERIPROSTHETIC EFFUSION ON THE RIGHT SIDE. A REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583812 MOTIVA IMPLANTS ERGONOMIX ROUND SILKSURFACE FTR ESTABLISHMENT LABS S.A. ERSM 290 24051732

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention