BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA IMPLANTS

    MDR report key: 21143201 · Received January 13, 2025

    Report

    Report Number
    3012883202-2025-00296
    Event Type
    Injury
    Date Received
    January 13, 2025
    Date of Event
    June 26, 2023
    Report Date
    January 13, 2025
    Manufacturer
    MOTIVA USA LLC
    Product Code
    FTR
    UDI-DI
    07445161003089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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, ET AL. 2017). ¿SEROMA CAN PRESENT BOTH EARLY AND LATE, WITH THE LATTER BEING RECENTLY LINKED WITH MALIGNANT GROWTHS AND PROLONGED ONSET.¿ (SFORZA, ET AL. 2017). SOME ANALYSES HAVE REVEALED THAT THE POCKET PLAYS A SIGNIFICANT ROLE IN DEVELOPING SEROMA, PATIENTS WITH SUBMAMMARY POCKET DEVELOPED SEROMA IN HIGHER RATES WHEN COMPARED WITH PATIENTS WITH SUBMUSCULAR POCKET. SUBMAMMARY POCKET INCREASES THE ODDS OF DEVELOPING SEROMA BY 7.5 TIMES. (SFORZA, ET AL. 2017). SOME FACTORS ARE SIGNIFICANTLY ASSOCIATED WITH SEROMA DEVELOPMENT: A HIGH BMI, LARGE IMPLANT SIZE, SUBMAMMARY POCKET, AND SMOKING WHICH SIGNIFICANTLY AMPLIFIED THE EFFECTS OF OTHER VARIABLES. (M. SFORZA, ET AL., 2017 UNRAVELING FACTORS INFLUENCING EARLY SEROMA FORMATION IN BREAST AUGMENTATION SURGERY. AESTHETIC SURGERY JOURNAL 2017, VOL 37(3) 301¿307 © 2016 THE AMERICAN SOCIETY FOR AESTHETIC PLASTIC SURGERY, INC. DOI: 10.1093/ASJ/SJW196. LARGER IMPLANT SIZE IS ALSO KNOWN TO BE RELATED TO HIGHER INCIDENCES OF OTHER COMPLICATIONS SUCH AS CAPSULAR CONTRACTURE AND HEMATOMA. (COLLINS JB, VERHEYDEN CN. INCIDENCE OF BREAST HEMATOMA AFTER PLACEMENT OF BREAST PROSTHESES. PLAST RECONSTR SURG.2012;129(3):413E-420E). 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 FOR THE SECTION OF SURGICAL PRECAUTIONS 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 HYPO VASCULAR 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 FLUID8 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. SURGICAL WOUND DEHISCENCE ¿ SURGICAL WOUND DEHISCENCE (SWD) IS THE SEPARATION OF THE MARGINS OF A CLOSED SURGICAL INCISION THAT HAS BEEN MADE IN THE SKIN WITH OR WITHOUT EXPOSURE OR PROTRUSION OF UNDERLYING TISSUE, ORGANS OR IMPLANTS. SEPARATION MAY OCCUR AT SINGLE OR MULTIPLE REGIONS, INVOLVE THE INCISION'S FULL LENGTH, AND AFFECT ONE OR MORE TISSUE LAYERS. A DEHISCED INCISION MAY OR MAY NOT DISPLAY CLINICAL SIGNS AND SYMPTOMS OF INFECTION. 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. WHEN THE INVESTIGATION PROCESS IS COMPLETED, THE APPLICABLE FINDINGS WILL BE INCLUDED IN A SUPPLEMENTAL MEDWATCH.

    Additional Manufacturer Narrative · 0

    A CLINICAL EVALUATION OF THE REPORT WAS CONDUCTED, CONFIRMING EARLY SEROMA AND DEHISCENCE BASED ON THE CLINICAL EVIDENCE PROVIDED. A RELATIONSHIP BETWEEN THE REPORTED EVENTS AND THE DEVICE WAS IDENTIFIED. · A COMPLETE REVIEW OF THE DHR FOR LOT 22051685 WAS CARRIED OUT, NO DEVIATION WAS FOUND IN THE MANUFACTURING PROCESSES. 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. · POTENTIAL FACTORS UNRELATED TO THE MANUFACTURE OF THE DEVICE THAT MAY LEAD TO EARLY SEROMA AND DEHISCENCE INCLUDE, BUT ARE NOT LIMITED TO: SEROMA: PREVIOUS INFECTION, HEMATOMA AND/OR SEROMA. PATIENT'S UNDERLYING CONDITION. SURGICAL TECHNIQUE/ENVIRONMENT. DEHISCENCE: TYPE OF SURGERY OR INCISION. PREVIOUS INFECTION, SEROMA OR NECROSIS. SURGICAL TECHNIQUE. · 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: · 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. · DEHISCENCE: SURGICAL WOUND DEHISCENCE (SWD) IS THE SEPARATION OF THE MARGINS OF A CLOSED SURGICAL INCISION THAT HAS BEEN MADE IN THE SKIN WITH OR WITHOUT EXPOSURE OR PROTRUSION OF UNDERLYING TISSUE, ORGANS OR IMPLANTS. SEPARATION MAY OCCUR AT SINGLE OR MULTIPLE REGIONS, INVOLVE THE INCISION'S FULL LENGTH, AND AFFECT ONE OR MORE TISSUE LAYERS. A DEHISCED INCISION MAY OR MAY NOT DISPLAY CLINICAL SIGNS AND SYMPTOMS OF INFECTION. ¿SOME PATIENTS MAY EXPERIENCE A PROLONGED WOUND HEALING TIME. SMOKING MAY INTERFERE WITH THE HEALING PROCESS. DELAYED WOUND HEALING MAY INCREASE THE RISK OF INFECTION, EXTRUSION, AND NECROSIS. WOUND HEALING TIMES MAY VARY DEPENDING ON THE TYPE OF SURGERY OR INCISION. · 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 EXHIBITED REDNESS, SWELLING, WOUND DEHISCENCE, AND SEROUS FLUID DISCHARGE FROM THE SURGICAL SITE OF THE LEFT BREAST. A CULTURE OF THE AFFECTED SITE WAS CONDUCTED, WITH RESULTS CONFIRMING NO MICROBIAL GROWTH. CONSEQUENTLY, THE IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425982 MOTIVA IMPLANTS SILKSURFACE PLUS WITH QID FTR MOTIVA USA LLC 22051685 07445161003089

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Unknown Required Intervention