BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA FLORA TISSUE EXPANDER

    MDR report key: 18704662 · Received February 14, 2024

    Report

    Report Number
    3012883202-2024-03953
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    January 18, 2024
    Report Date
    April 10, 2024
    Manufacturer
    MOTIVA USA LLC
    Product Code
    LCJ
    PMA / PMN Number
    K211676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER ANALYZING THE REPORT AND THE EVIDENCE PROVIDED AT THE TIME OF THIS INVESTIGATION WE COULD NOT CONFIRM THE ALLEGED INFECTION DUE TO INSUFFICIENT CLINICAL EVIDENCE PROVIDED. AN INTERNAL INVESTIGATION WAS CONDUCTED AND THERE WERE NO INDICATIONS OF ABNORMALITIES IN RAW MATERIALS OR MANUFACTURING PROCESSES WHICH MAY HAVE AFFECTED THIS PARTICULAR BATCH. SHELL MANUFACTURING: NO DEVIATION OR ABNORMALITY DETECTED. GEL MIXING: NO DEVIATION OR ABNORMALITY DETECTED. PRIMARY PACKAGING: NO DEVIATION OR ABNORMALITY DETECTED. STERILIZATION: NO DEVIATION OR ABNORMALITY DETECTED. SECOND STERILIZATION ROUND: NO DEVIATION OR ABNORMALITY DETECTED. SECONDARY PACKAGING: NO DEVIATION OR ABNORMALITY DETECTED. LABELING: NO DEVIATION OR ABNORMALITY DETECTED. 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. 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: "INFECTION CAN OCCUR WITH ANY SURGERY OR IMPLANT. MOST INFECTIONS RESULTING FROM SURGERY APPEAR WITHIN A FEW DAYS TO WEEKS AFTER THE OPERATION. HOWEVER, INFECTION IS POSSIBLE AT ANY TIME AFTER SURGERY. IN ADDITION, BREAST AND NIPPLE PIERCING PROCEDURES MAY INCREASE THE POSSIBILITY OF INFECTION. INFECTIONS IN TISSUE WITH AN IMPLANT PRESENT ARE HARDER TO TREAT THAN INFECTIONS IN TISSUE WITHOUT AN IMPLANT. IF AN INFECTION DOES NOT RESPOND TO ANTIBIOTICS, THE IMPLANT MAY HAVE TO BE REMOVED, AND ANOTHER IMPLANT MAY BE PLACED AFTER THE INFECTION IS RESOLVED". "LACK OF ADEQUATE TISSUE COVERAGE, LOCAL TRAUMA OR INFECTION MAY RESULT IN EXPOSURE AND EXTRUSION OF THE IMPLANT. THIS HAS BEEN REPORTED WITH THE USE OF STEROID DRUGS OR AFTER RADIATION THERAPY OF BREAST TISSUE. IF TISSUE BREAKDOWN OCCURS AND THE IMPLANT BECOMES EXPOSED, IMPLANT REMOVAL MAY BE NECESSARY, WHICH MAY RESULT IN ADDITIONAL SCARRING AND/OR LOSS OF BREAST TISSUE". GENERAL CONCLUSION: THE EVENT REPORTED AS INFECTION WAS NOT CONFIRMED. ADDITIONALLY, THE ORIGIN OF INFECTION IN WOMEN WITH IMPLANTS REMAINS DIFFICULT TO DETERMINE, BUT POTENTIAL SOURCES INCLUDE A CONTAMINATED IMPLANT, THE SURGERY ITSELF OR THE SURGICAL ENVIRONMENT, THE PATIENT'S SKIN OR MAMMARY DUCTS, OR, AS SUGGESTED BY MANY REPORTS, SEEDING OF THE IMPLANT FROM REMOTE INFECTION SITES. "SURGICAL TECHNIQUE AND THE PATIENT'S UNDERLYING CONDITION ARE THE MOST IMPORTANT RISK FACTORS FOR INFECTION ASSOCIATED WITH BREAST IMPLANTS". (PITTET ET AL, 2005) AT ESTABLISHMENT LABS, WE ARE COMMITTED TO PATIENT SAFETY AND CONTINUALLY EVALUATE THE PERFORMANCE OF OUR DEVICES THROUGH POST-MARKET SURVEILLANCE OF REPORTED COMPLAINTS & ADVERSE EVENTS.

    Additional Manufacturer Narrative · 0

    ESTABLISHMENT LABS HAS NOT RECEIVED YET THE PROPER CLINICAL INFORMATION TO FURTHER ASSESS THE ALLEGED INCIDENT. ADDITIONAL ATTEMPTS TO GET MORE INFORMATION ABOUT THE EVENT WILL BE REQUIRED. IN THE MEANTIME, THE FOLLOWING INFORMATION HAS BEEN REVIEWED: DFU REVISION: 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: INFECTION: RISK OF A PERIPROSTHETIC INFECTION MAY BE INCREASED AS RESULT OF AN ACTIVE INFECTION. DO NOT EXPOSE THE TISSUE EXPANDER OR INJECTION NEEDLES TO CONTAMINANTS, WHICH INCREASE THE RISK OF INFECTION. PATIENTS WHO PRESENT WOUND DEHISCENCE, TISSUE EROSION, ISCHEMIA OR NECROSIS HAVE AN INCREASED RISK OF PERIPROSTHETIC INFECTION. DURING SURGERY, PROTECTIVE MEASURES MUST BE TAKEN TO AVOID POSSIBLE INFECTION OF THE AREA. INFECTIONS CAN COMPROMISE THE EXPANSION PROCESS, THEREFORE, ANY SYMPTOMS THAT OCCUR, SUCH AS TENDERNESS, FL UID ACCUMULATION, PAIN OR FEVER, MUST BE REPORTED TO THE SURGEON AS SOON AS POSSIBLE TO BE AGGRESSIVELY TREATED AND THUS AVOID SERIOUS COMPLICATIONS. PREMATURE TISSUE EXPANDER REMOVAL MAY BE REQUIRED IF THE INFECTION DOES NOT RESPOND TO TREATMENT, OR IN THE CASE OF A NECROTIZING INFECTION. 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. SHELL MANUFACTURING: NO DEVIATION OR ABNORMALITY DETECTED. GEL MIXING: NO DEVIATION OR ABNORMALITY DETECTED. PRIMARY PACKAGING: NO DEVIATION OR ABNORMALITY DETECTED. STERILIZATION: NO DEVIATION OR ABNORMALITY DETECTED. SECOND STERILIZATION ROUND: NO DEVIATION OR ABNORMALITY DETECTED. SECONDARY PACKAGING: NO DEVIATION OR ABNORMALITY DETECTED. LABELING: NO DEVIATION OR ABNORMALITY DETECTED.

    Description of Event or Problem · 0

    ALLEGEDLY, THE PATIENT PRESENTED AN "INFECTION AND DEEP INFLAMMATION OF THE LEFT BREAST REASON FOR RECOVERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390018 MOTIVA FLORA TISSUE EXPANDER MOTIVA FLORA TISSUE EXPANDER LCJ MOTIVA USA LLC 23081073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other