BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA IMPLANTS

    MDR report key: 25051630 · Received April 30, 2026

    Report

    Report Number
    3012883202-2026-02278
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    March 9, 2025
    Report Date
    April 30, 2026
    Manufacturer
    ESTABLISHMENT LABS S.A.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DFU AND LABELING EVALUATION. THE EVENT IS A KNOWN, WELL-DOCUMENTED COMPLICATION ASSOCIATED WITH SILICONE BREAST IMPLANTS. IT IS CLEARLY ADDRESSED IN THE PRODUCT¿S DIRECTIONS FOR USE (DFU), WHICH STATES: ¿BREAST IMPLANTS CAN RUPTURE WHEN THE SHELL DEVELOPS A TEAR OR HOLE. RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR OVER TIME. SILENT RUPTURE IS COMMON AND OFTEN ASYMPTOMATIC; THEREFORE, PATIENTS SHOULD UNDERGO REGULAR MRI SCREENINGS STARTING AT 3 YEARS POST-OP, THEN EVERY 2 YEARS.¿ CANCER ¿ BREAST-CANCER REPORTS IN MEDICAL LITERATURE REVEAL THAT PATIENTS WITH BREAST IMPLANTS ARE NOT AT A GREATER RISK OF DEVELOPING BREAST CANCER THAN THOSE WITHOUT BREAST IMPLANTS. REPORTS IN MEDICAL LITERATURE INDICATE THAT BREAST IMPLANTS DO NOT SIGNIFICANTLY DELAY BREAST-CANCER DETECTION OR ADVERSELY AFFECT CANCER-SURVIVAL PROGNOSIS IN IMPLANTED WOMEN. SOME STUDIES EVEN SUGGEST LOWER RATES OF BREAST CANCER IN WOMEN WITH BREAST IMPLANTS. THE DFU ALSO EMPHASIZES THE RESPONSIBILITY OF THE SURGEON TO FULLY INFORM THE PATIENT OF POTENTIAL RISKS AND COMPLICATIONS DURING THE PRE-OPERATIVE CONSULTATION. PATIENTS ARE PROVIDED WITH THE DOCUMENT ¿MOTIVA IMPLANTS®: INFORMATION FOR THE PATIENT,¿ ACCESSIBLE AT IFU.MOTIVA.HEALTH. LITERATURE REFERENCE: HANDEL, N., GARCÍA, M. E., & WIXTROM, R. (2013). BREAST IMPLANT RUPTURE: CAUSES, INCIDENCE, CLINICAL IMPACT, AND MANAGEMENT. PLAST. RECONSTR. SURG. 132(5), 1128. "A NUMBER OF RISK FACTORS FOR RUPTURE HAVE BEEN IDENTIFIED; THE MOST COMMON CAUSE IS SURGICAL INSTRUMENT DAMAGE." HÖLMICH LR, MELLEMKJAER L, GUNNARSDÓTTIR KA, TANGE UB, KRAG C, MØLLER S, MCLAUGHLIN JK, OLSEN JH. STAGE OF BREAST CANCER AT DIAGNOSIS AMONG WOMEN WITH COSMETIC BREAST IMPLANTS. BR J CANCER. 2003 MAR 24;88(6):832-8. DOI: 10.1038/SJ.BJC.6600819. PMID: 12644818; PMCID: PMC2377078. DEVICE HISTORY RECORD (DHR) REVIEW: A COMPREHENSIVE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE AFFECTED LOT WAS COMPLETED. NO DEVIATIONS, NON-CONFORMANCES, OR ANOMALIES WERE IDENTIFIED DURING MANUFACTURING. ALL RAW MATERIALS AND PROCESS PARAMETERS CONFORMED TO SPECIFIED QUALITY REQUIREMENTS.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: ALLEGEDLY, IT WAS REPORTED A "BREAST CANCER AND DEVICE RUPTURE." FRANCE. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION ON (B)(6) 2022, HAD AN IMAGING TESTS THAT REVEALS AN INVASIVE CARCINOMA OF UNSPECIFIED TYPE GRADE I ON THE UPPER QUADRANT OF THE LEFT BREAST, ALSO A DEVICE RUPTURE ON THE SAME SIDE WAS FOUND ((B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183830 MOTIVA IMPLANTS MOTIVA SMOOTHSILK ROUND AND ERGONOMIX BREAST IMPLANTS FTR ESTABLISHMENT LABS S.A. ERSF 500Q 22101624

    Patients

    Seq Age Sex Outcome Treatment
    1