BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 16877374 · Received May 5, 2023

    Report

    Report Number
    9617229-2023-06985
    Event Type
    Injury
    Date Received
    May 5, 2023
    Date of Event
    April 11, 2023
    Report Date
    May 5, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: HADAD, E., SUALHI, I., LEGARDA, C., SELIGMAN, Y., SORKIN, A., DOR, O., MENASHE, S., HELLER, L., & WISER, I. (2023). "SILICONE BREAST IMPLANT RUPTURE IS MORE PREVALENT IN THE DOMINANT LIMB SIDE, A RETROSPECTIVE COHORT STUDY". JOURNAL OF PLASTIC RECONSTRUCTIVE AND AESTHETIC SURGERY, 80(2023), P.126-132. HTTPS://DOI.ORG/10.1016/J.BJPS.2023.02.016. CORRESPONDENCE CONTACT: DR. (B)(6). DEPARTMENT OF PLASTIC SURGERY. (B)(6) MEDICAL CENTER. (B)(6) ISRAEL. EMAIL: (B)(6). ADDITIONAL CONTRIBUTING DOCTORS: (B)(6). THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THROUGH THE JOURNAL ARTICLE " SILICONE BREAST IMPLANT RUPTURE IS MORE PREVALENT IN THE DOMINANT LIMB SIDE, A RETROSPECTIVE COHORT STUDY. JOURNAL OF PLASTIC RECONSTRUCTIVE AND AESTHETIC SURGERY." THAT PATIENTS ARE MORE LIKELY TO EXPERIENCE RUPTURE OR CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) FOR BREAST IMPLANT DEVICES IS MORE PREVALENT IN THE DOMINANT LIMB SIDE. THE DEVICES HAVE BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678227 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention