BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 7650769 · Received June 29, 2018

    Report

    Report Number
    9617229-2018-05412
    Event Type
    Injury
    Date Received
    June 29, 2018
    Date of Event
    October 24, 2016
    Report Date
    June 29, 2018
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION CONTAINED IN THIS REPORT WAS PREVIOUSLY SUBMITTED THROUGH ASR ON 04/15/2017. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT WAS RECEIVED ON NOVEMBER 22, 2016 WITH LOT NUMBER 2042789. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED CLEAR FLUIDS INSIDE THE DEVICE, RED PARTICLES IN THE FILL CHANNEL, AND WEAR ABRASION. FILL INSPECTION WAS PERFORMED AND IDENTIFIED NO BLOCKAGE IN THE VALVE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: NO ISSUES FOUND RELATED WITH THE MANUFACTURING PROCESS. THE EVENTS OF CAPSULAR CONTRACTURE AND "PATIENT HAS SUFFERED BODILY INJURY AND RESULTING PAIN AND SUFFERING, MENTAL ANGUISH, DISABILITY, DISFIGUREMENT, AND LOSS OF THE CAPACITY FOR THE ENJOYMENT OF LIFE [¿]. THE LOSSES ARE PERMANENT OR CONTINUING IN NATURE, AND [PATIENT] WILL SUFFER THEM IN THE FUTURE¿ ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. DEVICE LABELING: POTENTIAL ADVERSE EVENTS THAT MAY OCCUR WITH SALINE-FILLED BREAST IMPLANT SURGERY INCLUDE: REOPERATION, PAIN, WRINKLING, ASYMMETRY, IMPLANT PALPABILITY/VISIBILITY, IMPLANT REMOVAL, CAPSULAR CONTRACTURE, CHANGES IN NIPPLE AND BREAST SENSATION, IMPLANT DISPLACEMENT/MIGRATION, IMPLANT DEFLATION, SCARRING, INFECTION, HEMATOMA/SEROMA, BREASTFEEDING COMPLICATIONS, IMPLANT EXTRUSION, NECROSIS, DELAYED WOUND HEALING, BREAST TISSUE ATROPHY/CHEST WALL DEFORMITY, CALCIUM DEPOSITS, AND LYMPHADENOPATHY. DEFLATION ¿ BREAST IMPLANTS ARE NOT LIFETIME DEVICES. SALINE BREAST IMPLANTS DEFLATE WHEN THE SHELL DEVELOPS A TEAR OR HOLE. DEFLATION CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT THEY ARE MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. THE FOLLOWING THINGS MAY CAUSE IMPLANTS TO DEFLATE: DAMAGE BY SURGICAL INSTRUMENTS; FOLDING OR WRINKLING OF THE IMPLANT SHELL; EXCESSIVE FORCE TO THE CHEST (E.G., DURING CLOSED CAPSULOTOMY, WHICH IS CONTRAINDICATED); TRAUMA; COMPRESSION DURING MAMMOGRAPHIC IMAGING; AND SEVERE CAPSULAR CONTRACTURE. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. LABORATORY STUDIES HAVE IDENTIFIED SOME OF THE CAUSES OF DEFLATION FOR ALLERGAN¿S PRODUCT; HOWEVER, IT IS NOT CONCLUSIVELY KNOWN WHETHER THESE TESTS HAVE IDENTIFIED ALL CAUSES OF DEFLATION. CAPSULAR CONTRACTURE - PATIENTS SHOULD BE ADVISED THAT CAPSULAR CONTRACTURE MAY BE MORE COMMON FOLLOWING INFECTION, HEMATOMA, AND SEROMA, AND THE CHANCE OF IT HAPPENING MAY INCREASE OVER TIME. CAPSULAR CONTRACTURE OCCURS MORE COMMONLY IN REVISION PATIENTS THAN IN PRIMARY AUGMENTATION OR RECONSTRUCTION PATIENTS. CAPSULAR CONTRACTURE IS ALSO A RISK FACTOR FOR IMPLANT DEFLATION, AND IT IS ONE OF THE MOST COMMON REASONS FOR REOPERATION. PATIENTS SHOULD ALSO BE ADVISED THAT ADDITIONAL SURGERY MAY BE NEEDED IN CASES WHERE PAIN AND/OR FIRMNESS ARE SEVERE. THIS SURGERY RANGES FROM REMOVAL OF THE IMPLANT CAPSULE TISSUE TO REMOVAL AND POSSIBLE REPLACEMENT OF THE IMPLANT ITSELF. THIS SURGERY MAY RESULT IN LOSS OF BREAST TISSUE. CAPSULAR CONTRACTURE MAY HAPPEN AGAIN AFTER THESE ADDITIONAL SURGERIES. CAPSULAR CONTRACTURE MAY INCREASE THE RISK OF DEFLATION.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. ADDITIONAL INFORMATION: A PATIENT REPRESENTATIVE REPORTED LEFT SIDE ¿VERY HARD¿, ¿HAVE CREATED BACK PAINS AND OTHER DISCOMFORT¿, ¿SIGNIFICANT CAPSULAR CONTRACTURE¿ BAKER GRADE NOT PROVIDED, AND ALLEGES THE PATIENT HAS ¿SUFFERED BODILY INJURY AND RESULTING PAIN AND SUFFERING, MENTAL ANGUISH, DISABILITY, DISFIGUREMENT, AND LOSS OF THE CAPACITY FOR THE ENJOYMENT OF LIFE [¿]. THE LOSSES ARE PERMANENT OR CONTINUING IN NATURE, AND [PATIENT] WILL SUFFER THEM IN THE FUTURE¿. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494677 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2042789

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention