BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 6766130 · Received August 3, 2017

    Report

    Report Number
    9617229-2017-00568
    Event Type
    Injury
    Date Received
    August 3, 2017
    Date of Event
    January 10, 2017
    Report Date
    December 21, 2017
    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 · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO FDA REPORT NUMBER 5070669. CONCOMITANT PRODUCT(S): - VITAMIN C, BIOTIN. 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. DEVICE LABELING: UNDERGOING ANY TYPE OF SURGERY INVOLVES RISKS. THERE ARE A NUMBER OF LOCAL COMPLICATIONS (PROBLEMS AT OR NEAR THE BREAST/SURGICAL INCISION SITE) THAT MAY OCCUR AFTER YOUR BREAST IMPLANT SURGERY. THE FOLLOWING SECTIONS PRESENT RESULTS FROM ALLERGAN¿S CORE CLINICAL STUDY CONDUCTED ON NATRELLE ® SILICONE-FILLED BREAST IMPLANTS. GLOSSARY: CAPSULAR CONTRACTURE - A TIGHTENING OF THE SCAR TISSUE (ALSO CALLED A CAPSULE) THAT NORMALLY FORMS AROUND THE BREAST IMPLANT DURING THE HEALING PROCESS AFTER SURGERY. IN SOME WOMEN, THE SCAR TISSUE (CAPSULE) SQUEEZES THE IMPLANT. WHEN THIS OCCURS, IT IS CALLED CAPSULAR CONTRACTURE. THIS RESULTS IN FIRMNESS OR HARDENING OF THE BREAST, AND IS A RISK FOR IMPLANT RUPTURE. CAPSULAR CONTRACTURE IS CLASSIFIED BY BAKER GRADES. CAPSULAR CONTRACTURE BAKER GRADES III AND IV ARE THE MOST SEVERE. BAKER GRADE III OFTEN RESULTS IN THE NEED FOR ADDITIONAL SURGERY (REOPERATION) BECAUSE OF PAIN AND POSSIBLY ABNORMAL APPEARANCE. BAKER GRADE IV USUALLY RESULTS IN THE NEED FOR ADDITIONAL SURGERY (REOPERATION) BECAUSE OF PAIN AND UNACCEPTABLE APPEARANCE. CAPSULAR CONTRACTURE BAKER GRADE II MAY ALSO RESULT IN THE NEED FOR SURGERY. EACH GRADE IS DESCRIBED BELOW. BAKER GRADE I ¿ NORMALLY SOFT AND NATURAL APPEARANCE. BAKER GRADE II ¿ A LITTLE FIRM, BUT BREAST LOOKS NORMAL. BAKER GRADE III ¿ MORE FIRM THAN NORMAL, AND MAY LOOK ABNORMAL (CHANGE IN SHAPE). BAKER GRADE IV ¿ HARD, OBVIOUS DISTORTION, AND TENDERNESS WITH PAIN. RUPTURE - A HOLE OR TEAR IN THE SHELL OF THE IMPLANT THAT ALLOWS SILICONE GEL FILLER MATERIAL TO LEAK FROM THE SHELL. RUPTURES CAN BE INTRACAPSULAR (INSIDE THE SCAR TISSUE CAPSULE SURROUNDING THE IMPLANT) OR EXTRACAPSULAR (OUTSIDE THE SCAR TISSUE SURROUNDING THE IMPLANT). WARNINGS: RUPTURE OF A SILICONE-FILLED BREAST IMPLANT IS MOST OFTEN SILENT. THIS MEANS THAT NEITHER YOU NOR YOUR SURGEON WILL KNOW THAT YOUR IMPLANTS HAVE A RUPTURE. THEREFORE YOU WILL NEED REGULAR MRI SCREENINGS OVER YOUR LIFETIME IN ORDER TO DETERMINE IF RUPTURE IS PRESENT. YOU SHOULD HAVE AN MRI 3 YEARS AFTER YOUR BREAST IMPLANT SURGERY AND THEN EVERY 2 YEARS AFTER THAT FOR AS LONG AS YOU HAVE YOUR BREAST IMPLANTS. IF IMPLANT RUPTURE IS NOTED ON AN MRI, YOU SHOULD HAVE THE IMPLANT REMOVED, WITH OR WITHOUT REPLACEMENT.

    Description of Event or Problem · 1

    ADDITIONALLY HEALTH PROFESSIONAL REPORTED LEFT SIDE REMOVAL DUE TO "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, RUPTURE, AND A SEROMA" AND THAT THE DEVICE WAS DISCARDED AFTER SURGERY.

    Description of Event or Problem · 1

    PATIENT REPORTED LEFT SIDE, "HAIR LOSS, VAGINAL ISSUES, CAPSULAR CONTRACTURE [BAKER GRADE UNKNOWN], FORGETFULNESS, AGING (FACE AGED AROUND 5-10 YEARS IN 6 MONTHS), TINNITUS, NOT BEING ABLE TO REMEMBER WORDS...BADLY RUPTURED, THERE WAS BROWNISH FLUID IN THERE ALSO." THE DEVICE HAS BEEN EXPLANTED. THIS MEDWATCH IS FOR THE LEFT SIDE. SEE MFR # 9617229-2017-00569 FOR THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543915 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1302862

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RX MEDS: SINGULAIR ®, OTC MEDS, VITAMIN D