BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN HEYER-SCHULTE

    MDR report key: 241127 · Received September 7, 1999

    Report

    Report Number
    MW1017191
    Event Type
    Injury
    Date Received
    September 7, 1999
    Report Date
    August 5, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 1980 RPTR WAS IMPLANTED WITH HEYER-SCHULTE BREAST IMPLANTS AFTER A MASTECTOMY. RPTR BELIEVES THEY RUPTURED VERY SHORTLY AFTER IMPLANTATION. IN 11/98 THIS WAS PROVEN BY AN MRI, AND THEY WERE REMOVED 3/3/99. RPTR'S SURGEON TOLD HER THAT IF SHE HAD WANTED REPLACEMENTS (RPTR DIDN'T) SHE WOULD HAVE HAD TO WAIT FOR SIX MONTHS SINCE SHE WAS "SO MESSED UP". RPTR HAS HER IMPLANTS IN THE SEALED SPECIMEN BAGS FROM THE LAB. AS STATED IN SURGICAL NOTES, THE RIGHT ONE IS VIRTUALLY EMPTY OF SILICONE. IT TOOK OVER 18 YEARS TO GET A DR TO LISTEN TO RPTR AND SEND HER FOR TESTING. THIS WAS A PRODUCT THAT RPTR WAS TOLD WOULD LAST A LIFETIME AND WOULD NEVER BREAK, SHORT OF HAVING AN ELEPHANT STAND ON HER CHEST. "THIS IS A VERY, VERY DEFECTIVE PRODUCT IN GENERAL - NOT JUST MINE - THEY ALL RUPTURE." PREOPERATIVE DIAGNOSIS: BILATERAL RUPTURE OF SILICONE-FILLED IMPLANTS WITH SILICONE EXTRUSION, MORE ON THE LEFT THAN THE RIGHT. POSTOPERATIVE DIAGNOSIS: BILATERAL RUPTURE OF SILICONE-FILLED IMPLANTS WITH SILICONE EXTRUSION, MORE ON THE LEFT THAN THE RIGHT. OPERATION: REMOVAL OF EXTRUDED SILICONE TISSUE FROM RUPTURED IMPLANTS BILATERALLY WITH BILATERAL CAPSULECTOMIES AND REMOVAL OF IMPLANTS. ANESTHESIA: GENERAL. ESTIMATED BLOOD LOSS: 100 CC. DRAINS: ONE JACKSON-PRATT WAS LEFT IN EACH BREAST. "AN INCISION WAS MADE IN THE RIGHT INFRAMAMMARY AREA AND CARRIED DOWN THROUGH SKIN AND SUBCUTANEOUS TISSUE TO THE PECTORALIS. THE PECTORALIS WAS OPENED. A VERY THICKENED CAPSULE WAS IDENTIFIED. THE CAPSULE WAS DISSECTED FROM THE PECTORALIS ON ALL SIDES AND FROM THE RIBS. HOWEVER, THE UPPER PART OF THE CAPSULE WAS RUPTURED WITH LOOSE SILICONE OUT INTO THE TISSUE. THIS WAS CAREFULLY CLEANSED FROM THE PECTORALIS MUSCLES AND FROM TISSUES LEADING TOWARD THE AXILLA. THE IMPLANT, WHICH WAS A RUPTURED BILUMEN IMPLANT, WAS REMOVED. IT HAD ALMOST BEEN EMPTIED OF SILICONE. AFTER CAREFUL CAPSULECTOMY AND CLEANSING, HEMOSTASIS WAS OBTAINED. A 7 MM FLAT JACKSON-PRATT DRAIN WAS PLACED IN THE WOUND AND BROUGHT OUT THE MEDIAN INCISION. THE INCISION WAS CLOSED WITH INTERRUPTED DERMAL SUTURES OF 4-0 VICRYL AND A RUNNING 5-0 VICRYL SKIN SUTURE. ATTENTION WAS DIRECTED TO THE OPPOSITE SIDE. A SIMILAR INCISION WAS PLACED. THE BREAST IMPLANT CAPSULE WAS IDENTIFIED AND WAS DISSECTED OUT. HOWEVER, ON THE LEFT SIDE, THERE WAS AN EVEN GREATER AMOUNT OF SILICONE EXTRUSION SUPERIORLY. CAREFUL COMPLETE CAPSULECTOMY WAS DONE. THE RUPTURED IMPLANT WITH LOOSE SILICONE MATERIAL IN TISSUES OUTSIDE THE CAPSULE WAS REMOVED AND SENT TO PATHOLOGY. PATHOLOGY WAS ASKED TO SAVE THE IMPLANT FOR THE PT. AFTER ALL EXCESS SILICONE WAS OUT, A CLOSURE WAS DONE IN A SIMILAR FASHION TO THE OPPOSITE SIDE. THE PT WAS AROUSED AND TAKEN TO THE RECOVERY ROOM AFTER STERI-STRIPS, BULKY DRESSING AND AN ACE WRAP WERE PLACED. THERE WERE NO COMPLICATIONS TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN HEYER-SCHULTE Implant BILUMEN SILICONE GEL MAMMARY IMPLANT FTR BAXTER HEALTHCARE CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R| S