BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 6156920 · Received December 8, 2016

    Report

    Report Number
    9617229-2016-00208
    Event Type
    Death
    Date Received
    December 8, 2016
    Report Date
    December 8, 2016
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: KAPPEL RM, BOER LL, DIJKMAN H (2016) GEL BLEED AND RUPTURE OF SILICONE BREAST IMPLANTS INVESTIGATED BY LIGHT-, ELECTRON MICROSCOPY AND ENERGY DISPERSIVE X-RAY ANALYSIS OF INTERNAL ORGANS AND NERVOUS TISSUE. CLIN MED REV CASE REP 3:087. R.M. KAPPEL1, L.L. BOER AND H. DIJKMAN. (B)(4). THE EVENTS OF DEATH, LYMPHADENOPATHY, PAIN, AND NEUROLOGICAL SYMPTOMS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. CURRENTLY NO DEVICE DETAILS EXIST AND IT IS UNKNOWN IF ALLERGAN IS THE MANUFACTURER OF THE DEVICE, HOWEVER, THE ARTICLE IDENTIFIED THE DEVICE AS ¿SILICONE IMPLANTS.¿ IF INFORMATION IS RECEIVED REGARDING DEVICE DETAILS AND AN ALLERGAN DEVICE IS CONFIRMED, A DEVICE HISTORY REVIEW WILL BE PERFORMED AND THE RESULTS OF THIS WILL BE INCORPORATED IN SUBSEQUENT REPORTS. DEVICE LABELING: PAIN - AS EXPECTED FOLLOWING ANY INVASIVE SURGICAL PROCEDURE, PAIN OF VARYING INTENSITY AND DURATION MAY OCCUR FOLLOWING IMPLANTATION. IN ADDITION, IMPROPER SIZE, PLACEMENT, SURGICAL TECHNIQUE, OR CAPSULAR CONTRACTURE MAY RESULTS IN PAIN ASSOCIATED WITH NERVE ENTRAPMENT OR INTERFERENCE WITH MUSCLE MOTION. UNEXPLAINED PAIN MUST BE PROMPTLY INVESTIGATED. GEL DIFFUSION - MINUTE QUANTITIES OF SILICONE MAY DIFFUSE THROUGH THE ELASTOMER ENVELOPE OF GEL-FILLED IMPLANTS. THE DETECTION OF SMALL QUANTITIES OF SILICONE IN THE PERIPROSTHETIC CAPSULE, AXILLARY LYMPH NODES, AND OTHER DISTAL REGIONS IN PATIENTS WITH APPARENTLY UNRUPTURED, CONVENTIONAL GEL-FILLED IMPLANTS HAS BEEN REPORTED IN THE MEDICAL LITERATURE. HOWEVER, THERE HAS BEEN ONLY LIMITED EVIDENCE IN MEDICAL LITERATURE ASSOCIATING GEL DIFFUSION WITH LOCAL COMPLICATIONS IN BREAST IMPLANT PATIENTS. IF SIGNIFICANT GEL DIFFUSION OCCURS, THE DEVICE SHOULD BE CHECKED FOR ANY POSSIBLE LEAKAGE OR FLAWS. RESEARCH ON SILICONE IMPLANTS - IN 1999, AN INDEPENDENT REVIEW FORM A COMMITTEE AT THE INSTITUTE OF MEDICINE IN THE US REPORTED THAT CONNECTIVE TISSUE DISORDERS, CANCER, NEUROLOGICAL DISEASES OR OTHER SYSTEMIC COMPLAINTS OR CONDITIONS ARE NO MORE COMMON IN WOMEN WITH BREAST IMPLANTS THAN IN WOMEN WITHOUT IMPLANTS. THEY CONCLUDED THAT A REVIEW OF THE TOXICOLOGY STUDIES OF SILICONES AND OTHER SUBSTANCES KNOWN TO BE IN BREAST IMPLANTS DOES NOT PROVIDE A BASIS FOR HEALTH CONCERNS.

    Description of Event or Problem · 1

    TELEVISION PROGRAM REPORTS ON THE (B)(6) TV AND A PRESS ANNOUNCEMENT QUESTIONING THE SECURITY OF SILICONE IMPLANTS IN GENERAL AND IN PARTICULAR THE QUESTION OF MIGRATION OF SILICONE PARTICLE IN THE ENTIRE BODY (FOLLOWING AN AUTOPSY OF A PATIENT WITH SILICONE IMPLANTS WHO DIED AND MANY PARTICLES OF SILICONE WHERE FOUND ALL OVER THE BODY). PHYSICIAN PROVIDED RESEARCH ARTICLE "GEL BLEED AND RUPTURE OF SILICONE BREAST IMPLANTS INVESTIGATED BY LIGHT-, ELECTRON MICROSCOPY AND ENERGY DISPERSIVE X-RAY ANALYSIS OF INTERNAL ORGANS AND NERVOUS TISSUE." THE ARTICLE COMMENTS OF A PATIENT WITH MULTIPLE COMPLAINTS FOLLOWING BREAST IMPLANT SURGERY THAT HAD A SUBSEQUENT AUTOPSY. THE PATIENT FIRST HAD BREAST IMPLANTS FROM AN UNKNOWN MANUFACTURER PLACED IN 1985 AND HAD UNSPECIFIED ¿ADVERSE REACTIONS.¿ THEY WERE REPLACED WITH OTHER BREAST IMPLANTS FROM AN UNKNOWN MANUFACTURER IN 2001 AT WHICH TIME IT WAS FOUND THAT [THE PATIENT'S] PREVIOUS IMPLANTS WERE RUPTURED. PATIENT THEN DEVELOPED A CAPSULAR CONTRACTURE OF THE LEFT BREAST AND UNDERWENT CAPSULECTOMY. AT THAT TIME THE PATIENT ALSO COMPLAINED OF PAINFUL BREASTS, BURNING SENSATION IN THE BREASTS, LYMPH PACKAGES IN THE LEFT ARMPIT, MEMORY DYSFUNCTION, WALKING DYSFUNCTION, SLEEP DISTURBANCE, BOWEL FUNCTION PROBLEMS, SKIN DISORDER, A FEELING OF CHRONIC ILLNESS, AND LEG NUMBNESS. IN 2002 BOTH IMPLANTS WERE REMOVED. IN 2003 THE PATIENT DEVELOPED SWOLLEN LYMPH NODES IN THE LEFT AXILLA WHICH WERE REMOVED AND BIOPSIED. FROM THE HISTOLOGICAL EXAM THE LYMPH NODE REACTIONS WERE THOUGHT TO BE A REACTION TO SILICONE. THE PATIENT ALSO DEVELOPED SWOLLEN LYMPH NODES IN THE LEFT GROIN, BUT WE HAVE NO INFORMATION REGARDING SUBSEQUENT FOLLOW UP ON THOSE. IN 2004 THE PATIENT DEVELOPED INVASIVE DUCTAL CARCINOMA OF THE LEFT BREAST, HOWEVER IT MIGHT BE COINCIDENTAL AND NOT LINKED TO THE SILICONE IMPLANTS. THE PATIENT DEVELOPED MULTIPLE METASTASES AND SUBSEQUENTLY DIED OF THE DISEASE. PER THE PATIENT REQUEST, AN AUTOPSY WAS DONE LOOKING FOR EVIDENCE OF SILICONE MIGRATION ONTO OTHER ORGAN SYSTEMS. EXAMINATION WAS DONE BY LIGHT AND ELECTRON MICROSCOPY. MEASUREMENTS FOR ELEMENTAL SILICON WERE ALSO PERFORMED. SILICONE WAS FOUND IN ALMOST ALL TISSUES EXAMINED INCLUDING BRAIN AND SPINAL CORD. IT WAS CONTAINED IN THE FORM OF PLAQUES AND VACUOLES. THE PLAQUES TENDED TO ALSO INCLUDE TITANIUM. SIGNS OF CHRONIC INFLAMMATION WERE SEEN AROUND SILICONE DEPOSITS IN LYMPH NODES BUT NOT IN OTHER TISSUES. THERE IS NO EVIDENCE THAT THE PATIENT¿S DEVICES WERE ALLERGAN IMPLANTS. THIS MFR# 9617229-2016-00208 IS FOR THE LEFT SIDE DEVICE IMPLANTED IN 2001. SEE MFR# 9617229-2016-00209 FOR THE RIGHT SIDE DEVICE IMPLANTED IN 2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806805 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR UNKNOWN MANUFACTURER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death