FDA Adverse Event Injury Summary report: N

SILICONE BREAST IMPLANT

MDR report key: 3840198 · Received May 23, 2014

Report

Report Number
MW5036321
Event Type
Injury
Date Received
May 23, 2014
Date of Event
May 15, 2014
Report Date
May 19, 2014
Product Code
FTR
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

IN 1997 AFTER A HYSTERECTOMY, I HAD LOST ALMOST ALL MY BREAST FORM AND TISSUE DUE TO LACK OF HORMONES. I RECEIVED MCGHAN SALINE IMPLANTS BUT WITHIN 2 MONTHS, I DEFLATED. I OPTED TO HAVE GEL BREAST IMPLANTS IN 1998. IN 2006 I FELT THAT THOSE IMPLANTS WERE LEAKING AND SO I SCHEDULED AN MRI. THE MRI WAS SENT TO THE SURGEON WHO DID THE IMPLANTS. AT THE APPOINTMENT, I ASKED HER IF SHE HAD READ THE MRI AND SHE SAID "THAT MRI'S WERE NOT RELIABLE" AND THAT THE ONLY WAY TO KNOW WAS TO HAVE SURGERY. I RECEIVED A QUOTE FOR OVER (B)(6) DOLLARS AND DID NOT HAVE THE MONEY TO PURSUE THE SURGERY. I TOOK HER WORD THAT THE MRI WAS NOT RELIABLE. SOON AFTER THAT I STARTED HAVING MANY ILLNESS SYMPTOMS INCLUDING MS, LUPUS, GUILLAIN-BARRE, AUTO IMMUNE DISORDER, ETC. I SAW 7 SPECIALISTS INCLUDING A NEUROLOGIST AT (B)(6), ENDOCRINOLOGISTS, AN ORAL SURGEON, AND INTERNISTS. NONE OF THEM SEEMED TO KNOW WHAT WAS WRONG. I ALSO SAW A DOCTOR IN (B)(6) WHO RAN HAIR ANALYSIS AND BLOOD WORK THAT SHOWED MANY OF MY FUNCTIONS - I.E.: LIVER, WHITE BLOOD COUNT, THYROID, ADRENALS, ETC., WERE NOT NORMAL. OVER THE LAST 6-7 YEARS MY SYMPTOMS HAVE CONTINUED TO WORSEN, MORE TESTS, AND NO ANSWERS. IN (B)(6) 2014, I DECIDED TO SEE A SECOND DOCTOR HERE IN (B)(6), A PLASTIC SURGEON, AND TOLD HIM THAT I FELT MY IMPLANTS MAY BE LEAKING. HE BLEW ME OFF AND DID NOT AGREE THAT LEAKING IMPLANTS CAUSE HEALTH ISSUES. AT THIS POINT, I DECIDED TO MOVE OUT OF TRADITIONAL MEDICINE DUE TO NO ANSWERS OR HELP FOR MY CONDITIONS. DUE TO ALL MY SYMPTOMS, SOME WHICH INCLUDE: PARTIAL PARALYSIS, HEADACHES, CENTRAL NERVOUS SYSTEM DISORDER, GRAVES DISEASE, SHAKINESS, TREMORS, ETC., I STARTED SEEING DR (B)(6) WHO PRACTICES (B)(6) MEDICINE AND ACUPUNCTURE HERE IN (B)(6). AFTER A FEW TREATMENTS, I WAS GETTING ONLY PARTIAL RESULTS. I MENTIONED TO HIM THAT I THOUGHT MY SILICONE IMPLANTS MAY MBE LEAKING. HE IMMEDIATELY FELT THAT WAS WHAT WAS CAUSING ALL MY SYMPTOMS. HE SAID HE HAS HAD MANY PATIENTS OVER THE YEARS WHO HAD IMPLANTS LEAKING AND SOME WERE SO SICK THEY COULD NOT EVEN HAVE THE SURGERY FOR REMOVAL. I WAS REFERRED TO DR (B)(6). I GOOGLED HER ONLINE AND FOUND THAT SHE WAS SPECIALIZED IN IMPLANT EXPLANTATION AND WAS DOUBLE BOARD CERTIFIED. SHE HAS DONE OVER 3,000 EXPLANT PROCEDURES. I MET WITH DR (B)(6) IN (B)(6) AND SHE SPENT LOTS OF TIME EXPLAINING HOW LEAKING IMPLANTS COULD CAUSE ALL THESE HEALTH ISSUES. AFTER EXAMINATION, SHE DEFINITELY FELT MY IMPLANTS WERE LEAKING AND/OR RUPTURED. DR (B)(6) RECOMMENDED THAT THIS WAS MEDICALLY NECESSARY FOR ME TO CONTINUE TO STAY ALIVE. I CONTACTED MCGHAN REGARDING MY IMPLANTS. THEY TOLD ME THEY SHOW THAT IN 2006 MY IMPLANTS WERE STILL UNDER WARRANTY AND ASKED FOR A COPY OF THE MRI. I CONTACTED MY SURGEON IN (B)(6) WHO DID THE ORIGINAL SURGERY AND ASKED THEM IF THEY HAD MY MRI FROM 2006. IMAGINE MY SURPRISE WHEN IT SAID THAT THE RIGHT IMPLANT WAS RUPTURED WAY BACK THEN! SHE HAD NEVER SHARED THIS REPORT WITH ME. THE SURGERY WAS COMPLETED ON (B)(6) 2014. THE RIGHT IMPLANT WAS TOTALLY DETERIORATED FROM A RUPTURE AND THERE WAS SO MUCH SILICONE THAT THE OPERATING ROOM NURSE SAID THIS WAS ONE OF THE WORST SHE HAD EVER SEEN. THE LEFT IMPLANT WAS INTACT BUT LEAKING. THE COST OF THE REMOVAL INCLUDING ANESTHESIA AND SURGERY CENTER WAS (B)(6) DOLLARS. AT THIS POINT MCGHAN HAS SAID THEY WILL ONLY COVER UP TO (B)(6) DOLLARS PER IMPLANT IF RUPTURED. I HAD TO BORROW THIS MONEY AS ALL THESE FEES HAD TO BE PAID UP FRONT BUT I KNEW MY LIFE DEPENDED ON IT. THE MONEY FOR THIS LOAN HAS TO BE REPAID BY (B)(6) 2014. I DO NOT KNOW WHERE I AM GOING TO GET THIS MONEY. I FEEL THAT MCGHAN SHOULD PAY FOR THIS REMOVAL. THEIR PRODUCT WAS OBVIOUSLY DEFECTIVE WHILE UNDER WARRANTY AND NO ONE INFORMED ME ABOUT THE MRI REPORT. IN 1997 I WAS SUPPOSED TO BE PART OF AN (B)(6) STUDY BUT NO ONE EVER FOLLOWED UP OR CONTACTED ME. A CLASS ACTION LAWSUIT WAS SETTLED IN 2010 WITH MCGHAN (ALLERGAN) BUT I WAS NEVER CONTACTED. THE SILICONE IS NOW IN MY LUNGS, MY LYMPH SYSTEM, AND MY LIVER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
307108 SILICONE BREAST IMPLANT SILICONE BREAST IMPLANT FTR STYLE 110 37615
307109 SILICONE BREAST IMPLANT SILICONE BREAST IMPLANT FTR STLYE 110 37615
307210 SILICONE BREAST IMPLANT SILICONE BREAST IMPLANT FTR STYLE 110 37615

Patients

Seq Age Sex Outcome Treatment
1 52 YR Life Threatening| R| S