Description of Event or Problem · 1
I HAD TEXTURE MCGHAN 468 BREAST IMPLANTS PLACED (B)(6) 2002. BEGINNING IN 2004, I STARTED HAVING STRANGE SYMPTOMS THAT EITHER MIMICKED OR MANIFESTED AS THYROID, ARTHRITIS, SEVERE INTENSE ITCHING OF BREASTS, ARMPITS AND GROIN, LARGE CYSTS ALL OVER MY HEAD, GOITER, WEIGHT GAIN, FOOT FUNGUS, EXTREME CHRONIC FATIGUE, AND MYRIAD OF OTHER SYMPTOMS THAT COULD NOT BE EXPLAINED THROUGH TESTING OR EXAMINATION. AS THEY GOT PROGRESSIVELY WORSE, I VISITED MY SURGEON THAT PLACED THE IMPLANTS IN 2014 AND VOICED MY CONCERN, PARTICULARLY BECAUSE HE HAD TOLD ME AT IMPLANT THAT WARRANTY IS TEN YEARS. I THOUGHT MAYBE BECAUSE THEY WERE OLD, IT WAS CAUSING THE ITCHING (WHICH WAS MY MOST BOTHERSOME AT THE TIME). HE SAID THAT THE TIMELINE WAS JUST A SUGGESTION AND HE DID NOT SEE, UPON PHYSICAL EXAM) ANYTHING THAT WOULD INDICATE THEY NEEDED REMOVED AND I SHOULDN'T FIX WHAT ISN'T BROKE. SO I LEFT THEM IN UPON HIS RECOMMENDATION. SYMPTOMS KEPT GETTING WORSE. THEN IN 2018 MY FEET HURT SO BAD I COULD BARELY WALK. THINKING ONE WAS EVEN BROKE. I WAS REFERRED TO A RHEUMATOLOGIST AND WAS DIAGNOSED WITH PSORIATIC ARTHRITIS. I FELT THAT WASN'T THE PROBLEM, BECAUSE IT DIDN'T MAKE SENSE THAT EVERY SINGLE JOINT AND LIMB HURT THE SAME WAY, ALL THE TIME. BUT I TOOK THE MED I WAS GIVEN, HOPING IT WOULD HELP. I IMMEDIATELY HAD TROUBLE BREATHING, GAINED 30 LBS WITHIN 4 WEEKS COULDN'T CLIMB STAIRS BECAUSE I COULDN'T BREATHE, AND THEN EVENTUALLY EVEN GET OFF THE COUCH WITHOUT FEELING LIKE I WAS GOING TO FALL OVER FROM EXHAUSTION. I STOPPED TALKING THE ARTHRITIS MEDS AND WAS ABLE TO BREATHE BETTER IN A FEW DAYS. HOWEVER , MY SHORT TERM MEMORY WAS SO BAD OTHERS AT WORK NOTICED, MY ANXIETY WAS SO BAD I ONLY LEFT THE HOUSE TO GO TO WORK, I WOULD ALSO FIND MYSELF LITERALLY FALLING ASLEEP WHEN TALKING TO PEOPLE. MY EYES COULD BARELY BE KEPT OPEN FROM NOT ONLY CHRONIC FATIGUE, BUT BECAUSE MY EYE LIDS WERE SWELLING SO BAD MY EYES WERE ALMOST SHUT. I THEN HEARD A NEWS CAST IN (B)(6) 2019 ABOUT A THING CALLED BREAST IMPLANT ILLNESS. I STARTED DOING RESEARCH AND LEARNED THAT THE TEXTURED IMPLANTS WERE CAUSING A VARIETY OF AUTO IMMUNE DISORDERS AND IN SOME CASES, LYMPHOMA. SINCE I HAD SEVERAL AREAS WHERE MY LYMPHNODES WERE HAD BEEN ITCHING FOR SEVERAL YEARS, AND I HAD NOTICABLE LUMPS IN THOSE AREAS, I KNEW I HAD TO GET THEM REMOVED. I WENT TO A RENOWNED MICROSURGEON THAT SPECIALIZES IN EXPLANTS. SHE HAD A NINE MONTH WAITING LIST. HOWEVER, WHEN SHE HEARD I HAD THE TEXTURED IMPLANTS, SHE GOT ME IN RIGHT AWAY FOR A CONSULT AND THEN SCHEDULED SURGERY FOR A MONTH LATER. I EXPLANTED THE IMPLANTS (B)(6) 2019. AS SOON AS I WOKE UP FROM SURGERY, I NOTICED THE SWELLING IN MY FACE HAD DIMINISHED DRASTICALLY. MY EYES WERE FULLY OPEN. OVER THE NEXT FEW DAYS, I NOTICED I WASN'T TIRED. I WASN'T FORGETFUL, AND MY JOINT PAIN WAS NON EXISTENT. I'M NOW THREE MONTHS POST OP AND CAN'T BELIEVE THE DIFFERENCE IN SO MANY SYMPTOMS. MOST ARE GONE, BUT SOME HAVE COME BACK A LITTLE, WHICH I BELIEVE TO BE MY BODY TRYING TO DETOX ALL THE HORRIBLE THINGS THAT HAD BEEN IN MY BODY FOR 17 YEARS. HOWEVER, I AM FEARFUL THAT SOME OF THE AUTO IMMUNE ISSUES WILL ALWAYS BE WITH ME. I DID HAVE CAPSULAR CONTRACTURES, WHICH FLATTENED MY RIB CAGE. MY DR DIDN'T SEND MY CAPSULES FOR LYMPHOMA TESTING, AND I WONDER EVERYDAY IF I MAY HAVE A FORM OF UNDETECTED LYMPHOMA. PRIOR TO IMPLANTS, I HAD ALWAYS BEEN VERY HEALTHY, WHICH IS WHY I COULD NEVER UNDERSTAND THIS PROGRESSION OF ILLNESSES. SINCE EXPLANTED, ALLERGAN'S TEXTURED IMPLANTS HAVE BEEN RECALLED. SINCE MCGHAN WAS BOUGHT OUT BY ALLERGAN, MY IMPLANTS WOULD NOT BE PART OF THE RECALL (ONLY UNIMPLANTED DEVICES WERE ON THE RECALL). MY CONCERN IS THAT THOSE OF US WHO HAVE THE TEXTURED IMPLANTS FROM A PREVIOUS COMPANY WILL BE IGNORED AND NOT INCLUDED IN SAFETY UPDATES OR RECALLS. THIS NEEDS TO BE ADDRESSED. IF NEW IMPLANTS ARE NO LONGER SAFE TO BE IMPLANTED, THEN THOSE WITH ALREADY IMPLANTED DEVICES NEED TO BE INFORMED AND ADVISED TO HAVE THEM REMOVED. FDA SAFETY REPORT ID# (B)(4).