Description of Event or Problem · 1
I HAD A PROPHYLACTIC DOUBLE MASTECTOMY DUE TO A BRCA2 MUTATION ON (B)(6) 2013 AT (B)(6). DR (B)(6) WAS MY BREAST SURGEON AND DR (B)(6) WAS MY PS. HE DOES TO USE ALLERGAN NATRELLE 410 HIGHLY COHESIVE TEXTURED GEL IMPLANTS WITH ALLODERM FOR ME. I WAS NOT AWARE NOR DID I SIGN OFF ON WHAT HE WAS GOING TO USE BEFORE SURGERY. I WAS NOT TOLD THAT THERE IS A RISK OF BIA-ALCL WITH ALL IMPLANTS, AND POSSIBLY A MUCH HIGHER RISK WITH TEXTURED. I ALMOST IMMEDIATELY STARTED TO DEVELOP CAPSULAR CONTRACTURE IN MY RIGHT BREAST AND I HAD A STRANGE RED RASH UNDER MY RIGHT BREAST IN THE SHAPE OF THE "SLING" FROM THE ALLODERM THAT WAS USED AND WAS TOLD WHEN I HAD A F/U THAT IT WAS "NORMAL" AND OF NO CONCERN. OVER A FEW YEARS, I STARTED TO DEVELOP MORE PAIN IN MY RIGHT BREAST AND CORDING, WHICH LEAD TO MANY OTHER ISSUES AND SYMPTOMS CONSISTENT WITH BREAST IMPLANT ILLNESS AND BIA-ALCL, SUCH AS FROZEN SHOULDER, NERVE PAIN IN RIGHT ARM, HAND, AND INDEX FINGER, EXTREME FATIGUE, EXTREME HAIR LOSS, DRY SKIN, HAIR, EYES, RED, BLOODSHOT EYES, SHARP SHOOTING PAINS IN MY CHEST AND UPPER BACK, WEAKNESS, TINGLING, NUMBNESS, AND SWELLING IN RIGHT HAND, ETC. THERE ARE SOME OF THE MANY SYMPTOMS THAT HAVE GOTTEN PROGRESSIVELY WORSE. I RECENTLY WENT BACK TO DISCUSS WITH PS AND HE BRUSHED OFF AS "NORMAL AND OF NO CONCERN". HE SAID I COULD GET THE IMPLANTS OUT IF I CHOOSE, BUT SAID HE DIDN'T THINK IT WAS NECESSARY AND THAT I COULD JUST BE WATCHED. THIS IS UNACCEPTABLE AND THESE TEXTURED IMPLANTS SHOULD BE OFF OF THE MARKET IN ALL COUNTRIES. MY PS'S STATISTICS ALONE ARE 1 IN 460 PTS WITH ALMOST EXCLUSIVELY ALLERGAN NATRELLE 410 TEXTURED IMPLANTS. WHY ARE THESE STILL ON THE MARKET IN THE U.S? YOUR DATA AND STATISTICS ON BIA-ALCL ARE INCORRECT AND NEED TO BE UPDATED TO REFLECT THE TRUE RISING NUMBERS OF WOMEN BEING DIAGNOSED. I SHOULD NOT BE CONCERNED ABOUT GETTING CANCER WHEN THE REASON I HAD A PBM WAS TO AVOID CANCER. IT'S UNCONSCIONABLE. I'M SURE THAT THESE IMPLANTS ARE STUCK TO MY CHEST WALL, RIBS, AND MUSCLES AND COULD POTENTIALLY BE EXTREMELY DANGEROUS TO REMOVE. I'M MEETING WITH ANOTHER PS TRAINED IN EXPLANTING WITH ENBLOC THIS WEEK AND WILL SEE HOW TO BEST MOVE FORWARD. I BEG OF YOU FDA, TO REMOVE THESE TEXTURED IMPLANTS FROM THE MARKET AND PROTECT WOMEN AS IT IS YOUR JOB. MANY WOMEN THAT I'M IN TOUCH WITH HAD RUPTURES AND MRI'S THAT MISSED THEM. PLEASE ADVISE. FDA SAFETY REPORT ID# (B)(4).