AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: NA. MANUFACTURER?S REFERENCE NUMBER: (B)(4).
D
Patient 1
MEDWATCH NUMBER: MW5092251. IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNKNOWN BREAST SURGERY WITH MENTOR MEMORYGEL 375CC SILICONE BREAST IMPLANTS WHICH THE PATIENT REPORTED THE FOLLOWING: IN 2018 I STARTED EXPERIENCING SEVERAL METABOLIC, DIGESTIVE, NEUROLOGICAL, AND IMMUNE ISSUES. I HAVE BEEN TESTED FOR LUPUS, AND FOOD SENSITIVITIES, AND EVERYTHING COMES BACK 100% NORMAL. HOWEVER, SOME OF MY INFLAMMATORY TESTS HAVE COME BACK A LITTLE ON THE HIGHER SIDE BUT, STILL CONSIDERED NORMAL RANGE. AFTER RESEARCHING THIS I HAVE FOUND THAT IT MAY BE LINKED TO BII (BREAST IMPLANT ILLNESS). THE ISSUE WAS NOT CONFIRMED BY THE PHYSICIAN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR 1 OF THE 2 IMPLANTS.