Description of Event or Problem · 1
I HAD A PROPHYLACTIC BILATERAL MASTECTOMY FOR CHEK2 ONCOGENE MUTATION WITH SILICONE TISSUE EXPANDERS ON (B)(6) 2017 AND SILICONE IMPLANTS ON (B)(6) 2017. THE IMPLANTS WERE THE ALLERGAN NATRELLE INSPIRA COHESIVE BREAST IMPLANT 560 CC FOR BOTH LEFT AND RIGHT. LEFT IMPLANT: REF SCX-560, SN (B)(4), RIGHT IMPLANT: REF SCX-560, SN (B)(4). WITHIN FOUR TO SIX WEEKS, SIGNIFICANT HEALTH PROBLEMS AND DECLINE BEGAN. I GOT CARPAL TUNNEL SYNDROME IN BOTH ARMS, INTENSE, DEBILITATING, EXCRUCIATING BILATERAL JOINT PAIN AND INFLAMMATION (SHOWN ON NUCLEAR BONE SCAN ON (B)(6) 2017) FROM TOP TO BOTTOM, ALL JOINTS INCLUDING HANDS AND FEET. (ALSO SHOWN ON REPEAT NUCLEAR BONE SCAN PERFORMED ON (B)(6 2019). SEVERE PERIPHERAL EDEMA, SIGNIFICANT EDEMA IN FEET, ANKLES, HANDS AND FACE; TWENTY FOUR HR URINE ELEVATED PROTEIN IN URINE, FREE LAMBADA LT CHAINS, UR< 0.05 LOW/KAPPA/LAMBADA RATIO, U > 36.80 HIGH, SEVERE COGNITIVE DECLINE, MEMORY LOSS, INABILITY TO THINK CRITICALLY, EMOTIONAL SWINGS THAT I DID NOT USED TO HAVE. NUMBNESS, TINGLING ALL OVER BODY. HORRIBLE RASH AT BREAST AND SURGICAL INCISION SITES. DEBILITATING CHRONIC FATIGUE THAT PROHIBITS ME FROM WORKING AND DOING MY FORMER ACTIVITIES. COULD BARELY WALK. MY ENTIRE HEALTH CONDITION WENT FROM 4 TO 5 TIMES A WEEK UP TO 4 MILES TO BE BEDRIDDEN, UNABLE TO WORK, IN FMLA AND REASONABLE ACCOMMODATION AT WORK. I'VE HAD TO TAKE LARGE AMOUNTS OF NARCOTICS, ANTI-INFLAMMATORY PAIN PATCHES, CHIROPRACTIC, ACUPUNCTURE, MASSAGE, LYRICA, GABAPENTIN, VALIUM/FLEXERIL FOR MUSCLE RELAXERS. NOTHING WORKED EXCEPT NARCOTICS PROVIDED SOME RELIEF. COULD NOT SIT UP OR GET OUT OF BED ON ANY DAYS. THE PAIN WAS OVERWHELMING AND EXCRUCIATING, EVEN THE NARCOTICS COULD NOT CONTROL IT NOR KEEP IT GONE FOR LONG. THE CARPAL TUNNEL ONSET WAS SUDDEN AND I COULD NOT FEEL MY ARMS FROM THE SHOULDERS ON DOWN BUT WOULD THEN HAVE BURNING PAIN, TINGLING AND NUMBNESS. ELEVATED LIVER ENZYMES, GGT, LDH, ELEVATED PLATELETS. BONE MARROW BIOPSY SHOWED ALL SORTS OF ABNORMALITIES AS WELL AS MONOCLONAL LYMPHOCYTOSIS OF UNCERTAIN SIGNIFICANCE(MLUS). I ALSO GOT INFLAMED SWOLLEN THYROID GLAND CONSISTENT WITH HASHIMOTO'S OR GOITER. DIFFICULTY SWALLOWING, COMPLETE LOSS OF APPETITE BUT GAINED 30 POUNDS ALTHOUGH I COULD RARELY EAT. MY BLOOD PRESSURE WHICH HAD ALWAYS BEEN 110/70 WAS NOW UP TP THE 170-190S/90-110S. ELEVATED A1C AND FASTING GLUCOSE WAS EXTREMELY ELEVATED DESPITE NOT EATING. SOME DAYS I WOULD GO ALL DAY WITHOUT URINATING. A PET SCAN IN (B)(6) 2018 SHOWED HILAR AND MEDIASTINAL LYMPHADENOPATHY AND HYPERMETABOLIC TRACER UPTAKE. EBUS SHOWED POSITIVE FOR SARCOIDOSIS. CHRONIC MIGRAINES STARTED. ALONG WITH HEART PALPITATIONS I HAD SEVERAL ABNORMAL EKGS. IN FALL IF 2018 I GOT CAPSULAR CONTRACTURE IN MY BREAST IMPLANTS, WORSE ON LEFT SIDE THAN RIGHT BUT BOTH EXTREMELY PAINFUL. MY INFLAMMATORY MARKERS, WHICH HAD BEEN REPEATEDLY TESTED IN THE PAST AND ALWAYS NEGATIVE WERE NOW POSITIVE FOR ANA=/>1:640 WITH ANA PATTERN: SPECKLED. A PREVIOUS ANA IN (B)(6) 2018 HAD SHOWN BORDERLINE AT 1:80. PRIOR TO THIS ALWAYS NEGATIVE. IN (B)(6) 2018 I GOT SECONDARY ADRENAL INSUFFICIENCY MORNING CORTISOL WAS 2.6 UG/DL FURTHER TESTING HAS SHOWN LOW MORNING CORTISOL AND ACTH. CAUSE UNKNOWN. ACTH STIMULATION DID ELEVATE MY CORTISOL BUT MY REGULAR MORNING CORTISOL HAS BEEN 2.8 UG/DL AND MY ACTH (ADRENOCORTICOTROPIN) WAS 5< (ESSENTIALLY UNREADABLE). SO MY PITUITARY GLAND IS NOT PUTTING OUT THE ACTH TO STIMULATE CORTISOL PRODUCTION. COMPETE LOSS OF SEX DRIVE ( I DID NOT LOOSE MY SEX DRIVE AFTER MY HYSTERECTOMY AND SALPINGO - OOPHORECTOMY IN (B)(6) 2016). ONLY AFTER SECONDARY ADRENAL INSUFFICIENCY AND ILL HEALTH FOR SO LONG DID I LOSE IT. MY LIFE HAS BEEN IRREVOCABLY CHANGES/DAMAGED FROM ALMOST THE MOMENT I GOT THE SILICONE IMPLANTS. I HAD THEM REMOVED ON (B)(6) 2019 AND AM HOPING MY SYMPTOMS WILL RESOLVE. DETERIORATING HEALTH ISSUES. I HAD REQUESTED THAT MY SURGEON KEEP THE IMPLANTS BUT HE DID NOT DO SO. THE HOSPITAL DISPOSED OF THEM. HOWEVER HE REQUESTED SURGICAL PATHOLOGY SO THEY DO HAVE SLIDES. RESULTS STATE: DIAGNOSIS: A. LEFT BREAST CAPSULE, CAPSULECTOMY: FIBROTIC CAPSULAR TISSUE WITH FOREIGN BODY GRANULOMA AND MILD CHRONIC INFLAMMATION- NEGATIVE FOR MALIGNANCY B. RIGHT BREAST CAPSULE, CAPSULECTOMY:FIBROTIC CAPSULAR TISSUE WITH FOREIGN BODY GRANULOMA AND MILD CHRONIC INFLAMMATION-NEGATIVE FOR MALIGNANCY. FDA SAFETY REPORT ID # (B)(4).