FDA Adverse Event Injury Summary report: N

NATRELLE INSPIRA COHESIVE SILICONE BREAST IMPLANT

MDR report key: 8301300 · Received February 1, 2019

Report

Report Number
MW5083654
Event Type
Injury
Date Received
February 1, 2019
Date of Event
March 10, 2017
Report Date
January 31, 2019
Manufacturer
ALLERGAN
Product Code
FTR
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ALL I KNOW IS THAT BEFORE (B)(6) OF 2017, I TRULY WAS ¿LIVIN¿ THE DREAM¿. GREAT HUSBAND, THREE AMAZING KIDS, THE #1 TOP EARNER IN A NEW, EXPLODING HEALTH AND WELLNESS NETWORK MARKETING COMPANY. BUT AFTER GETTING IN THE BEST SHAPE OF MY LIFE AND WINNING 1ST PLACE AT AGE (B)(6) IN AN (B)(6) BIKINI BODYBUILDING COMPETITION, I TOOK MY JUDGES COMMENTS (¿WORK ON YOUR CLEAVAGE¿) AND MY POSING COACH¿S ADVICE (¿IF YOU WANT TO GO PRO, GET A BOOB JOB¿) TO HEART AND, AS MY (B)(6) BIRTHDAY GIFT TO MYSELF, I GOT BREAST AUGMENTATION. ALLERGAN¿S NATRELLE INSPIRA 365CC COHESIVE (¿GUMMY¿) SILICONE IMPLANTS. WITHIN A MONTH, SMALL CHANGES IN MY HEALTH BEGAN TO OCCUR. AN ALMOST-IMMEDIATE 10 POUND WEIGHT GAIN, BRAIN FOG, EYE ISSUES AND JOINT PAIN. THE JOINT PAIN FIRST SHOWED UP AS A PAIN IN MY WRIST SO SEVERE THAT I THOUGHT I HAD BROKEN IT SOMEHOW BUT, AFTER JUST 3 DAYS, IT SUDDENLY DISAPPEARED. THEN, A FEW MONTHS LATER, A SUDDEN SHARP KNEE PAIN HIT ME THAT FELT AS THOUGH SOMEONE HAD TAKEN A HAMMER TO MY PATELLA, BUT AFTER ALMOST 2 WEEKS IT WAS GONE AS QUICKLY AS IT CAME. DURING ALL OF THIS MY EYES BECAME SO GRITTY AND DRY THAT SOME MORNINGS IT FELT LIKE SOMEONE HAD PUT SAND IN THEM. MY VISION WORSENED. THEN MY EXCRUCIATING LEFT BUTTOCK/HIP PAIN STARTED. AS AN ENTREPRENEUR/BUSINESS OWNER AND PRIMARILY SELF PAY, I SOUGHT CHIROPRACTIC CARE FIRST, LEADING ME TO TWO AIRROSTI TREATMENTS AND SOME PHYSICAL THERAPY AT HOME. THE HIP/GLUTE PAIN ONLY WORSENED, SOMETIMES RADIATING ACROSS MY LOWER ABDOMEN TO WHERE I COULDN'T EVEN BEND OVER IN THE MORNINGS TO TIE MY SHOES, PUT ON PANTS OR EVEN FILL MY DOG¿S BOWL WITH WATER. OTHER TIMES, THE PAIN WOULD SHOOT THROUGH MY LEFT LEG AND GROIN TO WHERE IT WOULD SPASM EVERY TIME I PUT WEIGHT ON IT. I BEGAN TO TELL PEOPLE THAT I FELT LIKE SOMEONE HAD SAWED ME IN HALF AND PUT ME BACK TOGETHER IN THE NIGHT. STIFFNESS AND PAIN WOULD BECOME AN EVERYDAY OCCURRENCE AND SPASMS WOULD HIT ME SO HARD UPON STANDING UP OR GETTING UP OUT OF BED OR A CHAIR THAT IT WOULD ALMOST DROP ME TO MY KNEES. I TRIED STRETCHING, WALKING AND EVEN YOGA. IT PERSISTED BUT WOULD COME AND GO. I INITIALLY WROTE IT OFF AS PELVIC ADHESIONS (DUE TO MY 3 C-SECTIONS AND HYSTERECTOMY) BUT ALSO BEGAN TO WORRY THAT MAYBE IT COULD BE OVARIAN CANCER AS MY HYSTERECTOMY HAD LEFT ME WITH ONE OVARY ON THE LEFT SIDE THAT WAS HURTING, AND I HAD LOST BOTH MY PARENTS TO CANCER BEFORE I WAS (B)(6). I DECIDED TO GO AND SEE MY OB/GYN WHO DID A FULL HORMONE PANEL (WITH TSH - ALL NORMAL) AND AN OVARIAN CANCER BLOOD TEST (NEGATIVE) PLUS A VAGINAL ULTRASOUND (NEGATIVE). THE DOCTOR ALSO SENT ME FOR A MAMMOGRAM (NEGATIVE) AND MY FIRST-EVER BONE DENSITY TEST WHERE THEY INFORMED ME I HAD MILD OSTEOPENIA, AND ¿SHOULD DO MORE WEIGHT BEARING EXERCISES¿, (WHICH I FOUND QUITE IRONIC, AS I¿D BEEN WEIGHT TRAINING FOR TRAINING FOR THE PAST 4 YEARS). STILL IN PAIN AND SEARCHING FOR ANSWERS, I WENT TO SEE MY GASTROENTEROLOGIST TO RULE OUT ANYTHING DIGESTIVE. SHE STATED THAT SHE DOUBTED IT WAS RELATED TO MY COLON AS MY COLONOSCOPY FROM JUST TWO YEARS PRIOR WAS CLEAR. SHE SUGGESTED I GET AN MRI (WITH/WITHOUT CONTRAST) OF MY PELVIS. TO MY TOTAL SURPRISE, THE MRI OF MY PELVIS CAME BACK CLEAR BUT MY HIP-TO-HIP PAIN WAS STILL SO HORRIBLE THAT I DECIDED TO SEE AN ORTHOPEDIC HIP SPECIALIST FOR A SECOND OPINION. THE ORTHOPEDIC HIP SPECIALIST SAW NO PROBLEMS STRUCTURALLY, SAID IT COULD BE ARTHRITIS OR RADIATING PAIN FROM MY BACK AND REFERRED ME TO A LOWER LUMBAR SPECIALIST IN HIS SAME OFFICE. AFTER AN MRI OF MY LOWER LUMBAR, I WAS FINALLY DIAGNOSED WITH 3 BULGING DISCS BUT ONLY SLIGHT TO MODERATE IN NATURE. I ALSO SHOWED A ¿SLIGHT¿ ANNULAR TEAR ON MY RIGHT SIDE AND THE PHYSICIAN WAS PUZZLED AS TO WHY THE PAIN WAS PRIMARILY ON MY LEFT SIDE. OVERALL, HE SAID THAT NONE OF THESE ISSUES APPEARED TOO CONCERNING AND REFERRED ME FOR PHYSICAL THERAPY. IT WAS DURING MY SEARCH FOR ANSWERS THAT FRIENDS REACHED OUT, TOLD ME ABOUT BII AND SUGGESTED IT THAT COULD BE MY IMPLANTS. EXPLANTED YESTERDAY AND FEEL AMAZING!

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
91488 NATRELLE INSPIRA COHESIVE SILICONE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR ALLERGAN
91489 NATRELLE INSPIRA COHESIVE SILICONE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR ALLERGAN

Patients

Seq Age Sex Outcome Treatment
1 53 YR Disability