FDA Adverse Event Injury Summary report: N

SMOOTH ROUND GEL BREAST IMPLANT

MDR report key: 8174572 · Received December 18, 2018

Report

Report Number
MW5082186
Event Type
Injury
Date Received
December 18, 2018
Date of Event
September 15, 2008
Report Date
December 15, 2018
Manufacturer
MENTOR
Product Code
FTR
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

A 325 SMOOTH ROUND HIGH GEL BREAST IMPLANTS. WHILE PREGNANT WITH MY 1ST SON I INFORMED A LEFT ILIAC DVT AND SEVERAL OTHER BLOOD CLOTS IN LEGS. HE WAS BORN TONGUE TIED AND LIP TIED. THIS MADE IT VERY DIFFICULT TO BREASTFEED, ONLY BLOOD AND BLOOD CLOTS CAME OUT, HE ENDED UP IN THE HOSP DUE TO DEHYDRATION, SOURCE OF BLOOD WAS UNK ORIGINALLY, LUCKILY IT WAS FROM ME. IN 2013 MY SECOND SON WAS BORN, ALSO TONGUE TIED AND WITH EAR CANAL ABNORMALITIES. HE WAS NOT ABLE TO HEAR UNTIL HE WAS (B)(6) AND HAD SWALLOWING ISSUES. WE HAD TO HAVE A SWALLOW STUDY, HE WAS PARTIALLY ASPIRATING HIS FOOD AND DRINK DUE TO A PROBLEM IN HIS ESOPHAGUS, I FED HIM BREAST MILK WITH THE HELP OF A PUMP AND A THICKENING AGENT. TODAY BOTH OF MY CHILDREN ARE DEVELOPMENTALLY DELAYED, ONE IS TESTING HIGH ON THE AUTISM SCALE, I DO NOT HAVE A DEFINITE DIAGNOSIS FOR HIM YET. WE HAVE BEEN TESTING FOR 5 YEARS, SYSTEM ISN'T EASY. HE HAS BEEN DIAGNOSED WITH ADHD, ODD AND ANXIETY, HE HAS SAID HE HAS WANTED TO HURT HIMSELF AT (B)(6). LUCKILY TESTING HAS STARTED FOR MY (B)(6). LIFE IS INCREDIBLY DIFFICULT FOR THEM. I AM AN ACTIVE WOMAN WHO DOES YOGA, IS OUTGOING AND LOVES TO HAVE FUN, I HAVE ALWAYS BEEN STRONG FOR MY SIZE AND PEOPLE AROUND ME WOULD DESCRIBE ME AS UPBEAT. WELL THAT USED TO BE ME. OVER THE YEARS MY HEALTH HAS DECLINED AND I THOUGHT, WELL I AM GETTING OLDER, I AM STRESSED, THAT'S GOT TO BE IT. IT IS SO MUCH THAN THAT, MY BREAST IMPLANTS HAVE BEEN MAKING ME SICK FOR 10 YEARS. WHAT PROMPTED ME TO DO ADD'L RESEARCH WAS MY MEMORY LOSS AND BRAIN FOG. I AM SO SCARED TO CONVERSE WITH PEOPLE OUT OF FEAR I WILL LOSE WORDS, FORGET SOMETHING THEY TOLD ME OR SOUND DUMB. I FORGET ABOUT APPOINTMENTS, OR I GO ON THE WRONG DAYS. MY DR THOUGHT MAYBE MY INABILITY TO CONCENTRATE WAS ADHD AND NOW I AM ON MEDICATION FOR THAT, I USED TO BE SO SHARP, HAD TO HANDLE ON EVERYTHING, REMEMBERED WHERE EVERYTHING WAS, YOU COULDN'T GET ANYTHING PAST ME. SEVERE DEPRESSION, MOOD SWINGS AND ANXIETY WITH SUICIDAL THOUGHTS. MY BOYS ARE WHY I AM STILL HERE, SOME DAYS ARE SO UNBEARABLE. I AM NOW ON MEDICATION FOR THIS. FOR THIS - I HAVE TINGLING IN MY FINGERS, MY ARM AND IN MY TOES WHICH GO NUMB AND GET COLD. RIB AND STERNUM PAIN MOST OF THE TIME, HURTS TO BREATHE, WEAR A BRA, LAY OR SIT IN ONE POSITION FOR TOO LONG, ETC. NIGHT SWEATS, EXCESSIVE SWEATING OVERALL. I NEVER USED TO SWEAT MUCH, I WAKE UP DRENCHED. I AM EITHER SUPER COLD OR HOT. I SMELL DIFFERENT NOW. MY UNDERARMS SMELL SOUR, MY URINE SMELLS BAD. I GO OFTEN AND I FEEL MY BLADDER SPASM - MIGRAINES, THAT PUT ME IN BED. I NOW TAKE A DAILY MEDICATION FOR THOSE, PLUS WHEN I FEEL ONE COMING ANOTHER 3. I STARTED GETTING VAGINAL INFECTIONS AND ODOR. SKIN ISSUES, ADULT ACNE, PERIORAL DERMATITIS THAT WILL LAST FOR MONTHS, SCALP ISSUES AND HAIR IS DRY AND FALLING OUT, SKIN IS DRY. I HAVE AGED TREMENDOUSLY IN THE LAST COUPLE OF YEARS. MY EYES ARE NOT AS BRIGHT AS THEY USED TO BE AND ARE DRY, SO IS MY MOUTH. MY KNEES ARE STARTING TO HURT AND I GET SHARP PAINS IN MY HANDS. HEART PALPITATIONS, CHEST PAIN AND THE FEELING MY THROAT IS TIGHTENING, FEEL LIKE I'M HAVING A HEART ATTACK. SWOLLEN GLANDS IN NECK AND GROIN FOR 6 MONTHS OR MORE. FLASHES OF LIGHT IN MY EYES. EYES ARE SENSITIVE TO LIGHT. LOUD NOISES AND PRESSURE BOTHERS MY EARS. VENOUS INSUFFICIENCY IN LEGS AND REMOVAL, VERY LOW VITAMIN D. BRUISE EASILY, OVARIAN CYST, HAD SIGNIFICANT WEIGHT LOSS AND LEFT LIKE I WAS DYING. I WAS AT (B)(6), DUE INACTIVITY I PUT SOME BACK ON. I HAVE BECOME EXTREMELY TIRED AND WEAK, I WALK STAIRS AND GET WINDED AND MUSCLES BURN. I SHAKE WHEN I DO YOGA CLASSES. I FOUND A LUMP IN MY BREAST AT THE BASE OF MY RIGHT IMPLANT TOWARD THE UNDERARM. I HAD IT CHECKED OUT, WENT FOR A MAMMOGRAM AND IT WAS INCONCLUSIVE. I CONTINUE TO HAVE PAIN AND I STILL FEEL THE LUMP. MY BREASTS HURT, I FEEL SHARP PAINS AND MY RIGHT ONE BURNS CONSTANTLY. ULTRASOUND TO LOCATE SUSPECTED RUPTURE NEXT WEEK. WE HAVE BEEN LIVING A NIGHTMARE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1015980 SMOOTH ROUND GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR REF 350-3254BC 5839912
1015981 SMOOTH ROUND GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR REF 350-3254BC 5839912

Patients

Seq Age Sex Outcome Treatment
1 30 YR Congenital Anomaly| L| R| S ADDERALL| BIOTIN| MULTIVITAMIN | TOPIRAMATE| VITAMIN D| WELLBUTRIN