FDA Adverse Event Summary report: N

MENTOR IMPLANTS

MDR report key: 3161630 · Received June 4, 2013

Report

Report Number
MW5030480
Date Received
June 4, 2013
Date of Event
April 18, 2013
Report Date
June 4, 2013
Manufacturer
MENTOR
Product Code
FTR
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
WI, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD SILICONE IMPLANTS PLACED UNDER MY BREAST MUSCLE IN (B)(6) 2004. I HAD BREAST FED BOTH OF MY CHILDREN AND WANTED TO REPLACE THE VOLUME LOST AFTERWARDS. I MET WITH A PLASTIC SURGEON ABOUT MY OPTIONS AND HE SUGGESTED SILICONE IMPLANTS DUE TO THEIR SOFTNESS AND ABILITY TO FEEL MORE NATURAL THAN A SALINE IMPLANT. IN (B)(6) 2012 I BEGAN TO HAVE MEDICAL PROBLEMS. IT STARTED WITH THORACIC BACK PAIN THAT WAS INTENSE AND SEVERE. IT THEN RADIATED TO MY NECK, SHOULDERS AND CHEST AREA. I HAD NUMEROUS TESTS RUN ON ME AND NOTHING PROVED TO BE THE CAUSE FOR THE PAIN I WAS FEELING. I HAD MRIS, X-RAYS, BLOOD WORK, HAD EXTENSIVE PHYSICAL THERAPY, DEEP TISSUE MASSAGE AND ACUPRESSURE FOR MONTHS AND MONTHS. I HAD INJECTIONS AND VARIOUS MEDICATIONS GIVEN TO ME TO TRY AND HELP WITH THE PAIN. IT DID NOT HELP AND I CONTINUED TO WORE. I FELT LIKE SOMETHING WAS WRONG WITH MY IMPLANTS AND PERHAPS THIS WAS THE CAUSE SINCE THIS CAME ON FROM NOWHERE AND HAD ALWAYS BEEN HEALTHY AND QUITE ACTIVE. THE SURGEON WHO PLACED THEM INSIDE ME BARELY EXAMINED ME AND TOLD ME IN (B)(6) 2012 THAT IT WAS NOT FROM MY IMPLANTS AND TO SEARCH ELSEWHERE. HE DID NOT REQUEST AN MRI OF MY IMPLANTS OR ANY ADDITIONAL TESTING. AT THIS POINT I AM BECOMING MORE AND MORE FATIGUED, I AM FEELING HARDNESS IN MY LYMPH NODES IN MY BREAST AREA, AND NECK AREA. I CAN BARELY MOVE AND HAVE NO ENERGY. I AM NO MISSING A LOT OF WORK DUE TO MY SUDDEN AND PROBLEMATIC HEALTH ISSUES. I CONTINUED TO SEARCH FOR THE CAUSE. I WENT TO (B)(6) BASED ON THIS DOCTOR TELLING ME TO LOOK ELSEWHERE. AFTER A YEAR OF THIS CONTINUED PAIN AND SWELLING AND NUMEROUS DOCTOR BILLS I WENT TO ANOTHER PLASTIC SURGEON FOR HIS OPINION. HE IMMEDIATELY TOLD ME THAT MY BREASTS WERE TOO LARGE AND THAT THEY DIDN'T LOOK RIGHT. HE SAID I SHOULD HAVE THEM REMOVED TO HELP ME IMPROVE MY HEALTH. I HAD THESE IMPLANTS REMOVED ON (B)(6) 2013 AND AFTERWARDS THE SURGEON TOLD ME THAT THE IMPLANTS HAD COMPLETELY RUPTURED AND THAT THE IMPLANTS HAD LEAKED THE SILICONE EVERYWHERE. HE SAID IT WAS ONE OF THE WORSE CASES HE HAD SEEN. MY RECOVERY HAS BEEN HORRIBLE. MY LYMPH NODES ARE TOTALLY SWOLLEN AND IT IS OBVIOUS AND VERY VISIBLE. MY BACK PAIN FROM THE TRAUMA OF THE REMOVAL OF THE LEAKED SILICONE HAS BEEN INCREDIBLE. I HAVE HAD A MAJOR WEIGHT GAIN WHICH APPEARS TO BE FROM FLUID RETENTION AND MY LYMPHATIC SYSTEM APPEARS TO NOT BE WORKING PROPERLY. I NOW HAVE TO MEET WITH AN AUTOIMMUNE SPECIALIST TO TRY AND FIGURE OUT WHAT IS GOING ON SINCE NO OTHER DIAGNOSIS HAS BEEN DETERMINED. I HAVE NOW LOST MY JOB DUE TO MY FAILING HEALTH AND TRULY FEEL IT IS BECAUSE OF THE RUPTURED SILICONE THAT HAD BEEN LEAKED INTO MY BODY EVERYWHERE. I HAD BEEN DISMISSED BY THE ORIGINAL SURGEON WHEN CLEARLY HE SHOULD HAVE REQUESTED AN MRI WHICH WOULD HAVE SHOWN THE RUPTURED IMPLANTS. INSTEAD I WENT ANOTHER YEAR IN MAJOR PAIN WHEN MY IMPLANTS HAD LEAKED. MY NORMAL PHYSICIAN ALSO BELIEVES THERE IS AN AUTOIMMUNE ISSUE GOING ON WITH ME DUE TO THE IMPLANTS. MY LIFE HAS BEEN DRASTICALLY AFFECTED IN MANY WAYS. IT HAS DESTROYED MY HEALTH, CAREER, PERSONAL RELATIONSHIPS AND HAS FINANCIALLY DEVASTATED ME. I AM DISGUSTED THAT THE ORIGINAL SURGEON DID NOT STEP UP TO HELP DIAGNOSE THE POSSIBILITY THAT MY IMPLANTS HAD RUPTURED AND WAS CAUSING ME TO BE SICK. AT THE VERY LEAST HE SHOULD HAVE REQUESTED OR SUGGESTED THAT IN (B)(6) 2012. MY BREASTS LOOKED DEFORMED AND WERE TOO BIG AND THIS WAS VERIFIED BY MY OTHER SURGEON. I AM WANTING THIS TO BE DOCUMENTED TO TRY AND HELP OTHERS. (B)(6) NEVER RETURNED ANY OF MY EMAILS OR CALLS IN REGARDS TO THIS. THEY ONLY KEPT IN CONTACT WITH ME FOR THEIR STUDY THE FIRST YEAR AFTER HAVING THEIR IMPLANTS PLACED IN ME. FRUSTRATED AND UPSET, (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
245761 MENTOR IMPLANTS MENTOR SILICON FTR MENTOR

Patients

Seq Age Sex Outcome Treatment
1 41 YR Required Intervention