Description of Event or Problem · 1
I HAD SILICONE BREAST IMPLANTS INSERTED ABOUT 3 YEARS AGO. I WAS EXAMINED REGULARLY OVER THE 3 YEARS BECAUSE I WAS PART OF A SILICONE IMPLANT STUDY PRIOR TO THE FDA'S OFFICIAL APPROVAL OF SILICONE IMPLANTS FOR THE GENERAL PUBLIC. RECENTLY, I DECIDED TO HAVE THEM REMOVED DUE TO SOME DISCOMFORT AND DISSATISFACTION WITH THE RESULTS OF THE SURGERY. I SAW A NUMBER OF SURGEONS TO DISCUSS REMOVAL OF THE IMPLANTS AND WAS EXAMINED BY A NUMBER OF DOCTORS, NONE OF WHICH MADE A RECOMMENDATION THAT I GET AN MRI. NONE OF THEM EVEN SUSPECTED A RUPTURE. I CHOSE A SURGEON WHO AGREED TO REMOVE THE IMPLANTS WITHOUT REPLACING THEM. I WAS TOLD IT WOULD BE A FAIRLY STRAIGHT FORWARD PROCEDURE. DURING SURGERY, HE DISCOVERED THAT ONE OF MY IMPLANTS HAD RUPTURED AND IT APPEARED AS THOUGH IT HAD BEEN RUPTURED FOR A WHILE. DUE TO THE RUPTURE, THE SURGERY BECAME MORE COMPLICATED AS HE HAD TO SPEND A LOT MORE TIME CLEANING UP THE MESS CREATED BY THE RUPTURED SILICONE IMPLANT IN MY LEFT BREAST. IN THE PROCESS OF REMOVING THE SCATTERED SILICONE MORE BREAST TISSUE THAN ORIGINALLY EXPECTED WAS REMOVED DURING THE "CLEAN UP". FOLLOWING THE SURGERY I AM LEFT WITH A BREAST WHICH IS TAKING A LOT LONGER TO HEAL, I HAVE HAD A NUMBER OF PROBLEMS WITH LEFT BREAST FOLLOWING THE SURGERY INCLUDING A LOT OF FLUID BUILD UP AND MULTIPLE DRAINS INSERTED TO HELP WITH THE FLUID DRAINAGE AND HEALING AND I'M STILL EXPERIENCING PAIN. I AM ALSO LEFT WITH UNEVEN BREASTS DUE TO THE COMPLICATION OF THE RUPTURED IMPLANT, AND THE ADD'L BREAST TISSUE REMOVED FROM THE BREAST WITH THE RUPTURED IMPLANT. NOW MY REASONS FOR REPORTING THIS ARE: BECAUSE I BELIEVE THAT ALLERGAN PRODUCED A FAULTY IMPLANT WHICH LEFT ME IN THIS PREDICAMENT AS THERE IS NO OTHER INCIDENT -TRAUMATIC OR OTHERWISE- THAT COULD HAVE POSSIBLY CAUSED THIS RUPTURE AND THEY ARE NOT TAKING RESPONSIBILITY, IN FACT THEY ARE NOT EVEN HOLDING UP THEIR END OF THE WARRANTY BECAUSE I DISCOVERED THE RUPTURE DURING SURGERY AND NOT BEFORE WHICH LEADS ME TO THE SECOND REASON FOR REPORTING THIS: THERE IS NO WAY TO DETECT A RUPTURE IN A SILICONE IMPLANT EARLY ON BEFORE THE DAMAGE IS SEVERE. ACCORDING TO ALLERGAN, THEY RECOMMEND GETTING MRIS AFTER A CERTAIN NUMBER OF YEARS OR WHEN SUGGESTED BY A PHYSICIAN. I WAS EXAMINED MORE THAN MOST SILICONE IMPLANT PTS WOULD TYPICALLY BE, SINCE I WAS PART OF A STUDY WHICH REQUIRED CLOSE EXAMINATION AND REGULAR FOLLOW-UPS, AND I WAS NEVER TOLD TO GET AN MRI AND I WAS NEVER GIVEN ANY INDICATION THAT THE IMPLANT COULD HAVE RUPTURED EVEN WHEN I WAS EXPERIENCING SOME DISCOMFORT. CURRENTLY, ALLERGAN HAS THE IMPLANTS AND ARE INVESTIGATING THE CAUSE OF THE RUPTURE AND I'M STILL WAITING TO HEAR BACK FROM THEM. I DO NOT THINK THAT ALLERGAN HAS PUT THE APPROPRIATE MEASURES IN PLACE TO HELP PTS IDENTIFY RUPTURES EARLY ON TO AVOID LONG TERM PROBLEMS, SUCH AS PERMANENT DISFIGURATION AS I'VE EXPERIENCED. AND THEY CERTAINLY ARE NOT FOLLOWING APPROPRIATE BUSINESS PRACTICES TO RESOLVE ISSUES WHEN THEY OCCUR. IT IS COMPLETELY UNFAIR AND UNETHICAL BUSINESS PRACTICE TO REFUSE TO PAY OUT THE SURGICAL COSTS OF THE IMPLANT REMOVAL BASED ON WHAT THEY SEE AS A "LOOP HOLE" WHEN THEIR WARRANTY SAYS THAT SURGICAL AND IMPLANT REPLACEMENT COSTS WILL BE PAID IF AN IMPLANT IS FAULTY. I DO NOT WANT THEM REPLACED AFTER THE TRAUMA I HAVE EXPERIENCED WITH THE FIRST IMPLANTS BUT I DO WANT THE SURGICAL COSTS FOR REMOVING THE IMPLANTS TO BE PAID FOR BY ALLERGAN AS THIS IS WHAT THEIR WARRANTY IS FOR. I'M SURE THEY DO THIS TO MOST PTS IN THE SAME SITUATION BECAUSE OF ALL THE PEOPLE I KNOW WHO HAVE BREAST IMPLANTS, NONE ARE TOLD TO GET MRIS, SO I DON'T SEE HOW ANYONE IS GOING TO BE AWARE OF A RUPTURE UNTIL IT IS TOO LATE AND THE EFFECTS ARE IRREVERSIBLE. I CONSIDER MYSELF LUCKY TO HAVE DETECTED THE RUPTURE NOW, HAD I NOT TAKEN ANY ACTION TO HAVE THEM REMOVED, I MAY HAVE DISCOVERED THIS YEARS DOWN THE TRACK WHEN IT MAY HAVE CAUSED MUCH MORE DAMAGE TO MY LEFT BREAST, TO THE POINT WHERE I MAY HAVE LOST THE ENTIRE BREAST AND NOT JUST HALF OF IT! SO CLEARLY SOMETHING NEEDS TO BE DONE ABOUT THE PROCESS FOR DETECTING RUPTURED SILICONE IMPLANTS EARLY ON THE ALLERGAN NEEDS TO BE HELD RESPONSIBLE WHEN A FAULTY IMPLANT DOES RUPTURE IN ONE OF THEIR CLIENTS CAUSING IRREVERSIBLE DAMAGE.