Description of Event or Problem · 1
KUGEL MESH: RECALL OF CERTAIN COMPOSIX KUGEL MESH PATCH USED IN HERNIA REPAIRS. I HAD THE KUGEL MESH PUT IN AND OUT 3 TIMES AND STILL HAVE ONE IN THAT NEEDS TO BE TAKEN OUT. DON'T KNOW WHERE TO GO FOR HELP. PLEASE ADVISE ME ON WHAT TO DO. I KNOW THERE WAS 10 ON THE LIST THAT WAS RECALL. OUT OF TEN, THEY USE 3 ON ME. I WAS NEVER REALLY FIX UP RIGHT BECAUSE I AM STILL IN PAIN NOW. (B)(6) HOSP DID THE WORK ON ME, I HAVE BEEN GOING THERE FOR YEARS, LOOK THERE FOR MY RECORDS ((B)(6)). SPECIFIC LOT NUMBERS OF THE COMPOSIX KUGEL MESH PATCHES, USED TO REPAIR VENTRAL (INCISIONAL) HERNIAS CAUSED BY THINNING AND STRETCHING OF SCAR TISSUE POST-SURGERY, WERE RECENTLY RECALLED BY MFR DAVOL, INC., A SUBSIDIARY OF C.R. BARD, INC. THE RECALL OCCURRED AFTER IT WAS DISCOVERED THAT THE "MEMORY RECOIL RING," WHICH OPENS THE PATCH, CAN BREAK UNDER THE STRESS OF PLACEMENT IN THE INTRA-ABDOMINAL SPACE. THIS CAN LEAD TO SERIOUS INTESTINAL CONDITIONS SUCH AS BOWEL PERFORATION AND/OR CHRONIC INTESTINAL FISTULAE (ABNORMAL CONNECTIONS OR PASSAGEWAYS BETWEEN THE INTESTINES AND OTHER ORGANS). AFFECTED LOTS WERE RECALLED BETWEEN DECEMBER 2005 AND MARCH 2006. IN MARCH, THE FDA SENT A RECALL LETTER TO PHYSICIANS AND PTS ADVISING PTS IMPLANTED WITH ONE OF THE RECALLED LOT NUMBERS TO SEEK IMMEDIATE MEDICAL ATTENTION IF THEY EXPERIENCE PERSISTENT OR UNEXPLAINED ABDOMINAL PAIN, FEVER, TENDERNESS AT THE IMPLANT SITE OR OTHER RELATED SYMPTOMS. PTS SHOULD ALSO CONTACT THEIR PHYSICIAN, IF THEY HAVE NOT DONE SO, FOR FURTHER EVALUATION. THIS RECALL IS PRODUCT CODE AND LOT SPECIFIC AND APPLIES TO THE LARGE SIZED PATCHES. I HAVE OTHER COPIES SO YOU MAY USE THESE. I BELIEVE THIS IS WHAT THEY USE IN ME. IT ALL ADDS UP ALSO IT IS A CLASS ACTION SUIT. I NEVER GOT PAID FOR IT. PLEASE TRY AND UNDERSTAND THAT I STILL NEED HELP AND I AM STILL HAVING PROBLEMS WITH MY BOWEL. I BELIEVE THE BANDS BROKE AGAIN. I HAVE ALL THE SYMPTOMS. PLEASE HELP. ALSO, I NEVER GOT THE MONEY.