Description of Event or Problem · 1
THE INTENT OF THIS FORM IS TO HAVE PRODUCT CODE 0010201 AND LOT NUMBER 43 EMD237 INCLUDED IN THE MANDATORY RECALL OF BARD COMPOSIX KUGEL MESH. FOLLOWING IS AN EXPLANATION OF THE HISTORY FOR THIS REQUEST. DESCRIBED FIRST IS HOW I LEARNED OF THE RECALL. WHILE VISITING MY MOTHER IN 2007, I VIEWED A TELEVISION ADVERTISEMENT. THE AD WAS SEEKING PARTICIPANTS IN A CLASS ACTION LAW SUIT AGAINST THE MANUFACTURERS OF THE FDA RECALLED SURGICAL MESH. SINCE I HAD SUFFERED FOUR (4) INCISION HERNIA SURGERIES BETWEEN 2002 AND 2004, IN WHICH SURGICAL MESH WAS REPLACED, I CALLED THE TOLL-FREE NUMBER. I WAS INFORMED AT THE TIME THAT BARD COMPOSIX KUGEL MESH PATCH WAS SUBJECT TO MANDATORY FDA RECALL DUE TO MANY FAILURES. AFTER RECEIVING MY MEDICAL RECORDS FROM MY SURGEONS, I DISCOVERED THAT THE VERY SAME MESH WAS IMPLANTED DURING THE SECOND SURGERY AND REMOVED DURING THE THIRD SURGERY. I AM CURRENTLY UNAWARE OF THE MFR OF THE SURGICAL MESH IMPLANTED DURING THE OTHER (3) SURGERIES. I ENROLLED AS A PLAINTIFF IN THE CLASS ACTION LAW SUIT AND AM REPRESENTED. SUBSEQUENTLY, I REREAD THE SPECIFICS OF THE FDA MANDATORY RECALL OF THE BARD COMPOSIX KUGEL MESH PATCH, AND THE AMENDED RECALLS TO INCLUDE ADDITIONAL PRODUCT CODES AND LOT NUMBERS. NOWHERE, TO THE BEST OF MY KNOWLEDGE, DOES THE PRODUCT CODE AND LOT NUMBER IMPLANTED IN MY SECOND SURGERY APPEAR IN THE MANDATORY FDA RECALLS. I WILL NOW PRESENT A BRIEF HISTORY OF MY SURGERIES AND THE ADVERSE EFFECT OF THE IMPLANTATION OF THE BARD COMPOSIX KUGEL MESH PATCH. THE FIRST HERNIA SURGERY, 2001 DID NOT TAKE, IT BURST THROUGH, AND THE SECOND HERNIA SURGERY IN 2002 HAD TO BE DONE WITH KUGEL PATCH. DR. DIAGNOSED BOTH HERNIA'S AND DID BOTH SURGERIES. THE THIRD SURGERY WAS DONE IN 2003 BY ANOTHER DR. FOR AN INFECTED AND RECURRENT INCISIONAL HERNIA. THE INCISON WAS 1/2 RED AND 1/2 NORMAL WITH THE 1/2 RED ALWAYS MUCH WARMER THEN THE OTHER NORMAL HALF AND WITH THE RED 1/2 HAVING LITTLE BUMPS, LIKE MARBLES, POPPING UP IN THE INCISION. DR(SECOND) ORDERED AN MRI OF MY INCISION AND DETERMINED FROM THE MRI THE BARD COMPOSIX KUGEL MESH PATCH NEEDED TO BE EXPLANTED. A FOURTH SURGERY WAS DONE ON THE FOLLOWING MONTH BY DR(SECOND) TO REMOVE MESH AND REPAIR A HERNIA. APPARENTLY THE MUSCLES TO WHICH THE MESH WAS BEING ATTACHED, WERE TOO WEAK TO HOLD, BECAUSE OF THE PREVIOUS SURGERIES. AS FOR ADVERSE EFFECTS, NOT SPECIFICALLY CAUSED BY THE BARD COMPOSIX KUGEL MESH PATCH, BUT SOME RESULTING FROM SURGERY, I OFFER THE FOLLOWING: INFECTION, FEVER, FRONTAL LOBE ANEURYSM REQUIRING EMBOLIZATION AND FOLLOW-UP, STROKE, EXACERBATION OF HYPOTHYROIDISM AFTER ANY SURGERY, REQUIRING MEDICATION, SURGERIES SHOCKED MY BODY AND THREW OFF ALL MEDICATIONS, COLLAPSED LUNG DURING ONE SURGERY DUE TO PAIN MEDICATION AND ANESTHESIA, WEIGHT GAINS DUE TO HYPOTHYROIDISM, BLOOD PRESSURE DUE TO WEIGHT GAIN, ON AND ON AN ON. DOSE OR AMOUNT: UNSURE OF EXACT SIZE, NOT SURE IF PRODUCT OR DEVICE. D&E COMLPLETED.; FREQUENCY: ONCE. ROUTE: 033. DATES OF USE: 2002 - 2003. DIAGNOSIS OR REASON FOR USE: RECURRENT ABDOMINAL INCISIONAL HERNIA. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO.