In 2005, the U.S. Food and Drug Administration recalled the Composix Kugel Mesh Patch from Bard and again, recently recalled the patch, which is affecting thousands of hernia sufferers. The patch was recalled due to the possibility that intestinal fistulae or bowel rupture can occur if the patch breaks while inside of a patient. Serious side effects may occur and the patient will likely require surgery to repair the damage. Composix Kugel Mesh Patches are manufactured by Bard, a subsidiary of Davol. In addition to its hernia repair devices, the company makes and markets devices for laparoscopy, wound management, hysteroscopy, and orthopedics. The Extra Large Oval, Oval, Large Oval, and Circle sizes are subject to the hernia patch recall, which now encompasses product codes 0010202 and 0010204. Because of previous health concerns related to the patch, the company, Davol, had recalled some of the patches voluntarily; it has also issued a redesigned product marked with labels that indicate the product was "redesigned for improved integrity". The larger sizes of the hernia patch from Bard, are the ones the FDA's recall applies to. The defect occurs because the Composix patches, which are inserted behind incisional hernias in order to reinforce the thinned or stretched post-operative scar tissue that forms there, fail to engage properly. Their "memory recoil ring," a structural component designed to open the mesh patch after its has been folded and inserted, can fail to spring open or even break under the strain of placement, causing the side effects listed above. If you had a ventral (incisional) hernia surgery involving a Composix Kugel Mesh Patch, you may be affected. It is advisable for patients who have undergone surgery to repair a hernia, that they contact their medical professional immediately to protect themselves from the adverse side effects of a patch tear. For information about the legalities related to the patch recall, it is advisable to contact a medical device attorney to learn more. You may be eligible for monetary compensation for your medical bills, lost wages and other expenses associated with the defective hernia patches.
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