Hernia Patch Recall Affects Thousands of Patients

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.

Bard, a subsidiary of Davol, are responsible for manufacturing the faulty patches known as Compsix Kugel Mesh Patches. 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. The memory recoil ring has allegedly failed to spring open under the strain of placement, thus causing the adverse side effects previously stated. If you had a ventral (incisional) hernia surgery involving a Composix Kugel Mesh Patch, you may be affected.

Contact your doctor immediately to see if the hernia patch recall affects you and if you need the device removed or replaced. 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.

Article Source: http://articles.drbonomi.com

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