Ventral hernia sufferers are rushing to their doctors after hearing that the federal Food and Drug Administration (FDA) has issued an updated recall for Bard's Composix Kugel Mesh Patch. The patch, which is used in hernial repair surgeries, was first recalled in late 2005, but the FDA has posted another recall which affects more of the implantable mesh patches on the market. The U.S. has the world's highest rate of deaths due to incisional hernias per year.
The FDA's alert states that the Composix hernia patch can break inside the intra-abdominal space of the patient's belly, causing chronic intestinal fistulae and bowel rupture or perforation. Intestinal fistulae affect the passages connecting the intestines and other organs, and such ruptures can cause side effects such as abdominal pain, tenderness and fever. These can present additional strain to hernia sufferers who have already undergone surgical intervention with the hernial patches and require additional surgeries to repair the damage.
Composix Kugel Hernia Mesh Patches are manufactured by the Bard subsidiary of Davol. Davol also manufactures and markets devices for hysteroscopy, wound management, laparoscopy, and orthopedics. The hernia patch recall affects Extra Large Oval, Oval, Large Oval, and Circle sizes of the kugel mesh patch, including product codes 0010202 and 0010204. Davol has withdrawn some Kugel Mesh Patches from the market in the past due to health concerns and also issued a redesigned product marked with labels that indicate the product was "redesigned for improved integrity".
The hernia-mesh recall applies to larger Composix Kugel Mesh Patch sizes. Composix patches are inserted behind incisional hernias in an attempt to reinforce stretched or thinned post-operative scar tissue. The defect occurs when the Composix patches fail to engage properly. The "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 serious side effects for hernia patients.
If you had a ventral (incisional) hernia surgery involving a Composix Kugel Mesh Patch, contact your doctor immediately to see if you need the device removed or replaced. If you have suffered from side effects or symptoms due to your implantable mesh patch, get in touch with an experienced medical device attorney to find out about your legal rights in this matter. You may be eligible for compensation for your present and future medical bills, lost wages and other expenses associated with the defective mesh hernia patches.
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