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. Ventral hernias are prevalent in the United States; in fact, the nation has the world's highest rate of deaths due to incisional hernias per year. In its recent medical device recall alert, the FDA noted 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. Fistulae affect the passages that connect organs and the intestines, and such ruptures can cause side effects including tenderness, abdominal pain, or fever. These can present an additional strain to hernia sufferers who already have undergone surgical intervention with the hernial patches and cause additional surgeries 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. Davol has withdrawn some Kugel Mesh Patches from the market in the past due to health concerns; it has also issued a redesigned product marked with labels that indicate the product was "redesigned for improved integrity".

The FDA's hernia mesh recall applies to the larger sizes of the Composix Kugel Mesh Patches. Because the patches have failed to "engage" the scar tissue that forms behind the post-operative area, the patches are considered defective. 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. For details about potential compensation on a hernia patch medical claim, an individual can contact an experienced attorney who will provide answers.