Hernia Patch Withdrawal Affects Many Patients

Patients suffering from ventral hernia are rushing to their health care professionals or doctors after learning about the recent updated recall on Bard’s Composix Kugel Mesh Patch by the United States federal Food and Drug Administration. FDA recalled the patch, commonly used in hernial repair surgeries for the first time in late 2005 and announced another updated recall affecting more implantable mesh patches available in the market. Ventral hernias are more prevalent in the United States. In fact, the country accounts for the world’s highest death rates caused due to incisional hernias annually.

In its recent medical device withdrawal or recall, the FDA found that there is high possibility that the Composix hernia patch could break in the intra-abdominal space of the patient’s stomach, causing perforation or bowel rupture and intestinal fistulae. Fistulae affect the functioning of passage connecting the intestines and organs and ruptures like this may lead to severe side effects including fever, tenderness or abdominal pain. This can cause an additional strain to the patients of hernia who have already undergone surgical intervention with the Composix hernial patches and one has to undergo additional surgeries in order to heal the damage.

Bard, a subsidiary of Davol, manufactures Composix Kugel Mesh Patches. In addition to its hernia repair medical devices, the firm manufactures and markets various medical devices for orthopedics, wound management, laparoscopy and hysteroscopy.  The Circle Sizes, Oval, the Extra large Oval and Large Oval are now subjected to hernia patch recall or withdrawal encompassing product codes 0010202 and 0010204. In the past also, Davol withdrew some of its Kugel Mesh Patches off the shelves because of serious health concerns associated with its usage. It also introduced a redesigned medical devices marked with labels that indicated that the device was “redesigned for improved integrity”.

The Food and Drug’s Administration recall applies to the much larger size of the Composix Kugel Mesh Patches. According to the researchers, this defect occurs because the Composix patches inserted behind the incisional hernias to reinforce the stretched or thin postoperative scar tissue fails to engage appropriately there. Their memory recoil ring, a structural component that is designed in such a way that it opens the mesh patch after being inserted and folded. However, it can fail to break or spring open under the placement’s strain causing several side effects listed above.

If you have undergone a Composix Kugel Mesh Patch then you may be affected. Immediately contact your doctor or health care professional to check whether the recall of hernia patch affects you or not and if you need to replace or remove the device. If you believe that, you suffered from the symptoms and side effects of implantable mesh patch then seek the advice of an experienced medical device lawyer to learn more about your legal rights regarding this matter. He will help you infilling a lawsuit so that you may get some monetary compensation for your lost wages, medical bills and other expenses linked to the defective hernia patches.