A potential defect among the Bard Composix Kugel Mesh Patches has sparked a recall of the product. Because of the recall, the medical community is advising all patients who have undergone a surgical procedure within the last two to three years to be aware of the serious complications that exist for the defective product.
The patches, which are used in the repair of ventral (incisional) hernias, were first recalled by the federal Food and Drug Administration (FDA) in 2005. However, the FDA has issued a new hernia mesh recall for additional sizes of the Composix patches. The culprit? Some of the serious side effects that can occur because of the defective patches, specifically the defective memory recall rings, are severe intestinal fistulae, bowel rupture or punctured organs.
How Composix Mesh Patches Can Damage Your Intestines
Composix Kugel patches are inserted behind the area of a ventral hernia. The hernia patch snaps open to its full size to reinforce the hernia area that has been weakened; this occurs when a small incision is made and the memory recall ring is folded and placed in the incision. However, the “memory recall rings” in larger Composix mesh patches can fail to engage properly, causing the hernia patch to fail. This failure can cause complications in the interabdominal cavity, some of which include bowel issues or even intestinal fistulae.
Intestinal Fistulae Explained
Intestinal fistulae are common in patients with gastrointestinal ailments such as irritable bowel syndrome and Crohn’s disease.
They occur when bowel inflammation “tunnels” down through intestinal tissue, forming tubes that connect the bowel with the skin or other organs. This invasive form of intestinal inflammation can cause intense pain, irregular bowel drainage, or even cause the a bypass of certain intestinal segments. Infections or abscesses can form, endangering the victim’s life and leading to painful surgical procedures to repair the intestines.
Some intestinal fistulae respond to antibiotic treatment, but this treatment regimen usually does not cause the fistulae to close all the way and may lead to reopening. At times, a patient suffering from intestinal fistulae may be unable to control their bowel movements and will require surgical intervention to assist with the condition.
Are You Affected by the Mesh Patch Recall?
Individuals who know they have a Bard Composix Kugel Mesh Patch are encouraged to seek medical assistance immediately, as the risk for severe consequences only continues to increase. Individuals who have suffered because of the recall and defective patch are advised to contact a medical device lawyer who can offer legal counsel on the development of a lawsuit and thus potentially receive monetary compensation for their injuries.
Because of the injuries sustained from a mesh patch recall can be considered avoidable and the fault of manufacturers, the potential for being awarded damages may exist. Damages that may be awarded may assist a victim in paying medical bills associated with the mesh-induced injuries.
Source by Peter Kent