Davol, a subsidiary of C.R. Bard, Inc., is the company that manufactures the Composix Kugel Mesh Patch and has voluntarily issued a Class 1 recall and market withdrawal of its hernia patches. Davol has received complaints and reports of the hernia patch malfunctioning during and after surgery. The Composix Kugel Mesh Patch is considered a dangerous device because of the serious medical risks it poses.
The Composix Kugel Mesh Patch is designed to repair a ventral or incisional hernia that may develop after surgery from the thinning or stretching of scar tissue. The patch is placed behind the hernia through a small incision. A memory recoil ring deploys after placement and is meant to hold the patch in place.
Risks Involving the Composix Kugel Mesh Patch
The class 1 recall was issued because of several reports that the memory recoil ring malfunctioned either during or after surgery. The stress of surgical placement may cause the memory recoil ring to break. Some of the reports state that the broken ends of the memory recoil ring poked through the mesh and perforated the intestines causing conditions such as bowel perforation and chronic enteric fistulas.
Some of the symptoms caused by the breaking of the ring are:
- Unexplained abdominal pain
- Tenderness at the surgery site
If you or a loved one has experienced any of these symptoms, please seek medical assistance immediately.
Davol lists the product codes and lot numbers of the Composix Kugel Mesh Patches that are subject to the recall on their website. All healthcare professionals and physicians should discontinue use of the patches that are recalled and are urged to distribute information about the recall and patches to anyone who has the patch. You may find the information about the recall and the products being recalled by visiting the Davol site’s page about the Composix Kugel Mesh Patch Recall.
Thousands of patients have been treated with the Composix Kugel Mesh Patch. It is unknown how many patients will experience the unfortunate symptoms of this dangerous device.