Davol Patch Information
The FDA recommends seeking medical attention immediately if symptoms that could be associated with Davol Patch ring breakage exist. These symptoms include persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.
In December of 2005 a medical device marketed to assist in hernia repair known as the Davol Patch was partially recalled. A mechanical defect was causing the Davol Patch to fail after being implanted in hernia patients. Davol Inc. proceeded with a voluntary partial recall in 2005; in 2007 the larger Davol Patches were recalled as well.
Some confusion over the product name has emerged in the lawsuits over the Davol Patch: it is also known as the Bard Composix Kugel Hernia Mesh Patch or the Kugel Mesh Patch. The consumer lawsuits filed by patients who have been harmed by this device have been directed at Davol Incorporated, the company who manufactures the patch. For that reason, many of the suits filed as consumer protection actions have collectively been known as legal action taken against the manufacturer of the Davol Patch.
The Davol Patch is a fine mesh patch in oval or circular form that is attached to a flexible plastic ring. The patch is folded over during surgery in order to insert it behind the herniated area. The plastic ring then springs back into its original shape, allowing the Davol Patch to act as a mesh support for the repaired hernia. The ring in the Davol Patch has failed at the point where its two ends are welded together; it has done so enough times that consumer protection has caused the company to engage in multiple recalls.