The Composix Kugel Mesh Patch—manufactured by C.R. Bard, Inc. subsidiary Davol, Inc.—was first linked to dangerous product defects in December 2005. At that time, a product recall was conducted citing problems with the “memory recoil ring” in certain devices. Over the following year, the recall was expanded on three separate occasions to include at least six other Composix Kugel Mesh Patch products.

All federal suits have been consolidated in the United States District Court in Providence, Rhode Island. U.S. District Judge Mary M. Lisi has been assigned these cases for pre-trial management. There is a parallel litigation in Rhode Island state court which is overseen by Superior Court Judge Alice B. Gibney. The primary reason for the Rhode Island litigation is that Davol has its headquarters in Rhode Island.  The consolidated federal litigation is known as "multidistrict litigaction." At this time, discovery is being done against Davol which will include obtaining their internal documents and taking depositions of employees. Attorneys doing this work on behalf of all plaintiffs will focus on 1)what Davol knew about their defective products, 2)when they knew this, and 3)what did they do with the information once they had it.

Product Defect
Composix Kugel Mesh Patches are surgically implanted medical devices used to repair ventral and incisional hernias. The devices contain a plastic “memory recoil ring” that opens once the patch is implanted. It is this plastic ring that is defective and prone to breaking.

When one of these rings breaks, it can cause serious internal damage such as bowel perforations, intestinal fistulae (abnormal passages between organs/intestines), and severe abdominal pain.

Reported Injuries
At the time of the March 2006 recall, 31 cases of broken rings had been reported and 20 of those involved injuries. Among the reported injuries were:

Seven cases of intestinal punctures
Two cases of infection after a broken ring drifted into/through a patient’s abdominal wall
One case in which a defective ring moved down into a patient’s vagina
One case of intestinal obstruction
One death after a patient had surgery to repair internal fistulae caused by a defective Composix Kugel Mesh Patch

Thousands of patients have been implanted with potentially defective patches. Individuals who currently have a patch inserted in their abdomen should report any unusual symptoms, including fever or abdominal pain, to their physician immediately.

Recalled Patches
The recalled products include Composix Kugel Extra Large Oval, Oval, Large Oval, and Large Circle patches. If you or your loved one has been implanted with one of these devices and suffered injury as a result, you should consult with an attorney to find out if you are eligible for compensation to cover your medical expenses and other losses. We have interviewed many potential clients. Often clients have had multiple surgeries and have used various products. It will expedite matters if you confirm with your surgeon that you did in fact have a Kugel mesh. Your medeical records should include written documentation of the exact Kugel mesh, which includes size and product number. Preserving the removed mesh is very important and the hospital should be told that the entire product should be preserved, not just isolated samples. If you are getting one removed, you may wish to give the surgeon a disposable camera to photograph it.