Cranston, RIOver the past 13 months, Davol, Inc., makers of Kugel Mesh Hernia Patches, issued a recall and then expanded it twice. Here is a timeline of the Kugel Mesh Patch recalls.
December 27, 2005: C.R. Bard notifies US customers of a voluntary Class I recall of the Bard Composix Kugel Mesh X-Large Patch by letter delivered via Federal Express. The recall is issued after reports that a component of the patch, known as the memory recoil ring, may not withstand certain stresses associated with specific surgical placement techniques. Breakage of the memory recoil ring can cause bowel perforations and chronic intestinal fistulae. At the time, approximately 32,000 units had been sold worldwide.
March 24, 2006: An urgent letter is sent by Bard to hospital administrators advising them that the Class I recall has been expanded to include certain lots of the Large Oval and Large Circle products, as well as all lots of the Oval product.
A letter sent to distributors of the Kugel Mesh Patch states that the recall includes lots manufactured up to and including December, 2003, and notes that "there is a risk that the welds could break under the stress placed on the large sized products during placement, which could lead to potential patient complications such as abdominal pain, bowel perforation or chronic enteric fistulas."
Finally, a letter is sent to surgeons the same day requesting that they immediately stop using the specific products listed in the recall and give copies of the Important Patient Management Information to professionals who are managing patients already implanted with the recalled products.
The expanded recall is issued because Davol, Inc., has learned of further ring breaks, including cases of bowel perforation, ring migration through the abdominal wall, bowel obstruction, and one instance in which a patient died after developing septic shock, consumptive coagulopathy and acute myocardial infarction from surgery to repair bowel fistulas caused by perforation from the broken ring.
December 18, 2006: A lawsuit is filed against Davol, Inc. related to the Kugel Mesh Patch. The plaintiff in the case, filed in Rhode Island, claims failure of the Kugel Mesh Patch resulted in severe pain and required bowel dissection surgery to remove the Patch, which had become stuck to the plaintiff's bowel. The bowel dissection surgery resulted in chronically inflamed bowels. Lawyers for the plaintiff argue that Davol, Inc., knew that there was a possibility of failure in the Kugel Mesh Patch but did not properly warn the public.
January 10, 2007: Davol extends the recall to include Large Sized Composix Kugel Patches (oval and circle) due to additional reports of memory recoil ring breakage. Another product with the same component design is also recalled because of the potential for breakage.
The letter sent to medical professionals notes that a new product design will include several alterations designed to address problems of breakage. These alterations include increasing the recoil ring weld strength and increasing the recoil ring weld overlap.
Davol, Inc. is a subsidiary of C.R. Bard, Inc. The voluntary recall of the Kugel Mesh Patches was serious enough to warrant a Class I recall which is used in cases where the recalled device could potentially cause serious injuries, pain and possibly death.
Signs that there may be a problem with an implanted Kugel Mesh Patch include unexplained or persistent abdominal pain, tenderness at the implant site, fever, or other unusual symptoms. If you have any of these symptoms, contact your doctor immediately to discuss your options.
If you or a loved one has suffered bowel perforation or chronic enteric fistulae due to the Kugel Mesh patch, please contact a [Kugel Mesh] lawyer who will evaluate your claim at no charge.