Murray Hill, NJThe US Food and Drug Administration and Davol, Inc., have recalled Bard Composix Kugel Mesh Patches. The Kugel Mesh Patches were recalled because a component of the patch, known as the memory ring, can break under the stress of placement.
Kugel Mesh Patches are used to repair ventral hernias that are caused by thinning or stretching of the scar tissue that can form after surgery. The patch is placed behind the hernia and held open by a memory recoil ring. The ring allows the patch to be folded for insertion through a small incision and spring open and lay flat once the Kugel Mesh Patch is in place.
In some cases, the stress of placement during surgery can lead the ring to break, causing serious problems for the patient. Bowel perforation and/or chronic enteric fistulae (abnormal connections between the intestines and other organs) are among the complications that can result from a broken memory ring.
If you have had one of the recalled Kugel Mesh Patches implanted and you notice any of the following symptoms, seek medical attention immediately. Symptoms associated with ring breakage include unexplained or persistent abdominal pain, fever, tenderness at the implant site and other unusual symptoms.
Surgeons and hospitals have been advised to stop using the Kugel Mesh Patches immediately and return all unused units to Davol.
The recall includes the oval "midline" size (product code 0010209), the large oval manufactured before 2004 (0010202) and the large circle (0010204) products. Also included are the extra-large patches.
Davol, Inc. is a subsidiary of C.R. Bard. The recall does not affect any of the company's other hernia products. Kugel Mesh Patches have been sold world-wide.
If you or a loved one suffered from bowel perforation or chronic enteric fistulae, please contact a [Kugel Mesh] lawyer who will evaluate your claim at no charge.