The affected patches are:
- Product Code: 0010202, Bard Composix Kugel Large Oval, 5.4" X 7.0"
- Product Code: 0010204, Bard Composix Kugel Large Circle, 4.5"
The new recall, which is in addition to earlier recalls in December, 2005, and January and March, 2006, affects Kugel Mesh Patches manufactured between January 1, 2004 and September 30, 2005.
In its letter to health care professionals, Davol noted that there is a potential for the ring welds to break if they are put under too much stress during implantation. Breakage of the welds can lead to serious problems such as abdominal pain, bowel perforation, or chronic enteric fistulas.
According to Davol, there were six reports of ring breaks which involved the Kugel Large Oval Patch. Of these incidents:
- One occurred during surgery and the Kugel Mesh Patch was not implanted;
- One occurred during surgery and the ring was removed but the mesh was left implanted;
- One occurred in which a broken ring migrated into the abdominal wall. The ring was removed but the mesh was left implanted;
- One occurred in which the mesh was taken out due to abdominal pain. At the time, doctors noted the Kugel Mesh ring was broken; and
- Two incidents were reported (but not verified) in which the mesh was taken out and doctors noted bowel perforation and broken Kugel Mesh rings.
Davol stated in its letter that the majority of patients with the Kugel Mesh Patch will still benefit from it and that the risk of removing the device is still greater than the risk associated with leaving the Patch in place. Doctors are advised to identify patients with the recalled Kugel Mesh Patches, inform them of the recall, determine if they have symptoms of a broken patch, and determine with each patient individually whether or not the Patch should be removed. In some cases, doctors can remove the broken ring while leaving the Kugel Mesh Patch itself in place.
Additionally, Davol is voluntarily withdrawing all remaining Bard Composix Kugel Large Oval and Large Circle Patches that have the same design as the lots included in the expanded recall, including those manufactured between October, 2005 and October, 2006. The company has come up with a plan to strengthen the memory recoil ring; including increasing the strength of the ring weld and increasing the ring weld overlap.
Symptoms of a Kugel Mesh memory recoil ring break include unexplained or persistent abdominal pain, tenderness at implant site and fever. If you have a Kugel Mesh Patch implanted and notice any of those symptoms, contact your doctor immediately to discuss your options.