Composix Kugel Mesh X
The Bard Composix Kugel Mesh X Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a "memory recoil ring" that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.
The "memory recoil ring" that opens the Bard Composix Kugel Mesh X can break under the stress of placement of the large sized products in the intra-abdominal (inside the belly area) space. This can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
On January 10, 2007, Davol, Inc., a subsidiary of C.R. Bard, sent letters to health care professionals and distributors notifying them of the most recent expansion of this recall of specific lots of Composix Kugel Mesh X Large Oval and Large Circle Mesh Patches for product codes 0010202 and 0010204. Surgeons and hospitals should stop using the recalled product and return unused units to the company.
Patients who have been implanted with one of the recalled devices should seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.
If you or a loved one has suffered an injury, illness or death, that seems to have been someone else's fault, call VanDerGinst Law at 1-866-843-7367 or click here for a FREE online case evaluation. The initial consultation is free of charge. If we agree to handle your injury case, we will work on a contingency fee basis, which means we get paid for our services only if, and when, there is a money recovery for you. In many cases a lawsuit must be filed before an applicable expiration date, known as a statute of limitations. So please call right away to ensure that you do not waive your right to possible compensation.
