Composix Kugel Mesh Patches, used to repair ventral (incisional) hernias caused by thinning and stretching of scar tissue post-surgery, were recently recalled by manufacturer Davol, Inc., a subsidiary of C.R. Bard, Inc. Affected lots were recalled between December 2005 and March 2006.
The recall occurred after it was discovered that the “memory recoil ring,” which opens the patch, can break under the stress of placement in the intra-abdominal space. This can lead to serious intestinal conditions such as bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs). The FDA warned :
Surgeons and hospitals should stop using the recalled product and return unused units to the company.
Patients who have 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.
Davol, Inc. (a subsidiary of C.R. Bard) notified U.S. customers of the recall by letter on 12/27/05 via Federal Express.
We are reviewing these case for our clients who may have concerns about the use and placement of such devises after undergoing hernia repair.