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KUGEL MESH PATCH FAILURE
by Jane Mundy
On January 10th , 2007 the FDA issued a "Class 1" recall of Bard Composix Kugel Mesh Hernia Patches. A "Class 1" category means that the defective product has a reasonable probability to cause serious adverse health consequences and even death.
Since the last recall expansion in March 2006, the manufacturer, Davol, Inc. (a subsidiary of C.R. Bard), received complaints of the recoil ring breakage in hernia patches manufactured between January 2004 and September 2005. The first Kugel Mesh Patches were recalled in December, 2005.
Davol notified health care professionals and surgeons by letters of the recall and the FDA stated on its website that surgeons and hospitals should stop using the recalled product and return unused units to the company.
The Kugel Mesh 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 reason for the recall is that the "memory recoil ring" that opens the Composix Kugel Mesh Patch after it has been inserted into the intra-abdominal space can break. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
The FDA has advised patients who have been implanted with one of the recalled devices to seek medical attention immediately if they experience symptoms such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.
If you have had a Bard Composix Kugel Mesh Hernia Patch implanted, you could be at serious risk, particularly if your hernia was repaired with a large Mesh Patch. Patients are advised to contact their hernia surgeon or the hospital where they had surgery to find out if the recalled Kugel Mesh Patch (there are several lot numbers) was used in their hernia repair.
For more information about the recall and a complete list of lot numbers recalled,
call Davol Customer Service at 1-800-531-4124 or visit the Davol website.
You may also want to seek legal help.
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