Hernia surgery is a fairly common procedure, with approximately 750,000 performed each year in the United States. But for those patients who have had the Kugel Mesh patch implanted as part of their hernia repair, this simple procedure can be painful or even fatal.
The U.S. Food & Drug Administration (FDA) initiated a recall beginning in December 2005 of the Bard(r) Composix(r) Kugel(r) Mesh Patch, a device used to repair incisional (or ventral) hernias. The patch is manufactured by Davol, Inc., a subsidiary of C.R. Bard. The patch contains a “memory coil ring” that allows the patch to be folded so it can be surgically implanted through an incision. The ring then springs open and the patch lies flat once it is in place. However, the ring within the patch can break, causing pain, bowel perforations, bowel obstruction, and life-threatening injuries.
The Kugel Mesh patch is estimated to have been used in 100,000 patients. More than 80 injuries and several fatalities have been reported to the FDA as a result of the use of the patch. Because the manufacturer, Davol, does not have access to patient records, it only notified its customers, who are hospitals and doctors. Although Davol has relied on
these hospitals and doctors to get the word out to patients, many patients have not been contacted…and many more patients may still be at risk.
If the ring in the patch breaks, patients may experience symptoms including unexplained or persistent abdominal pain, fever, tenderness at the implant site, or other unusual symptoms. Patients who have been implanted with these patches and who have these symptoms should seek immediate medical attention.
The FDA issued three recalls for the Kugel Mesh patch from December 2005 to January 2007. Six different sizes of the patch have been recalled, including extra-large oval, large oval, and large circle. If you think you may have a Kugel Mesh patch as a result of hernia surgery, it is best to consult with your doctor or surgeon.
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