New York, NYEarlier this month, the United States Food and Drug Administration (FDA) announced that it had upgraded the recall category of several Composix Kugel Mesh Hernia Patches to Class 1.
The announcement, issued February 1, was made because exposure to defective Kugel Mesh Patches carried a reasonable probability of causing serious health problems or even death. The FDA noted that breakage of the memory recoil ring portion of the Kugel Mesh Patch could lead to "bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs)."
Patients who have had a hernia repaired with the use of a mesh patch should speak to their surgeons to determine whether or not the recalled Composix Kugel Mesh Patches were used. Those who have been implanted with the recalled Kugel Mesh Patches should seek medical attention if they have unexplained or persistent abdominal pain, tenderness at the implant site, fever, or unusual symptoms.
Additionally, the FDA instructed surgeons and hospitals to discontinue use of the recalled patches and return any unused products to the company immediately.
Units affected by the reclassification include the Bard Composix Kugel Large Oval, 5.4"x7" and the Bard Composix Kugel Large Circle, 4.5". Both were initially recalled on March 24, 2006.
Prior to this announcement by the FDA, Kugel Mesh Patches were recalled three times. The first recall occurred December 27, 2005, the second occurred March 24, 2006, and the third occurred January 10, 2007.
At least one person has died after surgery to repair bowel fistulae caused by perforation from a broken memory recoil ring. Furthermore, one lawsuit has already been filed and others are pending in response to injuries suffered as a result of defective Kugel Mesh Patches. Lawyers for the plaintiff are arguing that Davol, Inc., makers of the Kugel Mesh Patch, knew about the possibility of failure in the patches but failed to warn the public.
If you or a loved one has suffered bowel perforation or chronic enteric fistulae due to the Kugel Mesh patch, please contact a [Kugel Mesh Attorney] who will evaluate your claim at no charge.