Medical Devices
Composix Kugel Mesh Patch
The FDA issued a Class I recall for the Composix Kugel Mesh Patch—the
strongest recall available to the FDA and usually reserved for dangerous or defective
products that could cause serious health problems or death. The
Class I recall was issued on December 22, 2005, and then updated on March 31,
2006, to include additional lots of defective patches.
The Composix 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 FDA said surgeons and hospitals should immediately stop using the
recalled products and return the unused patches to the company.
Patients who have been implanted with one of the recalled devices should seek
immediate medical attention if they experience:
- Persistent or unexplained abdominal pain
- Fever
- Tenderness at implant site
- Any other unusual symptoms
If you or someone you know has suffered injuries as a result of a defective
Composix Kugel Mesh Patch, please
contact us
immediately.
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