The Bard® Composix® Kugel® Mesh Patch, also known as the Kugel Hernia Patch, is a medical device that uses a tension-free mesh repair technique, which can significantly reduce operating time and postoperative pain from hernia surgery. In December 2005, manufacturer Davol Inc. recalled the patch because the FDA reported that the “memory recoil ring” that opens the patch can break, which can lead to bowel perforations and chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
In January 2007, Davol/Bard and the FDA notified health care professionals of an expanded Class 1 recall and withdrawal of large oval and large circle patches. A Class 1 recall is the most serious category.
The FDA has urged patients implanted with the device to seek immediate medical attention if they experience abdominal pain, fever, tenderness at the implant site or any other unusual symptoms. If you received a patch, you should speak with your doctor immediately to discuss whether the patch should be removed or replaced.
To learn more about legal claims relating to Kugel Mesh Patch, you should consult an attorney who practices in the area of drugs and medical devices.
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