Hernia Surgery Patch Failure: Composix Kugel Mesh Patch
Kugel Mesh Patch: Medical device conglomerate manufactures defective mesh patches used in hernia repair surgery. Numerous reports of hernia surgery complications have perpetuated the expanded mesh patch recall over many months to include further extended recalls. The serious hernia mesh patch problem continues to spread.
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The purpose of the Composix Kugel Mesh Patch is to prevent the hernia from pushing through weakened tissue walls, specifically when stomach muscles are too weak for surgery to repair the hernia.
The problem is caused by the mesh patch’s plastic memory recoil ring that cannot withstand the increased stress associated with certain surgical implant techniques.
According to the Food and Drug Administration (FDA) Recall Notice patients who have been implanted with a Composix Kugel Mesh Patch during hernia surgery should seek medical attention immediately if they experience symptoms that could be associated with hernia mesh patch memory recoil ring breakage. These symptoms include unexplained or persistent abdominal pain, fever, tenderness at the implant site, or other unusual symptoms.
Up to the latest hernia patch recall, there were 31 broken memory recoil rings, 20 of which led to pain and injury to the patient. In 11 cases the broken memory recoil ring migrated into or through the patient's abdominal wall, causing an infection. Seven patients suffered from bowel perforation, one person developed a bowel obstruction, and one person died after developing septic shock, consumptive coagulopathy (blood clotting), and acute heart attack after undergoing surgery to repair fistulae caused by the broken memory recoil ring.
Davol, Inc. is a subsidiary of C.R. Bard, Inc., a Murray Hill, New Jersey company engaging in the design, manufacture, packaging, distribution, and sale of medical, surgical, diagnostic, and patient care devices worldwide. At the time of the first recall in December 2005, the company sold approximately 32,000 units worldwide since 2002 and the products generated approximately $11 million in 2005 alone.
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