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Defective Medical Devices

Recall Issued for Kugel Hernia Mesh Patch

This Alert Affects:

Patients who have been implanted with the Composix Kugel Hernia Patch and suffered one of the injuries below.

Damages
The Kugel Mesh Patch has caused bowel obstruction or strangulations, bowel perforation, severe adhesion, sepsis, peritonitis, abdominal and digestive injuries and death.
Company(ies)
Bard Davol
Additional Details
The Composix Kugel Hernia Patch was used in hernia repair surgery (ventral, incisional and/or abdominal hernias).
Date
The Composix Kugel Hernia Mesh was recalled in December 2005.

The Composix Kugel Hernia Mesh Patch was designed to repair incisional hernias caused by stretching of scar tissue that forms after surgical operations. The Kugel Mesh Patch, which is held open by a memory recoil ring, is put behind the hernia through a small cut. Unfortunately, this ring can break and lead to life-threatening complications.

Patients implanted with the Kugel Mesh Hernia Patch have experienced bowel perforations, chronic fistulas, bowel obstructions, peritonitis and sepsis. Although the FDA issued a Class I recall, the most serious recall that can be issued, many patients had already experienced irreversible damage.

Davol first heard of complaints associated with the Kugel Mesh Patch in 2002. The company asserted that these complaints were not substantial enough to announce the patch’s complications to the public. In addition, Davol claimed that these side effects were not caused by the recoil ring, but rather by physician errors. Finally, in 2005, after several tests, the Kugel Mesh Hernia Patch was deemed defective.

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