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Hernia Mesh Patch Recall

Author : Gary Anderson

Submitted : 2010-07-05 21:59:46    Word Count : 496    Popularity:   39

Tags:   Hernia mesh recall, Hernia mesh lawsuit, Hernia mesh lawsuit, Kugel mesh settlement, Hernia mesh recall, Hernia patch recall

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A hernia mesh patch recall has been issued for a number of hernia mesh patches. If you received a hernia mesh patch, it is important to know which recalls have been issued.

What does a hernia mesh patch do?

A hernia mesh is a patch that 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.

What problems are associated with hernia mesh patches?

The hernia mesh patches that have been recalled were manufactured by Davol, Inc., and released under the brand names Bard, Composix, and Kugel. In some cases, the ring in these hernia repair mesh patches has broken. This has caused severe injuries to patients’ internal organs and tissue, including bowel obstructions, bowel perforations, and chronic enteric fistulas. Davol initially blamed the surgeons who installed the hernia repair mesh patch for the broken rings. Davol claimed that the doctors made mistakes which caused the breaks in the rings. However, tests conducted by Davol revealed that the failure almost always occurred at the spot where the ring was welded together, which was done by the company.

What recalls have been issued?

On December 22, 2005, Daval, Inc. recalled its extra large hernia mesh patch. In March 2006, the recall was expanded. The lots manufactured prior to January 2004 were recalled during the March 2006 expansion. Since the March 2006 recall expansion, Davol received four confirmed complaints of recoil ring breakage from one of their product codes manufactured between January 2004 and September 2005.

Davol notified U.S. customers of the initial recall by letter on December 27, 2005, which it sent via Federal Express. On March 24, 2006, Davol issued letters to hospitals and health care professionals alerting them to the additional recalled products. The letters included updated Instructions for Use (“IFU”) clarifying the proper insertion technique and Supplemental Patient Management Information.

On January 10, 2007, Davol, Inc. issued another hernia mesh patch recall for patches that were manufactured before October 2005. Davol sent letters to health care professionals and distributors notifying them of the most recent expansion of this recall of specific lots of Bard, Composix, and Kugel mesh patches. The letter stated that surgeons and hospitals should stop using the recalled product and return unused units to the company.

When should you seek medical attention?

The FDA recommends that patients who have been implanted with one of the recalled devices seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.

Author's Resource Box

John Larson is the author of this article on Hernia Mesh Recall.
Find more information about Hernia Patch Recall here.




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