What is Kugel Mesh?
A hernia mesh lawsuit can be a person’s only way to seek legal justice for harm caused by complications caused by a defective Kugel Mesh patch. Kugel Mesh is a patch designed to make hernia operations easier and reduce post-surgical pain for patients. The FDA approved the patch in 1996. The Kugel Mesh patch consists of two layers of synthetic mesh surrounded by a flexible plastic “memory recoil ring.” It is implanted at the site of a hernia. The “ring” then springs into place, which allows the hernia to heal and re-grow around the patch. Kugel Mesh was introduced to the market by Davol Inc. In 2002, problems began to surface.
What problems are associated with Kugel Mesh?
In some cases, the ring in the Kugel Mesh patch 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 Kugel 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 has the FDA done?
In the early part of 2006, the FDA inspected Davol’s manufacturing plant. The FDA found major problems in the system for tracking and reporting patients’ complaints about the Kugel Mesh side effects. The FDA concluded that Davol had been downplaying the severity of the injuries associated with the Kugel Mesh patch, including that one person may have died from this product. These findings by the FDA prompted two recalls.
Kugel Mesh Recalls
Davol issued a Kugel hernia patch recall in December 2005 for the extra large model of the Kugel Mesh patch. This came as a result of Davol’s tests that uncovered the design and manufacturing flaws. Davol issued two more recalls for its Kugel Mesh hernia patches in March 2006 and January 2007, at the prompting of the FDA after reports linked the hernia patch to more than 80 injuries and several fatalities.
Where would we file the lawsuit?
Where a Kugel Mesh lawsuit can be filed depends on a number of factors. The first lawsuit was filed in Rhode Island in December 2006. Since then, many other hernia mesh lawsuits have been filed. Attorneys representing victims of the Kugel Mesh product allege that their clients have suffered pain and were required to undergo bowel dissection surgery. If you have experienced any Kugel Mesh side effects or complications, you should contact an experienced Kugel Mesh lawsuit attorney to discuss your legal options.
