Minneapolis, St. Paul Injury Lawyers, Lord & Faris Can Help you Evaluate Your Kugel Claim.1-612-333-LORD.
Important Information for Kugel Hernia Repair Patch Recipients
The Kugel Hernia Repair Patch is a plastic mesh of “memory recoil” rings used as an implant for hernia repairs. It was approved by the FDA in 1996, but problems began to be reported in 2002 of injuries due to breakage of the rings.
The device was manufactured by Davol, and has since been the subject of a series of recalls by the manufacturer, prompted by action by the FDA after reports of problems.
The patch was developed with the intention of making hernia repairs easier and reducing patients’ postoperative pain. However, problems began to be reported due to ring breakage, especially in the extra-large patches. Initial problems from the Kugel Hernia Repair Patch were attributed to surgical error. Despite that claim, studies by the manufacturer indicated both design and manufacturing defects resulting in a breakage of the rings following surgical implant. Some have reported pain and problems requiring extensive bowel dissection surgery. The company issued a voluntary recall of the extra-large model of the device in 2002.
The FDA continued to receive reports of injuries relating to the patch subsequent to 2002, including at least one fatality. Its inspection of the manufacturing plant revealed severe deficiencies in the company’s tracking and response to patient complaints, and that they had understated the severity of the effects reported. A second recall was issued based on the FDA’s prompting. The first lawsuit involving a Kugel patch was filed in December of 2006 in Rhode Island.
Known dangerous side effects are:
Hundreds of lawsuits have been filed, and medical experts have indicated that those who have a Kugel hernia repair patch require constant medical monitoring for possible damage. Removal of the device is not recommended; such removal could cause additional injury.
If you or a loved one has had a hernia repair using a Kugel mesh repair patch, you may want to consider a free consultation with the dangerous medical device specialists at Lord & Faris. Call (612) 333-LORD today. There is no obligation and no cost to evaluate your situation and determine whether your device is covered by the recall notice We have three Twin Cities offices to serve you.
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