A new hernia mesh lawsuit has been filed against Covidien, Inc., accusing the company of concealing and downplaying the risks allegedly associated with its Parietex Mesh Composite device.
According to a complaint filed in the U.S. District Court, District of New Mexico, on October 5th, Janice Nowell received a 20 cm circular Covidien Parietex patch in October 2010 during hernia repair surgery.
“Thereafter, a CT scan of the abdomen and pelvis revealed a large fluid collection associated with the majority of the mesh,” the complaint states. “There was a sinus tracking from this to an area that had reopened in the left lower aspect of her incision.”
Novell underwent hernia mesh revision surgery on October 20, 2017, at which time an infected and disintegrated Parietex patch was removed.
“The Parietex Mesh caused Plaintiff serious injuries to her person including but not limited to abdominal pain, infection, tenderness at the site where the Product was inserted, trauma to the Plaintiff’s abdomen and thereafter severe emotional distress,” the lawsuit asserts.
“These symptoms of injury were caused by the Parietex Mesh defects, including but not limited to the effect of the disintegration and misshape of the Parietex Mesh on Plaintiff’s person. The physical structure of the disintegrated mesh caused trauma to the Plaintiff’s abdomen as it repeatedly came in contact with it,” the complaint continues. “Furthermore, the composition of the mesh itself caused and exacerbated infection since the materials used to construct the mesh were not chemically compatible to the Defendant’s tissue.”
The lawsuit notes that Covidien obtained regulatory clearance for Parietex mesh via the agency’s 510(k) program, which allows a device to come to market without undergoing human clinical trials if it can be shown that the product is substantially equivalent in design to a product previously approved by the agency.
The complaint further asserts that the FDA’s adverse event database has received numerous reports of Parietex mesh malfunctions, including serious pain in the groin, belly button and testicles, an electric jolt sensation between the testicles and legs, lower abdominal pain and spasms, and permanent disability.
“Contrary to Defendant’s representations and marketing to the medical community and to the patients themselves, the Product and other similar products made by the Defendant have high rates of failure, injury, and complications, fail to perform as intended, require frequent and often debilitating re-operations, and have caused severe and irreversible injuries, conditions, and damage to a significant number of women, including the female Plaintiff named in the Complaint, making them defective under the law.”