Covidien Parietex Lawsuit Claims Hernia Mesh Defective and Dangerous

Santa Clara, CACovidien and its parent company, Medtronic, was hit with another complaint last month. It joins 12 lawsuits pending in federal court and more than 140 state court cases all alleging Parietex Composite hernia mesh is defective and prone to failure. It results in patients needing revision surgery after suffering painful hernia complications, including severe adhesions, organ perforation, bowel obstructions, and infections.

This January 19, 2022 complaint, filed by Deborah Luzey in Massachusetts District Court before Judge Leo Sorokin also includes as defendants Tyco International, Surgical Solutions Group, and Sofradim Corp. for their part in manufacturing, selling and distributing Covidien Parietex mesh for use during hernia repair surgery. Luzey underwent ventral hernia repair surgery in 2018, when she received a Covidien Parietex Composite mesh. Just a few months later, during surgery unrelated to the mesh, her surgeon found a purulent draining wound near the ventral repair site and adhesions and subcutaneous tissue going into the mesh. Because the mesh’s collagen film barrier hadn’t lasted long enough for the body to heal, Luzey’s surgeon decided to remove the defective mesh. Unfortunately, the permanent injuries and pain couldn’t be removed: Luzey is seeking damages in excess of $75,000. (The case is Luzey v. Covidien, Inc. et al 1:22-cv-10076.) 

In 2019 a California man filed a similar complaint against Covidien and Medtronic. In 2013, Gary Northrup underwent laparoscopic ventral (abdominal) hernia repair and he was implanted with a piece of Parietex Composite mesh and a piece of Parietex Hydrophilic Anatomical Mesh in this repair. According to the lawsuit, Northrup developed abdominal pain, nausea, vomiting, and constipation, which caused multiple visits to the emergency room, more appointments with his primary care physician and surgery consultations and narcotic pain medication. By 2018, his surgeon removed mesh that had adhered to his tissues, which needed to be dissected to explant the mesh.

Hernia Mesh and the FDA

Even though the FDA has warned of hernia mesh complications after receiving hundreds of adverse event reports similar to Luzey’s and Northrup’s, no Covidien Parietex devices have been recalled. Currently, the FDA MAUDE database includes reports of adverse events for some Covidien Parietex mesh products. Some of the reports detail patients who suffered pain, needed additional surgeries, or were hospitalized due to the hernia mesh used in their surgical hernia repair.

The Cost of Covidien Parietex Hernia Mesh

Covidien introduced Parietex composite mesh in1999 and it was “the first hernia mesh to use a combination of polyester and a resorbable collagen barrier to promote tissue ingrowth and integration and limit visceral attachments,” according to the manufacturer’s product information guide. However, in 1998, one year before Parietex hit the shelves, the scientific community found polyester to be unsafe. A study published in the Journal of American Medical Association (JAMA) specifically advised against the use of polyester in hernia mesh devices. So why has Covidien Parietex hernia mesh been used regularly since 2011 and with it, increased reports of mesh complications?

Yet another study published by JAMA in January 2022 supports plaintiffs' allegations about the defects in defendants' hernia mesh products. It questions whether synthetic mesh is superior to biologic mesh in reducing 2-year risk of hernia recurrence during single-stage repair of clean-contaminated and contaminated ventral hernias. The study may also answer the question above: Biologic mesh is widely used for reinforcing contaminated ventral hernia repairs; however, it is expensive and has been associated with high rates of long-term hernia recurrence. “Synthetic mesh is a lower-cost alternative but its efficacy has not been rigorously studied in individuals with contaminated hernias…the price of biologic mesh was over 200 times that of synthetic mesh for these outcomes.”