Covidien Parietex Mesh Lawsuit Filed Over Complications Following Hernia Repair

Medtronic’s Covidien subsidiary faces a product liability lawsuit, alleging that complications following a hernia repair were caused by design problems with it’s Parietex Mesh, which disintegrated inside of a woman’s body and resulted in a dangerous fluid build up around the hernia patch.

In a complaint (PDF) filed earlier this month in the U.S. District Court for the District of New Mexico, Janice Nowell indicates that the manufacturer was aware that users face a high risk of Covidien Parietex mesh problems, yet failed to recall the product.

Nowell underwent hernia repair in October 2010, when a 20 cm circular Covidient Parietex patch was implanted. After experiencing complications, a CT scan revealed a large amount of fluid around the mesh, which was draining from a reopened part of her incision.

In October 2014, the hernia mesh was removed and doctors discovered that it had partially disintegrated and that the area around it was infected. Nowell suffered severe abdominal pain, infection, abdominal trauma and severe emotional distress, the lawsuit notes.

“The physical structure of the disintegrated [Covidien Parietex] mesh caused trauma to the Plaintiff’s abdomen as it repeatedly came in contact with it,” Nowell’s lawsuit indicates, stating that the mesh’s materials were not chemically compatible with human tissue. “The disintegration and misshapening and infection of the Parietex Mesh occurred because the product was unsafe and defective.”

The lawsuit notes that the Covidien hernia mesh is designed to be inserted into a patient’s body in an area that already has high levels of bacteria, which can adhere to the mesh and cause immune reactions, tissue breakdown, adverse reactions, and injuries.

In addition to those inherent risks, the lawsuit states that there are biomechanical issues with the Parietex hernia mesh design, which may cause it to disintegrate in the body. This can inflame the surrounding tissue. Eventually, the hernia mesh can degrade and fragment over time, leading to more adverse reactions.

Covidien failed to provide adequate warning to patients and the medical community regarding these risks, Nowell’s lawsuit claims. The lawsuit also accuses the company of underreporting information about cases where the Parietex mesh failed and caused injuries, adverse effects, and the need for revision surgery in other patients.

“The injuries, conditions, and complications suffered by numerous patients around the world who have been implanted with the Product and other products like it made by the Defendant include, but are not limited to, erosion, infection, inflammation, scar tissue, and pain, all of which have been experienced by the Plaintiff to a significant degree,” the lawsuit states. “In many cases, including the Plaintiff, patients have been forced to undergo extensive medical treatment including, but not limited to, operations to locate and remove mesh, tissue, the use of pain control and other medications, injections into various areas of the abdomen and operations.”

Nowell’s complaint is one of a growing number of hernia mesh lawsuits being filed against various mesh manufacturers in recent months, alleging that serious design problems were discovered after thousands of people had defective mesh implanted in their body.

In addition to Covidien Parietex Mesh lawsuits, similar allegation have been raised in Ethicon Physiomesh lawsuits and Atrium C-Qur lawsuits as well.

Nowell presents charges of negligence, design defect, manufacturing defect, failure to warn, and breach of warranty. She is seeking compensatory and punitive damages.