A patient says that a design defect in the Parietex Parastomal Mesh hernia mesh implantcaused her injury.

Plaintiff Kim J. says that she had laparoscopic ventral parastomal hernia repair on July 12, 2011 in Petaluma, Calif. According to Kim, a piece of Parietex Parastomal Mesh, Category Number PCOPM20, Lot Number PJD00549, was implanted in her body during this surgery.

Allegedly, this mesh is manufactured and sold by Coviden and Medtronic Inc. Coviden manufactures and distributes the mesh in question, and Medtronic acquired Coviden in 2015, and, according to the plaintiff, is responsible for the actions of Coviden.

Kim says that the Parietex hernia mesh implant is used for the treatment of hernia repair, as it as used in her surgery. Kim says that after her hernia repair surgery, she continued to suffer from abdominal pain, a skin rash near the incision, hernia recurrence, mesh extruding from her body, mesh erosion, and small bowel obstruction.

Kim’s hernia mesh lawsuit states that on or around June 10, 2015, she was admitted to the Emergency Room at Petaluma Valley Hospital. Allegedly, Kim then underwent a CT scan that showed a large adnexal mass (a lump in the uterus), as well as a small bowel obstruction. Allegedly, these problems were caused by the Parietex hernia mesh implant.

The Parietex lawsuit says that on or around June 15, 2015, Kim underwent removal of the Parietex hernia mesh implant which she claims failed due to a design defect. Kim says that during the removal surgery, it was discovered that Kim had a “high-grade small bowel obstruction due to an incarcerated bowel in stoma cite cause by a recurrent hernia which occurred due to failure” of the Parietex mesh.

Kim alleges the design of the hernia mesh is defective and the materials used in the mesh caused injury. Kim states that Coviden and Medtronic assert that the mesh is effective and safe for hernia repair, a representation that medical professionals and patients look to when making choices about what hernia mesh to use.

Kim argues that the device actually has a high rate of failure, injury, and complication. She says that the device does not perform as intended, and causes severe and irreversible injuries like those she suffered.

Kim’s Parietex hernia mesh lawsuit asserts that the Parietex hernia mesh implant is made with polyester, which is more likely to cause severe inflammation than an alternative hernia mesh material, polypropylene, despite the coatings that have been applied to the device.

Allegedly, the companies knew this, and knew that polyester is less sturdy than polypropylene, which causes difficulties during surgery.

Kim argues that the mesh’s makers knew or should have known that he unsealed edges of the mesh would cause it to far and disintegrate once it was implanted and, once that happened, organ perforation could result. She goes on to say that the device’s markers provides “no warning” to physicians that the collagen barrier designed to provide protection to organs quickly disintegrates, which exposes underlying organs to bare polyester.”

Kim says that hernia mesh side effects can result in infections and dense adhesions to the bowel, which result in bowel obstructions common to this mesh. Additionally, Kim says that insufficiencies in the mesh’s materials can cause the mesh to migrate from its original position, possibly causing further injury.

A number of brands of hernia mesh have come under fire recently for allegedly causing serious injury due to design defect. The BBC estimates that around 170,000 people who have had hernia mesh implants in England in the last six years could face complications.

Additionally, the U.S. Food and Drug Administration outlines possible hernia mesh complications to the public, noting that numerous complications related to hernia mesh use have been reported to the FDA. 

The Parietex Hernia Mesh Design Defect Lawsuit is Case No. 1:19-cv-01419, in the U.S. District  Court for the Northern District of California.