A Florida man says defects in an implant’s design caused him to suffer considerable hernia mesh implant side effects.

Plaintiff James C. is suing defendants Atrium Medical Corporation, Maquet Cardiovascular LLC, and Getige AB, all of whom were involved in the design, manufacture or marketing of the C-QUR mesh implant used for hernia repair.

James alleges these defendants failed to make the C-QUR safe for its intended purpose and failed to adequately warn doctors and patients about the associated risks of hernia mesh implant side effects.

According to this hernia mesh lawsuit, James was implanted with a C-QUR mesh during hernia repair surgery in July 2013. After surgery, he developed significant hernia mesh implant side effects, including pain, a hematoma and recurrence of bilateral hernias.

James says as a result of mesh side effects he developed a “hard mass covered in adhesions.” He finally had to undergo a second surgery to remove the C-QUR mesh in October 2016. He also had to undergo additional surgery to repair the hernia that the C-QUR failed to remedy, he says.

Due to the hernia mesh complications and subsequent surgery, James says he suffered from physical injury and pain, mental anguish, and scarring and disfigurement. He has incurred substantial medical expenses at the same time he has lost wages and earning capacity.

James now attributes his hernia mesh implant side effects to defects in the defendants’ C-QUR mesh.

“Defendants’ C-QUR Mesh was defectively designed and/or manufactured, and was not reasonably safe for its intended use in hernia repair, and the risks of the design outweighed any potential benefits associated with the design,” James claims.

The C-QUR is a polypropylene mesh layered with an “Omega 3” gel coating intended to prevent or minimize adhesions and inflammation. James claims the Omega 3 coating actually had the opposite effect, preventing the mesh from adequately incorporating into the body and causing an “inflammatory and chronic foreign body response.”

The Omega 3 coating also caused the C-QUR mesh to roll and deform upon implantation, further aggravating the inflammatory and foreign body response, James says.

The complications James suffered are just some of what can go wrong after implantation of a C-QUR mesh, according to James’s hernia mesh lawsuit. It claims defects in the implant design create an unreasonable risk of scarification, allergic reaction, granulomatous response, seroma formation, damage to nerves and other tissues, and potentially death.

Plaintiff Demands Better Warning About Hernia Mesh Implant Side Effects

These problems could have been avoided but for the defendants’ failure to properly address them, James argues. He says the companies violated numerous safety standards related to manufacture, quality control, and conformance with design specifications.

James argues the defendants failed to adequately warn him and his treating physicians about the risks of hernia mesh implant side effects associated with the C-QUR mesh. Had he been better informed about the relevant risks, he says, he would not have agreed to have a C-QUR mesh implanted in his body.

James’s Hernia Mesh Lawsuit is Case No. 1:16-cv-02760 in the U.S. District Court for the Southern District of Florida.