Atrium Hernia Mesh Lawsuit Filed Over ProLoop Polypropylene Mesh

A New Jersey man has filed a product liability lawsuit against Atrium Medical Corporation, alleging that problems with the design of the ProLoop polypropylene hernia repair mesh caused him to suffer a number of serious and debilitating complications.  

The complaint (PDF) was filed by Juan Paredes on March 5, in U.S. District Court for the Southern District of California. In addition to Atrium, the lawsuit names Premier Healthcare Alliance and Atrium’s parent companies Getinge Group and Maquet as defendants.

According to allegations raised in the Atrium ProLoop mesh lawsuit, Paredes was implanted with the polypropylene hernia repair mesh in July 2011, for a double inguinal hernia repair. As a result of complications allegedly caused by the design of the device, Paredes indicates that he had to undergo revision surgery on December 10, 2012 to have the mesh removed.

The Atrium ProLoop mesh plug is made of knitted rows of monofilament polypropylene with multiple protruding monofilament loops. The lawsuit claims that Atrium ProLoop mesh complications include a risk of shrinking, expanding, cracking and otherwise deforming, as well as causing foreign body reactions, chronic inflammation, migration, organ damage, nerve damage, chronic pain and sexual dysfunction.

Paredes’ complaint claims that he has suffered permanent injuries, substantial pain and suffering, emotional distress, medical expenses, lost wages and diminished earning capacity as a result of his injuries from the ProLoop mesh, which have also decreased the overall quality of his life.

The hernia mesh lawsuit presents claims for strict liability, failure to warn, negligence, negligent misrepresentation, fraud, and breach of warranty.

Atrium Mesh Lawsuits

The complaint filed by Paredes comes as Atrium faces a growing number of hernia mesh lawsuits over their C-Qur mesh products, which feature polypropylene mesh coated with Omega 3 fatty acid gel.

The Atrium C-QUR mesh, which is pronounced “Secure” mesh, was approved by the FDA on March 31, 2006. It is sold for use in hernia repair, chest wall reconstruction and to repair traumatic or surgical wounds.

In October 2012, the FDA issued a warning letter to Atrium, citing the company for failing to respond to complaints about the C-QUR mesh and other products. The FDA accused the company of failing to review or investigate any complaints involving C-QUR failures or infections.

A growing number of Atrium C-Qur mesh lawsuits are being pursued by individuals throughout the United States, who allege that the triglycerides in the hernia mesh can result in immune reactions that cause adverse events and injuries. The complaints also claim that the mesh can cause strong friction between it and the underlying tissue, resulting in injury, and that the mesh degrades over time, leading to internal tissue degradation and other injuries as well.