Repeated hernia mesh failure is the cause of action in a recent complaint filed against medical device manufacturer Atrium in a U.S. District Court.

Plaintiffs Phillip G. and his spouse, Donna O., have named Atrium Medical Corporation and two additional defendants in the most recent lawsuit to join ongoing multidistrict litigation. The complaint lists multiple counts of alleged wrongdoing, including negligence, fraud, defective design, failure to warn, breach of warranty, unjust enrichment, infliction of emotional distress and loss of consortium. The Arizona couple is seeking compensatory and punitive damages.

Case Background

Phillip states that in late October 2010, he underwent surgery for the treatment a large ventral hernia, using the Atrium C-QUR hernia mesh. Just over four months later, he claims, his injury recurred due to hernia mesh failure.

In March, 2011, he says he was implanted with a second Atrium device, the C-QUR Mesh V-Patch. Within less than two years, the second patch allegedly failed, requiring a third surgery to remove the devices. Because of these failures, Philip says he has suffered from recurrent hernias as well as bowel obstruction and other serious complications.

More Cases of Hernia Mesh Failure

Atrium is not the only medical device manufacturer to have legal troubles over alleged mesh failure. Other companies, including Johnson & Johnson’s Ethicon division and C.R. Bard Medical have also been targeted in mass litigation by plaintiffs claiming severe injuries caused by hernia mesh devices.

In July, 2013, only four months after Philip had his mesh devices surgically removed, the C-QUR V-Patch was subject to a Class 2 recall. This particular device was made of polypropylene, coated with omega-3 fatty acid (O3FA), which was intended to prevent adhesions.

After the initial surgery, the patient’s body should slowly absorb the O3FA coating. However, not all patients’ tissues can absorb this coating; furthermore, it has been known to peel off prematurely. As a result, patients have experienced severe organ damage as well as infections. These painful and serious infections are the result of an immune response to the O3FA coating, and has been known to develop within weeks of surgery.

Unfortunately, a Class 2 recall is only a warning; in order to take the product off the market altogether would require a Class 1 recall.

Hernia Specialists Report on Infections and Recurrence

In October 2018, three hernia specialists in Melbourne, Australia published the results of a study involving the C-QUR V-Patch. They found that infection rates associated with the product were as much as 19 percent, depending on the placement. In 2.5 percent of cases, the mesh had to be surgically removed with 4 to 12 months, the researchers reported.

Despite the high rate of hernia mesh failure, most of these devices remain on the market and continue to be used in hernia surgery today. The master complaint from the multidistrict litigation alleges that Atrium and its successors failed to test the O3FA coating under clinical conditions before introducing it to the market and either knew, or should have known about the potential complications that would result.

Philip and Donna’s Hernia Mesh Failure Lawsuit is part of Case No. 16-md-2753-LM, MDL No. 2753 , U.S. District Court, District of New Hampshire.