Atrium Medical Corp.’s C-QUR hernia mesh products are coated with a fish oil derivative similar to the Omega 3 nutritional supplement, intended to limit adverse effects, but the fish oil along with the defective design and manufacture of the device only worsen the hernia mesh side effects, according to hundreds of people suing the company.
More than 335 people have filed lawsuits against Atrium in U.S. District Court in Concord. The lawsuits charge that Atrium hernia mesh caused an “unreasonable risk of severe adverse reactions.” The fish oil did not prevent adverse events from occurring, the lawsuits contend. It created “an ideal breeding ground for bacteria.”
Not only is the fish oil coating an issue, but the polypropylene mesh can degrade in the body, eroding into organs, causing “catastrophic complications” to patients, according to the complaints. In August 2012, the company began receiving the first of about 33 adverse event reports, the second of which involved a patient death related to infected mesh that caused a small bowel obstruction.
A Food and Drug Administration (FDA) inspection at the company’s Hudson plant two months later uncovered several issues including sterility concerns and failure to investigate complaints. Among them were 35 confirmed instances in which hair was found in the sterile medical devices. Investigators also noted that line works’ hair was not contained in their hats.
In December 2012, the British Journal of Surgery reported a study in which 15 of 16 laboratory mice with Atrium mesh implants developed infections. Six months later, 145,000 mesh products were recalled to reissue instructions that the coating on the implants was adhering to the packaging during high humidity. Another FDA inspection in October 2013 resulted in nine new citations.
On Feb. 4, 2015, the U.S. District Court in New Hampshire at the request of the FDA slapped Atrium with a consent decree halting the company’s manufacturing and distributing of its products until it showed that it had corrected the deficiencies. Atrium was also fined $12 million.
Atrium is just one medical device company that manufactures hernia mesh devices facing lawsuits alleging defective design and injuries. At least 92 lawsuits against Ethicon’s Physiomesh were consolidated into a multidistrict litigation in the Northern District of Georgia in Atlanta, and claim that Ethicon did not adequately warn of the risks associated with its hernia repair kit.
Source: New Hampshire Business Review