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A South Florida woman who claims she suffered severe complications caused by a hernia mesh is suing the manufacturer, accusing the company of a host of charges including liability, breach of warranty, negligence, and fraud.
Deborah T. filed her hernia mesh lawsuit against Atrium Medical Corporation on July 21, 2017, in New Hampshire federal court. Atrium is based in Hudson, N.H.
In her complaint, Deborah states that her doctor implanted the Atrium C-QUR Mesh V-Patch on Oct. 10. 2013, at the West Boca Medical Center in Boca Raton, Fla.
As a result, the lawsuit states, she suffered an abscess, debridement of necrotic skin— medical verbiage meaning she required medical removal of dead, damaged or infected tissue—adhesions and a small bowel resection. She ultimately underwent hernia mesh removal on March 2, 2015.
Hernia Mesh Recall
In October 2012, a year before Deborah had her hernia mesh surgically implanted, the FDA issued a warning letter to Atrium, informing the company that it had failed to adequately address consumer complaints as well as violations found when the FDA conducted an inspection earlier that year.
The agency admonished Atrium for its failure to provide documentation of its corrective actions and revised complaint procedures and informed the company that it would be required to disclose to the FDA documentation of its completed reviews as well as its plans to prevent future violations.
In July 2013, Atrium recalled its C-QUR Edge Mesh, citing the need for additional language in the product’s instructions, specifically that “prolonged exposure to high humidity may result in increased rate of adherence of the C-QUR mesh to its handling sleeve.”
Atrium’s updated instruction also noted that its devices should be stored in a “controlled room temperature of 25 C / 77 F or less. Brief exposure to up to 40 C (104 F ) is acceptable.”
Atrium terminated the recall on March 18, 2016.
In October 2014, the FDA issued a safety communication about reports of hernia mesh complications including adverse reactions, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels.
More than one million hernia repairs are performed each year in the United States, according to the FDA, making it one of the most common surgical procedures.
Hernia mesh implants are used to provide additional support to weakened or damaged tissue. The most common adverse side effects following hernia mesh surgery are pain, infection, hernia recurrence, adhesion, bowel obstruction, mesh migration, and mesh shrinkage (contraction).
The FDA reports that the majority of surgical mesh devices currently available for use are constructed from synthetic materials or animal tissue.
Atrium’s C-Qur mesh, which received FDA approval in March 2006, is made of polypropylene with an outer coating of a gel constructed of triglycerides and Omega-3 fatty acids.
Significant pain improvement has been reported following hernia mesh removal. Hernia mesh removal is often used as a remedy when the mesh becomes infected.
If you or a loved one suffered from hernia mesh complications, legal recourse is available. Contact the experienced attorneys at McDonald Worley today for a FREE case evaluation.