A South Carolina man who suffered complications following the implantation of a hernia mesh has joined the growing number of plaintiffs filing hernia mesh infection lawsuits against medical device manufacturers whose products contain polypropylene, a plastic polymer used mostly in molding parts, electrical insulation, packaging, and clothing fibers.
In 2014, Columbia, S.C. doctors implanted Ethicon’s physiomesh flexible composite hernia mesh in plaintiff Henry S., who accuses the device makers, Johnson & Johnson and Ethicon, of knowing its product was unsafe for its intended use.
Hernia mesh recipients nationwide have reported complications ranging from pain and swelling to bowel obstruction, mesh migration and bacterial infections, often requiring additional surgeries to treat the complications.
In 2010, Michigan doctors implanted Atrium’s C-QUR mesh to repair an abdominal hernia in 49-year-old Tenley H. Five years later, Tenley needed revision surgery because the hernia mesh had damaged her internal organs, according to her hernia mesh infection lawsuit, filed in May 2017.
In her products liability suit against Atrium Medical Corp., Tenley is seeking damages for permanent injuries, significant pain and suffering, emotional distress, lost wages and earning capacity, and diminished quality of life.
Despite Atrium’s claims that the polypropylene mesh in its C-QUR mesh is inert, “a substantial body of scientific evidence shows that this mesh material is biologically incompatible with human tissue and promotes an immune response in a large subset of the population receiving Defendants’ Products,” Tenley’s hernia mesh infection lawsuit states.
“This immune response promotes degradation of the polypropylene mesh, as well as the surrounding tissue, and can contribute to the formation of severe adverse reactions to the mesh.”
Further, the hernia mesh infection lawsuit alleges that instead of clinical testing or other design verifications, Atrium “inadequately relied on predicate devices” to win approval from the U.S. Food and Drug Administration.
A predicate device is considered to be “substantially equivalent” to a legally marketed device on the market before May 28, 1976, and is similar to the device seeking FDA approval in terms of its design, material, chemical composition, energy source, manufacturing process or intended use. Predicate devices are not subject to premarket approval.
Despite warnings on their United States Material Safety Data Sheet by many of Atrium’s polypropylene suppliers that polypropylene is not to be permanently implanted in the human body, Atrium nonetheless maintained the safety of its product, according to the hernia mesh infection lawsuit, which also maintains that Atrium’s representations induced Tenley and her doctors to rely upon the defendants’ judgment.
Before C-Qur mesh hit the market, the FDA and other regulatory agencies expressed to Atrium “stark concerns” about “severe, life-threatening allergic reactions” from the Omega 3 Fatty Acid Fish Oil used as a coating on the device, the lawsuit states.
Fish, according to Tenley’s complaint, are commonly allergenic and if fish remnants remain in the hernia mesh coating, allergic reactions ranging from increased sensitivity and rashes to death can occur.
Atrium, the hernia mesh infection lawsuit alleges, “intentionally or at the very least, recklessly disregarded human life by lying to physicians about the possible causes of the allergic reaction, resulting in significantly more severe injuries.”
If you’ve suffered injuries due to a defective hernia mesh, contact the attorneys at McDonald Worley today. Their team of experienced hernia mesh lawyers offer a free case evaluation.