Aspide Faces Hernia Mesh Lawsuit Over Surgimesh Design Problems
A Georgia woman has filed a hernia mesh lawsuit against the makers of the Surgimesh, indicating that the hernia repair product was defectively designed, leading to infections and a painful failure only a few years later.
Sheila Sandoval filed the complaint (PDF) on October 31 in the U.S. District Court for the Southern District of Georgia, pursuing claims against BG Medical, LL and Aspide Medical as defendants, for selling a hernia repair mesh that was unreasonably dangerous when used for its normal and intended purpose.
Surgimesh XB mesh is a non-absorbable synthetic product made of polypropylene fibers, which is marketed for the repair of hernias and soft tissue deficiencies. It was approved through the FDA’s controversial 510(k) fast-track approval program, which only requires a device be “substantially equivalent” to other marketed devices that came before it, and has been linked to reports of painful and debilitating complications when the hernia mesh fails during the months or years after surgery.
Sandovl indicates in the lawsuit that Surgimesh is biologically incompatible with human tissue, causing adverse immune system responses which result in inflammation around the surrounding tissue, as well as other severe adverse reactions. This may cause the hernia mesh to degrade and weaken in the body, resulting in material failures, according to the complaint.
Surgimesh was used during a hernia surgery Sandoval underwent in December 2018, to repair an incisional ventral hernia. However, after the device was implanted, she suffered an infection of the abdominal wall, incision drainage for more than a year, and finally underwent revision surgery to have the mesh removed in November 2020, after learning that the Surgimesh failed.
The lawsuit claims the defendants knew about the problems with Surgimesh, and ignored reports from patients and healthcare providers long before Sandoval was implanted with the mesh. Long before her procedure, the company allegedly received reports of chronic and substantial pain once patients had Surgimesh implanted, and that the design did not prevent mesh infections or colonization by microbes, nor did it reduce the risk of adverse events compared to other designs on the market.
“Once implanted in the body, the polypropylene begins to degrade leading to severe inflammatory response and continuing cycle of degradation and inflammation,” the lawsuit states. “Surface degradation also causes flaking of the polypropylene, which increases the surface area of host tissue exposed to the biomaterial and, in turn, increasing the host Foreign Body Response (FBR) and accelerating the material degradation.”
The allegations raised in the claim are similar to those presented in other hernia mesh lawsuits filed in recent years against makers of different polypropylene products, including products sold by C.R. Bard, Ethicon, Covidien and Atrium Medical.
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