Surgimesh is a new type of hernia mesh implant made from non-woven polypropylene microfibers. The use of individual fibers of polypropylene was intended to make the Surgimesh smaller than other hernia mesh products and less prone to biocompatibility problems and other post-surgery complications. The design of the Surgimesh is therefore distinct from the design of many other hernia mesh devices that have generated thousands of product liability lawsuits in recent years (e.g., Ethicon Physiomesh, Atrium C-Qur, etc.).
A recently filed product liability lawsuit in New Mexico alleges that the Surgimesh has the same dangerous design flaws as the other polypropylene hernia mesh implants. This new Surgimesh lawsuit could potentially be the first of many and open a new front in the hernia mesh mass tort ligation.
Surgimesh is a line of hernia mesh and general surgical mesh implants manufactured by Aspide Medical (a French company) and distributed in the U.S. by BG Medical, LLC. The Surgimesh is a non-absorbable synthetic mesh, made of non-knitted, non-woven polypropylene fibers. One side of the mesh is coated with silicone to prevent abnormal tissue attachments.
Surgimesh was first released on the U.S. market for use in abdominal hernia repair surgery back in 2008. BG Medical and Aspide obtained “clearance” to market the Surgimesh product under Section 510(k) of the Medical Device Amendments to the Food, Drug, and Cosmetic Act. Section 510(k) permits the marketing of medical devices if the device is substantially equivalent to other legally marketed predicate devices. The Section 501(k) Premarket Notifications for every Surgimesh device released since 2007 state that preclinical testing was conducted and the device “functioned as intended.”
A product liability lawsuit was filed in the District of New Mexico in August 2021 alleging that the Surgimesh XB was defective because the polypropylene was not biologically compatible inside the body. The plaintiff, Melvin Todacheene, had a Surgimesh implanted during a hernia repair surgery in August 2017.
The Complaint alleges that Todacheene subsequently experienced pain, abscess, scarring, mesh migration, hernia recurrence, and seroma as a direct result of the failure of his Surgimesh implant. Exactly 1 year after the Surgimesh was implanted inside him, Todacheene claims that he had to undergo surgery to remove the Surgimesh in August 2018.
The Todacheene lawsuit alleges that the Surgimesh was defective in its design because the polypropylene material was not suitable for its purpose because it was not biologically compatible inside the body. Like other hernia mesh lawsuits, the Todacheene Complaint also claims that the polypropylene component of the Surgimesh is also prone to shrinking and contracting after being implanted in the human body, which results in multiple severe complications including but not limited to pain, hernia recurrence, organ perforation, device migration, and meshoma.
The lawsuit also claims that BG Medical failed to include proper warnings about the risks of the Surgimesh in the product labeling:
Contrary to Defendants’ representations, the Surgimesh product has a high rate of failure, injury, and complications associated with its intended use; the product fails to perform as intended resulting in debilitating subsequent revision surgeries for users of the medical device, including Plaintiff. Despite their knowledge of this dangerous side effect that can result from Surgimesh use, Defendants refused to warn patients, physicians and the medical community about the risks.
The Surgimesh lawsuit filed by Melvin Todacheene in August is not the first product liability case involving a Surgimesh product. There have been at least four other Surgimesh lawsuits filed against BG Medical and Aspide since 2018. A pair of Surgimesh lawsuits were filed in 2018 in Illinois state court. BG Medical sought to remove both cases to federal court, but they were subsequently remanded. A third Surgimesh lawsuit was filed in the Central District of California in 2019.
The factual allegations and product liability claims in these 3 previous Surgimesh lawsuits were essentially identical to the facts and claims in the recent Todaceene case, all of which are generally consistent with the claims in the other hernia mesh lawsuits.
BG Medical Contests Allegations in the Todacheene Complaint
Lawyers for BG Medical contend that the above referenced allegations in the Todacheene Complaint are “contrary to scientific studies” that supposedly prove that the Surgimesh does not have the same problems as other hernia mesh products. BG Medical also claims that the allegations in the Todacheene Complaint are not grounded in science, but rather just copied from other hernia mesh lawsuits.
What Is the Average Payout for a Surgimesh Lawsuit?
No one has any idea what Surgimesh settlements might be. Generally, hernia mesh lawsuits in the top settlement tier (those with the most serious injuries) could have a value of around $250,000 to $1,000,000. However, this will only represent a small percentage of the hernia mesh cases. The average hernia mesh lawsuit will probably have a settlement value of around $65,000 to $80,000.
Will these numbers apply to Surgimesh? Probably.
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