About Aspide Surgimesh
The Surgimesh WN is a non-absorbable, non-woven polypropylene surgical mesh cleared by the FDA in February 2007 (510(k) No. K061445) for reinforcement of hernia defects — including inguinal, femoral, crural, and ventral hernias — through open or laparoscopic extraperitoneal repair. The Surgimesh XB, cleared by the FDA in August 2008 (510(k) No. K072974), is a non-woven polypropylene mesh with a silicone coating on one side designed to minimize tissue attachment when the mesh contacts viscera, used for hernia reconstruction and temporary bridging of fascial defects.
Latest Updates
Both Surgimesh products were cleared by the FDA through the 510(k) pathway — a process that does not require clinical trials and clears a device based on claimed equivalence to a predicate device already on the market — and plaintiffs in Surgimesh cases allege that the company failed to adequately warn patients and surgeons about the risk of serious complications that emerged after implantation [1][2]. As of 2026, the broader hernia mesh litigation landscape includes more than 25,000 active lawsuits consolidated in four federal MDL proceedings targeting other mesh manufacturers, with the FDA having received approximately 55,000 adverse event reports related to hernia mesh products overall [3].
FDA Warnings on Surgical Mesh
The FDA has repeatedly warned about the risks associated with surgical mesh used in hernia repair. As of 2018, the agency was receiving more than 500 adverse event reports per month related to surgical mesh, and by 2023 had identified approximately 55,000 total hernia mesh adverse event reports in its MAUDE database.
The FDA has also acknowledged that surgical mesh — particularly lightweight, large-pore polypropylene mesh — carries risks of serious complications that may not appear for months or years after implantation, and that some complications requiring revision surgery cannot be fully corrected. The 510(k) clearance pathway used for both Surgimesh products does not require manufacturers to conduct human clinical trials demonstrating safety and effectiveness before the device reaches patients.
Surgical Mesh Complications
Hernia mesh complications can be severe, permanent, and difficult to treat — and many do not manifest until long after the initial surgery. Patients who received Aspide Surgimesh implants have reported complications consistent with the broader range of hernia mesh injuries documented in FDA adverse event reports and litigation across the industry.
Reported complications associated with polypropylene hernia mesh products include chronic pelvic or abdominal pain, mesh shrinkage and contraction, mesh migration from the implant site, adhesions to surrounding tissue, bowel obstruction and bowel perforation, fistula formation, infection, granuloma, seroma, hernia recurrence, and the need for one or more revision surgeries to remove or replace the mesh — procedures that carry their own risks and complications.
The Hernia Mesh Litigation Landscape
Hernia mesh litigation is one of the largest areas of active medical device product liability law in the United States. Four federal multidistrict litigation proceedings are currently active, targeting Bard/Davol, Covidien, Atrium Medical (C-QUR), and Ethicon, with more than 25,000 combined lawsuits pending as of 2026.
Earlier hernia mesh MDL proceedings resulted in substantial recoveries for plaintiffs: Bard settled approximately 2,600 lawsuits in its Kugel patch MDL for $184 million after a trial loss, and Ethicon has settled hundreds of hernia mesh cases. These proceedings establish the legal framework under which Aspide Surgimesh claims are evaluated — strict product liability for defective design, negligent failure to warn, and breach of implied warranty of fitness.
Can I File a Lawsuit?
If you received an Aspide Surgimesh WN or Surgimesh XB implant and subsequently experienced chronic pain, mesh migration, bowel obstruction or perforation, infection, hernia recurrence, or required revision surgery to remove or repair the mesh, you may have a product liability claim against Aspide Medical. Contact a medical device injury attorney as soon as possible, as state filing deadlines apply and the statute of limitations may begin running from the date you knew or reasonably should have known your injuries were connected to the mesh.
References
1. https://lawsuit-information-center.com/surgimesh-hernia-mesh-lawsuits.html
2. https://www.thelyonfirm.com/medical-device/hernia-mesh-injury/aspide-surgimesh/
3. https://drugwatch.com/hernia-mesh/recalls