SAN DIEGO, Calif., April 6, 2017 — Hernia repair surgeries are incredibly common. More than a million are performed in the U.S. each year and hernia mesh is used in a large majority of them.
Hernia mesh is a type of surgical mesh used to strengthen and support the weakened muscle near a hernia. Hernias occur when an organ or fatty tissue pushes through a weak spot in the muscle and tissue that surround it.
Hernias usually occur as a result of pressure or strain and can happen in many different areas of the body. The most common types of hernias occur in the groin or abdominal wall.
Treatment options for hernias range from “watchful waiting” to surgery. When surgery is the best option, surgeons often use hernia mesh to reduce the risk of the hernia occurring again. Hernia recurrence is a common complication of hernia repair.
A number of different mesh brands have been used in hernia repair over the years; some of these brands are no longer available because of the risks they posed to patients.
Though hernia mesh can help reduce the risk of hernia recurrence, they also carry their own risks of potential complications. These complications include erosion of the mesh, adhesion of the mesh to other organs and the need for additional surgery.
Patients who were harmed by various mesh brands are filing lawsuits against their manufacturers, accusing them of designing defective products and failing to warn about their risks.
There are dozens of hernia mesh lawsuits already filed in state and federal courts. Some of these lawsuits have been consolidated into a multidistrict litigation (MDL), including lawsuits against Atrium Medical’s C-Qur Hernia Mesh.
Hernia Mesh lawsuits accuse the various manufacturers of several legal claims, including:
Hernia mesh lawyers and attorneys are working with patients across the country who developed complications with their hernia mesh. These patients have experienced a number of serious injuries that have been documented in the dozens of lawsuits now filed in state and federal courts nationwide.
Hernia mesh injuries include:
There are a number of hernia mesh brands on the market today. Some hernia mesh brands are associated with a higher risk of complications than others and certain brands are no longer sold because of their risks. Ethicon’s Physiomesh, for example, was taken off the market in 2016 because it had a higher rate of hernia recurrence and re-operation compared to other mesh brands.
Problem brands involved in hernia mesh lawsuits include:
The U.S. Food and Drug Administration approved the problematic mesh brands involved in hernia mesh lawsuits through its 510(k) Premarket Notification. The program allows manufacturers of medical devices to bypass rigorous premarket clinical testing if their device is similar to another one on the market.
New Hampshire-based Atrium Medical gained approval for its C-Qur Hernia Mesh through the 510(k) program in 2006. C-Qur mesh was designed using a new Omega-3 gel coating that no other hernia mesh brand was using. Despite this new material, the FDA approved C-Qur without testing the mesh’s safety and effectiveness in people.
Ethicon Inc.’s Physiomesh was also approved through the FDA’s 510(k) program and was not tested in people before being brought to market. The FDA cleared Physiomesh in 2010; 6 years later, Ethicon pulled the device from the market for safety and efficacy concerns.
Unsurprisingly, Bard’s Sepramesh IP, 3D Max and Ventralex ST were also approved by 510(k) premarket clearance — none of the 3 meshes were rigorously tested before they were sold to physicians and implanted in patients.
People who were injured by problematic hernia mesh may be able to file claims against the device’s manufacturer.
Hernia mesh lawsuits accuse manufacturers of designing defective products and failing to warn about their risks.
Hernia mesh complications can be serious and may result in additional surgeries beyond the initial hernia repair.
If you were harmed by a hernia mesh product, you may be entitled to financial compensation.
FDA. Hernia Surgical Mesh Implants. (April 4, 2017). Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm
Judicial Panel on Multidistrict Litigation. Pending MDLs by District. (March 15, 2017). Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-March-15-2017.pdf
Theresa Callaway vs. Atrium Medical Corporation et al. in the United States District Court, Northern District of Georgia. Filed October 31, 2016. (Case No. 1:16-cv-04068)
FDA. C-Qur Hernia Mesh 510(k) Premarket Notification (K050311). (2006). Retrieved from
FDA. Physiomesh Flexible Composite Mesh 510(k) Premarket Notification (093932). (2010). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K093932
FDA. Sepramesh IP Composite 510(k) Premarket Notification (K040868). (2004). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K040868
FDA. Ventralex ST Hernia Patch 510(k) Premarket Notification (K101928). (2011). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K101928
FDA. 3D Max Mesh 510(k) Premarket Notification (K081010). (2008). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K081010