Hernia Mesh Complications
SAN DIEGO, Calif., April 6, 2017 — Hernia mesh is used in the majority of hernia repairs in the U.S. In 2000, more than 90% of surgeries performed to repair a hernia in the groin used mesh.
Surgeons use mesh because it provides additional support to weakened muscle and helps reduce hernia recurrence rates. Hernia recurrence is a common complication of hernia repair and can affect up to 15% of patients depending on the type of hernia.
Patients who undergo hernia repair with mesh may be reducing their risk of hernia recurrence, but they could be increasing their risk of other long-term complications.
Hernia mesh has been shown to cause serious injuries in some patients, many of which require additional surgery to treat. A recent study published in JAMA suggested the benefits that mesh provided — reducing the risk of hernia recurrence — were eventually offset by mesh-related complications.
Hernia mesh complications can be severe and people injured by the devices are starting to file lawsuits against their various manufacturers. The lawsuits accuse mesh makers of designing defective products and failing to warn about their potential risks.
There are numerous brands of hernia mesh on the market today, but some are more problematic than others. These problematic meshes are part of the dozens of lawsuits now filed in state and federal courts nationwide.
Hernia Mesh Complications
Hernia mesh patients have experienced a number of serious complications after undergoing hernia repair. These complications can be painful and sometimes life-threatening. Many patients must undergo additional surgeries to remove the mesh and treat their injuries.
Complications of hernia mesh include:
- Tissue or mesh erosion
- Chronic pain
- Internal scar tissue
- Fluid buildup at the surgical site
- Swelling of clotted blood within tissues)
- Hernia recurrence
- Need for additional surgery
Hernia Mesh Brands Linked to Complications
Several hernia mesh brands have been linked to complications, including:
- Atrium C-Qur Hernia Mesh
- Ethicon Physiomesh
- Bard Sepramesh
- Bard 3DMAX Mesh
- Bard Ventralex ST Hernia Patch
C-Qur Hernia Mesh | Atrium Medical
C-Qur Hernia Mesh was introduced to the market in 2006 by New Hampshire-based medical device company Atrium Medical.
The new hernia mesh was designed using an all-natural Omega-3 gel coating — the first mesh on the market to use the new coating. Atrium claimed the coating helped reduce adhesion of the mesh to other organs or tissue walls, a potential complication of hernia mesh.
It has now been more than a decade since C-Qur was approved and patients are filing lawsuits against Atrium accusing the company of designing a defective product and failing to warn about its risks. The lawsuits allege C-Qur’s novel Omega-3 coating actually incites an inflammatory response that leads to adhesion, mesh and tissue erosion, and other injuries.
C-Qur Hernia Mesh was cleared through the U.S. Food and Drug Administration’s 510(k) Premarket Notification program, which allows medical device makers to bypass rigorous premarket clinical trials if their device is similar to another one already on the market.
The FDA approved C-Qur without testing its safety or effectiveness in people even though the mesh used a new type of gel coating not used in other meshes on the market.
Physiomesh | Ethicon Inc.
Physiomesh Flexible Composite Mesh was approved by the FDA in 2010. It was manufactured by Ethicon Inc., the medical devices division of global conglomerate Johnson & Johnson.
Physiomesh featured a unique 5-layer design and, like all composite meshes, contained a coating.
Physiomesh was cleared by the FDA through 510(k) Premarket Notification. Ethicon did not have to perform extensive clinical tests to prove the safety and efficacy of Physiomesh and only needed to show the device was similar enough to another mesh on the market.
Ethicon sold Physiomesh for 6 years before eventually pulling it over safety and efficacy concerns. In a recall notice to health care providers in May 2016, Ethicon said unpublished data from 2 hernia mesh databases showed Physiomesh was prone to more hernia recurrences and re-operations compared to other mesh brands. It initiated a global market withdrawal the same day, urging providers to stop using the hernia mesh immediately.
Even though Physiomesh is no longer sold, thousands of patients may have already been implanted with the device. Ethicon told doctors to monitor patients with a Physiomesh as they would normally, but these patients may now face higher risks of mesh-related complications.
Sepramesh IP | 3D Max | Ventralex ST
C.R. Bard Inc. manufactures several different hernia mesh brands, some of which have been taken out of production.
The medical device company continues to sell its Sepramesh IP, 3D Max and Ventralex ST meshes. All 3 of the meshes could potentially be involved in lawsuits over mesh-related complications.
Sepramesh IP Composite Mesh is a modified version of the original Sepramesh. Approved in 2004 through the FDA’s 510(k) program, it was originally designed and manufactured by biotech firm Genzyme Corporation. Bard bought the rights to Sepramesh in 2007.
Sepramesh IP is coated with an absorbable coating on only one side — a design feature Bard claims helps reduce adhesion while allowing enough tissue to grow into the mesh to hold it securely in place.
Much like other hernia mesh approved through the 510(k) program, Sepramesh IP has been associated with complications like inflammation, infection, chronic pain and hernia recurrence.
Bard’s 3D Max and Ventralex ST have also been associated with similar complications. Both were approved through the 510(k) process (in 2008 and 2011, respectively) and both contain materials linked to mesh injuries.
Hernia Mesh Lawsuits
Hernia mesh patients who were harmed by the mesh that was supposed to help treat them are now filing lawsuits against the manufacturers.
Atrium Medical, Ethicon Inc. and C.R. Bard Inc. are facing mounting lawsuits that accuse them of designing defective hernia mesh products and failing to warn about their risks.
People have developed severe compilations as a result of these faulty mesh products and there may be significant cash settlements or other payouts available to those affected.
Hernia mesh lawyers and attorneys are now accepting cases related to Atrium’s C-Qur mesh, Ethicon’s Physiomesh, and Bard’s Sepramesh IP, 3D Max and Ventralex ST meshes.
If you were implanted with one of these meshes during your hernia repair surgery and developed complications, 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
UptoDate. “Recurrent inguinal and femoral hernia.” George A. Sarosi Jr. et al. (March 30, 2016). Retrieved from http://www.uptodate.com/contents/recurrent-inguinal-and-femoral-hernia
JAMA. “Long-term Recurrence and Complications Associated With Elective Incisional Hernia Repair.” Dunja Kokotovic et al. (Oct. 18, 2016). Retrieved from http://jamanetwork.com/journals/jama/article-abstract/2565771
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