What is a hernia?

Getting a hernia is the result of weakness or strain of your muscles. As you get older, your muscles gradually get weaker, which can increase your chance of a hernia. Certain life factors can weaken your muscles, increasing the risk of a hernia including persistent coughing, constipation, pregnancy, obesity or prior surgeries.

About 90 percent of hernia repair surgeries in the U.S. use hernia mesh. Surgeons in the U.S. use hernia mesh in one million surgeries every year. Mesh can prevent a hernia from recurring. But hernia mesh can also cause serious complications.

Complications From Hernia Mesh Products:

Some common problems that occur with defective hernia mesh products:

Mesh Migration: The movement of surgical mesh to other parts of the body. Mesh migration often results in significant bleeding or a fistula and requires operation.

Mesh Contraction: Shrinkage or contraction of the mesh or of the tissue surrounding the mesh (which can alter the physical structure of the abdomen or groin where the mesh was implanted).

Erosion: Erosion of the implanted mesh through tissue. When erosion occurs, infection, abscess, fistula, or obstructions are the most common sequelae.

Adhesion: When scar-like tissues stick other tissues together. Obstruction: A blockage in the large or small intestine.

Which Hernia Mesh Products Are Involved in Lawsuits?

Ethicon, a subsidiary of Johnson & Johnson, withdrew their Physiomesh™ Flexible Composite Mesh on May 27, 2016 - this is not the same thing as an FDA recall - this was a market withdrawal and all units were removed from the global market. The Ethicon Physiomesh design utilizes polypropylene to manufacture the base layer of the Physiomesh. Polypropylene is the same material that Ethicon utilized to make their transvaginal mesh and bladder slings. Ethicon added an absorbable film coating to each side of the polypropylene to create the Physiomesh. Ethicon’s Physiomesh was approved for market in the United States in April 2010. The FDA approved it with a 510(k) application, allowing it on the market without new safety studies by claiming it was similar to other types of hernia mesh already approved to be on the market. This allowed Ethicon Physiomesh to skip rigorous pre-market research and studies.

Proceed Surgical Mesh manufactured by Ethicon - Proceed Surgical Mesh was approved by the FDA on May 25, 2006 as a result of the FDA’s 510(k) premarket approval process. The Proceed Surgical Mesh is a sterile, thin, flexible laminate mesh designed for the repair of hernias and other fascial deficiencies. It is composed of an oxidized regenerated cellulose (ORC) fabric, and PROCEED™ Soft Mesh, a nonabsorbable polypropylene mesh, which is encapsulated by a polydioxanone polymer. The polypropylene mesh side of the product allows for tissue ingrowth, while the ORC side provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces during the wound-healing period to minimize tissue attachment to the mesh. The polydioxanone provides a bond to the ORC layer. Following implantation of the added protective layer, the layer is said to completely wear away, leaving behind the polypropylene.

On January 14, 2011, Ethicon voluntarily issued a small class II recall of Lot Number BMG618 as a preventative measure when they discovered a “potential for de-lamination,” in which the layers of mesh could separate, increasing the risk of bowel adhesions. Another class II recall was issued by the FDA on February 19, 2014 for a packaging defect causing delamination leading to potential adhesions.

Atrium Medical Corporation manufactures a variety of medical devices including their C-QuR surgical mesh. The Atrium C-Qur mesh was approved for market in the United States in 2005. Originally, Atrium recalled the C-QuR mesh because the fish oil, which is what the mesh came packaged in, caused the surgical mesh to stick to it’s packaging. When a surgeon attempted to remove the device, it would tear. In July of 2013, the FDA issued a Class II Recall on the C-QuR V-pack Mesh.

On April 26, 2018, the FDA posted a recall notice for the Versatex Monofilament Mesh manufactured by Sofradim Production. The official product name is Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M. According to the recall notice: “There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device’s Instructions for Use to make surgeons aware of risks in using the device in Transversus Abdominis Muscle Release (TAR) procedures.”

Bard Kugel Hernia Mesh: The Kugel Mesh won FDA approval in 1996. This device is made with two layers of monofilament polypropylene plastic (used in the manufacture of numerous consumer products ranging from food grade containers to carpet). This double layer forms a pocket, surrounded by a “memory recoil” ring that holds the device open and allows it to retain its shape. When the device is first implanted at the hernia site, it is folded. Once the device is in place, the memory recall ring causes it to spring back into its original shape, covering the injury and holding everything together during the healing process.

December 22, 2005 (expanded on January 5, 2006 and March 24, 2006) - Recall: Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula. In February 2007, the Food and Drug Association (FDA) issued a Class I recall warning that the “use or exposure to” the Bard Kugel Mesh Patch “has a reasonable probability to cause serious adverse health consequences, including death.”

As of March 31, 2012, Davol discontinued the Composix Kugel Patch and suggested replacing the product with the Ventrio or Ventrio ST Hernia Patch products. Davol noted that the newer hernia meshes utilize a lighter-weight mesh and absorbable materials, which leave less implant material behind in patients.

What Can I Do If I Have A Defective Hernia Mesh?

Just because your hernia mesh isn’t currently under recall doesn’t mean you don’t have a claim. Your pain could be due to a defective mesh used in your hernia repair. If it was, the manufacturer of that device is responsible for the pain their product caused. Contact Bowersox Law Firm right away for a fee consultation.


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