Hernia Mesh Lawsuits: Manufacturers May Be Liable

Cochran, Kroll & Associates is currently accepting cases involving patients who are experiencing complications due to mesh implants used in hernia repair surgeries.

Hernias are a very common medical problem, affecting thousands of people every year. A hernia is a weakness in a muscle (creating an opening) that allows an organ or tissue to squeeze through the opening. There are several different kinds of hernias, but a ventral hernia of the abdomen is the most commonly implicated in failed hernia mesh surgery.

A ventral hernia is a weakness in the muscles of the abdominal wall, creating an opening that allows other organs and tissue to squeeze through the abdominal muscles, creating a bulging appearance. The bulge is typically part of the intestine, but may also be other tissue. A ventral hernia often occurs over an incision from surgery that over time does not heal correctly.

While some hernias may not cause any harm, others require care and treatment. Frequently, surgeons perform surgery to close the opening in the abdominal wall. For most ventral abdominal wall hernia repairs, a mesh is used to close the opening in the abdominal muscle. The mesh is surgically implanted over the defect and then surgically connected to the surrounding tissue to hold everything in place. The side of the mesh that is attached to the wall is supposed to grow into the patient’s own tissue. The other side is usually coated with a substance that is supposed to keep the mesh away from the organs, such as the intestine.

There are four basic categories of mesh materials: plastic, gortex, collagen or a composite.

The composite mesh is the most commonly used for hernia surgeries and it combines the properties of the plastic mesh on one side and the gortex or collagen mesh on the other side, insulating the intestines (and other organs) from the plastic that could cause problems, while allowing strong adhesion to the abdominal wall.

If the hernia mesh composite product fails to properly insulate the intestines from the plastic mesh, complications such as adhesions, fistulas and infections can develop requiring additional surgery.

Recent findings have shown serious complications may arise in hernia patients who have had hernia repair surgery, including those using the following brands of surgical mesh implants:

• ETHICON PHYSIOMESH FLEXIBLE COMPOSITE MESH
• ATRIUM C-QUR MESH
• BARD VENTRALEX
• ALLODERM REGENERATIVE TISSUE MATRIX

ETHICON PHYSIOMESH FLEXIBLE COMPOSITE MESH

Sales of Ethicon Physiomesh Flexible Composite Mesh began in March 2010, after the FDA approved its use through a 510(k) process. A 510(k) application allows the sale of a product without clinical trials or studies that establish its safety. This sort of approval is limited to products that are “similar” to other products already on the market.

Ethicon’s Physiomesh Flexible Composite Mesh is used in laparoscopic repair of abdominal (ventral) hernias.

The polypropylene (plastic) component of the physiomesh product is laminated between two layers of poliglecaprone, a bioresorbable polymer used to form an anti-adhesion coating that acts as a barrier between the polypropylene and the patient’s organs. Utilizing an anti-adhesion coating on one side of a polypropylene mesh graft increases the risk that the graft will not incorporate into the abdominal wall, which can cause the mesh to fold, buckle and migrate, posing a threat to adjacent tissues and organs.

Poliglecaprone is the coating designed to be a protective layer but is known to cause an inflammatory response in soft tissue.

When poliglecaprone-coated mesh is implanted in a patient, an inflammatory response occurs, causing complications that include pain, mesh rejection, mesh migration, organ damage, adhesions, complex seroma, fistula, sinus tract formation, delayed wound closure, infection, sepsis and even death in some cases.

On May 25, 2016, the Ethicon Corporation issued an urgent field safety notice to withdraw its Physiomesh Flexible Composite Mesh from hospitals because of high failure rates and complications such as adhesions, fistulas and infections that resulted in pain and additional surgery.

When surgery is done with any mesh, an identifying sticker is incorporated into a patient’s medical records to show the exact product the physician implanted during surgery. Ethicon’s urgent safety notice lists the particular hernia mesh devices subject to the recall.