In April 2016, the Food and Drug Administration (FDA) warned that they had received many reports of complications related to hernia repair with recalled surgical mesh products. “Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh,” they stated.

Surgeons have used surgical mesh to help repair various types of hernias for decades, but many of the devices have been the subject of repeated recalls because of design and manufacturing defects that have led to serious and painful complications.

Individuals who have suffered serious injuries because of hernia mesh products may be able to pursue legal claims against the manufacturers. Some of these claims have already resulted in large awards for plaintiffs, including a $1.5 million verdict in a 2010 C. R. Bard Kugel hernia mesh case. In 2011, Bard also agreed to pay $184 million to settle more than 3,000 hernia mesh claims.

More recently, all federally-filed Ethicon Physiomesh product lawsuits were consolidated in the Northern District of Georgia for pre-trial proceedings.

What is Hernia Mesh?

A hernia is a bulge that occurs in an area of weakened or torn muscles. Over time, as the muscles become less able to support related fat, tissues, and organs, they allow those tissues and organs to push through, creating a bulge that can be felt and often seen.

Hernias are most common in the abdomen and groin. They can develop because of a congenital problem present at birth, or as a result of aging, muscle strain, abdominal surgery, obesity, and digestive problems. Smoking can also make hernias more likely.

Traditionally, to repair a hernia, a surgeon simply pushed the bulge back into place and sewed or stitched the muscles closed. Decades of research, however, showed that this type of repair was likely to lead to a recurrence of the hernia. The reason being that surgeons were using already weakened, thinned and damaged muscles around the hernia to repair the hernia, and the result was that the repair just wasn’t very strong.

It was clear that hernia repairs needed additional support if they were to last. According to a 2010 study, the concept of using a mesh product to repair hernias was introduced over 50 years ago, but it was in the late 1980s that the procedure started to gain widespread acceptance.

Mesh products are net-like patches made of sterile, woven material that surgeons use to shore up and support distended muscles and tissues. They were initially made of hard plastic, but these caused numerous complications. Today, they are made of softer, more flexible and lightweight materials that are intended to incorporate easily into the body’s muscles and tissues to help create a permanent hernia repair. Ideally, the mesh stabilizes and strengthens the area, supports organs and muscles, and acts as a scaffold for new tissue growth.

Currently, about one million mesh products are used every year worldwide. Though early studies seemed to suggest that repair with mesh was superior to repair without it, later studies have produced mixed results.

What’s Wrong with Hernia Mesh?

There is a wide range of hernia mesh products on the market, made by many different companies. Each is individually designed and manufactured to provide superior results in hernia repair procedures. Products may vary in shape, size, flexibility, and materials used, and may have unique characteristics to accommodate certain anatomical features.

Mesh may also be designed for a specific type of repair. Minimally invasive laparoscopic procedures, for example, in which surgeons use small incisions and a camera to insert the mesh, require that the mesh be flexible enough to fit through a small tube. More traditional surgical repair can accommodate thicker mesh products.

Studies around the turn of the century seemed to indicate that mesh products improved hernia repair procedures, resulting in fewer recurrences, less postoperative pain, and faster recovery. But in 2016, the scientific journal JAMA published a study that conflicted with these findings.

Researchers followed 3,242 patients who went through hernia repairs from 2007 to 2010 and compared outcomes with and without hernia mesh. Results showed that through the use of mesh was associated with a lower risk of hernia recurrence, the benefits were offset by other mesh-related complications. The risk of recurrent hernia repair was 12 percent for patients with open mesh repair and 10.6 percent for patients with laparoscopic mesh repair, compared with a higher 17.1 percent for patients with non-mesh repair.

Yet during the five years that the researchers followed up on the patients, there was an increasing number of mesh-related complications. These included bowel obstruction, bowel perforation, bleeding, and abscesses. The cumulative incidence of mesh-related complications was 5.6 for patients with open mesh repair, 3.7 percent for patients with laparoscopic mesh repair, and only 0.8 percent for non-mesh repair. Many of these complications required additional surgeries.

“Mesh implantation prevented the need for subsequent reoperation in relatively few patients,” the authors wrote, “suggesting that the benefits associated with the use of mesh are partially offset by long-term complications associated with its use.”

Problematic Hernia Mesh Products

Some hernia mesh products have been associated with a higher rate of complications than others. Some of the following mesh products have been pulled off the market because of higher than normal rates of problems, while others remain on the market, but have had similar complications reported:

1. Physiomesh: Manufactured by Ethicon, this mesh was initially advertised as being superior to other meshes because of its unique 5-layer design, which was supposed to encourage incorporation into the body. Instead, it caused fluid buildup that increased the risk of infections and was also prone to migration and shrinkage. In May 2016, Ethicon released an urgent field safety notice telling doctors and hospitals to stop using the Physiomesh because recurrences and reoperation rates after laparoscopic hernia repair were higher than the average rates of comparative mesh products. Proceed, another Ethicon mesh device, was also recalled in 2005.
2. C-QUR: Manufactured by Atrium Medical, a Maquet company, C-QUR hernia mesh is made from the same synthetic plastic material as that used in Physiomesh, but it has a different coating on it. The product was recalled in 2013 after reports indicated it could stick to the inner packaging liner during shipping and storage, particularly when exposed to high humidity. A total of about 32,000 products were removed from the market worldwide. Though this recall has not been connected to patient injuries, other studies have shown that C-QUR was associated with an increase in adhesions and infections. In 2015, the District Court of New Hampshire entered a permanent injunction against Atrium, preventing it from manufacturing and distributing C-QUR, but Atrium has produced other variations of the product that is still on the market.
3. Kugel: Manufactured by Davol, a C. R. Bard company, Kugel mesh was initially recalled because of problems back in 2005 because it was associated with complications like pain, infection, hernia recurrence, and adhesion. The company updated the design but was recalled again in 2006 and 2007 because of breakage and bowel perforations. Thousands of lawsuits were filed nationwide, and the company has paid out millions of dollars in lawsuit settlements and verdicts. Other brands of Bard mesh linked with complications include the 3DMax, Sepramesh, and PerFix.
4. Parietex: Manufactured by Covidien, a Medtronic company, Parietex is made of polyester rather than polypropylene. There were several problems with the initial product, so the company has put it through a number of revisionary designs. It is extremely lightweight, however, which has made it difficult for surgeons to place it correctly. It has unsealed edges, which can perforate the bowel and other organs, and may lead to fraying and tearing. The mesh also tends to contract and shrink. Though there has been no Parietex recall, the product is the subject of lawsuits in which patients seek to hold the company liable for serious injuries.

Types of Injuries Associated with Hernia Mesh

Patients who have been implanted with hernia mesh products and then experienced problems have reported injuries including the following:

• Pain
• Bleeding
• Seromas (fluid build-up)
• Infections
• Adherence
• Sepsis
• Organ puncture
• Bowel perforation
• Fistula formation
• Mesh migration or rejection
• Hernia recurrence
• Intestinal blockage

Hernia Mesh Lawsuits

Plaintiffs claim that hernia mesh manufacturers knew about the problems associated with their products, including the inflammatory properties of the materials, yet failed to provide adequate risk warnings on the labeling or in related product materials. They also claim the companies failed to adequately test the products in clinical trials before releasing them on the market.