Hernia Mesh Lawsuit
An estimated 4.5 million people in the United States suffer from an abdominal hernia each year, or about one in every sixty. Repair of serious hernias often requires surgery in which the doctor puts the distended tissues, organs, and muscles back into place. They can either stitch the area together, or use a synthetic mesh patch to help shore up and support the repair.
Starting in the 1990s, hernia mesh products became more popular because early research seemed to indicate that they provided stronger and longer lasting hernia repairs. Recent research, however, has questioned that conclusion. Some patients who have been implanted with hernia mesh products have gone on to suffer from serious injuries including pain, migration, and adhesion of the mesh to internal tissues and organs.
Pittsburgh residents who experienced these and other types of hernia mesh injuries are advised to speak to the hernia mesh attorneys at Chaffin Luhana immediately. Evidence shows that manufacturers were aware of the dangers, and failed to provide adequate warnings to doctors and patients. If your life has been stalled by repeated hospitalizations and medical treatments, contact us today for a free initial consultation.
What is Hernia Mesh?
In 2014, the Food and Drug Administration (FDA) noted that hernia repairs are common, but that they also have a high rate or recurrence. Surgical mesh is often used to help strengthen the repair, reduce the rate of recurrence, and reduce recovery time. But extremely serious complications have been reported with these products.
Surgical mesh is a net-like, woven device that can be made from a variety of materials, one of the most common being polypropylene, a synthetic material. Some mesh products also contain additional layers that are designed to help the mesh incorporate into the body.
Mesh products are offered in a variety of shapes and sizes to be used in particular procedures, and may be used in their entirety or cut to size. Most are used in one of two common types of hernia repair procedures:
- Laparoscopic: This is a minimally invasive procedure in which the surgeon makes small incisions and then uses camera-guided surgical tools to repair the hernia and insert the mesh, if one is used. Patients typically recover more quickly with minimal scarring.
- Open repair: The surgeon makes a larger incision near the hernia to repair it directly. The surgeon may or may not use mesh.
Hernia Mesh Linked with Serious Complications
Early studies of hernia mesh outcomes seemed to suggest that repair with mesh was better than repair without mesh. In 2003, for example, researchers compared the two types of treatment in over 10,800 patients who went through hernia repair. They found that the hazard for recurrence was 24.1 percent higher without mesh compared to when the mesh was used.
A 2014 study review also showed a slightly better outcome with hernia mesh repair. When analyzing 9 trials, researchers found that mesh repairs resulted in a 2.7 percent recurrence rate, while non-mesh repairs resulted in an 8.2 percent recurrence rate. Mesh repairs, however, resulted in more seromas (pockets of fluid) and surgical site infections (SSIs)—7.7 percent compared to 3.8 percent, and 7.3 percent compared to 6.6 percent, respectively.
“Mesh repair has a small reduction in recurrence rates compared with suture repairs for primary ventral hernias,” the researchers wrote, “but an increased risk of seroma and SSI was observed. Further high-quality studies are necessary to determine whether suture or mesh repair leads to improved outcomes for primary ventral hernias.”
Other studies have shown conflicting results. One of the most recent published in 2016 following over 3,200 patients compared outcomes using mesh in either open or laparoscopic techniques, vs. open repair without mesh. Again, the recurrence rate was higher when mesh wasn’t used. Results showed:
- Open repair with mesh: 12 percent risk of recurrence
- Laparoscopic repair with mesh: 10.6 percent risk of recurrence
- Non-mesh repair: 17.1 percent risk of recurrence
Yet as the researchers continued to follow these patients for years after the surgery, they found something disturbing: the number of mesh-related complications continued to increase for both types of procedures. At the 5 year follow-up, mesh-related complications were 5.6 percent for patients who underwent open mesh repair, and 3.7 percent for those that had laparoscopic mesh repair. In contrast, the long-term complication rate for patients who underwent non-mesh repair was 0.8 percent.
Complications included bowel obstruction, bowel perforation, bleeding, and abscesses.
“Mesh implantation prevented the need for subsequent reoperation in relatively few patients,” the researchers 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. The FDA has acknowledged that complications can occur with mesh products, particularly those that have been pulled off the market. These include pain, infection, recurrence, adhesion, obstruction, and perforation.
“In the FDA’s analysis of medical adverse event reports to the FDA,” the authors wrote, “recalled mesh products were the main cause of bowel perforation and obstruction complications.”
Some hernia mesh products have been recalled, while others, with the same or similar complications remain on the market. A few examples of these products include:
- Physiomesh: Manufactured by Ethicon, this hernia 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, the Physiomesh product caused fluid buildup that increased 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 mesh, 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.
- 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. Approximately 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 are still on the market.
- 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 that we’re currently investigating include the 3DMax, Composix, PerFix, Sepramesh, Ventralex, and Ventrio.
- 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:
- Seromas (fluid build-up)
- Organ puncture
- Bowel perforation
- Fistula formation
- Mesh migration or rejection
- Hernia recurrence
- Intestinal blockage
Hernia Mesh Lawsuits
In 2017, a Pennsylvania couple filed a hernia mesh lawsuit against Atrium Medical, claiming that its C-QUR mesh product caused the husband to suffer from serious injuries, including infection and mesh erosion into the bowel. He had to have the mesh and a significant portion of his bowel removed due to these problems, and underwent extensive antibiotic therapy post-surgery to manage the infection.
Other 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.
The attorneys at Chaffin Luhana are actively investigating potential hernia mesh lawsuits. Individuals in the Pittsburgh and Ohio Valley areas who were implanted with these products and then experienced serious injuries may be able to recover damages in a hernia mesh lawsuit. Call today for a free case evaluation at 1-888-316-2311.