Hernia Mesh Complications Partially Outweigh Benefits Over Nonmesh Hernia Repair: Study

Amid increasing concerns about safety problems with hernia mesh manufactured and sold by several different companies, new research casts doubt on the benefits of using the products, indicating that long-term risk of complications from hernia repair mesh may outweigh the potential benefits. 

In a study published last week in the Journal of the American Medical Association (JAMA), researchers looked at a comparison between the benefits and risks of non-mesh hernia repair surgery and those involving the use of mesh implants.

Researchers found that hernia mesh complications, such as mesh erosion, infections and organ perforation, negate some of the apparent benefits of provided by the hernia repair products over time.

The study looked at data from a national Denmark registry that looked at all elective incisional hernia repairs in that country from January 1, 2007, through December 31, 2010, including a total of 3,242 patients. They followed up on their progress until November 1, 2014, looking for the need for reoperation for recurrence and all mesh-related complications that required surgery.

The study looked at non-mesh hernia repair procedures, open mesh repair and laparoscopic mesh repair procedures.

According to the findings, laparoscopic and open mesh repairs had a lower rate of recurrent hernias, with 12.3% of open mesh surgeries having recurrences of hernias, and recurrence rates of 10.6% in laparoscopic mesh repairs. That compares to a recurrence rate among nonmesh repairs of 17.1%.

However, at five years of follow up, the researchers found that 5.6% of open mesh repair patients needed follow up surgery due to complications, as well as 3.7% of those who underwent laparoscopic mesh repairs. Less than one percent of patients who had nonmesh repairs suffered complications requiring surgery, the study found.

“Among patients undergoing incisional repair, sutured repair was associated with a higher risk of reoperation for recurrence over 5 years compared with open mesh and laparoscopic mesh repair,” the researchers concluded. “With long-term follow-up, the benefits attributable to mesh are offset in part by mesh-related complications.”

Hernia Mesh Litigation

The study comes following a steady stream of hernia mesh lawsuits filed in recent years against manufacturers of various different products that were found to contain dangerous design defects, resulting in a higher-than-expected number of problems after they were implanted in patients, including infections, complications where the mesh fused with parts of the body, and other internal injuries.

About 10 years ago, concerns emerged about problems with Davol Kugel hernia patch, resulting in a series of recalls and thousands of lawsuits throughout the United States. However, individuals continue to experience complications from the hernia mesh.

Over the past year, a growing number of Atrium C-Qur mesh lawsuits have been filed in courts nationwide, each involving similar allegations that the manufacturer failed to investigate or review complaints involving hernia failures and infections that may be caused by design problems. Pronounced “Secure”, Atrium C-Qur mesh was approved by the FDA on March 2006, for use in hernia repair, chest wall reconstruction and to repair traumatic or surgical wounds. In October 2012, the FDA issued a warning letter to Atrium, citing the company for failing to respond to complaints about the C-QUR mesh and other products.

More recently, an Ethicon Physiomesh recall was issued earlier this year in several countries after foreign registries uncovered a high number of complications among individuals who received the hernia repair product. While the action was classified as a “market withdrawal” in the United States, Johnson & Johnson’s Ethicon subsidiary has indicated that it has no intentions of returning the product to the market, after it was unable to identify the cause of the complications.

A number of individuals who had the hernia mesh implanted in their body are now pursuing an Ethicon Physiomesh lawsuit, alleging that severe and painful complications may have been avoided if the manufacturer had adequately tested and researched the product. Several of the complaints suggest that the problems may stem from the use of materials that are not inert and that react to human tissues, causing infections and increasing the risk that the hernia mesh migrates from the implant site to other parts of the body. Claims also indicate the mesh fails to perform and can abrade human tissue.