Hernia mesh litigation continues to move forward, with lawsuits alleging that the mesh devices caused complications; device makers are accused of failing to warn about the risks. Johnson & Johnson’s Ethicon unit is being sued over its Physiomesh Flexible Composite Mesh after the device was withdrawn from the market. Atrium Medical is also facing hernia mesh litigation. Lawsuits allege adverse events from the C-Qur (pronounced “secure”) hernia mesh.
The product liability attorneys at Parker Waichman LLP have decades of experience representing clients in medical device litigation. The firm continues to offer free legal consultations to individuals with questions about filing a hernia mesh lawsuit.
Ethicon withdrew its Physiomesh in May 2016, after data from two large independent hernia registries showed that the device was associated with a higher rate of recurrence and reoperation compared to other hernia mesh products. The Physiomesh is used for minimally invasive abdominal and groin hernia repair.
The company issued an Urgent Field Safety Notice stating that the issue appears to stem from a combination of factors. “Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors,” Ethicon stated.
“Consequently, Ethicon [has] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market,”
Ethicon does not plan to reintroduce the Physiomesh, the letter said.
Physiomesh lawsuits have been filed following product withdrawal. One complaint, for example, was filed in the U.S. District Court, Middle District of Florida on Sept. 22, 2016. Court records show that another Physiomesh lawsuit was filed in the Southern District of Illinois; that case is scheduled to go to trial on Jan. 22, 2018.
Atrium Medical is facing litigation over its C-Qur hernia mesh. The U.S. Judicial Panel on Multidistrict Litigation (JPML) has consolidated cases into a federal multidistrict litigation (MDL) in New Hampshire. MDLs are created when there are a number of lawsuits with common questions of fact. These cases are transferred to one court, with the goal of making litigation faster and more efficient.
Plaintiffs in the Atrium Medical C-Qur litigation allege that the hernia mesh is defective due to its omega-3 (fish oil) coating, which allegedly causes adverse events such as adhesions. The coating is intended to be an anti-inflammatory, anti-adhesion barrier that prevents organs from sticking to one another as the patient heals. However, lawsuits allege that the coating has led to complications.
Alleged injuries include infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, dental problems, bowel obstruction and abnormal liver function.
One Atrium Medical C-Qur hernia mesh lawsuit was filed on behalf of an Arkansas woman who was implanted with the C-Qur in 2011. According to her lawsuit, she suffered abdominal pain and recurrence (the hernia returned). When physicians decided to remove the mesh due to complications, they discovered that it had become trapped in the plaintiff’s abdomen surrounded by scar tissue.
Another Atrium Medical hernia mesh lawsuit was filed on behalf of a Georgia woman who alleges that the device caused chronic pain, nausea, vomiting, infections and other adverse events. She states that the mesh caused complications when it “bunched up in layers” and “folded up”.
Study Analyzes Rate of Long-Term Complications with Hernia Mesh
Parker Waichman notes that new research findings have shed light on hernia mesh complications. On Oct. 18, 2016, the Journal of the American Medical Association (JAMA) published a study on long-term complication rates of hernia repair. Researchers compared hernia mesh repair via open techniques, hernia mesh repair via laparoscopic techniques and open repair without mesh in Danish patients. The study found that, overall, hernia mesh benefits are partially off-set by the rate of long-term complications.
Patients with open or laparoscopic hernia mesh had lower rates of reoperation for recurrence, but they also had higher rates of complications. “For the entirety of the follow-up duration, there was a progressively increasing number of mesh-related complications for both open and laparoscopic procedures,” authors noted.
In patients undergoing open repair with hernia mesh, the rate of complications was 5.6 percent at 5-year follow-up and 3.7 percent in patients undergoing hernia mesh repair laparoscopically. In patients undergoing hernia repair via non-mesh methods, the rate of long-term complications was 0.8 percent.
“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,” authors concluded. “With long-term follow-up, the benefits attributable to mesh are offset in part by mesh-related complications.”
Hernia mesh adverse events may include “skin infections, nonhealing wounds, seroma formation to severe chronic pain, life-threatening bowel obstruction and chronic fistula development that may be caused by chronic mesh infection.”
Hernia Mesh and 510(k)
Most hernia mesh products were approved through 510(k), a fast-track route that allows devices onto the market without rigorous clinical testing. Devices cleared through 510(k) only need to be “substantially equivalent” to a previously approved device (called a “predicate”). Lawsuits and safety advocates have called attention to 510(k), in light of the fact that some controversial medical devices such as metal-on-metal hip implants and transvaginal mesh were approved through this route.
The U.S. Food and Drug Administration (FDA) has a stricter approval process known as premarket approval (PMA), where manufacturers must submit data showing that their devices are safe and effective before they are sold.
The authors of the JAMA study also discussed 510(k) with regards to hernia mesh, stating “the complete spectrum for the risks and benefits of mesh used to reinforce hernia repair is not known because there are very few clinical trial data reporting hernia outcomes as they pertain to mesh utilization. This highlights the need for more long-term studies of mesh repair using high-quality registries such as the one in Denmark.”