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.
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.
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.”
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