Dive Brief:
- The U.S. Food and Drug Administration released updated information on Thursday to help patients make informed decisions about the use of surgical mesh in hernia repair.
- Responding to concerns about the safety of hernia mesh devices, the FDA analyzed the adverse event reports it has received over the past 22 years and reviewed 45 research papers published in the past 11 years.
- The adverse event reports describe problems including pain, injury and disability, and the papers provide estimates on the incidence rate of common complications. While the FDA previously removed a different type of mesh from the market, it continues to monitor the safety of the hernia devices.
Dive Insight:
The FDA stopped the sale of mesh products for transvaginal repair of pelvic organ prolapse in 2019. Mesh devices have a longer history in the repair of abdominal hernias and have a better safety record in those procedures.
Even so, there are concerns about the hernia devices. A jury ordered Becton Dickinson subsidiary C.R. Bard to pay $4.8 million to a man treated with its Ventralex hernia mesh last year. BD faces more than 33,000 product liability claims involving its line of hernia repair devices. More trials are scheduled for the fall.
Against that backdrop, the FDA has shared its current understanding of the evidence on the safety of surgical mesh in hernia repairs. The agency presented data from two aspects of its safety monitoring program, listing the most common adverse events in its 55,000 reports and presenting the results of its analysis of the academic literature.
The most frequently cited adverse events in the reports submitted to the FDA include pain, injury, disability, infection, inflammation and nausea. There is some overlap with the literature. The FDA found incidence ranges of 0% to 21% for surgical site infection and 0.3% to 68% for pain in the literature. Pain resulting in a significant impact on quality of life had an incidence rate of up to 3.8%.