Abdominal wall hernias, one of the most common types of hernias, account for 348,000 hernia repairs each year.
Hernia mesh is known to cause complications. Infection and other problems often lead to the mesh being removed later, which means more medical expenses and more risk to patients.
How often do these complications occur? How long after the initial surgery do they occur? And how much do these hernia mesh complications cost patients?
A new study published in the Journal of the American College of Surgeons in January sought to answer those questions.
Researchers from Vanderbilt University looked at the rate of hernia mesh removals after abdominal wall hernia repair in 3 states — California, Florida, and New York — and calculated the average cost of removals to patients. They also looked at how long after the initial surgery the complications took place.
Using patient information databases, researchers looked at nearly 620,000 patients who had abdominal wall hernia repair surgery between 2005 and 2011.
Researchers found that about 0.07% of those patients had to have their mesh removed because of complications. This resulted in a clinically significant mesh removal incidence rate of about 1 in 1,000 patients, according to the study.
Researchers said the incidence rate was a “conservative” estimate and noted that their findings were lower than that of the few other studies that looked at hernia removal rates. They explained that other estimates have been based mainly on male-dominated studies of veterans, which is not necessarily representative of the general population.
When it comes to cost, study authors found hernia mesh removals cost patients about $21,889 on average compared to $6,983 for non-removals. That’s more than 3 times as much in medical expenses.
On top of the exorbitant costs, hernia mesh complications are apparently not being reported to regulatory agencies as often as they are occurring.
On average, the study found mesh removals occurred about one year after the mesh was implanted. In the study, about 80% of mesh removals occurred within 2 years of the initial surgery and 90% occurred within 3 years. Some removals occurred 6 years after the first hernia repair surgery.
The authors said this time frame is far outside the 30- to 90-day follow-up window when adverse events are typically reported to the U.S. Food and Drug Administration and other surveillance systems.
“Long-term follow-up is critically necessary to fully understand the ramifications of implanted devices,” the study authors wrote.
Post-market surveillance of medical devices, like hernia mesh, is grossly underestimated by the FDA, said the authors.
The FDA uses a voluntary database to collect reports of adverse events called Manufacturer and User Facility Device Experience, or MAUDE.
Researchers searched the MAUDE database for all mesh-related complications reported to the FDA during a 9-year period and found 252 adverse events from around the country.
In contrast, their study found almost twice as many adverse events related only to mesh removals after abdominal wall hernia repair during a 7-year period in just 3 states.
The study authors called on surgeons, manufacturers, and regulators alike to create a new surveillance system that can better detect rates of complications. They said it was especially important for devices like hernia mesh, whose complications can occur long after the initial procedure.
“Because these complications occur in the long term, it is paramount that the stakeholders involved in the repair of the abdominal wall, including surgeons, manufacturers, and regulatory bodies, collectively devise a system of surveillance to minimize the risk to patients. … The optimal duration of follow-up needed to detect the majority of complications has not yet been determined, but based on our data, patient surveillance should be extended at least 1 to 3 years after implantation of a mesh device.”
Hernia Mesh Lawsuits
The slew of complications related to hernia mesh products has prompted injured patients to file Hernia Mesh Lawsuits against the various manufacturers of these devices.
If you’ve been injured by a problematic hernia mesh product, you may be entitled to financial compensation.
To see if you qualify for a case, contact the experienced lawyers at Hood National Law Group today. We are available 24 hours a day, 7 days a week to assist you and answer any questions you may have.
Use the form on the right-hand side of your screen or call 1-800-214-1010 to speak with a member of our legal team for a free case evaluation.