JAMA Study Analyzes Recurrence, Complications with Hernia Repair
A recent study published in the Journal of the American Medical Association (JAMA) focuses on the long-term complication rates of hernia repair. The study, published on Oct. 18, 2016, looked at Danish patients undergoing hernia mesh repair via open techniques, hernia mesh repair via laparoscopic techniques and open repair without mesh. The authors found that, overall, the long-term complications of hernia mesh partially counter the benefits.
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.
Using a Danish registry, researchers gathered data on 3,242 patients undergoing incisional hernia repair in Denmark from Jan. 1, 2007 to Dec. 31, 2010. Researchers conducted follow-up until Nov. 1, 2014. The authors evaluated the risk of reoperation for recurrence as well as all mesh-related complications requiring surgery at five years among patients undergoing laparoscopic hernia mesh repair, open hernia mesh repair and open non-mesh hernia repair.
Researchers found that patients with open or laparoscopic hernia mesh repair had lower rates of operation for recurrent hernia compared to patients with non-mesh hernia repair. However, these techniques were also associated with higher rates of complications. The authors noted that “For the entirety of the follow-up duration, there was a progressively increasing number of mesh-related complications for both open and laparoscopic procedures.” The rate of mesh complications in patients undergoing open repair was 5.6 percent at 5-year follow-up and 3.7 percent in patients undergoing laparoscopic hernia mesh repair. Comparatively, the rate of long-term complications with non-mesh repair 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.”
The authors write that the rate of hernia long-term complications is unknown, noting a lack of randomized trials to determine the effectiveness and observational trials to determine long-term health consequences. According to the authors, complications associated with hernia mesh 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 Approved via 510(k)
The authors of the Oct. 2016 JAMA study point out that most hernia mesh products in the United States were approved through 510(k), a process used to clear some medical devices. Products approved through 510(k) do not need to undergo clinical testing for safety or efficacy, a requirement for all drugs. Manufacturers only need to demonstrate that the product is similar enough or “substantially equivalent” to an older device, referred to as a predicate. Devices can be approved through 510(k) even when the predicate had safety issues of its own.
Parker Waichman notes that some controversial medical devices, including transvaginal mesh and metal-on-metal hip implants, were approved through 510(k). In light of safety concerns, the route has come under increased scrutiny for certain products.
The authors note that since hernia mesh was approved through 510(k), “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.”
Ethicon Withdraws Physiomesh Hernia Mesh
In May 2016, Ethicon withdrew its Physiomesh Flexible Composite Mesh due to a high rate of recurrence and revision. The device is used in patients undergoing minimally invasive abdominal and groin hernia repair. Ethicon pulled the Physiomesh from the market after data two large independent hernia registries found a higher rate of recurrence and reoperation with the Physiomesh compared to other hernia mesh products.
“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 said in its “Urgent Field Safety Notice”.
“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,” the letter states.
The company does not intend to reintroduce the product, stating “Ethicon will not return the Ethicon Physiomesh composite mesh product to the market worldwide.”
Ethicon is facing Physiomesh lawsuits, filed on behalf of plaintiffs who allege that the company failed to warn patients and the medical community about the risks. Court documents show that one Physiomesh lawsuit was filed on Sept. 22, 2016 in the U.S. District Court, Middle District of Florida. Another Physiomesh case, filed the Southern District of Illinois, is slated to begin trial on Jan. 22, 2018.
Atrium Medical C-Qur Lawsuits
Lawsuits have also been filed over the C-Qur (pronounce “secure”) hernia mesh, manufactured by Atrium Medical. Federal cases have been consolidated into a multidistrict litigation (MDL) by the U.S. Judicial Panel on Multidistrict Litigation (JPML). MDLs are established when there are a number of lawsuits with common questions of fact.
An MDL transfers similar lawsuits to one court before one judge, eliminating duplicate discovery and streamlining proceedings. The goal is to make complex litigation faster and more efficient. Plaintiffs filed a motion to transfer lawsuits to the U.S. District Court, District of New Hampshire on Oct. 10, 2016.
Plaintiffs in the Atrium C-Qur MDL allege that the hernia mesh caused injuries and that the manufacturer failed to warn about the risks. According to court documents, at least 15 Atrium Medical C-Qur lawsuits have been filed. Alleged injuries include infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, dental problems, bowel obstruction and abnormal liver function.
Filing a Hernia Mesh Lawsuit
If you or someone you know suffered injuries related to the use of a hernia mesh product, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).