Physiomesh Withdrawn Due to High Rate of Recurrence, Revision
Ethicon, a unit of Johnson & Johnson, is being sued over its Physiomesh Composite Mesh used for hernia repairs. The company withdrew the product from the market in May 2016 due to a high rate of recurrence and reoperation. Plaintiffs allege that the recalled mesh caused complications and that Ethicon failed 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.
Ethicon pulled its Physiomesh Flexible Composite Mesh in May 2016 due to a high rate of recurrence and revision. The hernia mesh is used in patients undergoing minimally invasive abdominal and groin hernia repair. The company cited data from two large independent hernia registries, which showed that the Physiomesh had a higher rate of recurrence and reoperation 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 company states.
The hernia mesh will remain off the market, the company said, stating “Ethicon will not return the Ethicon Physiomesh composite mesh product to the market worldwide.”
Lawsuits have been filed alleging injuries from the Ethicon Physiomesh hernia mesh. Plaintiffs allege that the mesh caused complications and that Ethicon failed to warn patients or the medical community about the risks. According to court documents, one Physiomesh lawsuit was filed on Sept. 22, 2016 in the U.S. District Court, Middle District of Florida. Ethicon is also facing another lawsuit, filed in the Southern District of Illinois, which is slated to begin trial on Jan. 22, 2018.
Alleged injuries may include hernia mesh infection, prompting the need for revision surgery. Signs of hernia mesh infection may include inflammation, healing difficulty, warmth at the incision site and flu-like symptoms.
Atrium Medical C-Qur Hernia Mesh Lawsuits
Parker Waichman notes that other companies are also facing hernia mesh lawsuits. Atrium Medical, for example, is being sued over injuries allegedly caused by its C-Qur (pronounced “secure”) hernia mesh. Lawsuits allege that the C-Qur hernia mesh caused complications, and Atrium Medical failed to disclose the risks.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) has consolidated federal lawsuits into a multidistrict litigation (MDL), a type of mass tort where similar lawsuits are brought before one court and one judge. Plaintiffs in an MDL have common questions of fact. MDLs are created to streamline the legal process, eliminate duplicate discovery, and overall make complex litigation more efficient. On Oct. 10, 2016, plaintiffs filed a motion to transfer lawsuits to the U.S. District Court, District of New Hampshire.
Court records indicate that at least 15 Atrium Medical C-Qur lawsuits have been filed. Plaintiffs allege injuries such as infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, dental problems, bowel obstruction and abnormal liver function.
Hernia Repair Study Analyzes Rate of Long-Term Complications with Mesh
In October 2016, the Journal of the American Medical Association (JAMA) published a study focusing on the rates of long-term complication in patients undergoing hernia repair. The authors compared Danish patients undergoing hernia mesh repair via open techniques, hernia mesh repair via laparoscopic techniques and open repair without mesh. The study found that the benefits of hernia mesh are partially countered by long-term complications.
Using data from over 3,200 patients from Jan. 2007 to Dec. 2010, authors analyzed the rate of reoperation for recurrence at five years. Although hernia mesh was associated with lower rates of operation for recurrent hernia, mesh patients also had a greater risk 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,” the authors state. At five-year follow-up, patients undergoing open hernia mesh repair had a complication rate of 5.6 percent and patients undergoing laparoscopic mesh repair had a complication rate of 3.7 percent. Comparatively, the rate of long-term complications with non-mesh repair was 0.8 percent.
“With long-term follow-up, the benefits attributable to mesh are offset in part by mesh-related complications.” authors wrote.
Given the lack of randomized trials to determine effectiveness and observational trials looking at long-term health problems, researchers say the real rate of hernia long-term complications is unknown. 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 Approval: 510(k)
As noted by the authors of the Oct. 2016 JAMA study, most hernia mesh products in the United States were cleared through 510(k). This expedited review process does not require device makers to submit clinical data showing that their products are safe and effective, unlike for drugs or devices that go through the stricter premarket approval (PMA). The 510(k) route only requires that a new device be similar enough, or “substantially equivalent”, to a previously approved device.
Patient advocates and safety experts have questioned whether 510(k) is appropriate for certain devices, given that some products approved through this route have become controversial. Transvaginal mesh, for instance, was cleared through 510(k). Last year, the U.S. Food and Drug Administration (FDA) reclassified transvaginal mesh as high-risk, meaning the devices must now go through PMA.
According to the authors of the JAMA study, 510(k) approval of hernia mesh means that “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.”
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).