Canadian Hernia Society President Calls Hernia Mesh Problems an “Epidemic”
Hernia mesh complications have fueled safety concerns in both the United States and Canada. The devices, which are used for hernia repair surgeries, have been associated with reports of various injuries. In the U.S., hernia mesh injury claims have been filed against Johnson & Johnson’ Ethicon unit and Atrium Medical.
The product liability attorneys at Parker Waichman LLP have decades of experience representing clients in medical device injury litigation. The firm continues to offer free legal consultations to individuals with questions about filing a hernia mesh lawsuit.
Hernia mesh devices are also a concern in Canada, CTV News reported last month. Since 2000, some 12 brands of hernia mesh have been recalled or removed from the market in Canada, data from health regulators shows. Reported injuries included infections and perforations. Hernia mesh devices were associated with 185 reports of serious injury, including three fatalities.
Hernia mesh is often selected over open repair due to faster recovery and lower rates of hernia recurrence. According to Dr. John Morrison, president of the Canadian Hernia Society, hernia mesh may be overused and some patients may not need it. Dr. Morrison often removes hernia mesh due to complications; in some patients, the mesh has moved and perforated nearby organs. “I’ve seen pictures of it in the bladder, I’ve seen mesh in the stomach,” the physician said to CTV News. “The mesh can erode into other organs over a period of time.”
Studies suggest that 10 to 20 percent of hernia mesh patients are left with chronic pain, Morrison said.
“It is a very serious phenomenon that’s happened,” he noted. Morrison called hernia mesh problems “epidemic, and unfortunately, there’s no end in sight, it’s going to get worse because almost all hernias are now repaired with mesh.”
If patients are scheduled to undergo hernia mesh surgery, Morrison advises them to “ask their surgeon if they’re going to be using mesh, ask them exactly what type of hernia they have, why the mesh is being used.”
He said patients should research the side effects themselves before the operation, stating “An educated patient is the number one thing that will solve this problem,”
Ethicon Sued over Physiomesh Hernia Mesh Following Product Withdrawal
Hernia mesh lawsuits are being filed against Ethicon and Johnson & Johnson over the Physiomesh Flexible Composite Hernia Mesh. The device was withdrawn last May after data from two large, independent hernia mesh registries showed that the Physiomesh was linked to higher rates of recurrence and reoperation.
“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.
“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,”
Physiomesh plaintiffs allege that the device is defective and caused injuries; Ethicon is accused of failing to warn about the risks. Court documents show that the first Physiomesh trial in the U.S. is scheduled to begin Jan. 22, 2018. The plaintiff is a man who suffered an infection two years after receiving the hernia mesh. His infection led to other complications, including two abdominal abscesses and intestinal fistulas.
Ethicon is also being sued by Physiomesh users in Canada, according to CTV News. Canadian plaintiffs have filed a Physiomesh class action lawsuit alleging that the hernia mesh has a design defect, making it prone to contract, tear or migrate. Patients are subsequently at risk for injury, including infections, abscesses, perforations, adhesion formations and the need for additional surgery, the suit alleges. Adhesions are a type of surgical complication where tissues and organs can stick to each other while the patient heals.
Atrium Medical C-Qur Hernia Mesh Lawsuits
Ethicon is not the only device maker being sued over hernia mesh. Atrium Medical is facing product liability lawsuits over the C-Qur (pronounced “secure”) hernia mesh. The mesh device contains a fish oil, or omega-3 coating, intended as an anti-adhesion barrier.
Some plaintiffs allege that the coating caused complications, such as an allergic reaction, in certain patients. C-Qur hernia mesh lawsuits also allege infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, dental problems, bowel obstruction and abnormal liver function.
A federal multidistrict litigation (MDL) has been established for Atrium Medical C-Qur hernia mesh lawsuits in New Hampshire before U.S. District Judge Landya McCafferty. The U.S. Judicial Panel on Multidistrict Litigation (JPML) established the Atrium Medical hernia mesh MDL in December 2016. The MDL consolidates lawsuits over the Atrium C-Qur mesh, C-Qur TacShield and C-Qur V-Patch.
The JPML creates MDLs to make complex litigation more efficient; these mass torts are formed when there are a significant number of lawsuits with common factual allegations. Transferring them to one court before one judge streamlines the legal process and eliminates duplicate discovery.
Hernia Mesh Approved via 510(k)
Hernia mesh products were approved without substantial clinical testing in the United States because they were approved through 510(k). This fast-track process allows devices on the market so long as manufacturers can prove that their products are “substantially equivalent” to a previously approved device. Drugs and medical devices approved through the stricter premarket approval (PMA) process, on the other hand, must be clinically tested for safety and efficacy.
One JAMA study, published October 2016, found that the benefits of hernia mesh are partially offset by its risks. Researchers noted a lack of clinical data because hernia mesh was approved through 510(k). The authors wrote, “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,”
510(k) was used to approve certain controversial medical devices, including transvaginal mesh and metal-on-metal hip implants. As such, there has been debate about whether this route is appropriate for certain products.
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).