Ethicon Faces Physiomesh Hernia Mesh Class Action Lawsuit in CanadaApr 6, 2017
Canadian Patients Sue J&J Over Physiomesh Hernia Mesh
Physiomesh product liability litigation against Johnson & Johnson's Ethicon unit is apparently not limited to the United States. The company has been facing Physiomesh personal injury lawsuits ever since the hernia mesh device was withdrawn in 2016. Now, Physiomesh patients in Canada have reportedly joined a class action lawsuit.
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.
According to CTV News, Canadian hernia mesh patients are joining a class action lawsuit alleging injuries from the Physiomesh Flexible Composite Mesh. CTV reports that the Physiomesh was introduced to the Canadian market in September 2010. The hernia mesh product was recalled in the summer of 2016 due to a high rate of recurrence and reoperation.
Plaintiffs in the Canadian class action lawsuit allege that the Physiomesh contains a "design defect" that makes it prone to contract, tear or migrate. As a result, the suit alleges, patients are at increased risk of hernia mesh complications such as infections, abscesses, perforations, adhesion formations and the need for additional surgery. Adhesions are a type of surgical complication where tissues and organs can stick to one another while a patient heals.
According to CTV, one plaintiff is a 34-year-old woman who was implanted with the Physiomesh following a routine hernia surgery. She says that her mesh has since "stretched out". Her hernia has subsequently returned, causing severe pain. "The pain is always there," she said to CTV News. "It feels like my insides are going to explode."
"If I cough or sneeze I have to hold my stomach. It is a horrible pain, to be honest."
The woman underwent surgery in February 2016. The mesh was later withdrawn from the market.
Another plaintiff from Laval, Quebec, told CTV in French that she received the Physiomesh after experiencing pain following her hernia surgery. According to CTV, she says a surgeon informed her the mesh was not a good product and that it was no longer being used. In January 2015, the mesh was surgically removed. However, she told CTV that she still experiences pain. She describes feeling something "like a mass" inside her body.
According to CTV, the Physiomesh is implanted in some 30,000 patients in Canada. "Unfortunately, there is not a whole lot to do for patients that have it, and my advice for patients is to leave it alone and if they have any problems with it, then it will have to be dealt with at that time," said Chatham, Ontario surgeon Dr. John Morrison.
Physiomesh Withdrawal and Lawsuits in the U.S.
Parker Waichman comments that Ethicon is facing Physiomesh product liability lawsuits in the United States as well. According to court records, one lawsuit was filed in the U.S. District Court for the Middle District of Florida in December 2016. According to the complaint, the Physiomesh was used in a ventral abdominal hernia repair. The plaintiff suffered from complications, allegedly due to the defective nature of the mesh. The suit states that the mesh adhered to vital organs, causing injury. A second surgery was performed to remove the mesh.
Ethicon was also named in another Physiomesh lawsuit in the U.S. District Court for the Middle District of Georgia. According to the lawsuit, the plaintiff experienced nausea and severe pain. During a second surgery to address these complications, surgeons discovered a tear in the mesh through which the plaintiff's intestines protruded. The hernia mesh failure was described as "catastrophic", the lawsuit states.
The first Physiomesh lawsuit is scheduled to go to trial on Jan. 22, 2018. The plaintiff in that case suffered an infection and subsequent injuries, including two abdominal abscesses and intestinal fistulas, allegedly due to the mesh. The infection occurred two years after he received the Physiomesh, the complaint states.
Physiomesh was withdrawn from the U.S. market in May 2016. In an Urgent Field Safety Notice, the company said data from two large, independent hernia mesh registries showed that the Physiomesh was associated with higher rates of recurrence and reoperation compared to other 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. "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 U.S. Food and Drug Administration (FDA) approved the Physiomesh hernia mesh through 510(k), a fast-track route that allows devices onto the market without clinical testing for safety or efficacy. Devices approved through this process only need to be "substantially equivalent" to a previously approved device, known as a predicate. Substantial equivalence means that the new device is at least as safe as its predicate.
510(k) has come under scrutiny because it was used to approve certain controversial medical devices, including metal-on-metal hip implants and transvaginal mesh. Many medical device injury lawsuits involve products approved through 510(k).
The FDA has a stricter clearance process, known as premarket approval (PMA), where device makers are required to conduct clinical testing to prove that their products are safe and effective.
Other lawsuits have been filed against hernia mesh makers. For example, Atrium Medical is being sued over the C-Qur hernia mesh. Among other things, lawsuits allege that the mesh caused injuries due to its fish oil coating. Atrium Medical C-Qur hernia mesh lawsuits have been consolidated into a federal multidistrict litigation (MDL) in New Hampshire.
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).