Physiomesh Lawsuits Filed after Device is Withdrawn
Ethicon is facing mounting litigation over its hernia mesh device, the Physiomesh Flexible Composite Mesh, which was withdrawn from the market last year due to a high rate of recurrence and reoperation. One lawsuit was recently filed in the U.S. District Court for the Middle District of Georgia. The plaintiff alleges that the hernia mesh failed and ruptured, causing her hernia to return. The lawsuit alleges that the Physiomesh is defective and subsequently caused injuries.
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.
According to court documents, the plaintiff is a woman from Georgia who had the Physiomesh implanted for incisional hernia repair. She suffered from pain, nausea and vomiting and underwent surgery for hernia recurrence in 2016. When surgeons performed the operation for hernia recurrence, they allegedly discovered that the Physiomesh had ruptured and her intestines had poked through the mesh, leading to complications. The plaintiff alleges that the device is defective and subsequently caused these adverse events.
Other Physiomesh personal injury and product liability lawsuits have been filed against Ethicon, a Johnson & Johnson unit. Court records indicate that a Physiomesh lawsuit was filed on behalf of a Florida woman who alleges that the hernia device engulfed her internal organs, which subsequently had to be removed. The mesh was implanted via laparoscopic surgery in 2016 to repair a ventral abdominal hernia. According to the complaint, she developed complications within several months of receiving the mesh. She alleges that the mesh caused adhesions, hernia recurrence and debilitating pain. The plaintiff alleges that, “Defendants’ Physiomesh was defectively designed and/or manufactured, was not reasonably safe for its intended use in hernia repair, and the risks of the design outweighed any potential benefits associated with the design.” The suit was filed in the U.S. District Court for the Middle District of Florida.
Ethicon withdrew the Physiomesh from the market in May 2016, after data from two large independent hernia mesh registries showed that the device had a higher rate of recurrence and reoperation compared to other hernia mesh products. The company issued an “Urgent Field Safety Notice” stating, “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.”
“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,” Ethicon said.
Some plaintiffs allege hernia mesh infection, leading to revision surgery. Symptoms of hernia mesh infection may include inflammation, healing difficulty, warmth at the incision site and flu-like symptoms.
Lawsuits Allege Injuries from Atrium Medical C-Qur Hernia Mesh
Parker Waichman notes that lawsuits are also being filed over another hernia mesh product, the C-Qur (pronounced “secure”) manufactured by Atrium Medical. Plaintiffs allege injuries associated with the mesh’s fish oil (omega-3) coating. Lawsuits allege injuries such as infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, dental problems, bowel obstruction and abnormal liver function.
Federal Atrium Medical C-Qur lawsuits have been consolidated into a multidistrict litigation (MDL) in New Hampshire. MDLs are a type of mass tort created by the U.S. Judicial Panel on Multidistrict Litigation (JPML); similar lawsuits are transferred to the same court. The goal is to make complex litigation more efficient by eliminating duplicate discovery and other pretrial proceedings.
Atrium Medical C-Qur lawsuits allege that the hernia mesh is defective and caused injuries. One lawsuit was filed on behalf of an Arkansas woman implanted with the C-Qur mesh in 2011. According to her lawsuit, the mesh was defective and she subsequently experienced hernia recurrence and abdominal pain. When physicians attempted to remove the mesh due to adverse events, they found that the C-Qur was entrapped in the patient’s abdomen surround by scar tissue. The mesh had become “bunched up in layers” and “folded up”. Complications associated with the hernia mesh included chronic pain, nausea, vomiting, infections and other injuries, the plaintiff alleges.
Both the Atrium Medical C-Qur and the Physiomesh were approved through 510(k), a fast-track approval route that allows devices onto the market without substantial clinical testing. Products cleared through 510(k) only need to be “substantially equivalent” to a previously approved product. The U.S. Food and Drug Administration (FDA) has another approval route, premarket approval (PMA), that requires device makers to submit data showing that their products are safe and effective before obtaining approval.
Due to safety concerns with controversial medical devices such as metal-on-metal hip implants and transvaginal mesh, safety advocates have argued that 510(k) is inappropriate for certain medical products.
Study Assesses Long-term Complications with Hernia Mesh
In October 2016, a study published in the Journal of the American Medical Association (JAMA) assessed long-term complications with hernia repair methods. Overall, the study found that the risks of hernia mesh partially off-set some of its benefits.
Study authors analyzed Danish patients who underwent hernia mesh repair via open techniques, hernia mesh repair via laparoscopic techniques and open repair without mesh. Patients with hernia mesh had lower rates of recurrence, but higher rates 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 wrote.
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,” the authors said.
Researchers commented that, because hernia mesh was approved through 510(k), little data is available on long-term risks. 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.”
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).