Physiomesh Lawsuits Allege Hernia Mesh Caused Complications. Ethicon and parent company Johnson & Johnson continue to face lawsuits over its Physiomesh Flexible Composite Mesh, with plaintiffs alleging injuries such as adhesions, hernia recurrence, pain and other complications. The Physiomesh was taken off the market in May 2016 because a higher than expected number of patients were experiencing reoperation and recurrence (hernia returns).
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.
One plaintiff is a man from Massachusetts who had the Physiomesh implanted in 2013 to repair a parastomal hernia. According to the complaint, his hernia returned and contained loops of small bowel. The plaintiff alleges in the complaint, “There were several loops of small bowel contained within the hernia, with dense adhesions between the loops of the bowel. An extensive amount of time performing adhesiolysis was required in order to reduce them, as well as the adhesions between the fascial defect and the small bowel. Following this procedure, Plaintiff developed yet another hernia at the implant site of the Physiomesh and is currently awaiting consultation to determine whether further surgery is feasible.”
An adhesion is a type of surgical complication where organs stick to one another as the patient heals. The plaintiff alleges that the Physiomesh is defective and caused this complication, along with other painful and severe health problems. Physiomesh complications caused the need for ongoing surgery and recurring hernia, the suit alleges. Allegedly, Ethicon was aware of these issues but failed to warn patients or their physicians.
Court records indicate that other Physiomesh lawsuits have also been filed recently. One injury claim was filed on behalf of a Georgia woman who alleges that her hernia mesh ruptured, causing her intestines to poke through the mesh. She suffered from adverse events such as pain, nausea and vomiting, allegedly due to the Physiomesh. After the device was implanted she underwent surgery for hernia recurrence in 2016.
Another Physiomesh lawsuit was filed on behalf of a Florida woman who had the mesh implanted in 2016 via laparoscopic surgery. The procedure was performed to repair a ventral abdominal hernia. According to the complaint, the mesh is defective and led to serious complications; the plaintiff says the mesh engulfed her internal organs, which doctors had to subsequently remove. The lawsuit alleges that the defective nature of Physiomesh resulted in adhesions, hernia recurrence and debilitating pain. The lawsuit, filed in the U.S. District Court for the Middle District of Florida, alleges, “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.”
Lawsuits are also being filed over other hernia mesh devices, including the C-Qur (pronounced “secure”) by Atrium Medical. C-Qur hernia mesh 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. Plaintiffs allege that the product is defective due to its fish oil (omega-3) coating, which is intended as an anti-adhesion barrier. The U.S. Judicial Panel on Multidistrict Litigation (JPML) has established a multidistrict litigation (MDL) for Atrium Medical C-Qur hernia mesh lawsuits in New Hampshire. In an MDL, similar lawsuits are grouped together in one court to make the overall litigation faster and more efficient.
Plaintiffs in the C-Qur MDL allege that the hernia mesh is defective and caused injuries. For example, court records indicate that one plaintiff is suing after the mesh bunched and folded up in her abdomen, becoming entrapped in the body’s tissues.
Ethicon Takes Physiomesh Off the Market
Parker Waichman notes that adverse events prompted Ethicon to withdraw Physiomesh in May 2016. Compared to other hernia mesh products, patients with the Physiomesh were experiencing 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,” the company said in an “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,”
Ethicon said it does not plan to reintroduce the device. The withdrawal fueled personal injury and product liability lawsuits.
Ethicon Physiomesh Background
The Physiomesh was introduced in the United States in 2010. The device is used for laparoscopic ventral (abdominal) and inguinal (groin) hernia repair. The base layer of Physiomesh is composed of polypropylene plastic. Ethicon also uses this material to manufacture its transvaginal mesh implants, which has also sparked lawsuits, and bladder slings.
Hernia mesh devices, including the Physiomesh and Atrium Medical C-Qur, were approved through 510(k). Devices approved through 510(k) are proven to be “substantially equivalent” to a previously approved device, referred to as a predicate.
Substantial equivalence means that a new device is at least as safe as its predicate, according to the FDA. However, there has been some criticism surrounding the use of 510(k) for certain controversial medical devices, such as metal-on-metal hip implants and transvaginal mesh. 510(k), which was originally intended for low and moderate risk devices, does not require manufacturers to submit clinical data proving that their products are safe and effective. The FDA has another, more rigorous, approval process called premarket approval (PMA) that does mandate clinical testing for safety and efficacy.
Alleged injuries associated with hernia mesh may include: infection, chronic pain, hernia recurrence, adhesions, intestinal blockage and re-operation due to complications.