Ethicon Faces Lawsuits Alleging Complications with PhysiomeshMar 10, 2017
Physiomesh Hernia Mesh is Withdrawn Due to Recurrence, Reoperation
Ethicon's Physiomesh, used in hernia repair, is being named in product liability lawsuits alleging that the device is defective and caused adverse events. The Physiomesh was withdrawn in May 2016, after data from two large independent hernia mesh registries indicated a high rate of recurrence (i.e. the hernia returned) and reoperation. Lawsuits allege that Ethicon failed to warn about the risks of Physiomesh.
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.
The U.S. Food and Drug Administration (FDA) approved the Physiomesh in 2010.
Alleged complications that may be associated with the Physiomesh include:
- Organ damage
- Mesh shrinkage or migration
- Reoperation/corrective surgery
- Hernia recurrence
When Ethicon pulled the hernia mesh from the market last May, the company said the increased rate of recurrence and reoperation can be attributed to several different factors. "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 Urgent Field Notice read. "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Ethicon has faced growing litigation since the Physiomesh was withdrawn. The first Physiomesh trial is scheduled to begin on Jan. 22, 2018. The plaintiff in that case underwent surgery to correct his abdominal wall hernia in 2013. He was hospitalized two years later for a hernia mesh infection, leading to two abdominal abscesses and intestinal fistulas.
Court records show that lawsuits continue to be filed. One Physiomesh product liability lawsuit was filed on Feb. 2, 2017 in the U.S. District Court for the Middle District of Georgia. The plaintiff was implanted with the Physiomesh during an incisional hernia repair. Afterwards, she experienced pain, nausea, and vomiting. She suffered from hernia recurrence and intestinal obstruction, prompting the need for a second corrective surgery. The lawsuit alleges that the defective nature of the Physiomesh caused these adverse events.
"The central portion of the Physiomesh device was not incorporated into the abdominal wall and loops of" the plaintiff's "intestines were protruding through the ruptured central portion of the mesh, and she suffered an intestinal obstruction. The mesh was densely adhered to the loops of [her] intestines," the complaint states.
Atrium Medical C-Qur Lawsuits and Hernia Mesh Injuries
Parker Waichman comments that hernia mesh lawsuits are also being filed against Atrium Medical. Plaintiffs are suing over the C-Qur (pronounced "secure") hernia mesh, alleging that the device caused serious complications.
The C-Qur contains a fish oil (omega-3) coating, which some plaintiffs allege caused adverse events. The coating is designed to prevent inflammation and adhesions, a complication where tissues can stick to each other in the body when the patient heals from surgery. Lawsuits allege that the C-Qur is defective and caused adhesions, among other injuries. Other potential alleged injuries include: infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, bowel obstruction and abnormal liver function.
Atrium C-Qur hernia mesh lawsuits have been consolidated into a federal multidistrict litigation in New Hampshire. MDLs are a type of mass tort created by the U.S. Judicial Panel on Multidistrict Litigation (JPML). Lawsuits are consolidated into an MDL (meaning that they are transferred to one court before one judge) when there are common questions of fact. In the Atrium C-Qur MDL, plaintiffs similarly allege that the C-Qur is defective and caused injuries. Lawsuits in an MDL remain separate, and injuries can vary in severity between plaintiffs.
Court records show that one C-Qur lawsuit was filed on behalf of a plaintiff implanted with the hernia mesh in 2011. The complaint states that she suffered abdominal pain and hernia recurrence. When doctors performed a second surgery to remove the mesh, they discovered that the mesh was stuck in her body, surrounded by scar tissue. Doctors were unable to place a new hernia mesh.
In 2012, the FDA sent a warning letter to Atrium Medical citing manufacturing violations. Regulators said that the C-Qur hernia mesh and other products were subsequently adulterated. The sterile mesh contained foreign substances, including human hair.
Atrium recalled the C-Qur Edge mesh in 2013, although the product was never actually taken off the market. The company warned physicians that the mesh coating can stick to the inner lining of the packaging under humid conditions. "The notification identifies the problem, product, and risk factors. If the Product is exposed to excessive humidity for an extended period of time, then the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve," the company said.
Hernia Mesh Products Approved without Clinical Testing
The FDA approved the Physiomesh and the C-Qur hernia mesh through 510(k). This fast-track route circumvents the need for clinical testing. Instead, device makers only need to show that their products are "substantially equivalent" to a previously approved device. This means that the new product is at least as safe as an older product, even if that product had safety issues of its own.
The premarket approval process, on the other hand, is a stricter route where device makers must submit clinical data showing that their products are safe and effective in order to gain approval.
510(k) has been used to approve controversial products such as metal-on-metal hip implants and transvaginal mesh. As such, safety experts and advocates have criticized the use of 510(k) for certain medical products. Many medical device injury lawsuits involve products approved through this route.
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).