Physiomesh Lawsuit Alleges Hernia Mesh Caused Intestinal BlockageMar 1, 2017
Lawsuit Alleges Hernia Recurrence, Intestines Protrude Through Mesh
Ethicon is facing another lawsuit alleging injures from its Physiomesh hernia mesh. The Johnson & Johnson unit is seeing an increasing number of lawsuits after withdrawing the device in May 2016 due to a high rate of recurrence and reoperation. The new lawsuit, filed on Feb. 2, 2017, alleges that the Physiomesh is defective; the plaintiff's hernia returned and caused intestinal obstruction.
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 records, the lawsuit was filed in the U.S. District Court for the Middle District of Georgia. The plaintiff was implanted with the Physiomesh to repair an incisional hernia. After the hernia mesh was implanted, the plaintiff experienced pain, nausea, and vomiting, allegedly due to mesh defects. The complaint states that her hernia returned (recurred), prompting a second surgery on Aug. 1, 2016.
The lawsuit states that loops of the plaintiff's intestines protruded through the mesh. As a result, she experienced intestinal obstruction and severe pain.
The complaint states that, "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 suit states that surgeons attempted to remove the mesh, but some of the mesh remains in her body. The plaintiff "underwent a prolonged surgical procedure to attempt to remove the Physiomesh from her intestines and to remove the mesh that failed to incorporate into the abdominal facsia. Portions of the Physiomesh could not be removed," the complaint states.
The lawsuit alleges, among other things, that the Physiomesh was designed defectively. The hernia mesh is composed of five layers. The innermost layer is made of a polypropylene mesh. This mesh is coated by two layers of polydioxanone film ("PDS"), which is then covered by two layers of polyglecaprone-25 ("Monocryl") film. No other hernia repair product in the United States utilizes this design, according to the complaint.
The plaintiff alleges that Ethicon misrepresented the safety of the mesh, stating in the lawsuit "The multi-layer coating was represented and promoted by the Defendants to prevent or minimize adhesion and inflammation and to facilitate incorporation of the mesh into the body, but it did not," The lawsuit alleges defective design, failure to warn, negligence and loss of consortium.
Allegedly, the defective design of the Physiomesh hernia mesh leads to adverse events such as delayed wound healing, infection, foreign body response, rejection and other injuries. The lawsuit also alleges that the polypropylene mesh layers become stuck (adheres) to organs when the device degrades. This allegedly causes complications such as bowel perforation or erosion, fistula formation, bowel strangulation, hernia incarceration and other adverse events.
The lawsuit alleges that Ethicon failed to properly warn the plaintiff or her physician about the risks associated with Physiomesh.
In May 2016, Ethicon sent out an "Urgent Field Safety Notice" notifying consumers about the withdrawal of Physiomesh. The company cited a high rate of recurrence and reoperation compared to other hernia mesh products, based on data from two large hernia mesh registries.
"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 stated.
"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,"
Atrium Medical Hernia Mesh C-Qur Lawsuits
Parker Waichman notes that hernia mesh lawsuits are also being filed against Atrium Medical over its C-Qur (pronounced "secure") hernia mesh. In fact, the U.S. Judicial Panel on Multidistrict Litigation (JPML) has created a federal multidistrict litigation (MDL) for Atrium Medical C-Qur hernia mesh lawsuits in New Hampshire.
MDLs make the legal process faster and more efficient for lawsuits with the same basic allegations. Consolidation transfers similar lawsuits to one court before one judge. By doing this, MDLs avoid duplicate discovery and overall streamlines court proceedings before trial.
Lawsuits in the Atrium Medical C-Qur MDL allege that the hernia mesh is defective and caused injuries such as infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, dental problems, bowel obstruction and abnormal liver function.
Some plaintiffs also allege that the mesh caused injury due to its coating. The C-Qur mesh is coated with omega-3 fatty acid (fish oil). This coating is meant to prevent a surgical complication called adhesion, where organs and tissues stick to one another after surgery. Lawsuits are filed on behalf of plaintiffs who suffered abdominal adhesions, allegedly due to the defective nature of the C-Qur hernia mesh.
Hernia Mesh and 510(k)
The Physiomesh and C-Qur hernia mesh were both approved through the U.S. Food and Drug Administration's (FDA) 510(k) process. When devices are approved in this manner, it means that manufacturers were not required to perform clinical testing to show that their devices are safe and effective before placing them onto the market.
Instead, 510(k) requires "substantial equivalence" to a previously approved device (called a predicate). To the FDA, substantial equivalence means that the new device is at least as safe as its predicate. This route is not intended for high-risk devices. However, some high-risk devices were approved through 510(k) due to a temporary loophole.
The FDA has a stricter approval process called premarket approval (PMA), where device makers are required to clinically test their devices for safety and efficacy prior to obtaining approval.
510(k) has come under scrutiny, as it has been used to approve several controversial medical devices.
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).