J&J Faces Lawsuits over Physiomesh Hernia Mesh, After Device is Withdrawn
Ethicon and parent company Johnson & Johnson are facing lawsuits alleging injuries from its Physiomesh flexible composite hernia mesh. The Physiomesh was withdrawn from the market in May 2016 due to a high rate of recurrence and reoperation. Following the withdrawal, lawsuits have been filed alleging that the mesh caused complications and that Ethicon failed to warn about the risks. Lawsuits have also been filed over other mesh products, including Atrium Medical C-Qur hernia mesh and transvaginal mesh implants.
The personal injury attorneys at Parker Waichman LLP have decades of experience representing clients in lawsuits over injuries allegedly caused by defective medical devices. The firm continues to offer free legal consultations to individuals with questions about filing a hernia mesh lawsuit.
The Physiomesh flexible composite hernia mesh was approved through a fast-track process in 2010. The device is used for minimally invasive abdominal and groin hernia repair. In May 2016, Ethicon issued an “Urgent Field Safety Notice” stating that the Physiomesh was being withdrawn from the market.
According to the notification, unpublished data from two large independent hernia registries showed that patients undergoing laparoscopic (minimally invasive) ventral hernia repair with Ethicon Physiomesh Flexible Composite Mesh had higher recurrence/reoperation rates compared to the average rates of comparator set of meshes. One of the registries was Danish, and the other was German.
The company said the elevated rates of reoperation may stem from a number of 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,” Ethicon stated in its letter.
At the time, Ethicon said it was unable to make recommendations to reduce the risk of revision because the exact cause is unknown. “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 letter states.
“Ethicon will not return the Ethicon Physiomesh composite mesh product to the market worldwide.”
According to court documents, a Physiomesh lawsuit was filed in December 2016. The plaintiff is a Florida woman who alleges that the hernia mesh adhered to other vital organs, causing injuries. The plaintiff underwent another surgery to remove the mesh. According to the complaint, the hernia returned afterwards. The suit, filed in the U.S. District Court for the Middle District of Florida, alleges that the Physiomesh is defectively designed and that Ethicon failed to warn patients or the medical community about the risks.
Another type of mesh medical device, transvaginal mesh, has also triggered litigation for Ethicon and several other device makers. Pelvic mesh was approved to treat pelvic organ prolapse and stress urinary incontinence. Thousands of transvaginal mesh lawsuits have been filed alleging injuries. In January 2016, Ethicon agreed to a $120 million transvaginal mesh settlement, resolving 2,000 to 3,000 injury claims. A regulatory filing shows that even with the settlement, tens of thousands of lawsuits are still pending.
Atrium Medical C-Qur Hernia Mesh Lawsuits
Parker Waichman notes that other hernia mesh devices have been named in personal injury lawsuits. Atrium Medical is being sued over the C-Qur (pronounced “secure”) hernia mesh. According to court documents, one lawsuit was filed on behalf of a man who underwent surgery with the C-Qur in 2013. In January 2016, the mesh was removed. The plaintiff alleges that the hernia mesh caused complications leading to removal. The complaint states that the plaintiff suffered from abdominal pain, and a subsequent pathology report identified a “foreign body giant cell reaction”; tissue surrounding the mesh implant was scarred, the suit states.
The lawsuit alleges that Atrium Medical designed the C-Qur defectively. The company is accused of misrepresenting the safety of the hernia mesh to physicians and patients. The plaintiff alleges that Atrium Medical failed to properly investigate reports of adverse reactions, among other things.
Atrium Medical C-Qur lawsuits have been consolidated into a federal multidistrict litigation (MDL) in the U.S. District Court for New Hampshire, before Judge Landya B. McCafferty. The U.S. Judicial Panel on Multidistrict Litigation (JPML) establishes MDLs when there are many lawsuits with similar allegations. MDLs are a type of mass tort where lawsuits with common questions of fact are transferred to one court, eliminating duplicate discovery and streamlining the legal process.
Mesh Products and 510(k) Approval
Transvaginal mesh, Physiomesh and the C-Qur hernia mesh were approved through 510(k). Unlike premarket approval (PMA), where manufacturers need to submit data showing that their products are safe and effective to obtain approval, devices cleared through 510(k) do not need to undergo substantial clinical testing. This fast-track route only requires that the device be similar enough, or “substantially equivalent” to a previously approved product.
Following injury reports with transvaginal mesh and other devices cleared through 510(k), this route has come under some criticism with regards to certain products. In fact, the FDA has since reclassified pelvic mesh as “high-risk”, meaning now they can only be approved with clinical testing for safety and efficacy. Previously, transvaginal mesh was classified as “moderate-risk”.
In 2008, the FDA said that the most common adverse events reported with transvaginal mesh include:
• Mesh erosion
• Urinary problems
• Recurrence of prolapse
There were also reports of bowel, bladder and blood vessel perforation, the agency said. At the time, the FDA said that pelvic mesh complications were rare, but serious. This was amended in 2011, when the FDA said complications associated with transvaginal mesh implants were “not rare”. Additionally, the FDA said in 2011 that transvaginal mesh implants do not have clear benefits for patients with pelvic organ prolapse compared to non-mesh methods, and may pose more risks.
Hernia Mesh or Transvaginal Mesh Lawsuit Questions?
If you or someone you know suffered injuries related to the use of hernia mesh or transvaginal mesh implants, you may have valuable legal rights. Our transvaginal mesh lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).