Ethicon has issued a global market withdrawal for a hernia mesh patch linked to severe complications, including an increased risk for corrective revision surgeries:
Dozens of hernia patients have filed suit, accusing Ethicon of selling a medical device with clear design defects. Do I qualify for a hernia mesh lawsuit? Our attorneys can help answer that question for you. Call today for a free consultation.
Did you see a TV commercial alerting patients and their loved ones to a growing litigation around the Physiomesh hernia mesh patch? These medical products have been linked to a severe risk of adverse complications. Dozens of hernia repair patients have already filed personal injury lawsuits against the device’s manufacturer, Johnson & Johnson-subsidiary Ethicon.
Thousands of other Physiomesh patients may be eligible to secure significant financial compensation.
Several law firms have begun to advertise their services by running Physiomesh TV ads on local stations, offering hernia repair patients free legal consultations. In many cases, the commercials mention two specific forms of injury:
While these are not the only potential complications of defective hernia mesh, Physiomesh has been explicitly linked to an increased risk for both hernia recurrence and revision surgery.
A few commercials also report that a very similar litigation is proceeding against Atrium Medical, the manufacturer behind C-Qur hernia mesh. That’s true. Both Atrium and Ethicon are now being sued by current and former mesh patients who suffered severe side effects. Tragically, dozens of families have also filed lawsuits, accusing the companies of selling a product that ultimately killed their loved ones.
The danger was first made public after researchers at Ethicon reviewed a horde of statistics from European hernia registries, databases that track patient outcomes and compare the risks of various hernia mesh products. Their results were troubling. Compared to other hernia patches, patients who had received Physiomesh implants were significantly more likely to have their hernia come back and require another surgery to fix the problem. As a result, hundreds, if not thousands, of patients may have suffered unnecessary pain, all while racking up thousands in avoidable medical expenses.
Ethicon has been unable to provide an adequate explanation for the high risk of adverse events associated with Physiomesh. In the absence of a clear causal account, the company had no choice but to issue a global market withdrawal, effectively recalling the thousands of hernia mesh patches that had been sold around the globe.
The ads running on TV right now often single out patients who underwent laparoscopic hernia procedures between 2010 and May 26, 2016, the day after Ethicon officially pulled its Physiomesh Flexible Composite Mesh from the global market.
Ethicon says that the problem with Physiomesh may come down to multiple factors, including pre-existing patient characteristics and surgical techniques. The company has also tapped “possible product characteristics” as a potential contributing factor, suggesting that the mesh patches may be marred by a design defect.
In a series of product liability lawsuits, former Physiomesh patients claim they know exactly why their mesh patches led to severe injuries. Physiomesh is defective, they write, plain and simple.
The plaintiffs have noted the unique design of Physiomesh, calling the product’s multiple layers of synthetic material a “breeding ground for bacteria” that increases the likelihood for life-threatening infections. Moreover, patients accuse Ethicon of designing and manufacturing a patch that cannot be absorbed properly by the human body. The patch only degrades partially, plaintiffs say, leaving behind a layer of plastic that becomes attached to other internal organs.
Even the basic materials out of which Physiomesh is made have come under fire. Patients say the mesh patch is manufactured from polymers that are toxic to living cells, inhibiting wound healing and leading to allergic reactions.
On June 2, 2017, a panel of federal judges elected to send a number of Physiomesh lawsuits, all filed in federal courts, to a central court. After considering arguments from all sides, the Judicial Panel on Multi-District Litigation selected the US District Court for the Northern District of Georgia in Atlanta.
Shortly after, a growing collection of Physiomesh lawsuits were transferred to the Georgia federal court, where plaintiffs’ claims will undergo coordinated pre-trial proceedings. As of this writing (September 12, 2017), more than 80 lawsuits filed against Ethicon can be found pending in Atlanta, with many more on the way.
As in the case of Physiomesh, over 100 Atrium C-Qur lawsuits have been consolidated in the US District Court of New Hampshire. A smattering of additional C-Qur cases are also pending in federal courts from Arizona to Pennsylvania.
Physiomesh was a popular choice for surgeons hoping to reinforce the abdominal wall in patients suffering from ventral hernias. A common side effect after abdominal surgery, hernias begin when internal body tissues push through weak areas of muscle in the stomach area.
Between 350,000 and 500,000 patients undergo ventral hernia repairs every year in the United States, according to the Society of American Gastrointestinal and Endoscopic Surgeons. Prior to May 2016, thousands of these patients were treated using Ethicon-made Physiomesh patches. While many of these mesh products remain implanted in people, Ethicon has provided no additional guidance for current Physiomesh patients.
Ethicon’s market withdrawal relates only to a product known as the Physiomesh Flexible Composite Mesh. The company’s Physiomesh Open Flexible Composite Mesh has not been affected.
Continue Reading: Hernia Mesh Lawsuit Settlements & Compensation Amounts
SAGES: Ventral Hernia Repair Surgery Patient Information
German Federal Institute for Drugs and Medical Devices: Ethicon Physiomesh Field Safety Notice