In May, 2016, Ethicon, a Johnson & Johnson subsidiary, issued a global recall for their Physiomesh Flexible Composite hernia mesh due to potential dangers associated with the device. The company is facing significant class-action lawsuits, some of which are already set for trial, involving their Proceed, Prolene and Physiomesh devices.
Ethicon’s voluntary recall came as a result of two foreign observational hernia repair registries analyzed the product’s unacceptable success rate. It was determined that patients with the Ethicon device suffered above average hernia recurrence and re-operation rates following laparoscopic procedures.
According to the German registry and the Danish hernia databases, the Ethicon device failed at higher rates compared to that of similar hernia mesh repairs.
In an Urgent Field Safety Notice, the company says the recall was communicated to the U.S. Food and Drug Administration (FDA) and the European Competent Authorities.
It clarifies that the recall action involves only the Ethicon Physiomesh Composite Mesh product line, and does not include the Ethicon’s other hernia mesh devices including the Prolene and Proceed devices.
Joe Lyon is a highly-rated product liability lawyer and recall lawyer representing plaintiffs nationwide in a wide variety of defective medical device and civil litigation claims against Ethicon.
Mesh devices are commonly used to strengthen weakened or damaged tissue in hernia repair procedures. According to the U.S. Food and Drug Administration (FDA), hernia mesh accounted for roughly 90 percent of hernia repair procedures by the year 2000.
Hernias are a relatively common problem that for many requires surgery to alleviate daily pain, discomfort and other symptoms. Unfortunately, patients who selected Ethicon Physiomesh Flexible Composite hernia mesh as a solution may risk potential infections, hernia recurrence and further surgeries.
When defective, Ethicon’s devices may cause severe complications including the following:
• Severe abdominal pain
• Bowel Blockage
• Abdominal abscess
• Bowel obstruction
• Intestinal fistula
• Mesh migration
• Bacterial infection
• Hernia recurrence
• Additional surgery
Attorneys claim Ethicon Hernia Mesh was not properly tested before it was marketed and distributed as a safe solution. The device was approved by FDA 510(k) clearance, meaning it did not require FDA review or clinical trials to properly evaluate its safety.
In an important related 2016 settlement, Johnson & Johnson agreed to pay more than $120 million to resolve 2,000 to 3,000 suits alleging women suffered organ damage after mesh surgical inserts eroded in their bodies. The company faces over 42,000 more cases.
If you have had laparoscopic surgery to treat a ventral hernia using a mesh and you experience any signs or symptoms of recurrence of the hernia, talk to medical and legal experts. The Lyon Firm has experience litigating cases against Johnson & Johnson and other mesh device manufacturers.
In May 2016, Ethicon said their mesh product was associated with a “higher-than-average” number of reported hernia recurrences and secondary surgeries.
Some doctors, concerned about the overuse of mesh products, have said that complications associated with the use of hernia mesh have become “endemic.”
Hernia repair is one of the most common surgeries performed in the United States. Even so, many patients are reporting severe complications from inserted mesh devices, including nerve damage, seroma, granuloma, infections, bowel obstruction, bowel blockage, and hernia recurrence.
Doctors have used surgical hernia mesh devices for many years; the mesh, like Ethicon’s Physiomesh, supports damaged tissue. Physiomesh is made of a synthetic material called polypropylene, the same material that has generated thousands of lawsuits against Ethicon and other medical mesh manufacturers due to complications and adverse side effects.
Ethicon received clearance from the U.S. Food and Drug administration (FDA) to market and sell Physiomesh products in 2010. Ethicon’s Physiomesh Composite Mesh followed in October 2014 with a fast-track 501(k) clearance that failed to properly test the potential negative effects of the product.
The Physiomesh Composite Mesh was similar to other products previously used to repair abdominal hernias, but is made from a lighter-weight material, possibly making the mesh weaker and more likely to deteriorate in the body, causing extreme pain and lead to other serious side effects.
As a result, Physiomesh Composite Mesh was voluntarily pulled from the market after a short time. Ethicon issued a Physiomesh recall, and acknowledged that the recurrence and reoperation rates were unacceptable—much higher than with other mesh products.
In 2012, after a series of adverse reports, the U.S. Food and Drug Administration ordered Johnson & Johnson and other mesh makers to study rates of organ damage and complications linked to their physiomesh implant products.
This was not the first time the safety agency noted concerns with mesh devices. In 2011, the FDA published a report which analyzed all adverse events reported during a five-year period. Many of the events cited the need for prompt intervention, including surgical treatment and hospitalization.
The report identified thousands of reports of serious injury, malfunction and several deaths. Johnson & Johnson agreed in June 2012 to pull some dangerous products from the market.
Since the FDA first approved the Physiomesh product, patients across the country have filed product liability lawsuits against Ethicon.
Patients claim they have suffered serious complications directly related to the mesh. Hernia mesh complaints commonly allege that Physio mesh erodes within the body, adheres to internal organs, causes bowel obstruction, and results in other serious injuries to patients.
Lawyers are arguing the mesh has inherent design defects and that Ethicon should have known the dangers of its polypropylene design before marketing it to the public.
Attorneys are adamant that Ethicon knew about, or should have known about Prolene, Proceed and Physiomesh defects, but continued to market its product to profit at the risk of injuring patients. Either way, Ethicon failed to warn consumers about the risks of the mesh and is now facing the consequences.
Plaintiff attorneys are asking Ethicon to pay for past, present and future medical expenses, lost wages, and compensation for pain and suffering. Lawyers are also seeking punitive damages to punish Ethicon for marketing a defective medical device.
The 2016 settlement marked the first time J&J and its Ethicon unit agreed to resolve a significant number of mesh cases. At the time, the company faced over thousands of cases, many of which are still unresolved.
Ethicon’s recall came too late for many patients, many of who already suffered severe complications from Physiomesh Composite Mesh. Many of the health issues are obvious to patients, though some complications due to defective mesh products do not present until years after the mesh was implanted.
Anyone who had a hernia repaired using Physiomesh needs to be aware of complication symptoms.
Many product liability cases have had a positive impact on public health and safety, and we have witnessed improved lives and future injuries prevented as companies are forced to remove products and change designs and warnings as a result of litigation.