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 Cincinnati product liability lawyer and Ohio 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:
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.
Attorneys claim several hernia mesh devices were not properly tested before they were marketed and distributed as safe medical instruments.
The companies currently face thousands of pending hernia mesh injury lawsuits. If you have had surgery to treat a hernia using a device and you experience any signs or symptoms of recurrence of the hernia, please consult with a medical and legal expert. The Lyon Firm has experience litigating cases against medical device manufacturers.
Attorneys contend that some hernia mesh devices are not properly tested before they are distributed to the public as safe products. Device companies like Gore, Aspide, Ethicon, Bard, Covidien and Atrium have settled hundreds of lawsuits and currently face countless more injury claims.
If you are unsure about the mesh manufacturer and product used in your surgery and have questions about your hernia repair, contact your Ohio surgeon to obtain medical records. Contact a Cincinnati hernia mesh lawyer to discuss potential hernia mesh injury lawsuits and settlement.
Regardless of treatment, hernias have a high rate of recurrence, and surgeons often use surgical mesh to strengthen the hernia repair recurrence rate. The use of meshes is thought to reduce dramatically the incidence of hernia recurrence.
However, up to 50 percent of hernias may reoccur with an implanted device. This is commonly due to inadequate fixation during the original operation or shrinkage of the mesh. Light-weight meshes may have a higher risk due to their increased flexibility and movement.
Two-thirds of recurrences occur after three years. It is not clear if the type of mesh used has any effect on durability. All mesh products appear equally limited in effectiveness.
Repair of hernias are done by either suture repair or prosthetic mesh repair. The latter is associated with a lower recurrence rate but a higher incidence of complications. The most serious complication is the development of fistula.
Fistula is a late complication of prosthetic mesh repair and is usually due to chronic erosion of bowel by mesh placed in direct contact with intestinal loops both in open and laparoscopic repairs. Symptoms of fistulas may include the following:
Hernia mesh adhesions are scar tissue resulting from hernia mesh operations and the healing process. Following hernia repair surgeries, adhesions may form in the abdomen or peritoneum. The mesh repairs usually heal quickly but when adhesions form, organs connected by the scar tissue may not function properly.
The popularity of hernia mesh operations has led to increasing concern regarding mesh-related adhesions. Adhesions result from the fibrin exudates that follow any kind of trauma.
These exudates form temporary adhesions until the fibrinolytic system absorbs the fibrin. Absorption is delayed in the presence of inflammation or foreign bodies such as mesh devices. In these situations, they develop into tissue adhesions.
All mesh implants produce adhesions, though their extent varies. Abdominal adhesions are a common complication, occurring in a majority of people who undergo abdominal or pelvic surgery. Adhesions cause the majority of small bowel obstructions in adults, and are believed to contribute to the development of chronic pelvic pain.
X-rays do not reveal potential mesh issues or diagnose the presence of adhesions. An additional surgery is usually needed to diagnose or treat hernia mesh adhesions. However, revision surgeries carry risks and can lead to further health problems, including infection, bowel blockage, bowel perforation and chronic pain.
Adhesions may begin forming long before they are noticed by patients or doctors. Depending on the location, adhesions from defective hernia mesh devices may cause pain and affect the bowel in different ways. Even removing a defective hernia mesh product may not completely solve all health issues.
Symptoms of adhesion and hernia mesh injury may include:
Ohio Definition of Defective
Under Ohio law, a medical device is defective if it is unreasonably dangerous for its intended use. A legal cause of action can be based on several types of medical device product defects. Most jurisdictions a version of one or more of these cause of actions.
(1) Manufacturing/ Construction Defect of the medical device:
(2) Defective design and/or formulation of the medical device:
(3) Failure to warn or inadequate warning or instruction associated with the medical device:
(4) Misrepresentation on the Safety or Efficacy of the Medical Device:
(5) Fraud Related to the Safety or Efficacy of the Medical Device
(6) Negligent Distribution or Testing of the Medical Device
Our Firm will help you find the answers. The Firm has the experience, resources and dedication to take on difficult and emotional cases and help our clients obtain the justice for the wrong they have suffered.
Experience: Joe Lyon is an experienced Cincinnati Defective Device Lawyer. The Lyon Firm has 17 years of experience and success representing individuals and plaintiffs in all fifty states, and in a variety of complex civil litigation matters. Defective device lawsuits can be complex and require industry experts to determine the root cause of an accident or injury. Mr. Lyon has worked with experts nationwide to assist individuals understand why an injury occurred and what can be done to improve their lives in the future. Some cases may go to a jury trial, though many others can be settled out of court.
Resources/Dedication: Mr. Lyon has worked with experts in the fields of accident reconstruction, biomechanics, epidemiology, metallurgy, pharmacology, toxicology, human factors, workplace safety, life care planning, economics, and virtually every medical discipline in successfully representing Plaintiffs across numerous areas of law. The Lyon Firm is dedicated to building the strongest cases possible for clients and their critical interests.
Results: Mr. Lyon has obtained numerous seven and six figure results in medical device cases. He has litigated cases successfully against some of the largest companies in the world including: Johnson & Johnson, Biomet, Ethicon, Stryker, Coloplast, Smith & Nephew, American Medical Systems, Boston Scientific, Medtronic, Guidant, Bard, & Bayer.
Defective products on the market present safety and health hazards for adults and children. Cheap and defective products may pose fire and burn risks; electrocution, strangulation and choking risks; and severe health risks. The manufacturers of consumer products have a duty to foresee potential injury and properly design and test products before they are released.
Companies must also properly warn consumers of any risks associated with their products. Any failure to protect consumers that results in accidents and injury can lead to lawsuits filed by plaintiffs and their Cincinnati product liability lawyer