Ethicon, a subsidiary of Johnson and Johnson, is currently the target in numerous lawsuits nationwide because thousands of patients have been allegedly injured by hernia reparation devices, including the Proceed Ventral Patch.
Ethicon states on its Web site that the Proceed Patch model enables patients “to heal strongly, naturally, and comfortably.” But that claim has been discounted by thousands of hernia patients who have undergone surgery and had an Ethicon mesh device implanted. Infection, bowel obstruction, and other complications have been reported after the Ethicon patch disintegrated inside the bodies of patients.
Attorneys claim Ethicon knew that the polypropylene used to make the Proceed hernia mesh was not fit for human implantation. In fact, Ethicon added a coating to the Proceed in an attempt to mitigate injuries caused by the polypropylene. However, over time the coating disintegrates and only bare polypropylene remains.
The company claims a hernia recurrence rate of less than 10 percent, though patient reports suggest a much higher rate. The Proceed device has been recalled in the past after post-surgery complications, though the Ventral Patch continues to be implanted and cause serious health issues to patients.
Joe Lyon is a highly-rated product liability lawyer and recall attorney representing plaintiffs nationwide in a wide variety of defective medical device and civil litigation claims.
Thousands of Proceed hernia mesh units have been recalled in the last decade. All recalls initiated by the U.S. Food and Drug Administration (FDA) were due to the device coating delaminating, or peeling off of the polypropylene base material.
The FDA noted, “The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.”
In their recall statements, Ethicon admitted that there was a higher risk of adhesions and fistulas when the Proceed delaminates. They said the defective devices “could increase the risk of adhesions and bowel fistulization.”
These are serious complications that may lead to permanent injury or even death. However, the Proceed hernia mesh is still on the market and continues to be implanted in patients nationwide.
The first Proceed Patch recall was initiated in 2006, and over 18,000 units were affected, many of them already implanted in hernia patients. Further FDA recalls were announced in 2010, and another in 2014. Incredibly, the patch remains on the market and is sold as a safe mesh product.
Mesh and patch devices are commonly used to strengthen weakened or damaged tissue in hernia repair procedures. Hernias are a relatively common problem that may require surgery to alleviate persistent pain, discomfort and other symptoms.
However, patients who selected Ethicon’s Proceed Ventral Patch may risk potential infections, hernia recurrence and secondary surgeries. Patients and doctors have reported severe complications including the following:
• Severe abdominal pain
• Redness of skin
• Bowel Blockage
• Abdominal abscess
• Bowel obstruction
• Intestinal fistula
• Mesh migration
• Bacterial infection
• Hernia recurrence
• Revision surgery
The Ethicon Proceed Ventral Patch is facing scrutiny over its effectiveness and poor safety record, though it is only one of Ethicon’s hernia products that have been potentially unsafe. The other models of hernia devices include the following:
Attorneys claim Ethicon’s hernia-related products, first approved in April, 2010, were not properly tested before they were marketed and distributed as a safe hernia solution. The Proceed Ventral Patch was approved by FDA 510(k) clearance, meaning it did not require FDA review or clinical trials to properly deem it safe or unsafe.
A number of settlements have been reached over Ethicon mesh litigation. If you have had surgery to treat a hernia using a mesh and you experience any signs or symptoms of recurrence or complications, talk to medical and legal experts.
The Lyon Firm has experience litigating cases against Ethicon and other mesh device manufacturers including Gore, Aspide, Covidien, Atrium and C.R. Bard.
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.
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
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