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.
FDA Recalls Ethicon Proceed
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.
Ethicon Hernia Device Complications
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
• Adhesions
• Bowel obstruction
• Intestinal fistula
• Mesh migration
• Bacterial infection
• Hernia recurrence
• Revision surgery
Ethicon Hernia Mesh Injury
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:
• Proceed Ventral Patch
• Physiomesh
• Prolene 3D Patch
• Ultrapro Comfort Plug
Hernia Mesh Lawsuits
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.
