Hernia Mesh Lawsuit Filed Over Bard Perfix Plug, Ethicon Prolene Mesh
May 25th, 2017
Attorney Bradley L. Leger partner of the law firm of Leger Ketchum & Cohoon, PLLC, has filed a product liability lawsuit on behalf of his client, the Plaintiff, alleging that a number of severe and debilitating complications were caused by two different types of defective hernia mesh, including the Bard Perfix Plug and Ethicon Prolene Mesh.
The complaint, which is pending in the U.S. District Court for the Southern District of Texas, names C.R. Bard, Bard Davol, Inc., Johnson & Johnson, and its Ethicon subsidiary as Defendants.
The Plaintiff first received a Bard Perfix hernia plug in March 2015. However, days after the surgery, he developed problems like groin pain, a spreading rash and tests revealed that the hernia mesh had folded on itself and ultimately the hernia ruptured, resulting in the need for a second repair surgery. The Plaintiff then had to undergo another hernia surgery involving the use of Ethicon Prolene mesh. But the severe pain and complications continued following this procedure. Ultimately, it was determined that the mesh was reacting horribly within his body, resulting in yet another revision surgery.
“During the operation, Dr. Shin found that the original mesh had been tangled with the nerves and 2% of the mesh concreted onto [Plaintiff’s] spermatic cord, which he was unable to remove,” the lawsuit notes. “The operation took 25% longer than anticipated due to the complications that arose from the entanglement.”
It was determined that the Plaintiff, in part, had been suffering from an allergic response. However, he continued to experience a variety of complications, including swollen testicles, pain, balance issues and rashes which led doctors to believe both mesh implants had been defective and both caused allergic reactions. The Plaintiff continues to suffer and has permanent injuries and damages from these defective products.
The hernia mesh manufactured by these Defendants are both made of woven polypropylene, which is a cheap plastic that degrades and erodes through tissue once implanted. The woven design of the mesh creates small pores or holes throughout the mesh. Nerves grow into these pores and attach to the mesh soon after the implant. As the mesh erodes and moves, it pulls the nerves attached to it. The nerves stretching is what causes debilitating pain that patients, including Plaintiff, suffer. This pain is also essentially untreatable. Even opioids are not effective in treating nerve pain.
The scientific evidence shows that the polypropylene material from which the product is made is biologically incompatible with human tissue and promotes a negative immune response in a large subset of the population implanted with such products, including Plaintiff. In fact the Polypropylene Material Data Safety Sheet (MSDS) notes: “Prohibited Uses: Applications involving permanent implantation into the body.” However, that is exactly what this mesh is made of and it is intended to be permanently implanted into the body, despite this prohibition.
The product can then become infected via bacterial contamination and causes chronic inflammation. Biomechanical issues that result include shrinkage, contracting, creeping, and deforming of the mesh within the patient’s body. Most men have reported severe, chronic groin and leg pain after being implanted and many have lost one or more of their testicles. The negative health effects from these mesh products can be severe, debilitating, and permanent.
The lawsuit maintains that the manufacturers of the Bard Perfix Plug and Ethicon Prolene mesh products knew or should have known about the risk of problems, especially in relation to use of the hernia mesh in the groin area, which the FDA has warned can cause infections, chronic inflammation and other health problems. Defendants have known of these health and safety problems but have continued to promote them as safe and effective. However, no long-term trials have been conducted to ensure safety and efficacy.
The Plaintiff has alleged claims against the Defendants based on failure to warn, design defect, negligence, breach of warranty, fraud and deceit, and gross negligence. The case is one of a growing number of hernia mesh lawsuits filed against various manufacturers in recent months, each involving similar allegations that many commonly used products have major design and manufacturing defects, which make them unreasonably dangerous for use during hernia repair.
If you have suffered after a procedure involving mesh – whether transvaginal, pelvic, or hernia mesh – please contact Bradley L. Leger for a free, confidential case evaluation today. Your time to file a claim is limited.