A Florida woman recently filed a new Ethicon surgical mesh lawsuit in the Superior Court of New Jersey, Bergen County. She claims that after she was implanted with mesh devices made by the manufacturer, she suffered from serious injuries. She also says that the products are defective and that manufacturers Ethicon and parent company Johnson & Johnson mislead patients in their advertisements, failing to warn of the serious risks.
After Implantation of Ethicon Hernia Mesh Products, Plaintiff Has to Undergo Risky Revision Surgery
According to the complaint, the plaintiff went through abdominal hernia repair surgery on May 7, 2009, at the Union Hospital in Elkton, Maryland. During the surgery, doctors used a 4” x 6” Proceed mesh product. Ethicon’s website describes the product as having “optimized design for strength and performance,” adding that in two studies of patients receiving hernia repair, those receiving Proceed mesh “reported significant improvement in pain and movement limitations” at 12 months after the surgery.
On March 5, 2010, the plaintiff had to undergo a second surgery to repair an inguinal hernia. During that procedure, her doctor implanted a large Prolene hernia system. This product is designed specifically for inguinal hernia repair and is supposed to adapt to “various stresses encountered in the body,” according to the manufacturer’s website.
Doctors Find Mesh Adhesion During Proceed and Prolene Revision Surgery
Yet the plaintiff’s experience was not positive. On May 11, 2010, she had to undergo revision surgery of the original abdominal hernia operations because of problems with the Proceed mesh. Her doctor noted an “extensive amount of bowel adhesions on the right side of the mesh.” Because the mesh was adhering so strongly to the tissues, the doctor was unable to remove it all.
Despite this revision surgery, the plaintiff continued to experience problems. On July 31, 2015, she had to go through another surgery, this time to remove both the Ethicon Proceed and Ethicon Prolene mesh products. The surgeon had to remove adhesions from the patient’s small bowel. As he continued revision surgery, he noted that there were two nerves embedded in the mesh. The surgeon was able to free those up. There were also blood vessels that had grown into the mesh so he had to clip and divide these to complete removal.
The plaintiff states that she continues to experience severe pain, diarrhea, chills, inflammation, loss of appetite, and extreme weight loss as a result of these mesh problems.
Plaintiff Claims Ethicon Hernia Mesh Likely to Adhere to Tissues
The plaintiff notes that the mesh products did not undergo premarket approval, which would have required clinical trials, but instead were approved via the FDA’s fast-track 510(k) process, which requires only that the manufacturers prove their device is significantly similar to others already on the market.
She adds that the manufacturers stated their products had layers that were supposed to minimize tissue attachment, but that in truth, the products have “unreasonably high propensity for adhesion formation….”