Hernia Mesh Injury Lawsuit Takes Aim at Manufacturer
Severe injuries as well as pain and suffering form the basis of a new hernia mesh injury lawsuit filed by an Indiana woman.
The hernia mesh injury lawsuit filed by Marilee S. is just the latest in a string of suits filed against hernia mesh manufacturers for alleged defects. The product in question is made by Atrium Medical Corp and is the C-Qur model. The implant was received by the patient in January of 2014 and after that point she allegedly began experiencing severe pain and other problems.
The hernia mesh injury lawsuit names the manufacturer as responsible for failure to warn, design defects, manufacturing defects, a defective product, along with breach of express and implied warranties.
Hernias develop when organs or tissue bulges through a tear or a weak spot in a muscle wall. Many doctors prefer to use hernia repair surgeries to address the damaged wall directly to minimize the chances of the hernia coming back.
The implants are often given to patients undergoing hernia mesh repair surgery, but many patients have come forward with claims of serious injury and pain. The mesh implants can cause infection as well as other complications.
Thousands of lawsuits have already been filed by patients who have experienced pain and complications after going through a hernia mesh surgery. Many of these patients go through complex revision surgery that becomes risky when the hernia mesh has adhered to other parts of the body.
Patients who suddenly realize the serious side effects of this repair surgery may decide to file a hernia mesh injury lawsuit.
Certain types of hernia mesh implants, including the C-Qur model, have been the subject of adverse event reports and hernia mesh injury lawsuits. Patient who begin to experience unexplained symptoms after implantation often discover the problems for the first time when reporting them directly to a physician.
Some of the most common side effects include allergic reactions, infections, abdominal pain, bowel obstruction, mesh erosion, renal failure, and ulcers.
The U.S. Food and Drug Administration issued an injunction in 2015 that forced the Atrium Medical Group to discontinue the manufacture of the C-Qur hernia mesh. That was after the agency received many reports from injured patients, some of whom continued to experience pain for weeks. Others had to go through revision surgery and attempt to deal with the consequences.
The FDA approved the C-Qur product in March of 2006. The FDA 510(k) approval program was used, with the manufacturer arguing that it was substantially similar to other products on the market. This approval pathway allows makers of these products to avoid the traditional testing requirements for government approval of the drug or device in question. However, sometimes the use of this particular approval type raises questions about the safety of the product for consumers if comprehensive clinical testing has not been completed.
If you’ve experienced hernia mesh complications contact the attorneys at McDonald Worley for a free case evaluation.