When an organ, intestine, or fatty tissue is displaced and protrudes through a hole or weak spot in the nearby muscle or connecting tissue, it’s called a hernia.
According to the FDA, more than 1,000,000 hernia repairs are performed each year in the U.S. There are a few ways to treat a hernia, and your doctor will determine the best option for you. It’s important to note that one popular method of hernia repair is a mesh implant—and the FDA has advised consumers that adverse events as a result of hernia mesh devices are possible. Here’s what you need to know.
What is a mesh implant?
“Surgical mesh is a medical device that is used to provide additional support to weakened or damaged tissue,” says the FDA. “The majority of surgical mesh devices currently available for use are constructed from synthetic materials or animal tissue.”
While hernia meshes have been around for over 50 years, some devices have recently put patients at risk of serious complications. According to the FDA, “[t]he most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, and bowel obstruction. Some other potential adverse events that can occur following hernia repair with mesh are mesh migration and mesh shrinkage (contraction).”
The devices you need to be wary of, say Foley & Small Personal Injury Attorneys, are primarily manufactured by C.R. Bard, Ethicon, and Atrium.
C.R. Bard Hernia Mesh: C.R. Bard controls about 60 percent of the hernia mesh market in the United States and across the world. According to Foley & Small, Bard’s meshes are claimed to be defective through their use of heavyweight small pored polypropylene; the use of polypropylenes that were not medical grade and not suitable for human implantation; the addition of a ePTFE layer that is alleged to contract at a different rate from the polypropylene causing the buckling and balling of the device; the use of a Sepra coating that prevents healthy ingrowth and fosters adhesions.
The FDA has approved several Bard hernia mesh devices for use in hernia repair surgical procedures through the FDA 510(k) process. The 510k process does not require a manufacturer to prove that a product is safe for its intended use, but merely requires a showing that a device is a “substantive equivalent” to a product or products already approved by the FDA.
Ethicon Physiomesh Hernia Mesh: Sales of Ethicon Physiomesh Flexible Composite Mesh began in March 2010, after the FDA approved its use through a 510(k) process. Ethicon’s Physiomesh Flexible Composite Mesh is used in laparoscopic repair of abdominal (ventral) hernias. On May 25, 2016, the Ethicon Corporation issued an urgent field safety notice to withdraw its Physiomesh Flexible Composite Mesh from hospitals because of high failure rates and complications such as adhesions, fistulas, and infections that resulted in pain and additional surgery.
Ethicon’s Physiomesh’s alleged defective design utilized multiple layers of PDS—which is the result of failure to allow proper incorporation into the body, adhere to important organ structures causing injury, and otherwise fail to perform as intended, says Foley & Small. Importantly, even when the Physiomesh device properly incorporates into the body, the design of the polypropylene is alleged to have insufficient burst strength causing fracturing of the mesh and recurrence of hernias.
Atrium’s C-Qur Hernia Mesh: Atrium’s C-Qur Mesh devices are claimed to be defective due to their heavyweight small pore meshes being coated with fish oil, which is alleged to alter the patients’ body chemistry, allowing for increased infections.
Many physicians have reported to the FDA various problems with the C-Qur mesh, says Foley & Small. There were so many reported complications that on October 11, 2012, the FDA issued a warning letter to Atrium Medical Corporation, noting that the company was failing to adequately address complaints related to infections associated with the C-Qur hernia mesh.
The letter also revealed that Atrium Corporation appeared to be ignoring numerous sterility complaints, including at least 35 separate complaints of human hair found in medical devices that were supposed to be sterile.
The FDA’s letter also said Atrium added additional products to their sterilization load, including the C-Qur V-Patch, without proper evaluation. Additionally, Atrium modified the temperature during the manufacturing process of the C-Qur hernia mesh without approval of the FDA.
Despite the FDA’s warning letters, requests for compliance and mounting medical studies that questioned the safety of C-Qur mesh, Atrium continued to market its C-Qur composite mesh products. On February 3, 2015, at the FDA’s request, the US Department of Justice filed a lawsuit against Atrium, and ultimately, Atriu