Why Foley & Small?

C.R. Bard Hernia Mesh

C.R. Bard controls about 60% of the hernia mesh market in the United States and across the world;

Bard’s meshes are claimed to be defective through their use of heavy weight small pored polypropelene; the use of polypropelenes 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.  In fact, post-approval, the FDA has advised consumers that adverse events as a result of hernia mesh devices are possible.  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).”

Ethicon Physiomesh Hernia Mesh

Ethicon’s Physiomesh was removed from the market in 2016 due to its alleged defective design utilizing multiple layers of PDS which is the result in failure to allow proper incorporation into the body, adhere to important organ structures causing injury, and otherwise fail to perform as intended. Importantly, even when the Physiomesh device properly incorporates into the body, the design of the polypropelene is alleged to have insufficient burst strength causing fracturing of the mesh and recurrence of hernias.

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.

Atrium’s C-Qur Hernia Mesh

Atrium’s C-Qur Mesh devices are claimed to be defective due to their heavy weight small pore meshes being coated with fish oil. The presence of fish oil is alleged to prevent integration into the body causing adhesions and damage to important and is alleged to alter the body chemistry of the patient allowing for increased infections.

Many physicians have reported to the FDA various problems with the C-Qur mesh. 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 properly evaluating the additional challenges that this device may present to sterilization. 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 for introducing adulterated and misbranded medical devices into the marketplace. Ultimately Atrium was fined $6 million for noncompliance. The FDA also issued a permanent injunction.

This stopped the manufacture and distribution of C-Qur hernia mesh. Production cannot resume until the FDA finds the manufacturing, processing, packing, holding and distribution of Atrium’s devices are in compliance. Despite this, C-Qur mesh continues to be used in surgeries nationwide.

The side effects from C-Qur composite mesh can be painful and difficult to treat and include:

• Infection

• Allergic reaction and rash

• Adhesion or scar-tissue fusing together

• Intestinal blockage

• Mesh migration

• Mesh shrinking

• Bleeding

• A hole forming in neighboring tissues or organs

Foley and Small is accepting Hernia Mesh Implant cases. If you, or a family member, or a close friend have suffered injuries as a result of a Hernia Mesh Implant, contact Foley and Small.