Brands of Hernia Mesh Involved in Lawsuits and Investigations
Ethicon Proceed Hernia Mesh
Proceed is a composite hernia mesh with a partially absorbable layer made of a polypropylene base that entered the market in 2003. Because the coating is designed to absorb over a period, the polypropylene becomes directly exposed to patients organs causing severe life-threatening complications. Over 18,000 Proceed hernia meshes have been recalled. In 2005, the FDA issued a recall of this device due to reported complications that the device disintegrated inside patients’ bodies, resulting in severe infections, and causing serious adhesions and fissures. Ethicon itself has issued several recalls for the Proceed in 2011 and 2014. The Proceed hernia mesh is still on the market and continues to be implanted in patients nationwide.
Ethicon Physiomesh Hernia Mesh
Physiomesh was on the market for less than 6 years when Ethicon, a Johnson & Johnson subsidiary, took it off the market in May 2016 because of unusually high failure rates. Despite adverse events reported to the FDA, Ethicon removed Physiomesh from the market only after independent studies revealed high rates of complications associated with the Physiomesh. Ethicon failed to clearly explain why the high failure rates, but instead, vaguely stated it could be due to several factors: hernia mesh design, physician’s instructions, and patient selection. Physiomesh is made from the same material as Ethicon’s transvaginal mesh products, polypropylene, which have also been linked to numerous complications. Physiomesh has a unique design that has never been used in any other hernia repair product sold anywhere in the world.
Atrium C-QUR Hernia Mesh
C-QUR entered the market in 2006 and is made of polyethylene plastic and coated with Omega-3 fatty acid fish oil. C-QUR is intended to be a permanent implant. The fish is oil is supposed to prevent inflammation and scarring from tissues adhering to the mesh, but studies show the device has higher adhesion and infection rates that many other hernia mesh brands. The earliest independent studies found that there was a significant increase in adhesions and immune response around these mesh implants. The most recent case study in 2016 further supported these findings. In 2013, the FDA issues a recall of over a thousand C-QUR’s. Additionally, the FDA issued a warning letter to Atrium regarding the company’s failure to adequately address multiple complaints related to the infections from C-QUR. In 2015, the District Court of New Hampshire entered a permanent injunction against Atrium preventing it from manufacturing and distributing C-QUR. From 2008 to 2015, Atrium produced a number of other product variations of the C-QUR, all which are still available on the market. Lawsuits from around the country are being consolidated into a Multi-District Litigation in New Hampshire.
C.R. Bard Kugel Hernia Mesh
C.R. Bard manufacturers all these brands of surgical hernia mesh, and all have been linked to several different life-threatening complications.
The Kugel mesh patches are comprised of a double layer of monofilament polypropylene, to be used in minimally invasive laparoscopic procedures. When implanted it is folded for insertion into the body but opens up to its full shape and size with the help of a memory recoil ring. The Kugel was one of the first and most well-known hernia meshes to be recalled. Several recalls of the Kugel occurred between 2005-2007 because of a high number of devices breaking and causing bowel perforations. However, the real issue with the Kugel is that it is made of polypropylene, which shrinks over time, and as it shrinks, the device breaks. The Kugel is still on the market.
C.R. Bard 3DMax Hernia Mesh
The 3DMax mesh has been on the market since 2009 and is a bare polypropylene mesh that has a curved and cupped designed to fit the inguinal canal to treat groin hernias. It can also be attached to the spermatic cord in men. Because of its unique design and low-quality plastic which is known for premature failures, when the polypropylene begins to degrade and shrink, the 3DMax cracks, pieces break off, and it commonly folds on top of itself. Complications with the 3D Max have included severe debilitating pain after implantation, and in most extreme cases, when it is removed there is a heightened risk of losing a testicle. The 3DMax is still in the market.
C.R. Bard PerFix Hernia Mesh
The PerFix Plug is a woven polypropylene hernia mesh plug used to repair groin hernias. The PerFix Plug’s design has small pores (holes) throughout its mesh, and soon after implementation, the nerves grow into these pores and attach to the mesh. When the polypropylene degrades and erodes, the nerves become stretched causing debilitating pain. The PerFix Plug also runs the heightened risk of losing a testicle when removed if it has eroded into the spermatic cord. The FDA issued a recall in 2014 for labeling errors. The PerFix Plug mesh is currently on the market.
C.R. Bard Ventralex ST Hernia Mesh
Ventralex ST came to the market in 2002 and is a polypropylene hernia mesh patch with a similar coating to that used on the C-QUR. The Ventralex ST was designed based on the Kugel, another C.R. Bard mesh product which had several recalls. Reported complications of severe infections and allergic reactions have been reported. The Ventralex ST is still in the market.
C.R. Bard Sepramesh Hernia Mesh
SepraMesh entered the market in 2005 and is a composite polypropylene mesh with an absorbable coating. The lipid coating in the SepraMesh triggers high levels of chronic inflammation once implanted leading to slow wound healing and chronic infections. SepraMesh is still on the market.