HERNIA MESH LAWSUITS – INVESTIGATIONS – RECALLS
Hernia Mesh Lawsuits
The medical device attorneys at Maglio Christopher & Toale, P.A. are investigating all hernia mesh claims. Victims from around the country are reporting similar severe complications from hernia mesh products that are currently on the market, including: Ethicon Physiomesh, Ethicon Proceed, Atrium C-QUR, C.R. Bard Kugel, Sepramesh, 3DMax, and PerFix.
Many Lawsuits But No Recalls
Lawsuits are also racking up around the country for these brands of hernia mesh. At this point, the FDA has NOT issued any recalls for hernia mesh currently on the market. None of the mesh manufacturers has issued a voluntary recall of their products either. In some cases, they silently stop selling the defective mesh without warning patients about the potential for medical complications.
FDA Issues Safety Communication
In October 2014, the FDA issued a Safety Communication announcing patient reports of surgical mesh complications. To help the FDA in better understanding the life-threatening complications with hernia mesh products, you can file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program
Hernia repairs are common – more than one million hernia repairs are performed each year in the U.S. Surgical hernia repairs can be performed with or without hernia mesh. Surgeries are either laparoscopic (small incisions in the abdomen that allow surgical tools into the openings to repair) or complete open repair (incision near the hernia and the weak muscle area is repaired).
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What is Hernia Mesh or Surgical Mesh?
Surgical mesh is a medical device used by surgeons to reinforce and support weakened or damaged tissue. Most hernia mesh is made from a synthetic material called polypropylene, which can cause significant medical complications. Polypropylene mesh is manufactured as either knitted mesh or non-knitted sheet forms, and it can be absorbable, non-absorbable or a combination. The synthetic non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. The absorbable mesh is supposed to degrade and lose strength over time so that new tissue growth will provide strength to the repair.
Flawed Research Studies
Because hernias have a high rate of recurrence, the manufacturers of hernia mesh products funded studies to demonstrate that there was a lower rate of hernia recurrence when hernia mesh was used in surgeries. However, these studies failed to include long-term data in monitoring patients after mesh implantation and what were considered “normal complications”. People who have hernia recurrences and complications 10 years after a mesh implant are unaccounted for in the manufacturer-funded studies.
Hernia mesh frequently causes life-threatening complications as it can erode into the bowel, affect the small and large intestines, require multiple additional surgeries for extraction and partial bowel removal, weeks of hospitalization, colostomies, systemic infections, and more. Recently there has also been observed high rates of dental infections associated with hernia mesh failure. Various complications can occur depending on what part of the body the mesh is placed. A coated hernia mesh, also known as a “composite mesh,” is also more likely to cause injuries than a non-coated hernia mesh.
Composite Hernia Mesh – Big Profits and Major Complications:
Hernia mesh that is coated is known as composite mesh. It is coated because the underlying material, polypropylene, is well known to cause damage to the surface of any organ it touches. Polypropylene is believed to be biologically incompatible with human tissue. In a Material Data Safety Sheet (see below) published by polypropylene manufacturer LyondellBasell, it specifically says that prohibited use of the material includes “applications involving permanent implantation in the body.” However, instead of changing the polypropylene material to protect lives and make hernia mesh products safer, the manufacturers attempted a band-aid fix by putting a coating over the mesh material.
Why Not Fix the Problem?
Because to create a safer mesh, the companies would have to conduct pre-clinical studies to prove that the new hernia mesh was safer and undergo an FDA Pre-Market Approval (PMA). This takes a lot of time and money. So instead, hernia mesh makers decided to apply a coating to their polypropylene products to create a layer between the internal organs and the toxic polypropylene. The problem is that most of these coatings are absorbed by the body over time.
Increased Profits and Silent Recalls
Hernia mesh manufacturers quickly recognized the high demand for coated or composite hernia mesh. The companies increased their price for composite mesh about 15-20 times more than the uncoated polypropylene mesh. Hernia mesh manufacturers rushed to create and sell several different types of composite hernia mesh to get a cut of the big profits, and if one type of composite mesh caused too many side effects, the company would silently stop making that particular composite mesh and push sales of its other ones. We call this a “silent” recall because the company is basically pulling a defective product from the market without warning patients.
Known Hernia Mesh Complications:
- Hernia Recurrence
- Adhesions (scar-like tissue that sticks tissues together)
- Obstruction of the large or small intestines
- Bowel Obstruction
- Abnormal Connection between Organs, Vessels, or Intestines (fistula)
- Fluid Build Up at the Surgical Site (Seroma)
- Holes in the neighboring tissues or organs (Perforation)
- Mesh Migration
- Mesh Shrinkage (contraction)
Types of Mesh Placement
- Overlay – Hernia mesh is placed between the skin/subcutaneous tissue and the rectus abdominis. Mesh is easiest to remove when it is placed in the overlay position.
- Inlay – Hernia Mesh is placed between layers of the rectus abdmonisis.
- Underlay – Hernia Mesh is placed between the rectus abdominis and the peritoneum. Higher chance of attaching to the patient’s underlying organs when placed in the underlay position.
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
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.
Hernia Mesh Side Effects Studies and Research
Complications of Mesh Devices for Intraperitoneal Umbilical Hernia Repair: A Word of Caution – “We have seen several patients with serious late complications of these meshes placed intraperitoneally. Some of these patients needed small bowel resection and mesh removal. Others developed a recurrence because of improper deployment of the mesh in the intraperitoneal posit.” –Hernia, August 2011/time>,Volume 15,Issue 4, pp 463–468.
Ventral hernia repair with synthetic, composite, and biologic mesh: characteristics, indications, and infection profile – “Synthetic mesh, such as polypropylene (PP) or polyester, is characterized by high tensile strength and vigorous tissue ingrowth, but is unsuitable for intra-abdominal placement because of its tendency to induce bowel adhesions.” – Surgical Infections (Larchmt). 2012 Aug;13(4):209-15.
Comparison of outcomes of synthetic mesh vs suture repair of elective primary ventral herniorrhaphy: a systematic review and meta-analysis – “Mesh repair has a small reduction in recurrence rates compared with suture repairs for primary ventral hernias, but an increased risk of seroma and SSI was observed.” – JAMA Surg.2014 May;149(5):415-21.
Long-term evaluation of adhesion formation and foreign body response to three new meshes – “Microscopic evaluation revealed massive foreign body reaction to Hi-Tex Endo-IP(®), leading to an extensive and thick collagenous scar adherent to the abdominal wall. Fractioning of the Physiomesh(®) coating over time led to an increase in interfilamentary granuloma formation, leading to scar plate formation, but with only minimal to no abdominal wall adherence.” – Surg Endosc. 2015 Aug;29(8):2251-9.
FDA Article: Hernia Surgical Mesh Implants – “In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.” – FDA Article on Hernia Mesh
Tissue integration and inflammatory reaction in full-thickness abdominal wall repair using an innovative composite mesh – “When composite meshes are used in abdominal wall repair, seroma formation may persist and delay the desired integration leading to recurrence.” – Pascual, G., Sotomayor, S., Rodríguez, M. et al. Hernia (2016) 20: 607. doi:10.1007/s10029-015-1383-4.
Evaluation of long-term surgical site occurrences in ventral hernia repair: implications of preoperative site independent MRSA infection. – “The rate of 2-year SSO was higher with MRSA(+) compared to those without (46 vs. 29 %, p = 0.023), attributed to increased soft tissue necrosis, purulent drainage, serous drainage, cellulitis, and fistula. ” – Hernia 2016 Oct;20(5):701-10.
What is a Hernia?
It is when a part of your internal organs, muscle or tissue squeezes through a hole in the surrounding muscle or tissue. Most often hernias happen in the abdominal wall area and are caused when there’s a weak spot in the muscle or connective tissue wall. Sometimes you can feel a bulge where the tissues break through the tissue wall. Some of the reasons for increased pressure in your abdomen include obesity, lifting something heavy, constipation or forceful bowel movements, and even a chronic cough or sneeze.
Types of Hernias:
- Inguinal- An inner groin hernia
- Femoral- Upper thigh or outer groin
- Incisional- Happens because of a scar or incision in the abdomen
- Ventral- hernia in the ventral wall of the abdomen
- Umbilical- Hernia in the belly button area
- Hiatal- These hernias occur along the upper stomach or diaphragm area
Causes of Hernia
When there’s a weak spot in the muscle or connective tissue wall, pressure forces part of your organs to squeeze through that weakened opening. Sometimes you can feel a bulge where the tissues break through the tissue wall. Some of the reasons for increased pressure in your abdomen include obesity, lifting something heavy, constipation or forceful bowel movements, and even a chronic cough or sneeze.
 Rutkow, I.M. (2003). Demographic and Socioeconomic Aspects of Hernia Repair in the United States in 2003. Surgical Clinics of North America; 83(5): 1045-51, v-vi.