Filing a hernia mesh lawsuit may be an option for patients who experienced severe complications, including hernia recurrence and the need for revision surgery, following implantation of hernia mesh patches marketed by Ethicon, Inc., Atrium Medical Corp., C.R. Bard, and other medical device manufacturers.
Bernstein Liebhard LLP is offering free legal reviews to hernia mesh recipients who experienced recurrence and revision surgery following hernia repair. If you would like to learn more about your available legal options, please call (888) 994-5118.
A hernia occurs when an organ or fatty tissue squeezes through a weak spot in a surrounding muscle or connective tissue called fascia. The various types of hernias include:
Hernia mesh is used to repair both ventral hernias and inguinal hernias. Before mesh was introduced, hernia repairs were performed via a number of suture-only techniques, including:
The Shouldice technique was developed more than 70 years ago at the Shouldice Hospital in Montreal, Canada, where it is still used today. The hospital has maintained a 95% success rate repairing inguinal hernias using the Shouldice technique. The method can often be performed without general anesthesia, greatly reducing the risk of complications.
Many hernia mesh products, including some of those marketed by Ethicon, Atrium Medical, and C.R. Bard, were granted regulatory clearance under the U.S. Food & Drug Administration’s (FDA) 510 (k) approval protocols, which allows a new device to come to market without first undergoing human clinical trials if a manufacturer can show that it is substantially equivalent to a previously-approved product. Thus, many alleged hernia mesh complications were not apparent until these devices had been implanted in thousands of people.
The FDA has received a growing number of adverse event reports related to hernia mesh implants. However, the agency appeared to downplay the issue in an article published in April 2016:
“Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh,” the article states. “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.
Many allegedly defective hernia mesh products are made with a type of plastic called polypropylene. The Material Safety Data Sheet (MSDS) for polypropylene notes: “Prohibited Uses: Applications involving permanent implantation into the body.” But because it is relatedly cheap, many hernia mesh manufacturers continue to use the material in their implants.
Many hernia mesh manufacturers use various types of coatings on their polypropylene mesh products to create a layer between the bowel and the plastic. Most of these coatings are intended to be absorbed by the body over time. Multi-layer hernia mesh is known as composite mesh.
We are currently investigating injuries and complications allegedly associated with the following hernia mesh products.
Ethicon Inc.’s Physiomesh Flexible Composite Mesh device was brought to market in 2010, and received regulatory clearance via the FDA’s 510(K) program. One of the predicates for Physiomesh was another Ethicon product called Proceed Mesh, certain lots of which were included Class II medical device recall five years earlier, due to issues that could lead to an increased risk of adhesions and bowl fistulization.
Physiomesh Flexible Composite Mesh consists of flexible, non-absorbable polypropylene (plastic) filaments that are woven into fabric. The structure is then laminated. The patch is used to strengthen the abdominal wall during minimally-invasive repair of ventral hernias.
In May 2016, Ethicon announced a global market withdrawal of Physiomesh Flexible Composite Mesh products, after its analysis of unpublished data contained in two European databases indicted that the hernia patch was associated with higher rates of recurrence and revision compared to similar patches when used in laparoscopic ventral repairs. Ethicon was unable to determine the cause of this issue, but noted that it could be due to product characteristics, as well as operative and patient factors. The company said it would not be returning Physiomesh Flexible Composite Mesh to the worldwide market.
Doctors who have used the affected Physiomesh have been advised to follow their patients in the usual manner.
Ethicon Proceed Hernia Mesh
Ethicon’s Proceed hernia mesh was brought to market in 2003, and was constructed of polypropylene mesh covered with an Oxidized Regenerated Cellulose (ORC) fabric. The fabric is adhered to the plastic mesh with polydioxanone (PDS)
Ethicon promises Proceed’s multi-layer configuration promotes “safe and comfortable” healing. However, certain lots of Proceed mesh were recalled in 2005 due to the cellulose layer separating from the polypropylene and increasing the risk of bowel complications.
Plaintiffs who have filed Proceed hernia mesh lawsuits claim that the devices continue to delaminate and should be recalled.
Ethicon Prolene Hernia System
Ethicon’s Prolene Hernia System was brought to market in 1997 and utilizes heavy-weight polypropylene, Injuries allegedly associated with the Prolene Hernia System include debilitating pain, nerve damage, and sexual dysfunction necessitating testicle removal.
Ethicon introduced Ultrapro Hernia System in 2007. The Ultrapro system uses a light-weight polypropylene, which was believed to cause fewer complications than the heavy-weight material.
Covidien Parietex Mesh
Covidien introduced its first heavy-weight hernia mesh – Parietex – in 1999. Like polypropylene, polyester also shrinks and contracts to a great degree. The original Parietex mesh was allegedly linked to many complications, including adhesions, infections, and bowel complications. Because it contracts, Parietex can tear in the areas where sutures have been used to secure the mesh.
Covidien Parietex Composite Mesh
Parietex Composite mesh consists of a polyester base and a resorbable collagen barrier, which is intended to prevent the base from adhering to the patient’s bowel. Covidien touts the Parietex product as a unique material that “works with the body’s natural systems.” However, it is alleged that the collagen barrier is thin and delicate, disappears quickly, and does little to protect the underlying organs from the polyester base.
Patients implanted with Parietex Composite Mesh have reportedly suffered severe adhesions, bowel obstructions, and infections. Like Parietex mesh, Parietex Composite Mesh is also said to be prone to tears in the area where sutures have been used to attach it to the body.
Parietex ProGrip / Parietex Plug and Patch System
The Parietex ProGrip and the Parietex Plug and Patch System are constructed from polyester weaved together with a partially semi-resorbable polylactic acid coating. The Parietex ProGrip product is also a “self-fixating” mesh, and has thousands of hooks that are intended to keep the device in place. However, the hooks also cause patients to experience severe pain and make the hernia mesh nearly impossible to remove.
Atrium C-Qur Hernia Mesh
Atrium C-Qur features an Omega-3 barrier coating that purportedly reduces the risk of adhesions and allows for better fixation of the mesh to the abdominal wall. However, a growing number of hernia mesh lawsuit allege that the C-Qur mesh design causes an inflammatory response that promotes the formation of bowel adhesions, impedes proper abdominal wall fixation, and causes additional severe complications.
C.R. Bard 3DMax Hernia Mesh
C.R. Bard’s 3DMax product is a heavy-weight polypropylene mesh used to treat inguinal hernias. A light-weight polypropylene version – 3DMax Light – was launched in 2008.
Some men implanted with 3DMas products have experienced severe sexual dysfunction and testicular pain, allegedly due to the erosion of the mesh through soft tissue, resulting in attachment to the spermatic cord. There have also been reports that 3DMax has folded over upon itself and migrated inside the patient.
Complications allegedly associated with 3DMax hernia mesh have caused some men to lose a testical.
C.R. Bard Perfix Plug
C.R. Bard’s Perfix plug is a bare polypropylene mesh indicated for the treatment of inguinal hernias. Overtime, the polypropylene can allegedly become unwoven, causing patients to experience severe pain, as well as difficulty walking and exercising. These complications may also result in the loss of a testicle.
C.R. Bard Ventralex ST Hernia Mesh (Sepramesh)
C.R. Bard acquired the license for Sepramesh, which is intended to separate polypropylene from the bowel, from Sanofi Genzyme in 2007. Bard then developed its Ventralex ST hernia mesh by combining the Sepramesh with its Kugel mesh patch. Roughly a decade ago, Bard recalled several lots of the Kugel mesh product. However, no recall was ever issued for the Ventralex St. hernia patch.
Bard’s Ventralex ST Sepramesh, Ventrio ST, and Ventralight ST are allegedly associated with severe inflammatory reactions, infections, and adhesions.
A North Carolina man has filed a new hernia mesh lawsuit in New Jersey federal court alleging that C.R.Bard’s VentraLight ST product is defective and unreasonably dangerous.
According to a complaint filed in the U.S. District Court, District of New Jersey, on September 14th, Julio Nunez receive a Ventralight ST patch in August 2014 to repair a ventral hernia. Soon after, he began experiencing severe abdominal pain, nausea, and fatigue. Less than a month later, Nunez underwent surgery to remove the hernia mesh and have an abdominal abscess drained. He continues to experience chronic pain, allegedly due to Ventralight ST hernia mesh complications.
“The scientific evidence Defendant knew or should have known of demonstrates that the mesh is incompatible with human tissue and often causes a negative immune response in patients implanted with the Product, including Plaintiff,” Nunez’s complaint states. Read More
You may be eligible to file a hernia mesh lawsuit if you were implanted with any of the above products and suffered severe complications, including:
If you would like to discuss a potential case with one of our attorneys, please contact Bernstein Liebhard LLP by calling (888) 994-5118.
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