Hernia Mesh Implants and High Rate of Recurrence SurgeriesFeb 15, 2017
Hernia Mesh Implants and High Rate of Recurrence Surgeries
A hernia forms when the abdominal wall weakens, bulges, or tears. This causes the inner lining of the abdomen to protrude and form a sac outside of the abdomen. Abdominal contents, such as the small intestine, can move into and get stuck in this sac. Hernias may occur in different areas, but the most common site is the groin, according to Lifescript.com.
Hernias may be asymptomatic (produce no symptoms) or cause slight to severe pain. They nearly all have a potential risk of having their blood supply cut off (becoming strangulated). When the content of the hernia bulges out, the opening it bulges through can apply sufficient pressure that blood vessels in the hernia are constricted and therefore cut off the blood supply. It may then become a medical emergency. About one million Americans have hernia surgery every year.
Hernias have a high rate of recurrence, and surgeons often use surgical mesh to strengthen the hernia repair and reduce the rate of recurrence. Since the 1980s, there has been an increase in mesh-based hernia repairs. By 2000, non-mesh repairs represented less than ten percent of groin hernia repair techniques, according to the U.S. Food and Drug Administration (FDA).
Surgical Mesh for Hernia Repair
Surgical mesh is a medical device that provides additional support to weakened or damaged tissue. The majority of surgical mesh devices currently available are constructed from synthetic materials or animal tissue.
It is not uncommon for the body to reject synthetic mesh implants. Even mild inflammation can cause pain, excessive scar-tissue growth, adhesion, or hernia recurrence.
Parker Waichman LLP is a national personal injury law firm with decades of experience representing clients in lawsuits regarding medical devices, including hernia repair mesh implants.
Problems with Mesh Implants
Approximately ten years ago, manufacturers started selling hernia mesh implants with coatings they maintained were anti-inflammatory. However, more than 15 lawsuits allege the coatings can actually trigger inflammation, infections, allergic reactions, and other major problems that require revision surgery, reports the Daily Hornet.
Johnson & Johnson recalled Ethicon Physiomesh in May 2016 in Europe and Australia after a huge study linked it to higher rates of hernias returning and requiring another surgery. Physiomesh was withdrawn from the market in the United States, so, the FDA did not issue warnings. However, that did not stop lawsuits.
Hernia Mesh Lawsuits
A woman in Florida filed a law suit recently because she needed an additional surgery when her hernia returned less than four months after Physiomesh was implanted in her body. Physiomesh is a patch woven from plastic-like fibers. The patch is laminated between two layers of Monocryl (poliglecaprone).
It was alleged that instead of preventing or minimizing inflammation and adhesion, as promoted, it did not permit adequate incorporation of the mesh into the body and allegedly led to an intense inflammatory and chronic foreign body reaction.
Similar allegations have been raised in at least 14 lawsuits involving a different type of hernia mesh, the Atrium C-Qur. This mesh is coated in fish oil (Omega-3 fatty acid). The fish oil coating is promoted as an "anti-adhesion barrier" to prevent scar-tissue from sticking organs together during the healing process, a typical problem after hernia surgery.
Researchers published a case report in 2016, of a 61-year-old woman who had in inflammatory reaction to fish oil-coated hernia mesh. Researchers warned that very few studies have investigated the safety of hernia mesh coated in active agents.
The Atrium C-Qur was approved in 2006 by the FDA using their 510(k) fast-track method. This method allows devices onto the market without rigorous clinical testing. Products approved through 510(k) only need to be "substantially equivalent" to a previously approved product.
Ethicon Physiomesh was approved through the same process in 2010. In May 2016, Ethicon Inc. issued a voluntary global market withdrawal for Physiomesh Flexible Composite Mesh. According to an Urgent Field Safety Notice it was linked with higher rates of hernias re-opening and requiring another surgery. This was based on two large studies in Germany and in Denmark.
One lawsuit was filed by a man who was implanted with Physiomesh in 2013. The implant was stitched into his abdominal wall to repair a ventral (abdominal) hernia. Two years later, the plaintiff developed severe abdominal pain, fever, nausea, chills, and redness. He was diagnosed with an infection and treated for two abscesses and an intestinal fistula.
According to the lawsuit, the plaintiff continues to have serious health problems, including two open abdominal wounds that must be cleaned and packed daily. The case is set for trial on January 22, 2018.
Legal Help Filing a Hernia Mesh Lawsuit
If you or someone you know suffered injuries associated with the use of a hernia mesh product, you may have valuable legal rights. Parker Waichman personal injury lawyers offer free, no-obligation case evaluations. For more information, we urge you to contact our attorneys at 1-800-YOURLAWYER (1-800-968-7529).