Holly Kelly Ennis
Hernia Mesh Cases Still on the Rise
A hernia occurs when an organ, tissue or intestine is displaced and protrudes through a hole or weak spot in the surrounding muscle or tissue. Many hernias occur near the abdominal wall. Although hernias can occur from a variety of issues, they are most often caused by pressure or muscle weakness and can often be seen as an external bulge, particularly when straining or bearing down. The types of hernias include:
- Inguinal: occurs in the inner groin
- Femoral: occurs in the upper thigh/outer groin
- Incisional: occurs through an incision or scar in the abdomen
- Ventral: occurs in the general abdominal/ventral wall
- Umbilical: occurs at the belly button
- Hiatal: occurs inside the abdomen, along the upper stomach/diaphragm
Hernia mesh is a medical devcie product intended to provide repair and support to damaged and/or weakened muscle tissue. The majority of surgical mesh devices currently utilized are constructed from synthetic materials or animal tissue. While hernia meshes have been around for over 50 years, some of the more recent mesh materials have caused serious complications in patients implanted with these materials. According to the FDA and adverse event reports, the most common adverse events for hernia mesh repair are pain, infection, hernia reccurence, adhesion, mesh migration, shrinkage and bowel obstruction. According to the U.S. National Library of Medicine, incisional hernia repair utilizing mesh has a reccurence rate of 20-45%. Additionally, patients with complex ventral hernias (a bulge in the abdominal wall which can include incisional hernias) have a reccurence rate of nearly 30-40% nationally. There are just a few treatment options to treat hernias, which often recur.
- Non Surgical-The physician will watch the hernia and monitor the progress to ensure it is not increasing in size or severity. This is primarily for patients who are not having complications or symptoms associated with their hernias.
- Laparoscopic Surgery-The surgeon will make several small incisions in the abdomen which allow surgical tools into the openings to repair the hernia. This surgery can be performed with or without utilizing hernia mesh.
- Open Repair-The most serious of repair options involves the surgeon making an incision near the hernia and the weak muscle area to be repaired. Open repair can also be performed with or without mesh. Open repair which utilizes sutures to repair the area, without mesh, is called primary closure. Primary closure is used to repair inguinal hernias in infants, small hernias and strangulated or infected hernias. As hernias have a high rate of reccurence, physicians wil use hernia mesh to strenghten the hernia repair and to reduce the rate of reccurence. Although there is a reduced rate of recurrence with the use of mesh, often the problems caused by the mesh itself are much worse for the patient.
There are many hernia mesh manufacturers, but the hernia mesh products to be most leery of were manufactured by C.R. Bard, Ethicon and Atrium. C.R. Bard has nearly 60% of the hernia mesh market. Bard's hernia mesh material is alleged to be defective due to their use of heavyweight small pored polypropylene; using polypropylene that is not medical grade and not suitable for human implantation; the addition of an ePTFE layer that allegedly contracts at a different rate from the polypropylene, causing the buckling and balling of the device and the use of a Sepra coating that prevents healthy ingrowth and fosters adhesions. C.R. Bard was allegedly warned as long ago as 2004 or longer when Marlex, the Bard supplier of the synthetic resins, stated repeatedly they were afraid of being sued if their products were used in human implants. In 2004, Marlex sent formal notices to Bard, indicating that "Marlex was not for human implantation" and advised medical mesh companies that they did not want their custom mesh products used "at any price." Cases against C.R. Bard are currently pending in the Bard MDL 2846 before the Honorable Edmund A. Sargus, US District Court, Southern District of Ohio.
Another hernia mesh product which is the subject of significant litigation is the Ethicon Physiomesh Hernia Mesh. Sales of this product began in March 2010 after it was approved through the FDA's 510k process. The 510k process does not require a manufacturer to prove that its product is safe for its intended use, but merely requires a showing that a device is a "substantial equivalent" to a product or products previously approved by the FDA. This mesh was primarily used in laparoscopic repair of abdominal hernias. However, on May 15, 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. Although not as large as the C.R. Bard hernia mesh litigation, claims against Ethicon are pending in the Ethicon Physiomesh MDL 2782, before the Honorable Richard W. Story, US District Court-Northern District of Georgia. There are also cases pending in the Ethicon Physiomesh New Jersey Court Multi-County litigation in the Superior Court Atlantic County.
The last of the three major mesh manufacturers and litigation proceedings involve Atrium's C-Qur Hernia Mesh. These mesh devices are claimed to be defective due to their heavyweight small pore meshes being coated with fish oil, which interferes with the patient's body chemistry, allowing for increased infections. This mesh received so many adverse event reports, particularly from physicians, that on October 11, 2012, the FDA issued a warning letter to Atrium Medical Corporation, noting that Atrium was essentially ignoring complaints regarding infections from the C-Qur hernia mesh. Despite FDA warning letters, Atrium continued to market the product. On February 3, 2015, at the FDA's request, the US Department of Justice filed a lawsuit against Atrium, which was fined $6 million for non-compliance and the FDA issued a permanent injuction. Unfortunately, the side effects from the C-Qur composite mesh can be particularly difficult to treat and include infection, allergic reaction, adhesions, intestinal blockage, mesh migration, mesh shrinking and bleeding. There are hundreds of Atrium C-Qur hernia mesh cases pending in the U.S. District Court for the District of New Hamphire before the Honorable Landya McCafferty. The first bellwether cases are scheduled to be tried in February, 2020.
It is estimated that there are nearly one million hernia repair surgeries performed each year. Approximately 800,000 are done to fix hernias in the groin, and the rest are for other types of hernias in the abdomen. With these huge numbers, patients must educate themselves and discuss with their physicians the most effective and least dangerous alternatives for the hernia repair. In today's medical climate, patients need to take a greater role in their own healthcare and become their own patient advocates.