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Aggravated injuries due to defective hernia mesh products are a common denominator for lawsuits in the medical industry. At Raizner Slania, our knowledgeable attorneys will argue for your right to owed compensation.
According to the U.S. Food and Drug Administration (FDA), doctors perform over one million hernia repair surgeries every year. While there are several ways to repair a hernia, doctors most commonly insert a device called hernia mesh. Thousands of patients were hopeful the device would help them recover from painful hernias, but many of these devices are defective and have worsened patients’ injuries.
A hernia occurs when tissues or organs protrude through a weakening in the abdominal muscles. This weakening can be caused by a variety of factors, but hernias commonly occur after surgery. Surgery can cause a weakness in the abdominal wall for weeks, months, or sometimes even years after the surgery. Even incisions smaller than one inch can cause a serious hernia. Other factors that can cause a hernia include sudden weight gain, heavy weight lifting, pregnancy, persistent coughing, chronic constipation, and fluid in the abdomen, among others.
Hernia mesh is a medical product made up of plastic fibers woven together like a piece of fabric. This plastic patch can be placed over holes in the abdominal wall to prevent organs and tissues from protruding through it. Unfortunately, this patch comes with severe side effects.
The failure of hernia mesh to repair a hernia can be catastrophic for patients. The chances of a hernia successfully healing are significantly reduced with each recurrence of the hernia. Defective hernia mesh products have caused many patients to require additional surgeries and/or suffer permanent damage.
Since the mid-2000s, the FDA has recalled a number of different hernia mesh products from the market for causing severe side effects. In addition to FDA recalls, one large hernia manufacturer voluntarily withdrew its own hernia mesh products from the market after receiving a large number of reports of device failure.
The FDA approved many hernia mesh products via its 510(k) approval process. This process allows medical device manufacturers to sell their devices on the marketplace without conducting clinical studies on them, so long as the devices are “similar” to another device already approved by the FDA. This practice has allowed many defective hernia mesh products onto the market to the detriment of patients across the country.
Ethicon Inc. (part of Johnson & Johnson) introduced a type of hernia mesh called Physiomesh in March of 2010 after gaining approval through the fast-track 510(k) process. Unfortunately, Physiomesh is made out of a type of flexible plastic called polypropylene. The type of material used is the same material Johnson & Johnson used for its transvaginal mesh which caused serious injuries to women throughout the country.
By May 2016, Ethicon issued an Urgent Field Safety Notice, asking hospitals and physicians throughout the country to discontinue using Physiomesh and to return the products to the manufacturer. The material is not permanent, and will deteriorate and shrink over time, causing the device to weaken and fail. Break down of the material at the site leads to hernia recurrence, bacterial infection, and inflammation. Removing the failed mesh can be difficult because it can become adhered to internal organs, muscles, and/or tissues that often have to be removed with the mesh.
Atrium Medical Corporation manufactured a line of products as C-Qur Hernia Mesh. The original C-Qur mesh was approved in 2005 through the controversial 510(k) application process. The C-Qur line of hernia mesh products include the following:
C-Qur mesh is made from polypropylene fibers, but the products are unique because they contain an outer coating of gel made from omega 3 fatty acids, or fish oil. The C-Qur hernia mesh products were the first to utilize this type of coating. However, Atrium obtained FDA approval to put C-Qur on the market through the 510(k) process by representing to the FDA that C-Qur was just like other mesh products used in 1990’s. By doing so, Atrium bypassed critical testing that should have been conducted on the effects of implanting this new type of coating in the human body.
After the FDA started receiving complaints and reports of adverse events, the FDA issued warning letters to Atrium regarding its C-Qur mesh. In 2013, Class 2 Device Recalls were issued for over 100,000 of Atrium’s C-Qur hernia mesh products because the omega 3 oil coating can peel off. Atrium did not pull the products off the market. In 2015, the FDA filed a lawsuit against Atrium forcing the company to stop manufacturing and distributing C-Qur hernia mesh until the FDA Is satisfied that the device are safe.
Failure rates with Atrium C-Qur hernia mesh continue to be disproportionately high compared to other mesh products on the market. If the mesh product fails, the risk for hernia recurrence is high and patients are forced to undergo additional revision surgeries.
Additionally, if the coating or hernia mesh adheres to internal organs, it could cause painful side effects and lead to serious internal infections.
C.R. Bard subsidiary Davol, Inc. manufactures several different hernia mesh products, most notably the Composix Kugel Mesh patch, which is one of the first and most well known hernia meshes. The Composix Kugel mesh product was designed with a memory ring to help keep its shape. However, this ring can bend or break once implanted, causing serious injuries to the patient. The Composix Kugel Mesh is also made with polypropylene and as the material shrinks over time, the ring is forced to withstand additional pressure, causing it to malfunction.
In addition to the Composix Kugel Mesh patch, Bard manufacturers additional types of hernia mesh products which can cause serious complications due to their faulty design, including the following:
Manufacturers of hernia mesh have known their products are dangerous for years, but they continue to produce defective devices. Patients receiving hernia mesh are often unaware of the serious risks and learn too late how hernia mesh can cause permanent injuries. If you or someone you love had a hernia mesh implanted and suffered additional injuries, the experienced hernia mesh attorneys at Raizner Slania can help. It is not necessary to know the brand of hernia mesh you or a loved one received during your surgery.
Our attorneys have extensive experience handling defective medical device claims and aren’t afraid to take on large companies for our clients. Call us today to schedule a free consultation to discuss your legal options.