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Hernias occur when a hole or weak spot in the muscle or connective tissue forms that allows an organ, intestine or fatty tissue to come through the body cavity or abdominal wall. Two of the most common hernias occur in the inner groin (“inguinal”) and in the general abdominal or ventral wall (“ventral”). Hernias must be addressed, and ultimately by surgery. The surgery can be laparoscopic where several small incisions that are made allow the surgeon to repair the hernia with surgical tools, or by an open repair where an incision is made to make the repair. Hernia mesh has been used frequently in the incisional repair procedure. While surgical mesh may decrease the high hernia recurrence rate, it has many serious complications. The FDA’s own analysis of hernia mesh medical device adverse event reports and of peer-reviewed, scientific literature found that the most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, bowel obstruction, mesh migration and mesh shrinkage (contraction).
There are two polypropylene mesh “sandwich” products, Ethicon’s Physiomesh and Atrium’s C-QUR. In 2006, Atrium began to market and sell its C-QUR product, and in 2010, Ethicon began to market and sell Physiomesh. The word “sandwich” is used here to describe the polypropylene component being laminated between two layers of poliglecaprone, a bioresorbable polymer used to form an anti-adhesion barrier between the polypropylene and the host tissue. This anti-adhesion barrier increases the risk that the graft will not incorporate into the abdominal wall, causing the graft to fold, buckle and migrate, posing a threat to adjacent organs. It is also known to incite an inflammatory response in the implant’s surrounding soft tissue. That inflammatory response can cause complications that include but are not limited to pain, graft rejection, graft migration, organ damage, adhesions, complex seroma, fistula, sinus tract formation, delayed wound closure, infection, sepsis, and death.
On May 25, 2016, Ethicon sent a worldwide letter to doctors recalling their hernia repair product Physiomesh. On August 9, 2013, the FDA announced a class 2 recall of the C-QUR mesh.
Other dangerous medical products include IVC filters. Please stay informed of dangerous medical devices and products to protect yourself at all costs. If you or a loved one have been affected by any of these devices, call us today for a confidential discussion of how we can help you.
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