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Hernia Mesh Devices - A History of Failure

Hernia mesh repair devices are unnecessary and are complicating a relatively straightforward surgical procedure

Friday, November 2, 2018 - Thousands of hernia mesh lawsuits have brought new light to how advances in medical technology can create problems that previously did not exist. They also bring into question the approval process for new medical devices.

Hernias occur when a weakened intestinal or abdominal wall allows a small portion of the intestines to protrude through it causing a bulge. The spot of a hernia is usually more tender to the touch than normal. Hernias are generally treated with a "watch and wait" attitude by physicians. Indication that surgery may be necessary are pain, redness, swelling or bloating occurs indicating that the intestines have become strangulated with the potential to cause a dangerous blockage or reduce the blood supply to that portion of the intestines. Hernias today are repaired using laparoscopic surgery requiring an incision of only 1 to 2 centimeters. The most common forms of a hernia are inguinal, incisional and femoral. Most inguinal hernias are hereditary and occur in men. An incisional hernia can occur near an area of the abdominal wall that has been weakened by surgery. Femoral hernias occur in women during pregnancy or due to obesity. Being overweight increases the risk of developing a hernia in all people. For over a decade, surgeons have used a hernia repair mesh product to reinforce the surgically repaired abdominal wall.

Hernia repair mesh has come under fire for failing to live up to its expectations. Since around 1960, surgeons have used polypropylene mesh to reinforce hernias with mixed results. As it turns out, polypropylene has been found to be incompatible with organic tissue when placed inside the human body. As a result, hernia mesh devices tend to shrink, crumple and buckle when attacked by the body's natural immune system. When this occurs infections can develop in the abdominal wall allowing a hernia mesh to pull free from the area it was intended to support. According to the FDA, signs to look for that indicate a hernia mesh device has failed include, "pain, infection, hernia recurrence, adhesion, and bowel obstruction. Some other potential adverse events that can occur following hernia repair with mesh are mesh migration and mesh shrinkage (contraction)." (1) When a hernia repair mesh product pulls free and migrates it usually ends up in the lower abdominal cavity where it can cause serious bowel or intestinal perforation and/or blockages.

Since the year 2006, a high number of revision surgeries have forced the FDA or the companies themselves to recall or withdraw their polypropylene hernia mesh devices from the market. In 2006, Davol, Inc., a subsidiary of C.R. Bard, Inc., recalled a number of models and sizes of its Bard Composix Kugel Mesh Patch due to the device tending to break free and migrate to the lower abdomen and perforating it. This device was used after the repair of "ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery." (2) In 2013, the FDA issued a Class II recall of the Atrium's C-QUR was recalled because the device would decompose and stick to its packaging under conditions of high heat or high humidity. In 2016, Ethicon, a division of Johnson & Johnson, voluntarily pulled the Physiomesh hernia repair device from the market due to a higher than expected number of required revision surgeries reported to the European hernia database, Herniamed.

Sources:

(1) https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/herniasurgicalmesh/default.htm

(2) https://www.medscape.com/viewarticle/529032

(3) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119925

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OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. The Onder Law Firm has won more than $300 million in four talcum powder ovarian cancer lawsuits in St. Louis. Law firms throughout the nation often seek its experience and expertise on complex litigation.