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Thousands of lawsuits are filed against the manufacturers of hernia mesh per year. These lawsuits allege that the mesh has design defects and that, in some cases, the manufacturer was aware of the risks. Despite this, manufacturers have continued to sell defective hernia mesh products even after thousands of complaints had been reported.
There have been to date several hernia mesh manufacturers who have been subject to FDA recalls. In 2005-07, there were multiple FDA recalls issued for C.R. Bard’s Kugel hernia mesh due to inferior quality causing breaking and tearing resulting in fistula, or bowel perforation.
In 2012, Atrium produced a hernia mesh labeled C-QUR, which resulted in a lawsuit and recall after the FDA issued a warning letter stating the company had failed to address safety concerns in the manufacturing process, according to WSBT.
In 2016 a Johnson & Johnson subsidiary Ethicon faced an FDA recall after one of their Physiomesh products experienced a high number of injury and hernia recurrence. Ethicon was forced to recall the product globally but continues to sell the mesh as Physiomesh Open Flexible Composite Mesh.
Other surgical mesh products such as Perfix Plug, Sepra mesh, Covidien’s Parietex and Ventralex ST have also been found to cause extreme pain, mesh tearing, organ perforation, adhesions, abscess formation, seromas, bowel obstruction or hernia recurrence as well as several other health problems according to KVUE in Austin, TX.
Hernia mesh is a screen-like material that is implanted by surgery to stabilize muscle tissue to repair a hernia. While most patients who receive hernia mesh suffer from no complications, several have resulted in severe issues post-surgery. The results have been from minor pain and difficulties, necessary mesh removal and even death.
Doctors have used hernia mesh for several years and there are hundreds of thousands of people with hernia mesh implanted in them every year in the USA alone. Most of the time, hernia mesh strengthens and improves the affected area while the damaged tissue is repaired. However, for many others, there can be severe complications of which can take years to discover.
The first laparoscopic hernia repair was performed in 1979. Since that time, there have been several developments made in hernia mesh technology, with many of the newer advancements registered as improvements. Mesh is regulated under the classification of a medical device under division II, according to the FDA. This classification means use poses a moderate risk of harm but is still allowed the 510(k) fast-track approval. The approval process is much more rapid under this classification. However, a problem arises when a product has undergone several rounds of improvements to the point it no longer resembles the original product but does not undergo testing as a new product.
Each year there are estimated to be more than 50,000 hernia mesh lawsuits pending in US courts. If you feel you may have been injured by hernia mesh, you should seek professional legal counsel. Check a list of defective surgical mesh products to see if the material used in your procedure is listed.
Eric Ridenour’s journalism experience began in the 1990s. He was a contributing writer to various publications, investigating government waste and fraud while studying journalism at Citrus College in California. In 2002, he joined the staff of University Wire, or UWire, in Carlsbad, California, where he was an editor until 2010.