While hernia mesh has been a popular surgical solution for many years, the safety of some of these implants has been called into question due to serious complications in some patients.
Atrium's C-QUR mesh and Ethicon's Physiomesh, in particular, are facing dozens of legal claims because of the injuries caused by the hernia surgical mesh implants. Some studies found that certain materials used to make hernia mesh are unsafe for humans and can degrade in quality over time. For instance, C-QUR mesh is coated in a fish oil substance that may affect the rate of adhesion abnormal scar tissue that causes tissues and organs to become attached.
Some studies suggest the coating reduces adhesions in the short term, but may increase the number of adhesions over longer time periods. C-QUR mesh, various Ethicon products and a variety of other surgical meshes are created using a polymer called polypropylene, which is known to degrade over time.
As the material wears, this often leads to the mesh shrinking, causing irritation to the surrounding area and provoking an immune response.
Researchers noted that while hernia mesh is often considered necessary in treating any kind of hernia, the long-term side effects of these medical devices are still uncertain.
While some complications may arise even within days of surgery, a study found that 1, out of 3, hernia repair patients the substantial majority of whom had mesh repairs required an additional operation within 5 years of the original surgery to repair the hernia again or manage a mesh-related complication.
The researchers stated that many benefits of hernia mesh were offset by the late-term injuries. Many of these hernia mesh lawsuits allege that manufacturers of these implants, like Atrium and Ethicon, were well aware of the dangers of their products and didn't properly warn doctors and consumers of potential complications.
Many of the claims allege that these manufacturers didn't perform the proper safety protocols to ensure that the hernia mesh products would perform as intended. For some of these medical devices, including the C-QUR and Physiomesh, the FDA allowed for k premarket clearance , meaning the devices were alleged to be as safe and effective as a similar device already on the market.
Those suffering from complications from hernia mesh implants are claiming these manufacturers didn't do their due diligence with proper research and studies before putting these products to market. These medical device lawsuits claim the manufacturers ultimately produced defective devices, which lead to undue pain and suffering and further surgeries for many of these patients.
There have been many adverse event reports against these hernia mesh implants, such as C-QUR and Ethicon's Physiomesh. The FDA has documented dozens of adverse event reports against Physiomesh with some as recent as spring , including events where the mesh was broken into pieces, had a hole in the center, ruptured after surgery, and presented bowel obstruction among other problematic events.
In some of these reports, the surgeons even stated that the surgical mesh was a failure. Physiomesh isn't the only hernia mesh product with a number of adverse event reports. The FDA noted that the majority of these adverse events were related to bowel obstructions, pain, infection, adhesion and hernia recurrence.
Need to report a mesh malfunction? As a result of some of the complications arising from these surgical meshes, the FDA has recalled a variety of hernia mesh implants over the years. One of the first surgical meshes to be recalled was the Kugel hernia mesh, manufactured by C. Their devices were recalled in , and because of the dangers of the mesh breaking and leading to bowel perforation or enteric fistula, an abnormal connection between organs. Joseph H. Saunders Saunders and Walker. Load More.
More from Saunders and Walker view all articles. Popular on our Affiliate Network. Bard, the maker of the Kugel mesh patch, issued three recalls alone from due to a defect that could result in bowel perforations.
Since then, more than 3, hernia mesh recall lawsuits were filed across the. Results depend upon a variety of factors unique to each representation. Although this website may provide information concerning potential legal issues, it is not a substitute for legal advice and qualified counsel.
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