In May of 2016, a hernia mesh product made by Ethicon, a Johnson & Johnson subsidiary, was withdrawn from the market serious infections and other severe complications often leading to additional surgeries.
The recall was initiated after two studies revealed higher rates of hernias reopening and the need for more operations with the Ethicon mesh compared to similar hernia meshes.
When patients suffer complications, additional surgery is often necessary to remove the mesh, and in some cases, due to the development of scar tissue, removal of the mesh is not possible. This may prolong suffering.
Now, lawsuits are mounting, alleging serious – even fatal side effects – including:
- Mesh Migration
- Hernia Recurrence
- Bowel Obstructions
- Bacterial Infections
- Seromas (fluid buildup under the skin)
- Additional Surgeries to Treat Hernia Recurrence
The product was intended to repair hernias, which occur when an organ pushes through an opening in the muscle or tissue wall. Hernias are most common in the abdomen, and may be caused by exertion, obesity, or abdominal surgery.
The Physiomesh Flexible Composite Mesh device was approved to be marketed by the U.S. Food and Drug Administration (FDA) in March 2010 through the federal agency’s 510k fast-track approval program. This program allows medical device makers to pursue approval of a product by showing that it’s “substantially equivalent” to a similar product, without the standard requirements such as testing and research.
The market withdrawal of Ethicon’s Physiomesh Flexible Composite mesh announced in May 2016 was categorized as a “Market Withdrawal.” Ethicon failed to clearly define the factors behind the high failure rate.
While Physiomesh™ was recently recalled, other brands, including the C-QUR™ mesh products, have also been associated with similar problems.
Several hernia mesh lawsuits have been filed over failed Physiomesh hernia mesh products with some of the following allegations:
- Failure to perform adequate research of the product
- Failure to warn about the complications linked to the product
- Providing misleading information about Physiomesh’s safety
- Defective instructions for surgeons
- Failing to make a safer mesh product
At Reyes Browne Reilley Law Firm, you, as our client, will always come first.
Heria Mesh Free Consultation:
If you or a loved one suffered complications after an Ethicon hernia mesh device was used to repair a hernia, you may qualify to file a hernia mesh lawsuit or join a hernia mesh class action lawsuit by filling out the short form on this page, or by calling our offices at 214-526-7900.
Even if you’re unsure which brand of mesh was used in your surgery, we may still be able to determine if you can take legal action.