Safety Alert: Physiomesh Hernia
Ethicon’s Physiomesh Flexible Composite Mesh, used as a hernia patch, was pulled from the market following the discovery of data from two unpublished European registries about its durability. The studies found there were higher rates of hernia recurrence and the need for additional surgeries with use of Physiomesh as compared to similar mesh products. We are discussing legal options with patients and families who have experienced complications from a Physiomesh Hernia patch. We can help you navigate the next steps. Call us 1.800.877.8029 or fill out our Physiomesh case review to tell us your story.
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What is Physiomesh?
Physiomesh Flexible Composite Mesh is made by Ethicon, a subsidiary of Johnson & Johnson and is a non-absorbent, synthetic plastic patch intended to be used for hernia repair. In spring 2010, Physiomesh was approved by the FDA with a 510 (k) clearance, which does not require any clinical trials based on the similarity of Physiomesh with another, fully approved, product. More recently, In May 2016, Ethicon withdrew Physiomesh from the world market. In a letter to update health care providers of the withdrawal, Ethicon stated that they were not sure what was causing the issues with Physiomesh. The letter also stated they will not be returning Physiomesh flexible composite mesh to the market, but the withdrawal will not affect their Physiomesh Open Flexible Composite Mesh.
Physiomesh Complications
We are helping patients nationwide who have experienced complications as a result of their Physiomesh hernia patch. Some of the various complications that may require additional surgeries include:
- Bowel obstructions
- Seromas Infections
- Infections
- Hernia recurrences
How We Can Help
If you or a loved one have experienced recurring issues or required an additional surgery after receiving a Physiomesh hernia patch, it may be important to contact an attorney who can help you protect your potential legal claim. If you would like more information, or would just like to talk to a member of our device safety team, please call 1.800.887.8029.