Ethicon is a medical device company that manufactures the Physiomesh hernia mesh, a controversial device whose reoccurring revision rates led some patients to remove it and have ventral hernia repair.
A surgical mesh is a medical device used to provide additional support to weakened or damaged tissue — in this case, a hernia.
A hernia occurs when an organ, intestine or fatty tissue squeezes through a hole or a weak spot in the surrounding muscle or connective tissue. The majority of surgical mesh devices available for use are constructed from synthetic materials.
Surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheet forms. The synthetic materials used can be absorbable, non-absorbable or a combination of absorbable and non-absorbable.
Non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. It is used to provide permanent reinforcement to the repaired hernia. Absorbable mesh will degrade and lose strength over time. It is not intended to provide long-term reinforcement to the repair site. As the material degrades, new tissue growth is intended to provide strength to the repair. According to the FDA’s analysis of medical adverse events recalled mesh products and said that the main cause was due to bowel perforation and obstruction complications.
Why Is Physiomesh Dangerous?
Ethicon voluntarily withdrew its physiomesh products in May 2016 due to higher-than-average recurrence and re-operation.
The Johnson & Johnson subsidiary decided to withdraw the flexible composite mesh following analysis of data from two large independent hernia registries that showed higher-than-average rates of recurrence after laparoscopic ventral hernia repair compared to other meshes. Patients already implanted with the product should be followed as usual, the company said. The withdrawal does not involve any other Ethicon meshes.
According to the FDA, complications that may be caused by failure of the mesh to function as intended may include:
- Hernia recurrence
- Bowel obstruction
Some other potential adverse events that can occur following hernia repair with mesh are mesh migration and mesh shrinkage (contraction).
HSA Issues Recommendations About Dangers of Ethicon Physiomesh
Health Sciences Authority recently issued the official removal of Ethicon’s physiomesh from the market.
Ethicon is removing the product following an analysis conducted at the request of the Ethicon Medical Safety Team of unpublished data from two large independent hernia registries (Herniamed German Registry and Danish Hernia DatabaseDHDB). The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using Ethicon’s Physiomesh were higher than the average.
Can I File A Physiomesh Lawsuit?
Our Physiomesh lawyers can help if you or someone you care about contracted a severe — or possibly fatal — infection as a result of being exposed to bacteria from a contaminated heater-cooler device.
Our top Physiomesh case lawyers are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Both patients and their families are seeking compensation for injuries. You may be entitled to a settlement if you were harmed.
Our No-Fee Promise On Physiomesh Cases
You can afford to have our great team of Physiomesh lawyers on your side. If you choose us, it literally costs you nothing to get started. We promise you in writing:
- No money to get started
- We pay all case costs and expenses
- No legal fees whatsoever unless you receive a hernia mesh settlement
- Phone calls are always free
How Do I Start A Physiomesh Claim?
Our Physiomesh lawyers will help you file your lawsuit. To get started, you can:
- Submit the Free Case Review Box on this page, or
- Call (866) 280-3417 any time of day to tell us about your case.
We will listen to your story and answer your questions. If you have a claim, we will start immediately.
WARNING: There are strict time deadlines for filing hernia mesh lawsuit claims.