If you had hernia surgery between April 2010 and May 2016, you may have been implanted with defective Ethicon Physiomesh Flexible Composite Mesh, putting you at risk for serious complications and revision surgery. Physiomesh Flexible Composite Mesh was removed from the market due to a high rate of failure. If you do not know whether mesh was used in your surgery, or what type, your surgeon can tell you. No matter what type of hernia mesh was used, if you experience symptoms of hernia mesh complications, talk to your doctor right away.
Recalls and Market Withdrawal
In May 2016 Ethicon issued a Field Safety Notice announcing that it had initiated a worldwide device removal of its Ethicon Physiomesh Flexible Composite Mesh. Actual recalls were issued in Europe and Australia, along with the accompanying warnings to consumers from health authorities. In the U.S., Ethicon issued a market withdrawal which means that the product was removed from the market, but the FDA did not warn patients who had received the devices of the potential dangers.
Ethicon said that the device removal was prompted by its analysis of unpublished data from the German hernia registry and the Danish hernia registry which revealed that recurrence and reoperation rates were higher with Ethicon Physiomesh Composite Mesh than in patients with similar products. Ethicon said it did not yet know why the complication rate was higher with its product.
In June 2017, federally-filed Ethicon Physiomesh lawsuits were consolidated into a multidistrict litigation (MDL) in the U.S. District Court, Northern District of Georgia. At that time 18 lawsuits were transferred. By mid-August, the number of lawsuits in the MDL has grown to 92.
Ethicon Physiomesh Injuries
Ethicon Physiomesh Flexible Composite Mesh was approved by the U.S. Food and Drug Administration (FDA) in April 2010. Hundreds of adverse event reports involving the mesh have been filed with the in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. Complications associated with Physiomesh include, but are not limited to:
- Hernia recurrence
- Mesh migration
- Mesh shrinkage
- Mesh bunching up
- Inflammatory response
- Failure to incorporate into the body
- Surgery to remove the mesh sometimes including tissue that was healthy prior to damage by defective mesh
Hernia mesh complications can cause permanent injuries and can even be fatal. If you have been harmed by Ethicon Physiomesh Flexible Composite Mesh, please talk to an experienced defective medical device attorney right away to learn more about your rights and potential compensation.