The Ethicon Physiomesh Flexible Composite Mesh used in minimally invasive ventral hernia repair, has been withdrawn from the global market by Ethicon, a wholly-owned subsidiary of Johnson & Johnson. Ethicon initiated market withdrawal action after an analysis showed the hernia repair mesh places patients at higher rates of hernia recurrence and revision surgery. Ethicon said in an Urgent Field Safety Notice sent to health care providers in May 2016 that an analysis was conducted of unpublished data from two large independent hernia registries, the Herniamed German Registry and Danish Hernia Database. The data showed the recurrence and additional surgery rates after laparoscopic ventral hernia repair using Ethicon Physiomesh Flexible Composite Mesh were higher than the average rates of comparable meshes among patients in these registries. Ethicon said it was not sure why the rates were higher. The company also said in its safety notice that it was not able to issue further instructions to surgeons that might lead to a reduction in the recurrence rate.[bfarm.de/SharedDocs/Kundeninfos/EN/11/2016/4429-16_Kundeninfo_en.pdf?__blob=publicationFile&v=1, Ethicon, May 25, 2016]
[accessdata.fda.gov/cdrh_docs/pdf9/K093932.pdf, FDA, April 2010]
The Ethicon Physiomesh lawsuit attorneys at Wright & Schulte LLC are investigating legal claims of injuries due to the Ethicon Physiomesh Flexible Composite Mesh. If you or a loved one suffered serious injuries from Ethicon’s Physiomesh or other surgical mesh products, contact Wright & Schulte LLC for a free Ethicon Physiomesh hernia mesh lawsuit consultation by visiting yourlegalhelp.com.