Ethicon PhysioMesh Lawsuits
On 25, 2016 Ethicon Issued an Urgent Safety Recall for Physiomesh
The Ethicon Medical Safety Team announced an Ethicon Physiomesh® Transvaginal Mesh “Urgent Field Safety Notice” to stop using Ethicon Physiomesh® because of the high rate of failure. The mesh came in various sizes and shapes, including oval, square and rectangle. The mesh was packaged individually or in a Laparoscopic Hernia Pack.
The recall stated:
“Ethicon has initiated a voluntary product recall of ETHICON PHYSIOMESH™ Flexible Composite Mesh (for laparoscopic use) (“ETHICON PHYSIOMESH™ Composite Mesh”). Ethicon is recalling the product following an analysis conducted at the request of the Ethicon Medical Safety Team of unpublished data from two (2) large independent hernia registries (Herniamed German Registry and Danish Hernia Database-DHDB). The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries. Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors. Consequently, Ethicon have not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to recall ETHICON PHYSIOMESH™ Composite Mesh from the global market. Health care practitioners that have treated patients using ETHICON PHYSIOMESH™ Composite Mesh should continue to follow those patients in the usual manner. This voluntary recall has been communicated to the U.S. Food and Drug Administration (FDA) and the European Competent Authorities. This action involves only the ETHICON PHYSIOMESH™ Composite Mesh product line. It does not include the ETHICON PHYSIOMESH™ Open Flexible Composite Mesh Device, or other hernia mesh or device products manufactured or sold by Ethicon. The scope of this action includes all unexpired product”
Why the Mesh doesn’t Mesh!
In March 2016, The Journal of the Society of American Gastrointestinal and Endoscopic Surgeons reported a 20% failure rate with the Physiomesh® That means one in 5 will fail! The transvaginal mesh issues are well documented for a variety of reasons but physiomesh is a new issue. Physiomesh was approved by the FDA in 2010 on an expedited basis without human testing because it was based upon an earlier product. In this case, Ethicon stated that the predecessor product was Ethicon’s PROCEED mesh, a product that was at one point recalled, as well as being part of injury litigation. If the past is a predicator of the future, basing the approval on a product that failed is a failure by itself.
If you or a loved one used the Physiomesh call our lawyers toll-free at (877) 561-0000 to discuss your rights.