On May 25, 2016, Ethicon (a subsidiary of Johnson & Johnson) willingly recalled Ethicon Physiomesh. The recall came after Ethicon did an internal review of two, large, independent hernia registries which showed the recurrence rate and the reoperation rate after laparoscopic ventral hernia repair with Ethicon Physiomesh were greater than average. Click here to see a copy of the recall complete with product codes.
The Urgent Field Safety Notice instructed doctors to no longer use the Physiomesh for hernia repair. Incredibly, Ethicon cannot classify the product feature causing the problem and Ethicon is unable to provide any instructions to surgeons on how to avert the problems. You can also hire physiomesh attorney for your free case review via various websites.
What Was Ethicon PhysioMesh Used For?
In latest years, there have been numerous lawsuits stemming from the use of particular meshes including vaginal meshes. Ethicon Physiomesh was used chiefly in the repair of hernias, although the FDA approval also permitted it to be used in “other fascial deficiencies that need the addition of a reinforcing or bridging material to obtain the anticipated surgical result.”
Ethicon has two kinds of hernia repair meshes. The mesh presently being recalled is the type used in laparoscopic surgeries, which is called Ethicon Physiomesh Flexible Composite Mesh. At present, the mesh being placed through open surgery, Ethicon Physiomesh Open Flexible Composite Mesh has not been recalled.
Ethicon Physiomesh Flexible Composite Mesh is a sterile, low-profile, flexible composite mesh comprised of non-absorbable macroporous polypropylene mesh coated between two undyed polygelcparone-25 films. Another undyed polydiozanone film bonds the mesh and the films.
Ethicon Physiomesh can cause a myriad of problems comprising infections, fistulas, non-healing wounds, bowel adhesions, bowel perforations and bowel obstructions. These problems often need another surgery and long hospitalizations.
The Urgent Field Safety Notice issued by Ethicon simply instructs health care practitioners to treat patients in the “usual manner”. And therein lies the problem. The mesh has been surgically entrenched into patients.
The only method to reduce the risk of infections, non-healing wounds, bowel adhesions, bowel obstructions, bowel perforations, immune responses, etc. is to eliminate the mesh, which means another surgery for patients. And while Ethicon apologizes to health care providers for any disturbance and inconvenience caused by the recall, there is no apology to patients.