FDA website filled with reports of Physiomesh complications

physiomesh FDA website filled with reports of Physiomesh complicationsEthicon, a subsidiary of Johnson & Johnson, has been facing a growing number of complaints about its Physiomesh product, a mesh device used to repair hernias. However, reports on the U.S. Food and Drug Administration (FDA) website indicate the public isn’t hearing the whole story.

The FDA’s website is riddled with complaint after complaint about Physiomesh failing, allegedly causing infection or injury:

  • 11/30/2011: “Patient had mesh implanted. Patient returned to surgery 13 days later because mesh was infected”
  • 10/30/2012: “Patient returned to surgery. Mesh was noted to be pulled from suture line. Mesh had been in place for approximately 1 week. Mesh removed and replaced with new product.”
  • 4/19/2011: “Laparoscopic ventral hernia repair with Ethicon Mesh. Mesh pulled away from abdominal wall resulting in 2nd surgery Laparoscopic & Open (Laparotomy) removal of mesh, repair of recurrent ventral hernia using Bard mesh.”
  • 8/29/2017: “It was reported by an attorney that the patient underwent a laparoscopic ventral umbilical hernia repair on [undisclosed date] 2014 and mesh was implanted. It was reported that on [undisclosed date] 2015 the patient underwent a subsequent  removal surgery of the mesh, and found that the mesh had disconnected and was torn, leaving fragmentation of the mesh into surrounding tissue. The patient was implanted with mesh to fix the umbilical hernia  on [undisclosed date] 2015.   she has experienced and continues to experience pain in lower part of her stomach, sores on her stomach, blisters, stinging sensation around the area of surgery, and removal of her naval.”

Physiomesh is unlike any other hernia mesh repair device in the world because of its five distinct layers. It is usually inserted laparoscopically. Two of the device’s layers are made up of a polydioxanone (PDS) film, which is then covered by polyglecaprone-25 film, known as Monocryl. Both films coat a layer of mesh made of polypropylene.

The film was intended to reduce adhesion and prevent inflammation. The makers also claimed the film layers assisted in the mesh’s fixation into the abdomen. Many patients, however, claim the film layers interfere with proper incorporation of the mesh and encourage infection as well as other complications.