Mesh Medical Device News Desk, October 25, 2016 ~ The first lawsuits have been scheduled for the Ethicon Physiomesh, a hernia mesh used for repairs. The hernia mesh has been removed from the global market after reports it degraded inside patients and did not function as intended.
Medical professionals had until September 16, 2016 to return unused Physiomesh, hernia mesh, for a full refund after the product was recalled by its manufacturer, Ethicon, a division of Johnson & Johnson. Ethicon issued a recall of Physiomesh last May after studies showed it failed when used in hernia surgeries when compared to other similar hernia meshes.
The mesh was used in laparoscopoic and ventral and inguinal hernia repair surgeries.
The voluntary recall was conducted by Ethicon, the U.S. Food and Drug Administration and its European counterparts.
Two unpublished studies, one in the Danish Medical Registry and the other in the German Medical Registry, suggested its failure rate for laparoscopic ventral hernia surgeries were higher than the other meshes used on patients in these registries.
“The recurrence/reoperation rates (retrospectively after laparoscopic ventral hernia repair using Ethicon Physiomesh compositve Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.”
Physiomesh is made of polypropylene but the studies found it broke down in its structure which can allow the hernia to recur or cause bacterial infections and swelling at the surgery site, requiring another surgery. Ethicon suggests surgeons replace it with Proceed surgical mesh, Prolene, Prolene Soft, or Ultrapro mesh, all made by Ethicon.
Physiomesh was marketed after clearance under the FDA's 510(k) process in April 2010, which does not require clinical trials for safety and efficacy.
Physiomesh is made of a flexibile composite mesh “composed of nonabsorbable, macroporous polypropylene mesh laminated between two undyed polyglecaprone-25 films. An undyed polydioxanone film provides the bond between the polyglecaprone-25 film and polypropylene mesh.”
Ethicon developed Physiomesh Open the latest version of the type of mesh and it was introduced in 2014. Both meshes were marketed following the fast tracked 510(k) approval process by the FDA. Physiomesh Open is not involved in this recall.
On its website Ethicon claims “ Physiomesh Open is built on the proven technology of the #1 selling tissue-separating mesh Open Flexible Composite Mesh, and optimized for open ventral hernia repair.”
A number of lawsuits have already been filed. Matthew Huff was implanted with Physiomesh in 2013 to repair a ventral hernia. In July 2015, he developed severe abdominal pain, ever, chills, nausea and redness. He was treated for an infection and two abscesses and an intestinal fistula. His case is set for January 22, 2018 in the Southern District of Illinois. Case No. 3:16-cv-00368.
Another product liability lawsuit was filed in the U.S. District Court Middle District of Florida September 22nd claims the mesh is defective and caused her persistent abdominal pain, diminished bowel motility and bowel obstruction.
Here is an adverse event report submitted to the FDA that says the mesh pulled away from he abdominal wall resulting in a second surgery.
In June 2012, Ethicon removed four transvaginal meshes from the market- Prolift, ProliftM+, TVT Secur and Prosima Pelvic Floor Repair System. The company said the removal was for business reasons. ###