Defective Ethicon Physiomesh® Hernia Mesh Attorneys
Johnson & Johnson's subsidiary, Ethicon, withdrew Physiomesh® from the market in May 2016, due to unacceptably high rates of hernia recurrence and re-operation. When mesh fails and requires further surgery, a patient may experience significant pain, systemic infection, scarring and extended hospital stays. Through an "Urgent Field Notice," Ethicon has advised health care centers around the world to return unused defective mesh devices back to Ethicon and to terminate all future use of the mesh. The "Composite" version is the mesh subject to withdrawal (not the "Open" version).
If you have had an Ethicon mesh installed, call (888) 260-0473 to find out if you have grounds for legal action.
Problems Associated with Ethicon Physiomesh® Composite Mesh
Ethicon (subsidiary of Johnson & Johnson) stated in their Field Safety Notice that two European hernia registries found the following two complications "were higher than the average rates of the comparator set of meshes." These were:
- Recurrence of the hernias for patients implanted with Physiomesh®
- Reoperation rates for patients with Physiomesh®
Ethicon's Safety Notice stated potential reasons for this, although they have "not been able to fully characterize these factors." The available failure data showed the potential for:
- Product characteristics causing complications
- Operative factors
- Patient factors
Why Are There High Failure Rates with the Mesh?
This was one of the first mesh products used for laparoscopic hernia repair in the ventral area (stomach cavity). Physiomesh® was coated with polydioxanone (PDO) on both sides to facilitate the bonding of two poliglecaprone-25 layers. Some believe that these chemicals affected the ability of the mesh to properly adhere to tissue. In some cases the hernia came back, while in others the mesh came completely loose.
This mesh was approved in 2010 by the FDA under its "510k" process, which means the mesh was approved for the medical world without any human testing. This approval method is based on the fact that there is a predecessor product, but this earlier model mesh was once recalled by the FDA as well.
So What Went Wrong?
A recent study done by the Journal of the Society of American Gastrointestinal and Endoscopic Surgeons (March 2016) compared Physiomesh® to other mesh for laparoscopic ventral hernia. Physiomesh® came up short in several areas. The study was not completed due to safety reasons, but conclusions were still made with the remaining patients who underwent the procedure and study. It was found that Physiomesh® had a 20% increase in failure rates, as well as a greater rate of pain and hernia recurrence compared to another version of mesh. The study concluded that Physiomesh's® higher failure rate might be related to its lower level of elasticity. This hinders the mesh from being fully incorporated into the abdominal walls.
The Physiomesh® is composed of a permanent polypropylene fiber with polydioxanone (PDO) on both sides to facilitate bonding of two absorbable barrier layers, which can also be another reason for its downfall. The two absorbable barrier layers on both sides can hinder proper tissue growth and proper adhesion of the mesh.