Ethicon recalled its Physiomesh Flexible Composite Mesh from the global market in May 2016 after registry data showed higher rates of hernia recurrence and reoperation. The lawsuits that followed were resolved through settlements announced in 2021 and 2023. This page covers the history of Physiomesh, its recall and the litigation that followed.
What Is Physiomesh?
Physiomesh Flexible Composite Mesh is a hernia mesh made by Ethicon, Inc., a Johnson & Johnson company, for laparoscopic hernia repair. It is a lightweight polypropylene mesh laminated between layers of absorbable film, so that the coating covers both sides of the mesh rather than one. The coating was meant to keep the bowel and other organs from sticking to the polypropylene. Like most hernia mesh, Physiomesh reached the market through the FDA’s 510(k) process, which does not require clinical trials.
Ethicon also sold a separate product, Physiomesh Open Flexible Composite Mesh, for open surgery. The recall and the lawsuits involved only the laparoscopic Physiomesh.
The 2016 Physiomesh Recall
On May 25, 2016, Ethicon sent hospitals an urgent field safety notice announcing a voluntary recall of all Physiomesh Flexible Composite Mesh. The notice said unpublished data from two large hernia registries, the Herniamed German Registry and the Danish Hernia Database, showed that recurrence and reoperation rates after laparoscopic ventral hernia repair with Physiomesh were higher than the average for comparable meshes. Ethicon said the cause was likely multifactorial and that it could not give surgeons instructions that might reduce the rates, so it removed the product from the global market. See our page on hernia mesh recalls for other recalls.
Reported Complications
People who received Physiomesh reported complications including:
- Hernia recurrence
- Hernias through or around the mesh
- Mesh deformation and failure
- Adhesions and bowel obstruction
- Infection
- Revision surgery to remove the mesh
For more on these injuries, see our page on hernia mesh complications.
The Physiomesh Lawsuits
The lawsuits alleged that the multi-layer coating kept the mesh from properly incorporating into the abdominal wall and that the lightweight polypropylene could not withstand normal abdominal forces, leading to recurrence, rupture and deformation of the mesh. In June 2017, federal Physiomesh lawsuits were consolidated in MDL No. 2782 in the U.S. District Court for the Northern District of Georgia before Judge Richard W. Story. In July 2018, the New Jersey Supreme Court designated New Jersey Physiomesh cases as multicounty litigation in Atlantic County.
In September 2021, Ethicon agreed to a settlement covering more than 3,700 Physiomesh cases in the federal MDL and the New Jersey litigation. A second settlement in May 2023 covered 292 claimants who had been left out of the first, and in December 2023 the court dismissed more than 200 remaining MDL cases. The settlement amounts were confidential.
Hernia Mesh Lawsuits Today
Since the Physiomesh and Atrium C-Qur settlements, hernia mesh litigation has centered on two other manufacturers. Claims over Covidien Parietex, ProGrip and Symbotex mesh are still being filed, and the first Covidien bellwether trial ended in an $88 million verdict in August 2026. Bard settled most of its hernia mesh lawsuits in 2024, but its MDL remains open, and people with severe injuries from Bard mesh such as the Ventralex can still seek compensation there. For more history, see our page on hernia mesh recalls.
Common Questions
Was Physiomesh recalled?
Yes. In May 2016, Ethicon voluntarily recalled Physiomesh Flexible Composite Mesh and removed it from the global market after registry data showed higher recurrence and reoperation rates after laparoscopic ventral hernia repair.
Did the Physiomesh lawsuits settle?
Yes. Ethicon agreed in September 2021 to settle more than 3,700 Physiomesh cases in the federal MDL and New Jersey state court, and a second settlement in 2023 resolved most of the remaining claims. The amounts were not made public.
Who makes Physiomesh?
Physiomesh was made by Ethicon, Inc., a Johnson & Johnson company. Ethicon also makes Proceed mesh, which was recalled several times for delamination.
Was Physiomesh Open part of the recall?
No. The 2016 recall covered only the laparoscopic Physiomesh Flexible Composite Mesh, not the Physiomesh Open Flexible Composite Mesh used in open surgery.
Why was Physiomesh taken off the market?
Ethicon said data from German and Danish hernia registries showed higher recurrence and reoperation rates than comparable meshes, and that it could not identify instructions for surgeons that would reduce those rates.