Ethicon Inc., a subsidiary of Johnson & Johnson, stopped selling all Physiomesh™ Flexible Composite Hernia Mesh worldwide after a large study discovered a possible safety risk for patients.
Ethicon recalled Physiomesh in Europe and Australia, but the same action was called a “market withdrawal” in the U.S., which is why the FDA did not make any announcements to warn patients.
According to an Urgent Field Safety Notice to surgeons on May 25, Ethicon recalled Physiomesh after analyzing unpublished data from two large independent hernia registries in Germany and Denmark.
The studies showed Physiomesh had higher rates of hernias returning and needing another surgery (called “recurrence and re-operation”) compared to similar types of hernia mesh for laparoscopic ventral hernia repairs.
Ethicon blamed the complications on multiple factors, including possible “product characteristics, operative and patient factors,” but decided to remove it from the market rather than fix the issues.
Ethicon said the “voluntary recall has been communicated to the U.S. Food and Drug Administration (FDA).” The FDA classified the action as a market withdrawal rather than a recall.
On June 9, the Australian Therapeutic Goods Administration (TGA) announced a recall for Physiomesh and asked surgeons to return all unused stock of the devices.
Before the recall, Physiomesh lawsuits accused Ethicon of selling a defective hernia mesh implant. The first case is set for trial on January 22, 2018 in Illinois — Case No. 3:16-cv-0036.
Hernia patients who were implanted with Physiomesh should continue to follow-up with their doctors as usual. The symptoms of a failed surgery may include the following injuries:
- Dense adhesions
- No ingrowth
- Bowel obstruction
- Hernia recurrence