Johnson & Johnson’s Ethicon division issued a full recall of its Physiomesh Flexible Composite Mesh.
The voluntary withdrawal came after two studies found higher rates of hernia re-opening versus similar products. The product is used in the laparoscopic repair and treatment of ventral hernias. Hernia mesh patches are stitched over the hernia to strengthen abdominal walls so the hernia will not reopen.
Complications with Physiomesh grew quickly and severe leading Ethicon to issue an Urgent Field Safety Notice to hospitals and surgery centers throughout the country advising of the problems with the mesh. See the notice here.
The notice withdrew from the market unused products, and invited surgeons to return products to the manufacturer to avoid further problems. Surgeons were also encouraged not to use Physiomesh when repairing hernia recurrence and were given a list of other Ethicon products available for use.
Ethicon’s voluntary withdrawal applies to the following Ethicon products:
1) Laparoscopic Hernia Pack
ELH5 PHY1515Q
2) Laparoscopic Hernia Pack
ELH10 PHY1515Q
3) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY0715R
Rectangle 7.5cm x 15cm
4) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY1015V
Oval 10cm x 15cm
5) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY1515Q
Square 15cm x 15cm
6) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY1520R
Rectangle 15cm x 20cm
7) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY1520V
Oval 15cm x 20 cm
8) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY2025V
Oval 20cm x 25cm
9) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY2030R
Rectangle 20cm x 30cm
10) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY2535V
Oval 25cm x 35cm
11) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY3035R
Rectangle 30cm x 35cm
12) ETHICON PHYSIOMESH
Flexible Composite Mesh
PHY3050R
Rectangle 30cm x 50cm
