Physiomesh received FDA 510(k) clearance in April 2010, and the product was launched in October 2010. The product was voluntarily withdrawn from market in May of 2016. The base layer is polypropylene, a permanent plastic material. This polypropylene mesh layer is coated on both sides with polymeric films that are intended to degrade, but which can remain in the body for a significant period of time. The film can cause inflammation and pain, and can prevent the body from properly incorporating with the mesh. This can result in an inadequate repair and can lead to other injuries to the patient, such as adhesions, infections, hernia recurrence, bowel obstruction, sepsis, and even death. The Physiomesh is intended for implantation with the IPOM technique.
The defective mesh product liability attorneys at Blasingame Burch Garrard & Ashley, P.C., represent men and women injured by the defective hernia mesh Physiomesh Flexible Composite, which was manufactured and sold by Ethicon, Inc., a subsidiary of Johnson and Johnson.