Beasley Allen has warned about the adverse side effects of Physiomesh, which is manufactured by Johnson & Johnson’s subsidiary Ethicon. Earlier this year, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated, at that time, nearly 70 lawsuits over reported adverse side effects of Physiomesh in a multidistrict litigation (MDL) in the Northern District of Georgia located in Atlanta. The JPML confirmed that as of November the MDL has grown to 318 lawsuits.
Physiomesh is used to repair areas of weak muscle, called hernias, in the abdomen. It is attached to and reinforces the abdominal wall to keep the hernia from reopening. However, Physiomesh is made of polypropylene, which is a flexible plastic product known to erode once implanted. The deteriorating mesh separates from the abdominal wall and travels through the body allowing mesh fragments to potentially perforate or puncture organs and cause chronic pain, infections and even death.
In April 2010, the Food and Drug Administration (FDA) approved Physiomesh through its fast-track 510(k) process. The device bypassed rigorous medical testing because of its similarities to a product already on the market – Ethicon’s Proceed transvaginal mesh. Proceed transvaginal mesh was also fast-tracked to market. Because both devices were fast-tracked to market, scientists did not have the opportunity to observe the adverse side effects prior to mass production and marketing.
In fact, Ethicon issued a Field Safety Notice in May 2016 and quietly withdrew Physiomesh from markets in the U.S., Europe and Australia. The Notice warned that Physiomesh seemed to have higher rates of hernia recurrence and re-opening in patients using the device as compared to patients using similar devices. However, neither Ethicon nor Johnson & Johnson officially recalled Physiomesh. Approximately 330,000 Physiomesh hernia repair kits were sold worldwide. Half of them were likely sold in the U.S.
U.S. Judicial Panel on Multidistrict Litigation