In June 2017, 18 lawsuits alleging serious injuries from Ethicon’s Physiomesh used for hernia repair were consolidated into a multidistrict litigation in the Northern District of Georgia in Atlanta. Since then through mid-August, the number has grown to 92, and the MDL is expected to continue to grow as more people learn about the serious risks of Physiomesh.
Johnson & Johnson’s subsidiary Ethicon Inc. obtained Food and Drug Administration (FDA) approval for its Physiomesh Flexible Composite Mesh in April 2010. Since then, the agency has received hundreds of adverse event reports. Reported complications include hernia recurrence, mesh migration, fistulas, mesh shrinkage, mesh bunching, inflammatory response, and the need for surgery to remove the mesh and, in some cases, surrounded tissue damaged by the device. Many of the injuries allegedly linked to Ethicon’s hernia mesh are permanent and in some cases fatal.
In May 2016, Ethicon quietly issued an urgent Field Safety Notice announcing that it had initiated a removal of the Ethicon Physiomesh Flexible Composite Mesh in Europe and Australia. In the U.S., Ethicon issued a market withdrawal, but the FDA did not warn patients who had received the devices about the potential risks.
At the time, Ethicon revealed that its decision to remove the hernia mesh from the market was based on an analysis of unpublished data from German and Danish hernia registries that showed higher recurrences and reoperation rates in patients who had been treated with Ethicon’s product compared to similar mesh products.
Physiomesh is made from polypropylene, the same material as transvaginal mesh, a device used to treat urinary incontinence and pelvic organ prolapse. Polypropylene is a flexible plastic product that is known to erode once implanted into the body. Yet, Ethicon fast-tracked both mesh products onto the market without adequately testing the devices to determine its risks, lawsuits allege.
In January 2016, Ethicon settled about 3,000 lawsuits related to problems with its polypropylene transvaginal mesh as part of an MDL, with approximately a thousand more claims pending.
Approximately 330,000 Physiomesh hernia repair kits were sold worldwide, nearly half of which are believed to have been sold in the U.S.
Beasley Allen Law Firm
Johnson & Johnson Medical