The Jere Beasley Report recently described mounting claims against another Johnson & Johnson mesh product. The pharmaceutical giant and its subsidiary, Ethicon, are facing approximately 18 claims against Physiomesh – Ethicon’s hernia mesh – and those claims are expected to grow. In fact, Drugwatch.com, reported that, in March, plaintiffs asked the Judicial Panel on Multidistrict Litigation (JPML) to consolidate the claims into a multidistrict litigation (MDL) docket in the Middle District of Florida in anticipation of future filings.
Physiomesh is used to repair hernias, or areas of weak muscle, in the abdomen. The mesh is attached to the abdominal wall to reinforce the wall and prevent the hernia from re-opening.
Ethicon’s Physiomesh and its problematic transvaginal mesh are both made of polypropylene – a flexible plastic product known to erode once implanted. As the structure deteriorates inside the body, layers of the mesh separate, leaving the polypropylene exposed. As the mesh fragments travel through the body they can perforate or puncture organs, causing chronic pain, infections and even death.
In April 2010, the U.S. Food and Drug Administration (FDA) approved Physiomesh through the 510(k) process. Through this process, medical devices can bypass more rigorous medical review if the device is substantially similar to one that has already been approved. The companies relied on Ethicon’s Proceed mesh to fast-track the hernia mesh to market. Proceed surgical mesh was also fast-tracked, so neither mesh product was safety-tested in humans prior to entering the market.
Ethicon has not officially recalled Physiomesh; yet, last May it quietly withdrew the product from markets in the U.S., Europe and Australia. The withdrawal came on the heels of two studies that revealed higher rates of hernia recurrence and re-operation in patients who were implanted with Physiomesh when compared to other similar devices.
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If you or a loved one has received hernia treatment that included Physiomesh and have experienced complications, contact Melissa Prickett.
Jere Beasley Report (2017, January), Ethicon Physiomesh Flexible Composite Mesh, page 17.