The Ethicon Physiomesh Mesh places patients at higher risk of revision surgeries and hernia recurrence, according to an analysis of the hernia repair product. As a result, Johnson & Johnson’s subsidiary Ethicon Inc. voluntarily withdrew it’s Physiomesh in May 2016. The devices can cause complications including infection, organ perforation, chronic nerve damage, and chronic pain.
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Physiomesh is a large pore, flexible composite mesh made of non-absorbable polypropylene and used in minimally invasive ventral hernia repair and other fascial deficiencies. A hernia occurs when an organ, intestine or fatty tissue squeezes through a hole or a weak spot in the surrounding muscle or connective tissue. A ventral hernia is a bulge through an opening within the abdominal wall muscles. Synthetic mesh in hernia repair is preferred over using sutures because it reduces the risk of infection and pain, and provides quicker recovery time.
The action affects the Ethicon Physiomesh Composite Mesh product line. The product codes affected include PHY0715R, PHY1015V, PHY1515Q, PHY1520R, PHY1520V, PHY2025V, PHY2030R, PHY2535V, PHY3035R, and PHY3050R.
The withdrawal does not affect the Ethicon Physiomesh Open Flexible Composite Mesh device or other Ethicon mesh products.
Surgical mesh is a type of medical product that supports damaged or weak tissue. Unfortunately, defective surgical mesh can lead to serious, even devastating, medical complications. These include:
Patients and surgeons have been complaining about the complications and the need for re-do surgery when the abdominal or inguinal hernia recurred.
The Physiomesh device was a big hit for Johnson & Johnson. Before the Physiomesh recall, Ethicon developed the Physiomesh Open. Ethicon submitted a 510(k) application for the Physiomesh Open in June, 2014, and received clearance in October, 2014.
Ethicon gave the Physiomesh Open about half a year to gain market traction before they finally decided to “voluntarily withdraw” the regular Physiomesh from the market.
Several Physiomesh lawsuits have been filed against Ethicon and Johnson & Johnson, with the first one slated to go to trial in January 2018. Ethicon has been battling lawsuits for years against its transvaginal mesh products, which are also made from polypropylene.
According to the lawsuits, the Physiomesh products were defectively designed and manufactured, using plastic materials that react to human tissues, causes infections and can migrate to other parts of the body. The lawsuits also indicates that the plastic mesh can cut tissues and fails to actually perform as intended leading to recurrence of the hernias.