Ethicon, a division of Johnson & Johnson Company, released an urgent safety notice of Ethicon Physiomesh Recall on 25th May 2016, alerting all the physicians, hospitals and medical centers to stop using their ‘Physiomesh’ a product used for hernia treatment.
This product was recalled from the market because in an analysis it was found that the reoperation and recurrence rates after hernia repair surgery involving Physiomesh were higher than the average rates of the other set of meshes among the patients.
Also, several people who have been suffering from complications after using an Ethicon Physiomesh filed lawsuits against the manufacturer, claiming that their product led to several health issues such as prolonged pain, infection and the need for correction surgery.
The complainants claim that Ethicon took a long time in pulling back their supposedly defective device off the market; they should have done it several years ago when the first case came into existence. In its place, they continued to make money out of it, leaving the life of the patients in danger.
What is the Ethicon Physiomesh?
The Ethicon Physiomesh was approved by FDA on 9th April 2010. No clinical trials were performed by the company on the device to prove its effectiveness and safety. The Physiomesh is a kind of net made up of polypropylene materials and is intended to be used for the repair of hernias.
This device was used by the surgeons to strengthen the weak and stretched muscles and tissues around a hernia bulge. It was made of a material that is supposed to help lessen the risk of swelling and aid fast recovery.
Why Ethicon recalled the Physiomesh?
The main reason behind the hernia mesh recall was the increasing rate of revision surgeries. The higher rate of revision surgeries means more number of Ethicon Physiomesh lawsuits. However, there were no clear statements given as to why this mesh did not perform well.