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Ethicon Physiomesh Lawsuit News

Ethicon Takes Physiomesh Taken Off The Market ... Permanently

Rather than test, repair and relaunch Physiomesh, Ethicon has chosen to permanently pull the product

Tuesday, June 5, 2018 - Close to one half of a million hernia patients have been treated with the Physiomesh hernia repair device using minimally invasive laparoscopic surgery. During such surgery, a small incision of about one half a centimeter is made and the surgical equipment and camera inserted. The Physiomesh is placed over the spot of a hernia much where is hoped it will stay in place and intact. The device has not always worked as the company intended and is no longer available. A high number of revision surgeries required to fix the malfunctioning Ethicon Physiomesh has prompted the company to take the hernia repair device off of the market globally.

As a result of the need for a second surgery, patients are hiring Physiomesh attorneys and suing Johnson & Johnson claiming that Physiomesh was rushed to market using a substandard material. Physiomesh is made from Polypropylene a type of plastic whose original purpose was for product packaging and not to be inserted into the human body as a medical device. While the Food and Drug Administration requires the vast majority of medical devices to undergo strict human testing, Ethicon skirted the FDA requirements by showing the FDA that Physiomesh was substantially similar to other hernia repair mesh products already on the market. One particular change, however, to the material that makes up the hernia repair device went undetected by the FDA and may be the cause of Physiomesh's failure.

Polypropylene plastic is woven throughout the Physiomesh screen mesh material in order to give the product added strength and also to encourage irritation and the build-up of scar tissue to partially absorb the device at the intended spot over a patient's hernia. In an unacceptably high number of incidents, however, the polypropylene plastic material is rejected by the human body and the device is free to migrate within the abdominal cavity. Patients complain of sharp, searing pain in the area of the bowels and small intestines. Surgeons often find Physiomesh has migrated from an original hernia and perforated these organs. In other patients, the polypropylene is attacked by the body's natural defense mechanism causing the device to weaken, crumple, and buckle allowing for an original hernia to break through. Other times Physiomesh disintegrates into pieces making it hard to locate and its complete removal from multiple spots in the body challenge. Patients have had to have repairs to multiple organs and multiple parts of their intestines. Others have had to have parts of their intestines removed because of damage caused by Physiomesh. Even when Physiomesh remains attached to the herniated organ it can become so encased in scar tissue that its removal is next to impossible without removing the underlying organ itself. Physiomesh patients that do not act immediately to have the device removed may face the loss of a substantial part of their intestines as a result.

Rather than exacerbate an already terrible situation, Ethicon, a company with a history of medical device failures, voluntarily withdrew the device from the global market via an "Urgent Field Safety Notice" sent to all of the appropriate medical personnel, citing a need to further study the device. The company did not admit that there was a specific problem. Years earlier Ethicon was sued by thousands of women after Ethicon's transvaginal mesh device used to female incontinence was the subject of a mandatory FDA recall.

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Lawyers for Ethicon Physiomesh Lawsuits

OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. The Onder Law Firm has won more than $300 million in four talcum powder ovarian cancer lawsuits in St. Louis. Law firms throughout the nation often seek its experience and expertise on complex litigation.