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Physiomesh Hernia Repair Mesh Lawsuits May Focus On The Government's Lack of Supervision

The FDA fast track approval process allows a medical device like hernia repair mesh to enter the market if it is similar to another failed device

Wednesday, March 31, 2021 - Hernia mesh lawsuits brought by plaintiffs that allege they have been injured by the malfunctioning of the Ethicon Physiomesh, Proceed and Prolene hernia repair mesh are being organized in multi-district litigation (MDL) in New Jersey and the Northern District of Georgia. New Jersey is the home state of Johnson & Johnson, the parent company of Ethicon, and the state's biggest employer. The first bellwether trial will begin in June.

The Physiomesh hernia repair mesh is made of several different materials. One of the materials is natural tissue designed to become absorbed into the spot above the hernia. The other, made from polypropylene plastic, is intended to give the area strength while maintaining flexibility. Polypropylene is an incredible plastic used in plastic resealable sandwich bags and microwavable plastic containers. Johnson & Johnson describes the Proceed product as "Designed to reinforce hernia repairs and other fascial deficiencies. Nonabsorbable Prolene Soft Polypropylene Mesh provides strength and allows for tissue ingrowth." In theory, polypropylene is the perfect material that will produce the desired outcome from hernia repair surgery. Johnson & Johnson may have overlooked scientific studies pointing to polypropylene as being incompatible with human tissue. This incompatibility causes an overreaction by the immune system to void the body of the foreign intruder. As this happens, the mesh weakens, and pieces can break free and migrate to other parts of the body, leaving the patient in chronic pain and making it difficult to locate and surgically retrieve them. Ethicon hernia mesh patients have reported bowel strangulation and lacerations from a piece of detached hernia repair mesh.

In 2016, Johnson & Johnson voluntarily recalled Physiomesh due to reports of product failure that resulted in the patient requiring revision surgery. The device was approved by the Food and Drug Administration (FDA) in March of 2010 under the arcane 510 k fast-track approval process. The 510 process circumvents human testing as long as the manufacturer can prove to a panel of FDA experts that the device is substantially similar to one already on the market. Hernia mesh patients were used as human test subjects, and many have suffered life-threatening injuries so that Johnson & Johnson could rush the product to market and make money. Tens of thousands of defective hernia repair mesh devices have slipped through the FDA's regulatory net and now threaten the lives of patients.

European health officials are calling the use of hernia repair mesh a full-blown public health crisis. Experts estimate that up to a third of the several million hernia mesh patients will require at least one revision surgery. Thousands of people accuse Ethicon and Johnson & Johnson of being negligent for not testing the medical device sufficiently before promoting its use. Physiomesh lawsuit proceedings are moving forward now that Covid-19 restrictions are being lifted.

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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. OnderLaw 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. OnderLaw 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.