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Ethicon Physiomesh Lawsuit News

Doctors Trusted the FDA to the Detriment of Physiomesh Patients

Doctors are obligated to administer an unwritten code of ethics when evaluating a patient and then recommending a course of action

Tuesday, October 16, 2018 - Today, financial pressure and the economics of modern medicine can cause a physician to cut corners. Drug and medical device sales representatives make their living convincing doctors to maximize the use their drugs or devices. Medical device sales reps have been known to accompany a doctor right up to the operating room trying to sell them a new medical device that they are sure a surgeon needs. A surgeon may make the mistake of blindly trusting Ethicon sales reps to honestly represent their medical device in spite of having the desire to do the right thing.

Ethicon Physiomesh Composite hernia repair device was implanted by thousands of doctors into hundreds of thousands of patients without regard for whether or not the product was safe. Doctors, in general, made the false assumption that if the medical device passed FDA scrutiny that it must be safe to use. That falsehood coupled with the constant pressure from Ethicon sales reps that ignored the device's potential for adverse side effects. It has just recently come to light that the FDA has dropped the ball when it comes to investigating the safety of a newly invented medical device and hernia patients are suffering.

The Ethicon Physiomesh was rushed to market using the FDA's fast-track 501 (k) process that allows a medical device to go directly on sale if it can be proven that the device is "substantially similar" to another medical device already on the market. The fuzzy logic behind this approach is that there is no guarantee that the device that the new one is being compared to was not itself fast-tracked. Many medical devices are in an approval chain with others that have failed and been recalled. Such was obviously the case with the failed Physiomesh. Experts speculate that Physiomesh may have been linked to Johnson & Johnson's other failed mesh, the transvaginal mesh. The transvaginal mesh has been known to fail and leave women permanently incontinent. Physiomesh was taken off of the market in 2016 in response to a high number of people requiring revision surgery to remove the device and repair an original hernia. Physiomesh has been shown to degrade, buckle, shrink and pull free from above a hernia that it was intended to support. When Physiomesh breaks up or breaks free it can travel to the lower abdomen and cause dangerous blockages to the lower intestines.

People having revision surgery for Physiomesh are now required to save the extracted mesh device as physical evidence and to send the specimen to a medical waste handling facility in Florida. Patients that choose to hire a Physiomesh attorney and to file a claim against Johnson & Johnson can then recall the degraded specimen as evidence of the device's failure. It can be reasonably assumed that Johnson & Johnson knew in advance that the Polypropylene component of Physiomesh was not organically compatible to be used in the human body based on studies cited by the National Institute of Health.

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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.