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Ethicon Physiomesh Lawsuit News

Patients Can Report Their Medical Device Problems to an FDA Online Database For Everyone to See

Ethicon Physiomesh patient reports to the MAUDE database may have forced Ethicon to voluntarily withdraw the medical device from the market and saved lives

Thursday, September 20, 2018 - Thousands of adverse event reports had been pouring into the US Food and Drug Administration MAUDE Adverse Events database claiming that the Ethicon Physiomesh Flexible Composite mesh was failing and requiring patients to undergo revision surgery. Physiomesh patients experienced the excruciating pain of the device shrinking, buckling and pulling away from the spot atop of a hernia it was intended to support allowing the hernia to re-rupture. In addition, Physiomesh Flexible Composite failure causes the device to migrate to other parts of the internal body cavity where gravity takes it down to the intestines that can be punctured and/or blocked.

One particular and typical report to the FDA database describes the issue as follows: "It was reported that a patient underwent a laparoscopic from hernia repair procedure on an unknown date and mesh was used. Approximately four to six weeks post-operative, the patient complained of pain. Approximately six months after the initial procedure, the patient underwent a reoperation. It was noted that the mesh did not have complete ingrowth. Also, the bowel adhered between the mesh and abdominal wall."

Another adverse event report complained that the patient immediately rejected the device and experienced excruciating pain. "... Twenty days postoperatively, the patient experienced severe inflammation due to the foreign body mesh and developed a recurrent incisional hernia. During (revision surgery) adhesions were found and the mesh was covered with a thick and whitish rind, which could be the pneumoperitoneum, with white bubbles, also present on the colon, as further evidence of excessive inflammatory reaction developed by the patient. The mesh was completely and easily removed because it was not integrated at all."

Yet another Physiomesh failure was reported by a patient suffering from the device crumpling after being attacked by the body's natural immune response, pulling free and causing the hernia to re-rupture. "...patient underwent hernia repair procedure on an unknown date and mesh was used. The patient experienced a recurrent hernia. The reoperation took place in 2012. During the procedure, it was noted that the mesh was found pushed together approximately one centimeter away from the hernial orifice."

Medical device companies are in business to make money, no question about that. So why would a company voluntarily take the industry's leading hernia repair medical device off of the market and sacrifice the millions, maybe billions of dollars in profits that the device stood to make them? The only logical explanation is that the Ethicon and its parent company Johnson & Johnson knows that something is terribly wrong with the product and that they stand to lose money by continuing to sell it. Ethicon signaled something must be wrong with Physiomesh in May of 2016 when the company issued an urgent notice to physicians demanding that they cease using the device and immediately return any unused products. Ethicon Physiomesh Lawsuits for hernia mesh problems continue to be filed due to thousands of women reporting problems after surgery.

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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.