No-Cost, No-Obligation Ethicon Physiomesh Attorney Case Review

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Ethicon Physiomesh Lawsuit News

Market Withdrawal or Compulsory Recall

The difference between a company voluntary market withdrawal and a total government recall is a matter of semantics

Saturday, May 5, 2018 - A market withdrawal of the Physiomesh Composite Hernia Repair Mesh recently occurred in the United States. The product was taken off of the market by its maker Ethicon, in response to an official "Urgent Field Safety Notice" issued by Switzerland's Health Agency and sent to all supervisory medical management personnel in the country. The agency immediately notified the US Food and Drug Administration and the European Competent Advisors. The field safety notice was in response to the abnormally high percentage of Physiomesh patients that filed adverse event reports with the Swiss agency, complaining that they were in so much pain following hernia surgery that they needed a second, revisionary surgery to repair or remove the mesh. Patients affected had Physiomesh implanted during laparoscopic ventral hernia surgery. The Field Safety notice was sent on May 25, 2016.

Unlike a product recall, a market withdrawal is voluntary on the part of the manufacturer and fewer medical personnel are required to be notified. A market withdrawal usually occurs for preventative reasons when a company is alerted that there might be a problem. When a medical device is officially recalled, it is due to a direct initiative from either the company or the FDA. There are several classes of recalls. Class one recalls are reserved when there is a reasonable probability that the product can cause serious injury or death. Class two recalls are made when there is a possibility that a product will cause adverse health consequences. Class three recalls state that a product is not likely to cause serious health consequences.

The medical community in the US was not officially alerted that Physiomesh was being taken, nor of the findings of the Swiss Health Agency. Doctors continued to use the hernia repair product. The designation of "market withdrawal" is no less important than a compulsory total recall if you are one of the victims experiencing complications from Physiomesh and have required revision surgery. Physiomesh's maker, Ethicon, is a subsidiary of Johnson & Johnson, a company with a checkered history of putting profits ahead of consumer safety. In fact, the Ethicon Physiomesh Composite Hernia Mesh was rushed to market, circumventing the usual stringent testing required by the FDA using the FDA's 501 clause which allows medical devices that are substantially similar to others already approved to be "fast-tracked" and offered to the public.

To date, more than 300,000 people are experiencing complications, pain or even death from the malfunctioning Physiomesh hernia repair mesh and revision surgery to remove the device and properly repair their hernia using traditional methods in an attempt to alleviate their pain. Abscesses, infections, swelling, redness and severe pain are some of the symptoms reported to the Swiss agency who in turn found that the Polypropylene coating used on Physiomesh may be responsible. The polypropylene used in Physiomesh is a flexible, non-absorbable laminated filament. Many patients are filing Physiomesh lawsuits to recover medical costs, lost wages and all other monetary damages they have suffered.

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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.