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Over 200 Deaths Due To Faulty Hernia Repair Mesh Have Been Uncovered By An FDA Whistleblower

Hernia repair mesh failures may be many times greater than what has been reported by the FDA

Wednesday, May 15, 2019 - Former FDA IT manager Madris Tomes left her job at the FDA and founded a company that makes it easier to quantify the number of adverse event complaints that have been made to the FDA as a result of the failure of a particular medical device. Her quest to expose the truth began years ago when she discovered over 300 fetal deaths attributable to the Essure birth control device after its maker had claimed merely 3. Ms. Tomes uses software that she developed to search not only the title of an adverse event but also the entire text of the complaint and her algorithm expands the number of relevant search terms applied. Ms, Tomes has uncovered over 25,000 fresh hernia repair mesh complaints as well as 200 deaths as a result of plastic hernia repair mesh devices. Tomes is concerned that hernia mesh complications are not getting the attention they deserve and according to KVUE News Austin, Texas said, "They really need to be looking at what are all the other devices just like this." "According to FDA reports, the most common problems from surgical mesh include infection, mesh adhering to internal organs like the colon or bowel and even sepsis and death" according to KVUE. Ethicon Physiomesh recall due to product failure and people being harmed from the mesh device have been baned world wide and no longer being sold.

According to the National Institute of Health around 90% of groin hernia repair operations are on male patients and only 10% female, however, women that have had a hernia mesh implant surgery suffer as much if not more than men. In addition to the dangerous and defective plastic hernia repair mesh some women have also had pelvic mesh implanted in them for the purpose of preventing a condition called pelvic organ prolapse, a form of urinary incontinence caused primarily due to childbirth. The U.S. Food and Drug Administration recently banned the pelvic mesh device from being sold in the US and some speculate that hernia repair mesh, a "substantially similar" device could be next.

Experts suspect that the fundamental problem with both the pelvic and hernia mesh is the plastic material it is made from. Polypropylene is used for its strength and flexibility and one would think it would be the ideal material to withstand the rigors demanded by the abdominal wall. Polypropylene, however, has been found to be incompatible with human tissue and eventually degrades or outright disintegrates when left within the human body. When polypropylene mesh shrinks and buckles it can pull free from the hernia repair location and migrate to other organs including the bowels. It has been reported that hernia mesh sometimes perforates the bowels releasing feces into the abdominal cavity. One patient is on record reporting that he vomited his own feces as a result of such a perforated bowel.

In addition to the nightmarish pelvic mesh, women are at risk for serious injury and even death from plastic hernia repair mesh devices. FVUE ABC News Austin reported recently that Carmen Pacheco, 50, has had to undergo over additional surgeries due to hernia mesh infections and is struggling for her life as a result of receiving a plastic hernia repair mesh implant. Another woman, 45-year-old Jodie Callahan, had to undergo hernia repair mesh revision surgery after her hernia mesh "eroded" into her bladder and now has to undergo a third operation to remove plastic mesh that had been left behind.

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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.