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Ethicon Physiomesh Hernia Mesh Problems and Consumer Complaints

Physiomesh Composite Hernia Mesh Complaints Can Be Viewed on the FDA's MAUDE Database

Thursday, October 25, 2018 - Physiomesh composite hernia repair mesh was voluntarily withdrawn from the market worldwide by it maker Ethicon when the company became aware of the numerous reports of the device failing. A failed Physiomesh requires a second procedure called a revision surgery to first locate the 6 by 8-inch mesh device that may have disintegrated into pieces, remove all or as much as possible of the device, and then re-repair a hernia. The following are a few samples of such complaints registered with the FDA in its MAUDE adverse events database.

One event in 2010 was registered with MAUDE alleging tears, rips, and holes in Physiomesh observed when the device was removed from the patient. "It was reported that a patient underwent a primary incisional anterior abdominal wall hernia repair procedure in 2010 and mesh was placed using intraperitoneal onlay mesh technique. The patient developed severe pain with a visible recurrence and bulging, requiring a second laparoscopic procedure. The surgeon discovered that the mesh came loose partially. The mesh was frayed especially where the tackers were placed. Minimal adhesion was removed and the mesh was removed."

Physiomesh has been known to break free from the original area where it was intended to support and cause bowel obstruction. Such a Physiomesh hernia repair complaint was registered in February of 2012, this time complaining of severe abdominal pain after laparoscopic hernia repair surgery using Physiomesh, "The patient returned one week postoperatively presenting with vomiting, constipation, abdominal distention, and abdominal pain. ... underwent a ct scan which showed a transition point. The patient then had a laparoscopy which determined that there was no bowel obstruction but the small bowel was grossly swollen and dilated. There did not appear to be any mechanical obstruction. ... swelling seemed to be indicative of some sort of irritation/reaction."

It has been suggested that the polypropylene component of Physiomesh is responsible for the device's malfunctioning. The National Institute of Health has cited scientific studies that have found that polypropylene is not "organically compatible with human tissue" and will tend to degrade faster than other materials. Surgeons performing Physiomesh removal surgery are required by law to preserve the mesh specimens and to send them to a medical device holding facility in Florida to potentially be used as evidence. Hundreds of Physiomesh patient have chosen to file a claim against Ethicon and its parent company Johnson & Johnson for monetary compensation.

Plaintiffs seek to hold the company responsible for rushing a faulty medical device to market without sufficient pre-market human testing. Physiomesh was rushed to market under the now debunked FDA fast-track 501 (k) process. The fast-track program was intended to allow a small percentage of new medical devices to bypass the delays of premarket human testing if it could be proven that the device was nearly identical to another one already having been approved. That process has been abused and now upwards of 98% of new medical devices are merely compared to others for approval. There is no requirement that the target medical device is still on the market, nor that has not been the subject of complaints and litigation. Ethicon Physiomesh problems and side effects reported from consumers affected by the Physiomesh composite hernia mesh have filed complaints with the FDA.

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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.