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

Ethicon Physiomesh Attorney
Ethicon Physiomesh Lawsuit News

The Ethicon Physiomesh Pulled From The Market

Due to high failure rates requiring revision surgery, Ethicon has been forced to voluntarily recall the Physiomesh hernia repair device

Tuesday, April 3, 2018 - Patients using the Ethicon Physiomesh have reported health problems that include unnatural warmth, swelling, and redness at the hernia location, severe abdominal pain, infections, perforated organs, intestinal blockage, tissue damage, internal bleeding, and stomach ulcers so severe that revision surgery was necessary to remove the device. The hernia mesh is made from polypropylene and plastic in between layers of poliglecaprone. The materials were thought of as being inert, however, in many instances, the mesh triggers the body's natural immune response to reject the foreign object from the body. Plaintiffs suing Johnson & Johnson alleged that the device has migrated away from the site of implantation or has become encased in scar tissue causing abscesses and infections. Several scientific studies have come to the conclusion that the device is more likely to cause these problems than other similar products.

In April of 2010, the U.S. Food and Drug Administration approved the Ethicon Physiomesh device using 510(k) "fast-track" approval method, Ethicon having proven that the product was substantially similar to others already fully approved and currently on the market. The hernia mesh is used by doctors to reinforce bulging abdominal weak spots called hernias much like patching a small hole in a screen door. Those suing Ethicon allege that the company failed to adequately test the device before bringing it to market.

In May of 2016, an urgent field safety notice was issued by The Health Agency of Switzerland issued to all operating room supervisors, medical materials management personnel, and all chiefs of surgery in the country and the US Food and Drug Administration and the European Competent Advisors alerting physicians that the Ethicon Physiomesh Composite Mesh can cause around 250% as many revision surgeries to have to be performed in patients undergoing laparoscopic ventral hernia repair surgery. Scientific studies by the Health Agency found that the Polypropylene coating of which the mesh is made can be absorbed into the surrounding tissue causing abscesses, infections, and encasement in scar tissue.

Although the US FDA was alerted, no field safety alerts were issued in the United States and the defective Physiomesh hernia screen continued to be implanted through May of 2016. At that time Ethicon issued a voluntary "market withdrawal" of the product. A market withdrawal differs limits the number of health officials that must be notified and differs from a product recall. Hospitals and physicians in the US were not made aware that the product was being taken off of the market and patients continued to be implanted with the device.

From the year 2010 until 2016, Johnson & Johnson sold upwards of 300,000 units of the Ethicon Physiomesh Hernia Repair screen. Those experiencing adverse side effects of the flexible composite mesh hernia repair device also claim in lawsuits against the manufacturer that the company should have taken the product off of the market years earlier when the company first became aware that something could go wrong. Plaintiffs claim that like most companies in the medical device and pharmaceutical field Johnson & Johnson put profits ahead of patient safety and continued to sell the product without an adequate product warning label until forced not to. It was not until May of 2016 that Johnson & Johnson, the parent company of Ethicon, alerted the medical community in no uncertain terms to "stop using" Physiomesh, much too late for many suffering from Physiomesh's side effects. Ethicon Physiomesh lawsuits are not class action lawsuits and internal injuries caused by Physiomesh complications could qualify an injured patient through filing a hernia mesh injury lawsuit, the purpose of which is to hold Ethicon accountable for its disregard of product and consumer safety.

More Recent Ethicon Physiomesh Lawsuit News:

Lawyers for Ethicon Physiomesh Lawsuits

Onder, Shelton, O'Leary & Peterson, 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. Onder, Shelton, O'Leary & Peterson 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.