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Ethicon Withdraws Physiomesh From The Market

Faced with the likelihood of yet another expensive product recall, Ethicon voluntarily withdrew their Physiomesh product permanently from the worldwide hernia repair market

Friday, June 8, 2018 - On May 25, 2016, Ethicon issued an Urgent Field Safety Notice through Switzerland's Health Agency and sent to operating room supervisors, material management personnel, and other staff currently using Ethicon Physiomesh Flexible Composite Mesh, stating that in the interest of patient safety, they were withdrawing all product codes of Ethicon Physiomesh from the market permanently. The reason for the voluntary product recall is that the Ethicon Medical Safety Team reviewed unpublished data from two respected independent hernia registries that reported that patients that had laparoscopic ventral hernia surgery using Physiomesh had a higher than average rate of revision surgery. The notice went on to say that any number of factors could have contributed to the product's failure and that the company had not pinpointed the problem. The recall notice was sent to both US and European health authorities.

A voluntary market withdrawal differs from a mandatory product recall in that the voluntary recall does not have to be specific as to the reasons for taking a product off of the market. Mandatory medical device recalls must be classified as type 1,2, or 3 depending on the likelihood that the medical device will likely cause serious injury or death. Had an actual government mandated recall been issued, more publicity would have been given to the host of adverse event reports attributed to the product. Physiomesh has been reported to cause infection, inflammation, hernia reoccurrence, and damage to surrounding organs when the mesh breaks away from its intended location on top of a hernia and travels throughout the abdominal cavity. Patients have complained of the dislodged Physiomesh landing in the intestines causing painful and dangerous blockages and intestinal perforations that required the removal of not only the Physiomesh but also of a significant portion of a person's intestines... not exactly the minimally invasive laparoscopic hernia repair surgery the patient signed up for. Had a mandatory market recall been initiated it most certainly would have been of Type 1, the most serious.

The Urgent Field Safety Notice went on to instruct medical personnel to quarantine any inventories of Physiomesh and to arrange for doctors that had inventoried the product to return it to the main medical facility at once. The notice states that "Ethicon will not return the ETHICON PHYSIOMESH Composite Mesh product to the market worldwide."

Johnson & Johnson's Ethicon unit was forced to settle hundreds of lawsuits and pay millions in damages when their other mesh repair product, the transvaginal mesh, suffered substantially the same failure. The transvaginal mesh broke away from its intended spot and migrated and perforated other organs, leaving its victims permanently incontinent. Rather than face a certain FDA recall like they did with the transvaginal mesh, the company beat the government to the punch with the voluntary market withdrawal making a more serious recall unnecessary.

Nonetheless, hundreds of people who are the victims of Physiomesh are hiring a Physiomesh lawyer to sue Johnson and Johnson for bringing a faulty medical device to market. If you are experiencing pain from your Physiomesh hernia repair surgery, you should consider filing a claim against Johnson & Johnson to be reimbursed for your medical expenses, lost wages, and pain and suffering.

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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.