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Ethicon Physiomesh Was Not Adequately Tested Before Being Allowed on The Market

The Ethicon Physiomesh Composite Hernia Repair Mesh skipped clinical trials and was allowed by the US Food and Drug Administration (FDA) to be rushed to market

Monday, April 16, 2018 - Hundreds of lawsuits by those experiencing Ethicon Physiomesh failure allege that the company failed to adequately test Physiomesh Composite Hernia mesh for safety before rushing the product to market. Rather than subject Physiomesh to the rigors and delays of traditional FDA testing, the company sought and was granted FDA approval in 2010 via the 510(k) process whereby medical devices can circumvent clinical trials if the company can demonstrate that the product is substantially equivalent to others already approved. The company claimed that Physiomesh was substantially the same as other mesh devices they manufacture and were already approved and that Physiomesh Composite Mesh passed the necessary strength tests.

People undergoing hernia repair surgery put their trust in the surgeon performing the operation. Not only does a patient assume that their doctor is experienced and qualified to perform the procedure, they also assume that the medical devices that will be used have passed the scrutiny of US government safety regulators. When a medical devices company fails to do their due diligence to adequately test a new device or technique, a patient can become injured or killed as a result as has been the case with those implanted with Ethicon Physiomesh Composite hernia repair mesh. A high number of complaints from patients requiring additional surgery contributed to the FDA's recommendation that Johnson & Johnson, Ethicon's parent company, remove the hernia repair mesh from the market. Unpublished data from respected European sources claimed Physiomesh flexible composite failed at a much higher rate after laparoscopic ventral hernia repair than other comparable products as well. Ethicon complied with the recall order and in May of 2015 warned surgeons and physicians by releasing an Urgent Field Safety Notice.

There have been hundreds of adverse event reports made to the FDA regarding the Ethicon Physiomesh Composite Mesh. Results of revision surgeries have revealed that the device has shrunk, bunched up, and pulled away from the site of an original hernia. Other times the mesh has migrated within the body's abdominal cavity and has perforated the small intestines requiring their removal. Other findings include bowel obstruction and excessive scar tissue build-up that prevents the device's removal. All of the complications above come with the associated pain, redness, inflammation, swelling and infection that force a Physiomesh patient to take action.

Life_threatening complications reported by hernia patients whose surgeons used Ethicon Phyiomesh to repair their hernia has forced the company to issue a "market withdrawal" of the product. As per the company's urgent bulletin on May 27, 2016, to all hospitals and medical personnel, "We have initiated a worldwide medical device removal of ETHICON PHYSIOMESH Flexible Composite Mesh (for laparoscopic use) ("ETHICON PHYSIOMESH Composite Mesh"). "The most common complaint to the FDA was the need for a revision surgery to alleviate the pain, treat the infection, or repair or replace the device, often all of the above.

Physiomesh patients reporting these and other adverse side effects of the device and having to have revision surgery are hiring a Physiomesh hernia lawyer and suing Ethicon and Johnson & Johson for reimbursement of their medical expenses lost wages, pain and suffering, a diminished quality of life, and other monetary considerations as a result of the company"s negligence. The first bellwether Ethicon Physiomesh trial is scheduled for September of 2019. Ethicon Physiomesh lawyers are ready to assist anyone with questions in regards to the Ethicon Physhiomesh lawsuits.

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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.