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Ethicon Physiomesh Lawsuit News

Similarities Between Ethicon’s Physiomesh and Transvaginal Mesh Medical Devices

The same mesh design, the same support features, and the same device malfunctions make experts question the FDA's fast-track approval process

Tuesday, August 7, 2018 - The FDA's "fast-track" medical device approval program may have failed Physiomesh hernia patients.

More than 35,000 lawsuits were filed and are pending against Johnson and Johnson subsidiary Ethicon Inc. for the failure of the transvaginal mesh device. The transvaginal mesh is used to treat pelvic organ prolapse (POP). POP is an incontinence problem that affects approximately 25% of women and results in urine loss during physical activity, coughing, sneezing or laughing. The Ethicon Transvaginal mesh is a wire screen-like device that is inserted into the vagina to support a weak vaginal wall in order to prevent the bladder from collapsing and pressuring other organs.

Complaints about the Ethicon Transvaginal mesh started flooding in right from the start. According to "previously filed lawsuits include mesh contraction, fistula (an abnormal connection between two organs such as the vagina and rectum), inflammation, scar tissue, organ perforation, painful sex, blood loss, nerve damage, and pain." Many of these symptoms are the same as Ethicon's other polypropylene mesh device, Physiomesh. Physiomesh was recently taken off of the market due to an abnormally high number of revision surgeries. Physiomesh has been shown to shrink, buckle and pull free from the hernia repair site, migrate and painfully perforate other internal organs. Patients have also experienced infections from bacteria growing on the device.

Plaintiffs suing Ethicon and Johnson & Johnson are questioning how the FDA could approve Physiomesh if the agency was aware of so many transvaginal mesh complaints. Ethicon made both the transvaginal mesh and Physiomesh Flexible composite mesh from the same questionable material that seems to degrade when placed within the human body.

The Ethicon Physiomesh mesh is made from the same high strength, flexible, and lightweight plastic polypropylene component found in the Transvaginal mesh, the company's other failed mesh device. Physiomesh was used as a hernia repair support device until the company voluntarily and permanently withdrew the device from the market in 2016. Because of the similarities with the transvaginal mesh, the FDA approved Physiomesh using their 501 (k) fast-track program. The FDA fast-track approval side-stepped the normal rigorous pre-market testing required of a major medical device that is to be permanently implanted in the human body. The FDA's Physiomesh approval was in spite of the thousands of lawsuits against Ethicon and Johnson & Johnson for bringing the faulty transvaginal mesh to market. Analysts speculate that Ethicon's Physiomesh withdrawal was to limit the company's legal liability stemming from those requiring a revision surgery to remove Physiomesh to alleviate the pain the device was causing.

Ethicon Physiomesh patients that require a revision surgery to remove the failing Physiomesh are encouraged to speak with a Physiomesh attorney to determine if they qualify to file a claim for reimbursement of their medical expenses and all other damages including loss of income 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.