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Endo to Settle Remaining Vaginal Mesh Lawsuits for $775 Million

Endo International Plc has agreed to pay $775 million to settle all outstanding lawsuits related to the company’s vaginal-mesh implants. In total, the device maker has set aside more than $2.6 billion to resolve the product liability claims. Last year, Endo announced the closure of its Astora Women's Health device unit, which manufactured the defective medical devices.

Other manufacturers of vaginal mesh, including Johnson & Johnson and Boston Scientific Corp., still face thousands of product liability suits. Last year, the State of California filed a consumer fraud lawsuit alleging that Johnson & Johnson failed to warn doctors and patients about serious complications associated with its pelvic mesh devices. The suit further contends that J&J violated the state’s consumer protection laws by using deceptive advertising to market the vaginal mesh products.

FDA Oversight of Vaginal Mesh Products

As we have previously discussed on this blog, medical devices are often cleared by the FDA without clinical trial data requirements. Manufacturers who demonstrate their products are “substantially similar” to other products on the market are frequently given clearance to sell the device without undergoing a stringent review process. Under this system, vaginal mesh devices were cleared for use in treating incontinence in 1996 and for pelvic organ prolapse in 2002.

Over the years, it has been discovered that vaginal mesh actually does little to improve conditions such as pelvic organ prolapse (POP). In many cases, the defective medical devices do more harm than good.

According to the FDA, it has received thousands of reports of complications involving the use of mesh for transvaginal POP repair over the past several years. The most common problems reported include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation, and urinary problems from mesh eroding into surrounding tissues.

In 2016, the FDA reclassified vaginal mesh devices as class III, meaning they are generally considered high-risk devices. Manufacturers are also now required to support the effectiveness and safety of mesh by submitting a premarket approval (PMA) application.

Injured? Don’t hesitate to contact a San Diego injury lawyer at the Law Offices of Robert Vaage for a free consultation.