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.
Since then, the U.S. Food and Drug Administration (FDA) has concluded that
vaginal mesh implants do little to improve pelvic organ prolapse (POP),
a condition where a woman’s uterus, bladder, or rectum can slip
out of place. 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, which generally includes high-risk devices. It also now
requires manufacturers to submit a premarket approval (PMA) application
to support the safety and effectiveness of surgical mesh for the transvaginal
repair of POP.
If you or someone you care about has suffered serious harm due to vaginal
mesh or another dangerous medical device, don’t hesitate to contact
a San Diego injury lawyer at the Law Offices of Robert Vaage for a free consultation.