For years, transvaginal mesh devices have been used by doctors to treat medical issues like stress urinary incontinence and pelvic organ prolapse. Despite assurances that these devices were safe, research has shown that they can lead to serious and possibly life-threatening medical issues.
The vaginal mesh story began in the 1990’s, when the U.S. Food and Drug Administration (FDA) cleared the first transvaginal mesh implant for sale in the United States. Since that time, more research has come to light that establishes the serious health risks these devices can pose. Contact our legal team if you were injured due to defective vaginal mesh.
The first vaginal mesh device—the ProteGen Sling—was first approved by the FDA in 1996. This initial offering was designed to treat stress urinary incontinence or SUI. In 2002, a similar device was approved to treat pelvic organ prolapse (POP).
It did not take long for problems to arise. In 1999, Boston Scientific withdrew the ProtoGen Sling from the market due to consumer complications. However, they replaced this offering with other devices that had similar designs. Additional vaginal mesh products continued to be developed worldwide by a number of manufacturers, including Ethicon, Inc. (a division of Johnson & Johnson), American Medical Systems, Inc. (a now defunct subsidiary of Endo Pharmaceuticals), Coloplast Corporation and Cook Medical.
It was not until 2008 that the FDA first took action regarding vaginal mesh devices. That year, the FDA issued something known as a Public Health Notification based on severe health consequences linked to surgical mesh devices designed to treat both SUI and POP. The FDA issued additional guidance in 2011. This safety communication highlighted the fact that serious complications were not uncommon and that vaginal mesh was not more effective at treating the symptoms of SUI or POP than other treatment options which did not use mesh.
Although transvaginal mesh remained on the market throughout the world, the first series of lawsuits related to health complications caused by these devices were filed. In the summer of 2012, manufacturer C.R. Bard pulled their vaginal mesh device from the market prior to losing the first major verdict in vaginal mesh litigation. This verdict—worth $3.6 million—was a sign of things to come.
Other manufacturers faced their own lawsuits not long after. In 2013, Johnson & Johnson lost a trial verdict in federal court, while American Medical Systems reached a settlement agreement with plaintiffs the same year in an effort to avoid a large verdict. This litigation spread internationally, with Johnson & Johnson facing a major lawsuit in Australia in 2017.
Throughout the years of litigation and warnings from the FDA, the federal government did not take action to remove vaginal mesh devices from the market. This changed in 2019, with the FDA issuing a recall that barred manufacturers from selling these devices in the United States to treat pelvic organ prolapse.
This action from the FDA brought an end to all transvaginal mesh device sales in the U.S.. Manufacturers, including Johnson & Johnson, Boston Scientific, and American Medical Systems, Inc. have paid out hundreds of millions of dollars to patients injured by these devices.
Today, there are numerous lawsuits against the makers of vaginal mesh devices. These lawsuits are often in federal court. If you are ready to learn about your legal options regarding vaginal mesh injuries, reach out today for a confidential consultation with our legal team.