FDA seeks new studies on vaginal mesh implants

Back in November, we reported how hundreds of personal injury lawsuits have surfaced throughout the country as a result of complications with vaginal mesh implants, which are medical products used to repair pelvic organ prolapsevery (POP) and stress urinary incontinence.

The personal injury lawsuits allege that the vaginal mesh implants left women with serious injuries, including mesh erosion, pain, bleeding, scarring, infection, urinary problems and even death.

The U.S. Food and Drug Administration acknowledged the risks with the vaginal mesh product in 2008 and again in July 2011 with a public health notification to patients and doctors about the potential risks.

Most recently, though, the FDA ordered new safety studies to be conducted on the vaginal mesh implants, and said that the product could end up on a higher-risk category that would require manufacturers to jump through additional hoops before being approved for sale.

The FDA said it’s taking the safety measures after seeing a surge in the number of product-related complications being reported. The FDA said it received more than 1,500 reports of complication between 2008 and 2010, which was five times the rate reported from 2005 to 2007.

The FDA has asked 35 manufacturers of transvaginal surgical mesh for three-year studies of several hundred women who have had the implant to track side effects and the women’s overall quality of life. Additional studies are being requested from manufacturers that sell the product to repair POP.

After using surgical mesh to treat stomach hernias and other conditions since the 1950s, surgical mesh implants have only been used to treat POP and stress urinary incontinence since the 1990s.

The problem is that under FDA guidelines, the new devices aimed at POP and stress urinary incontinence never had to be tested on humans as long as makers could show that they were similar to pre-existing devices on the market.

A personal injury lawyer who represents women who have been injured by the vaginal mesh implants told Reuters that he hopes the lawsuits will bring some changes to FDA guidelines as well as compensation to his clients.

Source: Reuters, “FDA wants new studies on surgical mesh implants,” Anna Yukhanaov, Jan. 5, 2012