Product News and Recalls

Mesh implant ‘felt like razors’

A story in the Philadelphia Inquirer includes an interview with a Georgia woman named Kathy Barton who received a vaginal mesh implant to treat bladder leakage. But she alleges that the implant ended up causing even greater health problems for her, leaving her with chronic pain that “felt like razors were slicing her organs.”

The story says a sharp edge of the mesh also cut her boyfriend during sex. Although Barton eventually had the implant removed, she still suffers from pain allegedly caused by the mesh.

Barton is one of about 6,000 women who have filed federal lawsuits against some of the biggest manufacturers of pelvic mesh products, which are supposed to treat urinary incontinence and pelvic organ prolapse. Complaints include chronic pain, organ perforation and infection.

According to the story, the U.S. Food and Drug Administration has admitted that it erred in its initial assessment of the devices.

The FDA approved vaginal mesh implants in 2002 – “fast-tracking” the process without clinical testing in humans based on their alleged similarity to devices already on the market.

In a 2008 public notice, the FDA said problems connected with the devices were “rare.” But in July, 2011, the agency said its initial assessment was wrong – estimating that the most common problems occur in 10 percent of women within a year of surgery.

If you have a vaginal mesh implant, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a mesh lawyer to discuss your legal rights.

See the story here:

http://www.philly.com/philly/health/20130208_ap_thousandsofwomensueoversurgicalmesh.html