FDA Requires Transvaginal Mesh Makers to Further Study Risks


The Food and Drug Administration (FDA) on Wednesday issued an order to the makers of transvaginal mesh—also known as urogynecologic surgical mesh—to further study the risks of these potentially dangerous medical devices.

According to a statement on the FDA’s urogynecologic surgical mesh implants page, the agency is also considering reclassifying transvaginal mesh as a high-risk device.

Transvaginal mesh is used in the surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Nearly 300,000 transvaginal mesh devices were implanted in women in 2010, according to the FDA.

However, an increasing number of reports indicate the devices, which are intended to support the pelvic organs, are ineffective and can contribute to severe medical problems. According to a Jan. 5 article in Bloomberg News, more than 650 lawsuits have been filed against makers of transvaginal mesh devices.

Adverse effects have been attributed to a variety of transvaginal mesh models made by numerous manufacturers. The FDA issued 88 post-market study orders to 33 manufacturers of transvaginal mesh products.

Complications associated with transvaginal mesh include:

  • Infections
  • Internal bleeding
  • Vaginal pain
  • Vaginal scarring
  • Mesh erosion into the vagina
  • Organ damage
  • Pain during urination
  • Recurrence of POP or SUI

If you suffered harm related to a transvaginal mesh device used in the surgical treatment of POP or SUI, a product liability attorney may be able to help you pursue financial compensation.

Please contact PersonalInjury.com to locate an experienced product liability lawyer near you.