High-Risk Status may be Next for Transvaginal Mesh
A Food and Drug Administration (FDA) advisory panel recommended earlier this month that some transvaginal mesh devices used in the surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) be reclassified as “high-risk” medical device.
The panel was convened amid increasing reports of transvaginal mesh failure and related complications including:
- Recurrence of POP or SUI
- Internal bleeding
- Organ injury
- Vaginal pain
Also referred to as bladder slings, transvaginal mesh devices were first approved by the FDA in 1996. In the years that followed, a number of transvaginal mesh products made by various manufacturers flooded the market via the FDA’s 510(k) process, which allows a faster approval process with limited testing for products deemed essentially equivalent to existing medical devices.
As transvaginal mesh patches became a more popular surgical treatment option for POP and SUI, the complaints of side-effects grew. From 2008 to 2010, the FDA received almost 3,000 reports of complications associated with transvaginal mesh, which is more than double the complaints received between 2005 and 2007.
The FDA has not yet made a decision on its advisory panel’s suggestion to reclassify transvaginal mesh, although additional study into the potential hazards of transvaginal mesh are underway.
If you suffered complications after receiving transvaginal mesh in the treatment of POP or SUI, an experienced product liability attorney may be able to help you pursue the compensation you deserve and need to recover. Please contact us for a free case review and to locate a transvaginal mesh lawyer near you.