Transvaginal Mesh Kits Classified as “High Risk”
New regulations have been announced by the U.S. Food & Drug Administration (FDA) in relation to transvaginal mesh kits, which are commonly used to fix pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Transvaginal mesh kits, originally rated as moderate risk devices, are now being reclassified by the FDA as “high-risk” in response to the thousands of lawsuits filed by injured patients. The difference between the two ratings is that moderate risk devices do not require human clinical trials before the company is allowed to market them.
What Does This Mean?
Transvaginal mesh kits being reclassified as high risk means they will have to undergo additional scrutiny before they are approved. Manufacturers must submit a pre-market approval application for transvaginal mesh kits to be evaluated. Unfortunately, this may not be of much use or comfort to the many women who have already suffered from serious side effects because of their transvaginal mesh kits. The product was essentially “live-tested” on early users. Recent estimates put the number of lawsuits filed by women at around 50,000.
Many women who have used transvaginal mesh kits to fix POP or SUI did so with relative success. However, thousands of other women were not so lucky. The mesh allegedly caused infections or injuries to soft tissue, nerves, and organs in the area of implantation. Adhesion (a binding with the intestines) was reported in some cases. In others, internal bleeding became an issue because the mesh shifted out of place or migrated and caused damage.
Should the mesh bind with any soft tissues, revision surgery may not be able to fix the problem. Repeated surgeries may be required and even then the surgeon may not be able to remove the entire mesh. This can mean painful intercourse, urinary problems, and internal bleeding. The FDA began looking into the safety of transvaginal mesh kits in 2008 after thousands of complaints had been lodged about the product and put forward the idea of a “high-risk” reclassification in January of 2012.
The Legal Consequences