FDA Alert - Vaginal Mesh

On July 13th 2011, the FDA issued a safety communication regarding 'Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse'.

In other words, serious complications have been linked to the use of vaginal mesh or transvaginal mesh.  As discussed previously, this vaginal mesh is an implant used to strengthen vaginal  tissue that can weaken due to childbirth, hernias, etc.  According to the FDA, the purpose of their "serious concerns" are specific to pelvic organ prolapse (POP) and stress urinary incontinence (SUI).  

The most common complication that was reported for these vaginal mesh implants was an erosion of the device through the vagina, also known as a protrusion.  The vast majority of these reports came between 2008 and 2010.

Some of the most important revelations from the FDAs investigation (taken directly from the FDAs website) are as follows:

Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.

Mesh  placed abdominally for POP repair appears to result in lower rates of  mesh complications compared to transvaginal POP surgery with mesh.

There  is no evidence that transvaginal repair to support the top of the  vagina (apical repair) or the back wall of the vagina (posterior repair)  with mesh provides any added benefit compared to traditional surgery  without mesh.

While transvaginal surgical  repair to correct weakened tissue between the bladder and vagina  (anterior repair) with mesh augmentation may provide an anatomic benefit  compared to traditional POP repair without mesh, this anatomic benefit  may not result in better symptomatic results.

 

 Patients that experienced either mesh erosion or mesh contraction reported severe pelvic pain and/or discomfort.