In January, the FDA issued two final orders to strengthen the data requirements for vaginal mesh implants that are used to treat pelvic organ prolapse.

The orders affect mesh implants that are introduced transvaginally (through the vagina).

What is Pelvic Organ Prolapse?

Pelvic Organ Prolapse (POP) happens when a pelvic organ falls from its normal place in the lower torso and pushes against the walls of the vagina. This condition can occur when the muscles that hold the pelvic organs in place become weak or stretched from childbirth, surgery or aging.

Pelvic organ prolapse can be uncomfortable or painful, and more than one organ can be a problem at the same time. Among the organs that can be affected are:

• Bladder
• Urethra
• Uterus
• Small bowel
• Rectum

These organs are supported by the same muscles that are often strained during childbirth. When the muscles don’t heal with their previous strength intact, they can’t support the pelvic organs properly.

Vaginal Mesh Implant Issues

To correct pelvic organ prolapse, many women have a procedure to install a vaginal mesh implant that helps support the organs that have dropped from their original place.

Doctors can place the mesh through the abdomen or through the vagina, which is quicker and less invasive. When placed through the vagina, they are called transvaginal mesh implants.

These devices were originally classified as class II medical devices, which means they were of moderate risk. The FDA ordered them reclassified as class III, which includes high-risk devices.

The FDA also ordered that manufacturers of vaginal mesh implants submit a premarket approval (PMA) application to show the safety and effectiveness of the surgical mesh used in transvaginal repair of pelvic organ prolapse.

It is important to note that the new FDA orders do not apply to surgical mesh used for other reasons, such as stress urinary incontinence or abdominal repair of pelvic organ prolapse.

Currently, five companies manufacture vaginal mesh implants, and they will need go through a premarket approval application to prove safety and effectiveness.

The most common problems reported are:

• Severe pelvic pain
• Pain during intercourse
• Infection
• Bleeding
• Organ perforation
• Urinary problems from mesh eroding into surrounding tissue

Reports of severe pelvic pain and organ perforation have been reported with vaginal mesh implants. The new FDA orders to not apply to surgical mesh used for other reasons, such as stress urinary incontinence or abdominal repair of pelvic organ prolapse.

Manufacturers have up to 30 months to submit their premarket approval applications to the FDA.