Pelvic Organ Prolapse (“POP”)

As you may already know, the FDA has issued a Safety Communication bulletin this month regarding surgical mesh used to repair Pelvic Organ Prolapse (“POP”). Our firm is currently accepting these cases. In order to better inform you of this issue, please read the details below.

POP occurs when a pelvic organ, such as the bladder, uterus, and/or rectum, drops (prolapses) from its normal spot in the lower belly of a woman. The drop occurs because the muscles retaining these organs become weak or stretched due to age and/or childbirth. The organ drop can cause issues in the functionality of the organ and/or other organs surrounding it.

Between 30-50% of women will experience POP in their lifetime.

POP repair surgery is typically performed transvaginally. The surgery treats POP by supporting the muscles retaining the organs. The support can be created with or without mesh.

Over the last three years, the FDA has received thousands of adverse event reports concerning surgical mesh used specifically for POP repair surgery. A large number of these adverse events involved mesh erosion. Over time, the mesh will erode into certain pelvic organs of a woman, typically the vagina. The erosion can cause severe pain, irritation, infection, urinary problems, bleedings, and scarring. Usually the only treatment for the erosion is subsequent painful surgery to remove the mesh.

Over 300,000 POP repair surgeries are performed each year – one-third of them use the mesh. Despite this large number, after a thorough review of 15 years of scientific literature, the FDA could not find any benefit to the patient in placing the mesh as compared to not placing it. Regardless of this lack of benefit, the manufacturers have unveiled tremendous marketing campaigns to push their products to be used.