The Food and Drug Administration offers several suggestions for dealing with pelvic organ prolapse, depending on severity. For women experiencing “significant discomfort,” surgery is sometimes recommended. However, in 2002, the FDA approved a non-surgical treatment. This came in the form of a device placed in the vagina that acts like a screen, thus preventing pelvic organ prolapse (POP).
Benefits of Preventing Pelvic Organ Prolapse
When the pelvic area’s supporting muscles and tissue weaken, pelvic muscle support may fail. This, then, results in organ prolapse. Although there are several POP risk factors, it’s typically a result of aging and muscle damage during childbirth. Not all women show symptoms of POP. For those who do, prolapse can be embarrassing, painful, and disrupt healthy relationships.
The Downside to Preventing Pelvic Organ Prolapse
Patients should know that in 2008, the FDA became concerned about the safety of transvaginal mesh implants (TVM). In 2011, the FDA issued an investigation update on reported TVM failures linked to almost 2,900 injuries and deaths. 1,500 of those reports involved pelvic organ prolapse cases.
The Lawsuits
In California, several patients claiming to have suffered injury as a result of failed TVM devices are calling for a ban. Several lawsuits have been filed against TVM manufacturers. Symptoms of pelvic organ prolapse include pain, discomfort, and inability to engage in sexual intercourse. The FDA warning and pending lawsuits cite examples of transvaginal mesh implants causing the same symptoms. Bay Area women calling for a ban said their implants caused the very health and lifestyle problems TVM is designed to prevent.
Although TVM devices are still approved for use, the FDA recommends patients be fully informed about side effects before agreeing to implantation. The administration also recommends patients explore other options for the repair of pelvic organ prolapse before turning to TVM implants. Finally, the FDA hopes women will be aware of the signs of TVM failure, which include persistent vaginal bleeding or discharge, pelvic or groin pain, or pain during sex. If these symptoms occur, patients should seek immediate medical attention in order to avoid potentially life-threatening risks.
The Good News
Pelvic organ prolapse is treatable, and with the right medical care, women can enjoy normal health following prolapse. Although the non-surgical option of using a transvaginal mesh implant may sound appealing, women need to understand the potential health risks associated with the device before agreeing to its use.