The Food and Drug Administration ("FDA") announced last week that transvaginal placement of surgical mesh in connection with Pelvic Organ Prolapse repair poses "greater risk than other surgical options."
According to the American Urogynecologic Society, pelvic organ prolapse is a medical condition that occurs when the normal support of the vagina is lost, resulting in “sagging” or dropping of the bladder, urethra, cervix and rectum. As the prolapse of the vagina and uterus progresses, women can feel bulging tissue protruding through the opening of the vagina.
As the prolapse gets worse, some women complain of:
- A bulging, pressure or heavy sensation in the vagina that worsens by the end of the day or during bowel movements
- The feeling that they are “sitting on a ball”
- Needing to push stool out of the rectum by placing their fingers into the vagina during bowel movement
- Difficulty starting to urinate, a weak or spraying stream of urine
- Urinary frequency or the sensation that they are not emptying their bladder well
- The need to lift up the bulging vagina or uterus to start urination
- Urine leakage with intercourse
The FDA announcement stated that it was now recommending to physicians to "carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh."
The most frequently reported complications from surgical mesh used to repair POP include mesh becoming exposed or protruding out of the vaginal tissue (erosion), pain, infection, bleeding, pain during sexual intercourse, organ perforation from surgical tools used in the mesh placement procedure, and urinary problems. Some reports cited the need for additional surgeries or hospitalization to treat complications or to remove the mesh.
Adverse Event reports to the FDA regarding transvaginal placement of surgical mesh increased significantly from the period of 2008 to 2010.