The Food and Drug Administration (FDA) has been aware of transvaginal mesh problems since 2008, when it first sent out an alert to healthcare providers regarding the increasing number of health complications associated with the procedure. However, even then it wasn’t clear just how dangerous these devices could be. Typically, they are used to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI), both frustrating conditions that affect women, usually following pregnancy. However, complications arising from this procedure can leave a patient in much worse condition than before the procedure, and some of the side effects can be permanent or even life threatening.
WHAT COMMONLY CAUSES TRANSVAGINAL MESH PROBLEMS FOLLOWING THE PROCEDURE?
Several factors will determine whether or not a patient will suffer complications after implantation. When the procedure works correctly, the device will act as a sling inside the pelvis, supporting organs when pelvic floor muscles cannot. However, the patient’s health and estrogen levels, the material the implant is made from, the implant’s size and shape, and the hospital’s operating procedure will all affect the outcome of the treatment.
WHAT ARE THE MOST COMMON TRANSVAGINAL MESH PROBLEMS?
There are a number of complications associated with the treatment, though most have to do with the sling rubbing up against tissues and causing trauma. Some of these complications include:
- Vaginal tissue erosion
- POP or SUI reoccurrence, or worsening of POP or SUI symptoms
- Chronic pain, especially in the lower back
- A feeling that there is pressure being applied to the lower abdomen
- Pain during intercourse
- Urinary complications
- Vaginal bleeding, infections or scarring
If not addressed immediately, these side effects can lead to organ failure, dangerous levels of internal hemorrhaging or deadly infections. Some victims have been made infertile by complications arising from the implant. In almost all cases, the hospital will need to perform additional surgeries on the victim to remove the implant, which can cause additional issues and cost the patient even more money and recovery time.
WHAT IS THE HISTORY OF TRANSVAGINAL MESH PROBLEMS?
The FDA went public in 2008 regarding concerns with the implant, and nine device manufacturers were named in the safety alert. The FDA also announced that further research into the treatment was needed before it could be considered entirely safe.
In August 2010, Obstetrics & Gynecology published a study on the treatment, and their results were disconcerting. The study followed dozens of women who received the implant after being diagnosed with POP. Though the study started in 2007, it had to end prematurely after researchers noted an alarming rate of complications. In all, 15 percent of patients experienced transvaginal mesh problems within only three months of surgery, a rate that is considered clearly unacceptable.
In July 2011, the FDA sent out an official warning to patients and healthcare professionals regarding the implant, and stressed alternatives to the treatment. The FDA also noted that more than 10,000 women had received the procedure in 2010, ensuring a surge of hospital visits to correct the implant in the coming years. This concern was echoed in 2011 by The Journal of Obstetrics & Gynecology Canada, which stated that the treatment should be considered experimental and only used in trials.