The United States Food and Drug Administration met with outside experts to discuss further regulatory steps regarding vaginal mesh. The meeting could result in a recall of the device.
Vaginal mesh is a synthetic surgical device that can be implanted either vaginally or abdominally and is used to treat pelvic organ prolapse, or POP, and stress urinary incontinence, or SUI.
POP is a common condition in which the pelvic organs bulge, or descend, into the vagina. It is usually caused when the muscles and ligaments that hold these organs in place become too stretched or weakened either from childbirth or a hysterectomy. Also, as women age, these muscles can become loose and cause this condition. Most women do not experience any symptoms, but those that do, surgery is the most common form of treatment.
During surgery, a non-absorbable mesh is implanted via incisions and punctures made through the vaginal wall, and it is inserted to reinforce the prolapsed organ and prevent any future prolapse.
However, many complications of this surgery have occurred, including an additional prolapse. Another complication (and it is the most commonly reported, says the FDA) is one in which the mesh erodes into surrounding organs and can protrude through the skin. Women have also complained about painful sexual intercourse, painful urination, perforation of the bladder and incontinence.
After receiving more than one thousand manufacturer complaints, the FDA released a report warning women and health care professionals of the dangers of vaginal mesh. In its report, the FDA estimates that in 2010 approximately 100,000 women were treated with vaginal mesh to treat POP or SUI, and of those, 75,000 were implanted vaginally. According to the FDA, those who have had the device implanted vaginally seem to have more complications than those who have had it implanted through the abdomen.
The FDA began warning about the potential complications of vaginal mesh in 2008. The agency asked physicians to receive special training on how to implant the device and to warn their patients of any complications they deemed as serious, but rare.
Discussions at the meeting will include banning all marketing of these non-absorbable synthetic meshes, ordering all manufacturers to recall these devices, and requiring that any future versions be classified as a class III medical device which would require a stricter pre-market approval application process. Some of these changes may include creating well-designed studies using human subjects to assess the risks and benefits before the device is marketed and sold.
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