Transvaginal Mesh Side Effects Associated with Pelvic Organ Prolapse Repair
Vaginal Mesh Side Effects Have Plagued Thousands of Women
While most common among women who have given birth, pelvic organ prolapse can also be caused by hysterectomy or other pelvic surgeries. Pelvic organ prolapse (POP) occurs when the pelvic muscles become weakened or damaged and fail to provide sufficient support to the pelvic organs, causing them to prolapse, or sag, into the vagina. This may occur after childbirth or during menopause. While a significant portion of women (in the range of 30-50%) at some point experience pelvic organ prolapse, only about 2% suffer from symptoms and require surgical repair.
Symptoms of POP include a general feeling of pelvic pressure; the sensation of having something fall out of the vagina; a soreness, tightness or stretched feeling in the lower back or groin area; pain during intercourse; vaginal bleeding or spotting; urinary problems and incontinence; and constipation. These symptoms are often exacerbated through exercise. Women may have pelvic organ prolapse without experiencing any of these symptoms, in which case repair is unnecessary.
The organs that can be affected by POP include the bladder, the uterus, the rectum, the top of the vagina, and the bowel. Prolapse happens in degrees, and in many cases is not severe enough to require surgery. The severity of prolapse is determined through a course of tests that measure the strength of the pelvic floor muscles, the functionality of the urethra and bladder, and the physical location of each of these organs. In some cases, POP can be remedied through non-invasive means such as Kegel exercises, medication or physical therapy. For more severe cases, surgery is almost always required to alleviate symptoms.
Historically, surgical repair for POP was achieved with ordinary stitches, but the use of surgical mesh in this procedure has become far more common in recent years. Surgical mesh is a porous material made of either synthetic or biologic components, and is designed to be permanently implanted to strengthen the pelvic muscles and thereby support the sagging pelvic organs. It is the transvaginal (meaning it is placed through the vagina) use of surgical mesh to treat pelvic organ prolapse that was the subject of the July 2011 FDA Safety Communication.
Vaginal Mesh Side Effects
When transvaginal mesh is used to repair pelvic organ prolapse, some patients experience seriously detrimental side effects. These health problems can be debilitating, and in some cases, are permanent. The 2011 Safety Communication issued by the FDA confirms that the use of vaginal mesh is not to be undertaken lightly, and in fact may be entirely ill-advised. This conclusion was based on a review of complaints made to the FDA since 2006 as well as existing scientific literature. The FDA alert intones that, “serious complications associated with surgical mesh for transvaginal repair of POP are not rare…. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
Vaginal Mesh Side Effects Severe and Wide-Ranging
The risks outlined in this safety alert are wide-ranging and serious in nature. Vaginal mesh has been found to be likely to erode through the soft tissues of the vagina, leading to several different problems. The most common side effects caused by surgical mesh include debilitating pain, infection, inflammation, bleeding, pain during intercourse (dyspareunia), damage to nearby organs and urinary problems. Other less common outcomes of the transvaginal placement of surgical mesh to repair POP include recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems.
Erosion Leading to Pain Most Common Vaginal Mesh Side Effect
The single-most common side effect of vaginal mesh reported to the FDA is erosion or extrusion of the mesh through the vagina. One or more surgeries are required to remedy this problem, and in some cases, even surgery cannot resolve it. The FDA report makes it clear that resulting problems may be permanent, including severe pelvic pain and pain during intercourse. Male partners may also experience pain during vaginal intercourse in cases of surgical mesh extrusion.
A newly-documented side effect of transvaginal mesh placement is mesh contraction, or shrinkage of vaginal mesh. When transvaginal surgical mesh shrinks, it causes vaginal tightening, shortening and pain. This condition also interferes with sexual intercourse.
Nine different companies sell surgical mesh for POP repair. The FDA safety alert does not identify a specific brand of vaginal mesh as being more problematic than others, nor does it state whether absorbable, non-absorbable, synthetic or biologic surgical mesh is most likely to cause vaginal mesh side effects. In short, anyone who has had POP repair surgery may be at risk for developing transvaginal mesh side effects. If you are not sure if your surgery used mesh but you are experiencing the problems described on this page, consult with the surgeon who performed your procedure.