Thousands of women across the U.S. have received urogynecologic procedures using surgical mesh for the repair of pelvic organ prolapse (POP) or to treat stress urinary incontinence (SUI). The risks associated with these procedures, however, may not outweigh the benefits, leading to lasting complications or irreparable injury to women.
What is Pelvic Organ Prolapse?
Pelvic organ prolapse affects nearly 50% of women nationwide with 2% reporting noticeable symptoms. Due to life events such as childbirth, menopause or hysterectomy, organs in the pelvic region including the uterus, bladder or rectum may slip out of place causing the organs to bulge (prolapse) into the vagina. This creates pressure in the vaginal area causing discomfort that is sometimes accompanied by urinary incontinence.
What is Transvaginal Mesh?
Transvaginal mesh (also known as vaginal mesh, pelvic mesh, and bladder sling) is a medical device made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. By means of vaginal mesh repair surgery, the product is anchored to connective tissues in the vaginal wall to treat pelvic organ prolapse, or to support the bladder or urethra to reduce urinary incontinence. Brands include Apogee®, Elevate®, Gynecare®, Uphold®, Pinnacle Product Lines®, Bard Avaulta®, Perigee®, and Apical Product Lines®.
Transvaginal Mesh Complications Reported to the FDA
On October 20, 2008, after more than 1,000 cases of complications relating to surgical mesh products were reported, the FDA issued a Public Health Notification and Additional Patient Information that identified surgical mesh for transvaginal repair as “an area of continuing serious concern.”
In the three-year period from January 1, 2008 to December 31, 2010, the FDA received more than 2,800 reports of complications relating to transvaginal mesh surgeries, prompting the agency to issue an updated warning to alert women and physicians that complications relating to transvaginal mesh are not rare, as previously believed. This update stated:
“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.” – FDA (July 13, 2011)
Risks Associated with Transvaginal Mesh Complications
Complications and injuries that have been associated with transvaginal mesh products include:
· Mesh erosion through the vagina (also called extrusion, exposure or protrusion) *most common
· Pelvic and/or neuropathic pain
· Painful urination (dysuria)
· Pain during sexual intercourse (dyspareunia)
· Urinary problems
· Mesh contraction (shrinkage)
· Scar tissue formation
· Organ perforation
· Recurrence of incontinence and/or prolapse
Many of the complications associated with transvaginal mesh require additional intervention, including hospitalization and medical or surgical treatment. Transvaginal mesh is a permanent surgical implant, making it extremely difficult—and sometimes impossible—for it to be removed entirely. This can permanently compromise a woman’s health and cause unnecessary pain or problems in the future.
Transvaginal Mesh Complications – What Should You Do?
For those who are currently experiencing symptoms caused by pelvic organ prolapse or stress urinary incontinence, we urge you to ask your healthcare provider about all viable treatment options before opting for transvaginal mesh repair surgery.