Vaginal mesh is a synthetic implant used to hold pelvic organs in their original positions by providing internal support to structures and tissues that become lax through childbirth and the natural aging process. The mesh was first approved by the FDA to treat stress urinary incontinence in 1996, and the FDA expanded their approval of these devices in 2002 to address pelvic organ prolapse.
While many women have experienced successful treatment with vaginal mesh devices, others have suffered from serious gynecological mesh failure that has resulted in pain, infection and bleeding. Many instances of pelvic mesh failure have required additional surgery to correct the complications.
Surgical treatment may result in pelvic mesh failure
Many women experience POP during the menopause years, when pelvic structures change as part of the aging process. When the pelvic organs collapse, they place additional pressure on the vagina, which may result in discomfort, constipation, urinary incontinence and painful intercourse.
Traditional treatment for POP included surgery to internally adhere pelvic organs to their original positions through stitches made in vaginal tissue. However, surgical mesh was introduced as another treatment option that could be inserted vaginally, sparing a woman from more invasive surgery and a longer recovery time.
Recent studies, however, have noted the higher than expected rate of pelvic mesh failure makes this a less-than-optimal solution for many women.
Reasons for pelvic mesh failure
There are many complications that can contribute to pelvic mesh failure. Some of these problems might include:
- Recurrence of pelvic organ prolapse, requiring further repair
- Perforation of internal organs like the bowel or bladder
- Gynecological mesh failure when the device migrates through the vagina and affects surrounding tissue and organs, including the bowel, bladder and rectum
- Infection around the treatment site
- Urinary incontinence or recurring urinary tract infections
- Painful sexual intercourse or the inability to engage in intercourse completely after treatment
- Pelvic or vaginal pain that may be intermittent or ongoing
The FDA warning on pelvic mesh failure
Incidences of gynecological mesh failure were high enough to initiate a formal warning by the FDA in July, 2011. In their report, the agency stated that problems associated with pelvic mesh failure were not uncommon and other means of treating POP and SUI might be more effective.
The report also states that some women who had multiple surgical procedures to correct their pelvic mesh failure continued to experience problems long after corrective surgery was completed. At an FDA subcommittee meeting a few months later, it was recommended that manufacturers of vaginal mesh devices conduct additional studies to address ongoing safety issues.
At this time, thousands of injuries associated with pelvic mesh failure have been reported to the FDA, and hundreds of lawsuits alleging gynecological mesh failure have been filed against the manufacturers of these devices.