FDA warns against transvaginal surgical mesh
Transvaginally placed surgical mesh may pose greater safety risks for women with pelvic organ prolapse (POP) undergoing reconstructive surgery than other surgical options — without evidence of greater benefit.
Most cases of POP can be successfully treated without mesh, according to the FDA, and inserting the mesh transvaginally can make future surgical repairs more complicated, resulting in additional surgeries.
The FDA first issued safety warnings about surgical mesh in transvaginal POP surgery in 2008. Between 2008 and 2010 adverse event reports increased to 1,503 — more than five times the rate documented from 2005 to 2007.
Adverse events include mesh becoming exposed or protruding from vaginal tissue, pain, infection, bleeding, pain during sexual intercourse, organ perforation from surgical tools used during the procedure and urinary problems.
“The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh,” deputy director of the FDA's Center for Devices and Radiological Health, William Maisel, MD, MPH, said in a press release.
Surgery to repair POP can also be performed through the abdoment and using stitches without adding surgical mesh to reinforce the repair and correct the anatomy.
“Mesh is a permanent implant – complete removal may not be possible and may not result in complete resolution of complications,” Maisel said.
Apart from avoiding mesh all together, the agency advises clinicians consider placing the mesh abdominally rather than transvaginally, as this technique may result in lower complication rates.
An expert panel of obstetricians and gynecologists are scheduled to meet Sept. 8-9, 2011 to discuss the safety and efficacy of surgical mesh in POP and stress urinary incontinence treatment, as well as the necessity for clinical trials to address risks and benefits.
The panel will also decide on interim recommendations for health care providers and patients at that time. In the meantime, the FDA encourages patients to inquire about all POP options prior to surgery with the mesh, as well as continued routine follow-up care after surgery.
Patients who have had POP surgery with mesh should notify their surgeon if they develop persistent vaginal bleeding or discharge, or pelvic or groin pain during sex.
The current FDA warning against surgical mesh applies only to transvaginal placement in POP and does not apply to mesh implanted abdominally or used in stress urinary incontinence treatment.