Transvaginal mesh, commonly used to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI), is implanted in thousands of women worldwide. Women with mesh implants experienced severe pelvic pain and organ perforation, prompting the FDA to engage in premarket approval procedures.
The premarket approval procedures will ensure safety and effectiveness of mesh used specifically for the transvaginal repair of POP, but not for SUI. In the past, the FDA has issued a vaginal mesh warning to inform doctors and patients about surgical mesh complications.
In 2008, the FDA issued an initial public health communication about the dangers of transvaginal mesh. The FDA received more than 1,000 reports from nine surgical mesh manufacturers in three years, which prompted the organization to speak out.
Although breaking the silence was an important step, the initial safety communication described complications from transvaginal mesh as rare. Later, in 2011, the FDA released an additional communication informing patients that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.”
“Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern,” according to the 2011 safety alert.
In Sept. 2011, an advisory panel of experts rolled out recommendations for mesh-related actions. After the meeting, the advisory panel decided to require additional data before confirming the safety of transvaginal mesh.
Postmarket Surveillance Studies
In Jan. 2012, the FDA ordered mesh manufacturers to conduct postmarket surveillance studies. The studies were meant to focus on safety and effectiveness concerns when mesh is used to repair POP.
In May 2014, the FDA reclassified mesh devices from class II to class III.
- Class II drugs are categorized as moderate risk
- Class III drugs are classified as high risk, requiring a premarket approval
A premarket approval (PMA) is an application that will illustrate the safety and effectiveness of surgical mesh for the transvaginal repair of POP. Manufacturers will have 30 months to submit postmarket approval for mesh devices already on the market. If a manufacturer wants to release a new device, the PMA must be submitted before the device enters the public sphere.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, told the FDA.
“We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”