Regulatory Focus™ > News Articles > Use of Transvaginal Mesh Fell After Strongly-Worded FDA Safety Alert, Study Finds

Use of Transvaginal Mesh Fell After Strongly-Worded FDA Safety Alert, Study Finds

Posted 15 February 2016 | By Michael Mezher 

Use of Transvaginal Mesh Fell After Strongly-Worded FDA Safety Alert, Study Finds

Two safety communications issued by the US Food and Drug Administration (FDA) had different impacts on the use of surgical mesh to treat pelvic organ prolapse (POP), according to a recent study appearing in JAMA Internal Medicine.

The first look at the use of surgical mesh in New York between 2008 and 2011 found that use actually increased after FDA's first safety communication, from 21% of all procedures in 2008 to 30% in 2011. However, the use of surgical mesh later fell after a second, more severe FDA safety communication, from 30% of all procedures in 2011 to 23% in 2013.

The researchers theorize the difference in use patterns following the two safety communications can be partially explained by the use of "stronger language" in a 2011 warning.

Additionally, the researchers found that non-teaching and low- and medium- volume hospitals reported a greater decrease in the use of surgical mesh to treat POP. This decrease, they argue, may be explained by these hospitals treating less severe cases of POP and a "lower tolerance for litigation."

Vaginal Mesh

FDA first approved surgical mesh to repair POP in 2002 through the 510(k) pathway based on its substantial equivalence to surgical mesh used in abdominal hernia repair.

However, in 2008, after receiving more than 1,000 adverse event reports from manufacturers, FDA issued a safety communication warning of "rare" complications associated with surgical mesh used to treat POP and stress urinary incontinence (SUI), including tissue erosion, pain, infection, urinary problems and dyspareunia.

At the time, FDA said it could not determine what was causing the complications, but suspected that patient health and characteristics of the mesh or surgical technique were factors.

In response, the agency encouraged physicians to undergo training for surgical placement techniques, monitor patients closely for adverse events and inform patients of the risks of undergoing the procedure.

But between 2008 and the end of 2010, FDA received nearly 3,000 reports of complications associated with the use of surgical mesh to treat POP and SUI.

In 2011, FDA issued an updated safety communication warning that complications resulting from surgical mesh used to treat POP are "not rare," and said that "it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair."

The agency later ordered dozens of surgical mesh manufacturers to conduct postmarket studies to address concerns over the device's safety and effectiveness.

In January, FDA issued final orders reclassifying surgical mesh used to repair POP from Class II to the more stringent Class III, requiring manufacturers to submit a premarket approval (PMA) for the devices by 5 July 2018.

JAMA Internal Medicine


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