Reclassification of Mesh: FDA requiring pelvic mesh manufacturers to conduct additional trials
In an FDA announcement on Jan. 4, 2012, the agency stated it was considering strengthening the classification of pelvic mesh devices from a Class II to Class III.
The upgrade to a Class III device would make pelvic mesh subject to the greatest level of regulatory control and would require FDA approval before the devices are marketed. The FDA considers Class III devices to be those presenting the highest risk to patients.
Additionally, according to Bloomberg Businessweek, the FDA sent letters to 33 manufacturers of a variety of pelvic mesh devices notifying them that they will be required to conduct three years of trials on the safety of the product.
The mesh devices were initially approved through the FDA's 510(k) approval system. This system does not require patient testing for a device if a similar medical device is already available on the market. The FDA estimates that in 2010, nearly 300,000 women received pelvic mesh implants. According to the Bloomberg article, many of the pelvic mesh devices on the market today received FDA approval as the result of a pelvic mesh device that was recalled in 1999.