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Regulatory Focus™ > News Articles > FDA Cracks Down on Transvaginal Mesh, Will Require Companies to Submit Data or Pull Products

FDA Cracks Down on Transvaginal Mesh, Will Require Companies to Submit Data or Pull Products

Posted 29 April 2014 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has announced that it will seek to regulate transvaginal mesh products more stringently, calling them high-risk devices that will be required to undergo FDA's thorough premarket approval (PMA) process.


Transvaginal mesh has been used to treat female urological conditions, and in particular those caused by weakened pelvic muscles, which can lead to a pelvic organ prolapse (POP). In the EU, they have been used since the 1950s to repair abdominal hernias, and since the 1990s to treat stress urinary incontinence (SUI).

The products have been subject to numerous safety concerns, especially in the US, where the US Food and Drug Administration (FDA) has noted its "serious concern" about their safety.

A 2011 safety communication by FDA identified thousands of adverse events associated with the devices, including mesh erosion, pain, infection, bleeding, dyspareunia, organ perforation and urinary problems. FDA has also required the companies to study rates of organ damage and conduct at least three years of safety studies, according to Bloomberg.

FDA did not remove the products from the market, but one major manufacturer, Johnson & Johnson, announced it would cease marketing the product in June 2012.

Numerous other companies still market the device in both the US and EU.

New Requirements

Now FDA is moving to crack down on the devices in light of the elevated risks they pose to patients. While the devices were approved for some indications based on a 510(k) application-a type of application which assesses a device's similarity to an already-approved predicate, and rarely requires clinical data-the new approval pathway will require a PMA, FDA said.

That decision corresponds with a decision by FDA to re-classify the devices-when they are used to repair pelvic organ prolapses-as "Class III" devices, reserved for high-risk medical devices. The device was previously regulated as a Class II medical device under the premarket notification [510(k)] system.

FDA said it was not aware of any new information which would provide a basis for other recommendations or findings, but instead was acting based off a 2011 recommendation made by an advisory panel. Other information received by the agency since that time had only served to reinforce its decision, it said.

FDA added that it has determined that the general and special controls for Class II devices were insufficient to "provide reasonable assurance of the safety and efficacy of these devices."

The reclassification order covers surgical mesh for both transvaginal repair and urogynecologic surgical mesh, it said.

Manufacturers will have 30 months to develop a PMA once FDA's proposed reclassification order goes into effect. Otherwise they will need to remove their products from the market.

FDA's PMA Proposed Order

FDA's Proposed Reclassification Order


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