What do artificial hips and surgical mesh have in common? They are both considered moderate-risk medical devices and can be approved by the Food and Drug Administration (FDA) without rigorous testing through an expedited approval process known as 510(k).
Many of these devices also have allegedly caused patients serious and sometimes permanent disability. This has led critics to question the safety of approving devices for use before they have been fully tested.
For example, Johnson & Johnson subsidiary DePuy Orthopaedic received FDA approval through the 510(k) process in 2006 for its ASR metal-on-metal hip replacement system. The device manufacturer was able to prove that the new device was “sufficiently similar” to other devices that had already been approved by the agency. However, just four years after the hip implant hit the market, the FDA ordered a recall of the devices based on an unusually high number of complications, many of which resulted in the need for revision surgery to remove and replace the device.
This month, the FDA is taking a closer look at another problematic device that was approved through the same expedited process, transvaginal mesh. The surgical mesh is a product used to repair pelvic floor disorders including pelvic organ prolapse (POP) and urinary incontinence. From January 2008 to December 2010, the FDA received more than 1,500 reports of complications associated with the devices, many of which required hospitalizations and more surgeries. The agency is reviewing data on transvaginal mesh to determine if the product should remain on the market despite the risks.
Despite recommendations from third-party organizations to do away with the 510(k) process, the FDA is working instead to improve the system. This week the agency announced it has implemented two new training programs designed to improve the consistency of medical device reviews by enhancing the skills of the individuals tasked with reviewing pre-marketing applications at the agency’s Center for Devices and Radiological Health (CDRH).
This program is one of the 25 action items listed in the FDA’s Plan of Action for Implementation of 510(k) and Science Recommendations aimed at increasing the predictability and transparency of regulatory pathways and to strengthen the 510(k) process.