Four medical implants that escaped FDA scrutiny

April 30, 2012 by MassDevice

In July 2011, the FDA said that serious complications with mesh are "not rare" and may expose patients to more risk. In January of this year, the FDA finally ordered manufacturers to conduct studies of surgical mesh.

Heart Valve Rings

Heart Ring

A variety of commercially available heart valve repair rings.

An annuloplasty ring is a circular device used to repair faulty heart valves, by pinching together two flaps that normally prevent blood from leaking back into the lungs or another heart chamber. Given their critical role in sustaining life, the rings were originally classified in the highest risk class. For these very high-risk devices, manufactures often go through a premarket approval (PMA) process, which requires clinical data that a
device is safe.

But the FDA also clears dozens of high-risk medical devices each year through the less stringent 510(k) process – and over the past decade, that number has increased dramatically.

Number of high-risk devices approved through PMA versus 510(k)*

*Includes high risk devices in cardiovascular care, neurology, obstetrics, gynecology, and orthopedics. Data from the FDA and Harvard Medical School.

In 1997, after being petitioned by manufacturers, the FDA brought the heart valve rings down to a lower risk class, alongside hearing aids and glucose monitors. With a lower risk, manufacturers could more quickly — and cheaply — gain clearance.