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.
In the case of a heart ring called the Myxo ring, the manufacturers Edwards Lifesciences didn't seek clearance through the 510(k) — or any other process. Starting in 2006, the device was implanted in over a hundred people without FDA clearance, which current regulations allow. According to the agency, manufacturers with a cleared device on the market can make changes or modifications to the product without needing to submit an entire new application.
While patients didn't report any major complaints with the ring, many were troubled by the fact that a life-sustaining device could be on the market without any FDA supervision. Edwards Lifesciences maintained the ring was safe, but voluntarily recalled the device and applied for clearance.
In April 2009, after the Myxo ring had been subject to an FDA investigation and a Senate inquiry, the FDA retroactively cleared the device under a new name, saying it was safe. The agency said that Edwards Lifesciences should have sought clearance, but that they made an " honest attempt" to interpret the regulations.
Implantable defibrillator leads are wires that connect defibrillators (devices similar to pacemakers) to the heart. Defibrillators automatically monitor and administer shocks to the heart, and a malfunction can cause the device to fire unexpectedly, or fail to fire when a patient's life depends on it. Over the past decade, the $10 billion dollar heart device industry has seen several high profile cases of malfunctioning products that posed severe risks to patients.
The most recent episode concerns the St Jude's Riata lead, which has been implanted in approximately 79,000 people in the United States. Last year the device was recalled after it became clear that electrodes inside the lead could erode out of their lining, exposing electrical wire to the body and potentially causing a short circuit. Manufacturers had known about the problems with the Riata for a while. In fact, a full year before the recall, St. Jude stopped selling the device and sent a letter to doctors describing the problem.
A recent study found that the Riata lead was prone to yet another type of failure (malfunctioning at high voltages) and had been responsible for at least 20 deaths. St. Jude disputed the accuracy of the study, saying it was based on incomplete data. In a recent statement, the company said it has made significant design changes to its newer lead models to address these safety issues, and is also currently conducting an evaluation study of the Riata lead.
Critics point to the Riata lead as an example of FDA failure to adequately monitor devices once they go to market. A Government Accountability Office report found multiple problems with FDA oversight, including a passive system dependent on voluntary reports and a lack of complete information about how devices are used and who uses them.