Four medical implants that escaped FDA scrutiny

April 30, 2012 by MassDevice

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.

The FDA says it is currently working on a national surveillance strategy.

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