Product News and Recalls

Flawed FDA approval process results in deaths

A recent report in Scientific American takes a look at a faulty heart device that’s been responsible for at least 20 deaths.

According to the article, implantable defibrillator leads are wires that connect defibrillators – devices similar to pacemakers – to the heart. “Over the past decade, the $10 billion heart device industry has seen several high profile cases of malfunctioning products that posed severe risks to patients,” the article states.

The section about the implantable defibrillator leads is part of a larger report about the U.S. Food and Drug Administration’s lax oversight of medical devices.

Scientific American cites several medical devices that the FDA has failed to properly regulate. The report mentions DePuy Orthopaedics all-metal hip replacement joints and transvaginal mesh implants as two particularly harmful examples.

Scientific American says 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.

The St Jude’s Riata lead, which has been implanted in approximately 79,000 people in the United States, was recalled last year because of its potential for short circuiting. But manufacturers had known about the problems for at least a year before the recall. 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.

“Critics point to the Riata lead as an example of FDA failure to adequately monitor devices once they go to market,” the report says. “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.”

In the case of the DePuy hip joint and the transvaginal mesh implant, the report says, the problem is that the FDA allowed them to get onto the market without clinical testing, based on their alleged similarity to devices that had already been approved.

The artificial hip joint was eventually recalled in 2010 because nearly half of the recipients needed new surgery within six years. And the transvaginal mesh implants have generated thousands of lawsuits from patient reporting extreme pain and injuries including organ perforation.

See the article here: