Earlier this week, we began a look at common issues with the FDA’s approval process which have resulted in unsafe medical devices being approved for sale and use by patients in New Jersey and throughout the country and world. As a result, many patients who have received these medical products have reported adverse side effects including debilitating pain, injury and even death.
In general, devices that are considered ‘high-risk’ – meaning that they play a critical role in sustaining life – will not be approved without clinical data proving that they are safe. But every year, the FDA approves several such devices under the lax 510(k) process. One such example of this is the heart valve ring, which is used to repair faulty heart valves, and which lost its ‘high-risk’ status in 1997 after years of pressure from manufacturers.
However, that was irrelevant for one product called the Myxo ring, which was implanted in dozens of people with absolutely no FDA clearance whatsoever. Under FDA regulations, this was permissible: manufacturers who already have a cleared device on the market can release new versions of the product without seeking approval for those later designs. Although the Myxo ring does not appear to have caused any injury, the FDA process by which it was sent to market is a troubling reminder of what little oversight the agency really has.
The final product we will discuss is defibrillator leads, which are wires that connect defibrillators to the heart. In the past 10 years, several of these products have failed. Most recently, the St. Jude’s Riata was recalled after erosion exposed electrical wire within the body.
Critics say that this is just one example of the FDA’s failure to properly monitor devices after they have gone to market. In fact, a recent federal study found that the FDA’s reporting system is inefficient and that there are multiple problems with the agency’s oversight of its approved products.
If you have been injured as a result of a dangerous or defective medical product that has received FDA approval despite its many reported defects, contact Breslin & Breslin for a free consultation.
Source: Pro Publica, “Four Medical Implants That Escaped FDA Scrutiny,” Lena Groeger, April 30, 2012