Is Implantable Device Reform Almost Here?

It’s not always an easy question for a consumer to answer, yet it comes up for more people than you might think. In the case of certain heart defibrillators, for example, consumers with defective devices run the risk that their device will either deliver an unnecessary jolt of electricity—akin to being hit across the chest with a baseball bat—or, worse, simply fail, potentially leading to cardiac arrest and death. Unfortunately, more than a few implantable devices have become defective. An …

Regulatory Reform Options for Implantable Devices

In 2011, some widely used implantable heart defibrillators, designed to correct potentially fatal irregular heart rhythms, developed cracked insulation on their high-voltage electrical wires. The result was that in some cases they caused severe shocks, and even deaths. Consumers with the defective implants had to decide whether to undergo dangerous surgery to replace the device or simply monitor it. Until the defective device is replaced, consumers run the risk that it will deliver an unnecessary high-voltage jolt of electricity—described as …

More Price Transparency Needed for Implantable Devices

Implantable devices, such as hip replacements and heart valves, are a central part of medical treatment today. Americans receive about 370,000 cardiac pacemakers and about 1 million total hip and knee replacements per year. Despite how common the use of implantable devices is, little information is publicly available on the prices paid for these devices in the United States. Limited information about prices and performance of many implantable devices has raised concerns that providers, consumers and insurers may be paying …