Wieffering: Proceed with caution on 'reforms' of device OKs

The medical device industry is right. The approval process for new devices is badly broken.

But the cost has not been a loss of jobs or a lack of innovation, as industry leaders so often assert. Instead, it's the fear, uncertainty and excruciating pain endured by patients who increasingly serve as guinea pigs for products whose defects are discovered only after being placed in their bodies.

The latest public health nightmare to befall consumers involves artificial hips, specifically the metal-on-metal hips that were supposed to last longer and provide patients with a higher quality of life.

An artificial hip typically might last 15 years or more, but DePuy, a subsidiary of Johnson & Johnson, recalled its all-metal hip in December 2010, after receiving data from the United Kingdom showing that 13 percent of its ASR hips had to be replaced within five years.

Subsequent research, published earlier this month in the British medical journal the Lancet, found 6 percent of all metal hips needed to be replaced within five years, vs. 2 percent for people having plastic or ceramic joints.

Hip replacement is one of the more common orthopedic procedures performed in the United States, but the experience for those with metal hips has been anything but routine. The problems range from loosening of the hips to tissue and organ damage, sometimes permanent, caused by metal shavings in the bloodstream.

Artificial hips are considered high-risk, Class III medical devices, which typically are subjected to the most rigorous testing and review before being approved by the Food and Drug Administration for use on patients.

Given this, how come the problems with DePuy's all-metal hips didn't emerge until after they'd been on the market for several years?

The reason is that DePuy's artificial hips were never tested in real people, like many new Class III devices are. They were "cleared" under the FDA's much less stringent 510(k) review process, on the grounds that the all-metal hips were "substantially equivalent" to artificial hips already on the market.

This fast-track 501(k) standard has become a favored route for device manufacturers looking to get the latest iteration of a product into the hands of surgeons, even though it puts companies in the position of having to talk out of both sides of their respective mouths.

They tell the FDA that there's nothing materially different about version 2.0 of Product X, even while they tell doctors that there's nothing else like it. That's how all-metal hips rapidly overtook their plastic and ceramic brethren -- that is, until things started going wrong.

All-metal hips aren't the first Class III devices cleared by the FDA through the 510(k) route and subsequently recalled because of the dangers posed to patients. A study published in the Archives of Internal Medicine looked at 113 of the most serious recalls between 2005 and 2009, and found that 70 percent of the products received the less-stringent 510(k) clearance.

Last year, the Institute of Medicine, the independent, nonprofit health arm of the National Academy of Sciences, found the 510 (k) process to be fatally flawed and encouraged the FDA to replace it with a more integrated process that provides better assurance of safety and effectiveness.

I don't know that the FDA has to go that far. But at the very least, it should bar all Class III devices, such as stents and artificial joints, from the fast-track 510(k) process.

Industry plays defense

The FDA reacted coolly to the Institute report, while the device industry went to DEFCON 1. It has many complaints, some of them legitimate, about the FDA taking too long to approve entirely new devices and technologies, but it likes the 510(k) pathway very much, thank you. And it has successfully convinced Washington, including the entire Minnesota delegation, to effectively ignore the Institute of Medicine analysis and recommendation.

This has prompted a great degree of outrage among consumer groups. Even Consumer Reports, the magazine best known for its reviews of cars and computers, has weighed in with demands for stricter review and oversight. "The implant that fixed your knee or your heart may be a ticking time bomb that could disable or kill you," Consumer Reports President Jim Guest wrote in an e-mail sent to 1 million subscribers.

Let's face it: No medical device will ever be 100 percent safe and effective. Surgery always involves risk, and no amount of premarket scrutiny will be able to eliminate all of it. That's one reason the U.S. Supreme Court sided with Medtronic Inc. in 2008, ruling that product liability lawsuits could not be filed in state courts if federal regulators had approved a device.

That ruling makes sense, but only if regulators do the job consumers expect of them. And that means the human trials for some critical devices should begin before they are sold to the public, not after.

ericw@startribune.com • 612-673-1736