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Medical device regulations don't guard patients from harm

A new investigation by Consumer Reports revealed that while tens of millions of American consumers live with medical devices implanted in their bodies, many of these implants have never been tested for safety.

Manufacturers are often required to do nothing more than file paperwork and pay a user fee before bringing products to market. In fact, because of our broken regulatory system, in such cases the only safety "testing" that occurs is in the bodies of unsuspecting patients.

In 2011, a panel from the prestigious Institute of Medicine said the Food and Drug Administration should overhaul its device regulatory system because it fails to ensure patient safety before and after products go on the market.

Instead, Congress is now debating legislation that would keep the present system virtually intact and ratify an agreement between the FDA and the industry to get devices on the market even faster.

The CR investigation detailed the risks associated with four common devices:

*Surgical mesh: No testing. Tens of thousands of women have been implanted with transvaginal mesh for prolapse repair and bladder support.

Despite thousands of reports of adverse events, repeated alarms by women's-health and consumer-health advocates, and multiple lawsuits, these products are still being sold and are still classified as "moderate risk" devices.

Manufacturers got their products into the marketplace by taking advantage of a loophole in the law that allowed them to grandfather their products onto the market without any advance safety testing.

*Lap-Band: Minimal testing. More than 650,000 have been sold worldwide, according to the 2010 annual report from its manufacturer, Allergan.

Approval for Lap-Band was based on a lone study of 299 people. Of those participants, 51 percent reported nausea, vomiting or both, and 25 percent had their bands removed before the end of the three-year study because of complications or failure to lose enough weight.

*Metal hips: Missed alarms. The artificial hip was introduced in 2005 by DePuy, Johnson and Johnson's orthopedic division, and it was cleared by the FDA without clinical testing.

Instead, it went to market based on "substantial equivalence" to earlier devices, though metal-on-metal hips like this one had long been on the agency's high-priority list for requiring advance clinical trials.

DePuy recalled all 93,000 of these hips worldwide in 2010. Evidence suggests that metal-on-metal hips fail far more often than average and can cause metal poisoning and tissue destruction, leading to a litany of medical problems.

*Cardiac devices: Significant problems. Implantable cardioverter-defibrillators are just one of three types of cardiac devices described in the CR investigation that have had significant problems.

Since 2009, the FDA has received reports of close to 29,000 deaths or injuries from these devices, by far the most for any device type, according to CR's analysis of a federal database. The most troublesome aspect of the device is the lead wires that connect it to the heart.

CR recommends that consumers research devices by using the FDA's website, www.FDA.gov, which contains a wealth of information about warnings, complaints and recalls. Consumers can also search the Internet for patient forums.

Consumers Union, CR's advocacy arm, agrees with the Institute of Medicine that the current system of medical device regulation doesn't protect patients from harm. CU recommends that Congress strengthen the medical device law so that the FDA must take the following steps:

**Require that implants and other "life-sustaining" devices be tested at least as rigorously as drugs.

**End the practice of "grandfathering" high-risk new implants and life-sustaining devices.

**Create a "unique identifier system" for implants, so patients can be notified quickly about recalls and safety problems.

**Create national registries so problems can be spotted quickly and patients notified.

**Increase user fees paid by manufacturers for regulatory review so the FDA has enough money to do its job.