Plus, how to fix a broken regulatory system that fails to protect consumers
A new investigation by Consumer Reports reveals 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 and manufacturers are often required to do nothing more than file paperwork and pay a user fee before bringing their 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. The report is available online at www.ConsumerReports.org.
"While most of us have heard about the safety problems with metal-on-metal hips in the news, these devices are just one illustration of a much larger failure in our regulatory system," said Nancy Metcalf, senior program editor, Consumer Reports. According to a recent survey by the Consumer Reports National Research Center, nearly one in five (17 percent) American adults has an implanted medical device.
In 2011, a panel from the prestigious Institute of Medicine said the Food and Drug Administration (FDA) 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 industry to get devices on the market even faster.
The Consumer Reports investigation details the risks associated with four common devices: surgical mesh, Lap-Bands, metal hips, and cardiac 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. How did the manufacturers get their products into the marketplace? They took 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-Bands 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. "Imagine if a car had a recall rate that high," says John Santa, M.D., M.P.H, director of the Consumer Reports Health Ratings Center. "Consumers and regulators would be up in arms. But in the world of medical devices, these things often stay hidden."
Metal hips: Missed alarms. The artificial hip introduced in 2005 by DePuy, the orthopedic division of Johnson & Johnson, 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 such as 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 for the patient.
Cardiac devices: Significant problems. Implantable cardioverter-defibrillators are just one of three types of cardiac devices described in the Consumer Reports 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 devices are the leads—wires that connect them to the heart.
"Without major changes in the system, there really isn't much consumers can do to protect themselves, but we do urge people to ask their doctors about alternatives. Surgical mesh is a perfect illustration of a medical implant that is frequently unnecessary," says Metcalf.
Metcalf also recommends that consumers research the device by using the FDA's website at www.FDA.gov, where one can find a wealth of information about warnings, complaints, and recalls. Consumers can also search the internet for patient forums which will indicate whether patients are having trouble. Other recommendations for guarding against the risks posed by dangerous medical devices include writing down the type of device you have and the model number, serial number (if it has one; some devices don't), and asking your doctor what sorts of warning signs to look out for.
Consumers Union, the advocacy arm of Consumer Reports, 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 that patients can be quickly notified about recalls and safety problems.
- Create national registries so that problems can be spotted quickly and patients notified.
- Increase user fees paid by manufacturers for regulatory review so that the FDA has enough money to do its job.
"Medical device industry lobbyists are working overtime to pressure Congress to preserve weak federal oversight that puts patient lives at risk," said Lisa McGiffert, director of Consumers Union's Safe Patient Project (www.SafePatientProject.org). "We need common sense reforms to assure consumers that these devices are safe and work like they are supposed to."
Consumer Reports is the world's largest independent product-testing organization. Using its more than 50 labs, auto test center, and survey research center, the nonprofit rates thousands of products and services annually. Founded in 1936, Consumer Reports has over 8 million subscribers to its magazine, website and other publications. Its advocacy division, Consumers Union, works for health reform, product safety, financial reform, and other consumer issues in Washington, D.C., the states, and in the marketplace.
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