Overhaul FDA’s Oversight of Medical Devices, Urges Consumer Reports

Consumer Reports
Consumer Reports urges changes in medical-device safety regulations.

Consumer Reports doesn’t have much faith in the safety testing of medical devices. As described in a press release, a report issued on Wednesday, March 28 by the organization raised concerns about the regulatory oversight that goes into medical devices. It cited examples such as the Lap-Band weight-loss device, metal hip replacements, and certain cardiac devices where the devices appeared to compromise patient safety.

A news article by Consumer Reports, also published on March 28, described the organization’s investigation to include interviews with doctors and patients as well as an analysis of medical research and a device-safety database at the U.S. Food and Drug Administration (FDA).

On the same day, healthcare reporter Chad Terhune of the Los Angeles Times wrote in an article that the consumer magazine discussed pitfalls in the current method used by the FDA to allow some products onto the market. Terhune used the Lap-Band example to illustrate how FDA oversight may be insufficient. The Lap-Band is a product sold by Allergan, Inc. that is surgically implanted in obese patients with a body mass index over 40 to make their stomachs smaller and hold less food.

FDA approved the product based on a clinical study of only 299 patients. Terhune said the report found that 25% of the patients had their doctors remove their bands before the three-year study was completed because they either suffered complications or didn’t lose enough weight.

Allergan has sold more than 650,000 Lap-Bands globally and apparently controls more than 80% of the market. In 2011, FDA allowed the device to be sold to less-obese patients with body mass indices between 30 and 40.

Terhune writes:

Rita Redberg, a professor of medicine and cardiologist at UC San Francisco, said Allergan and other medical-device manufacturers are complying with current federal regulations. It’s those lenient standards that are the problem, she said.

‘What the device industry is doing is certainly legal,’ Redberg said. ‘There needs to be congressional action to improve the requirements for the safety and effectiveness of high-risk medical devices. A lot of people have these devices or they are candidates for one.’

The Institute of Medicine issued a report last year that was highly critical of the the current approval process for medical devices. It urged FDA to come up with a different mechanism to regulate medical devices that doesn’t compromise patient safety.

The advocacy part of Consumer Reports, Consumers Union, echoes (PDF) the Institute of Medicine in saying that the current system doesn’t do enough to protect patients from potential harm. In its article for the May 2012 issue, the Consumer Reports magazine says that the Consumers Union has the following recommendations for FDA:

  • 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,’ or IDs 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 the user fees paid by manufacturers for regulatory review so that the FDA has enough money to do its job.

In his LA Times piece, Terhune quotes Nancy Metcalf, a senior program editor at Consumer Reports and the author of the report, as saying that prescription drugs undergo more rigorous regulatory review than medical devices.

Terhune adds:

For now, Metcalf urges prospective patients to research devices on the FDA website and look into online forums where consumers indicate trouble with their device.

Consumers Union has its Safe Patient Project that allows people to contact their representatives in Congress to urge action on medical device safety.

Source: “Consumer Reports targets medical devices’ safety,” LA Times, 03/28/12
Source: “CR Investigates: Dangerous medical devices,” Consumer Reports, May 2012
Image by Consumer Reports, used under Fair Use: Reporting.

Rajendrani "Raj" Mukhopadhyay is a science writer and editor who contributes news stories and feature articles on scientific advances to a variety of magazines. Raj holds Ph.D. in biophysics from Johns Hopkins University.