Regulatory Focus™ > News Articles > Fed Up With Medical Device Lag, Some Patient Seek Obesity Treatment in Canada

Fed Up With Medical Device Lag, Some Patient Seek Obesity Treatment in Canada

Posted 11 April 2012 | By Alexander Gaffney, RAC 

A weight loss treatment available in Canada but not yet approved in the US is leading some patients to seek treatment across the border, reports The New York Times.

The Times highlights the case of intragastric balloons, which were once available in the US before being taken off the market by its manufacturer, American Edwards Laboratories, in 1988. The devices are implanted in the stomach by way of the esophagus and filled with fluid.

The device has since been approved for sale in Canada, Europe, South America and other parts of the world, and is rapidly approaching clinical trials in the US, reports The Times.

Some patients, however, are going across the border to seek treatment, saying they're fed up with waiting for the device to receive US marketing approval from the US Food and Drug Administration.

Patients are "desperate to find something that works," said Dr. Robin Blackstone, president of the American Society for Metabolic and Bariatric Surgery, "[but] it's important for people not to offer things that aren't well established."

The Times notes there is some skepticism about the treatment, with The Cochrane Collaboration saying the device "did not show convincing evidence of greater weight loss," and another review calling the device "a waste of money."

The issue highlights the difficulties of regulating products-particularly medical devices-in an increasingly global market where consumers are able to travel to seek treatment with relative ease.

Read more:

The New York Times - Impatience to Get Thin Sends Some to Canada

Regulatory Focus newsletters

All the biggest regulatory news and happenings.