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July 25, 2017

Monitoring Medical Devices: Missed Warning Signs Within Existing Data

Author Affiliations
  • 1Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor
JAMA. 2017;318(4):327-328. doi:10.1001/jama.2017.6584

Warning signs of unsafe or low-value care are detectable within existing data but often are overlooked. Rather than duplicate efforts and collect more data, health care leaders should renew their focus on making better use of available data. An example in which this is readily apparent involves the monitoring of medical devices.

The advent, increase, and decline in the use of the laparoscopic gastric band to treat morbid obesity illustrates how examination of existing data could have changed practice much earlier. The gastric band device (commonly referred to by its brand name, Lap-Band) was approved by the US Food and Drug Administration (FDA) in 2001 and peaked in usage by 2008 (Figure, A).1 However, use of the device gradually declined as reports emerged describing complications (eg, band erosion, band slippage) and variable effectiveness (eg, inadequate weight loss) that required reoperation to revise, replace, or remove the device.2 A recent study using Medicare claims found that of the $470 million paid for the gastric band device, $223 million (47%) was for reoperations.3