September 17, 2008
to Include Warnings About Infection Risks & Other Complications
WASHINGTON, D.C. – Ads for implantable medical devices should include warnings about the potential risk of infections and other complications according to Consumers Union, the nonprofit publisher of Consumers Reports. Direct to consumer (DTC) ads for medical devices, such as those used for knee, hip, and heart surgery, have become increasingly common but rarely include such warnings, the group noted in testimony today before the Senate Special Committee on Aging.
“There is no question that these medical devices can restore high quality of life to many patients who are suffering, said Ami Gadhia, Policy Counsel with Consumers Union. “But consumers need to know about the unintended deaths and serious injuries that occur all too often with medical device surgeries.”
A recent FDA report on data collected from fiscal year 2006 found a 25 percent increase in adverse events linked to medical devices over the previous fiscal year, including 2,830 deaths, 116,086 injuries, and 96,485 malfunctions. The CDC’s National Nosocomial Infections Surveillance (NNIS) System Report shows knee and hip replacement surgery to be a serious source of infection. In some of the NNIS reporting hospitals, the risk of infection may run as high as five percent or more.
Warnings of side effects associated with implantable medical devices in direct consumer ads are generally non-existent or minimal. A review by Consumers Union found no advertisements that advised consumers of the very real possibility of deadly infections or of the need to seek out surgical centers with low infection rates.
Given the increasing amount of advertising to consumers about medical devices and the lack of sufficient warnings about potential risks, Consumers Union recommended that:
• The FDA should be required to mandate that all DTC ads warn consumers about the risk of health-care associated infections that can result from such surgeries and follow-up care
• The FDA should be required to exercise stricter oversight of DTC ads, including a review process before the ads are issued
• The FDA should be given more resources for reviewing DTC ads and for taking enforcement action when ads are misleading, deceptive, or unbalanced.
• The FDA should inform consumers on its web page how they can report DTC ads that fail to adequately warn of potential risks associated with implantable medical devices.
In December 2007, Consumers Union petitioned the FDA to require warnings about infections and other complications in all DTC ads for implantable medical devices. The agency has not responded to Consumers Union’s petition.
“Ads for medical devices should warn consumers about the health risks associated with them, just as the law already requires pharmaceutical companies to warn about drug side effects,” said Gadhia. “Requiring warnings about medical device risks will help consumers make more informed healthcare decisions and encourage hospitals to do all they can to minimize infections and other complications.”
Ami Gadhia – 202-462-6262
Lisa McGiffert – 512-477-4431, ext 115