Infection-Risk Warnings Needed in Ads for Medical Devices, Group Tells FDA


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 5 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 healthcare-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."

A copy of Consumer's Union testimony to the Senate Special Committee on Aging can be found at:

Source: Consumers Union




Related Videos
Set of white bottles with cleaning liquids on the white background. (Adobe Stock 6338071172112 by zolnierek)
Medical investigators going over data. (AdobeStock 589197902 by Wasan)
CDC logo is seen on a laptop. (Adobe Stock 428450603 by monticellllo)
Association for the Health Care Environment (Logo used with permission)
COVID-19 germs, fungi, bacteria objects. (Adobe Stock 584704860 by chawalit)
Ambassador Deborah Birx, , speaks with Infection Control Today about masks in schools and the newest variant.
mRNA technology  (Adobe Stock 485886181 by kaptn)
Ambassador Deborah Birx, MD
Woman lying in hospital bed (Adobe Stock, unknown)
Related Content