Consumer Union wants FDA to strengthen medical device warnings in ads
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A consumer advocacy group wants the United States Food and Drug Administration (FDA) to warn consumers about infection risks and the limited lifetime of implanted medical devices in product ads.
Consumers Union is targeting advertisements for implantable devices, such as knee implants, and cosmetic implants in its petition to the FDA.
“We are only asking that consumers be given clear warnings about the dangers of infection during and following surgery,” the petition reads. “And information about how the devices are likely to last, and that consumers be advised to seek out facilities with the strongest anti-infection programs and devices with long term data about failure rates.”
The petition cites a June 2006 publication of Consumer Reports, in which a study found five percent of respondents reported having an infection after implant surgeries. Some of those infections were of Methicillin-resistant staphylococcus aureus (MRSA), which can be lethal. Other postoperative infections cited were deep vein thrombosis (DVT), pulmonary embolism, and decubitus ulcer.
Consumers Union is an independent and non-profit organization that publishes Consumer Reports.
Source: Consumers Union, Citizen Petition to the U.S. Food and Drug Administration, December 11, 2007; “Drug-resistant bug raises new concerns,” Consumer Reports, June 2007.

