Consumers Union Wants Warnings on Ads for Medical Devices, Implants
December 18th, 2007 amy
Per a recent press release, Consumers Union has filed a petition with the FDA requesting it require all advertisements for implantable devices — such as knee, hip and heart valve replacements, cosmetic implants and heart stents — carry a warning about the possibility of dangerous infections or failures of the devices once they are in the body.
Implantable device makers recently have launched a wave of direct-to-consumer advertisements for their products, and Consumers Union said a review of these ads show that most lack basic information about the possibility of severe or fatal side effects.
“There is no question that many of these devices can restore high quality-of-life in patients, but we are concerned that serious and possibly deadly side effects like infections are consistently understated in these device ads,” said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports.
“We are asking the FDA to require clear warnings about the dangers of infection during and following such surgery, and information about how long the devices are likely to last once they are in the body,”
Vaughan said.
