Consumers Union to FDA: Put More Warnings in DTC Device Ads
Consumers Union has sent a petition to the FDA asking the agency to require all direct-to-consumer (DTC) ads for implants warn consumers of possible infections or failures once the devices are implanted.
These devices include heart stents, cosmetic implants and knee, hip and heart valve replacements.
The consumer advocacy group pointed to a recent spike in ads for implantable devices and said a review of these ads shows that most lack basic information about the possibility of severe or fatal side effects.
The group wants clear warnings about the chance of infection during and following surgery and information on how long the devices will last once they are in the body, Bill Vaughan, senior policy analyst for Consumers Union, said.
H.R. 2900, the FDA Amendments Act of 2007, includes stronger authorities for the FDA to require pre-review and specific disclosures to ensure that consumers are warned in DTC advertisements about potential dangers and side effects.
The Consumers Union petition can be viewed at www.consumersunion.org/FDA%20PETITION-1.pdf.