Consumers Union wants more warnings on device DTC ads

Medical Product Outsourcing, Jan-Feb, 2008

A recent move by the Consumers Union (CU), based in Yonkers, NY--an non-profit advocacy group perhaps most recognized for publishing Consumer Reports magazine--targets medical device direct-to-consumer (DTC) advertising.

The group recently sent a petition to the FDA asking the agency to require all direct-to-consumer (DTC) ads for implants to warn consumers of possible infections or failures once the devices are implanted.

Devices targeted by the petition include heart stents, cosmetic implants and knee, hip and heart valve replacements. The CU pointed to a recent surge in device-related ads and said a review of these ads shows that most lack basic information about the possibility of severe or fatal side effects.

According to the petition, the quality of healthcare facilities in preventing infections varies. Some healthcare facilities make patient warnings and implant information available to the public as a result of state laws or voluntary disclosure, but others don't. To ensure consistency, the group asked the FDA to consider that implanted device advertisements include a warning such as the following:

"The surgery and care involved in the placement of this device may result in an infection, or other adverse events, that can lead to death or injury. Be sure to ask your doctor and hospital about infection rates at the facility where the surgery will be performed. In addition, ask your doctor about the long-term failure rates so that you are aware of when the implant is likely to need to be replaced."

The group highlighted its concern that the danger of adverse side effects--including death--are"consistently understated" in DTC advertising. As a longer-term goal, the CU hopes the FDA will review the quality of all medical device ads. However, for purposes of the petition, the CU only asked that consumers be given clear warnings about the dangers of infection during and following implant procedures and information about how long the devices are likely to last. The group also recommended that consumers be advised to seek healthcare facilities with the strongest anti-infection programs and devices with long-term data about failure rates.

The recently passed FDA Amendments Act of 2007 provides the FDA with stronger authority require pre-review and specific disclosures to ensure that consumers are warned in DTC advertisements about potential dangers and side effects.