Advertisements for Medical Devices, Implants Should Carry Warnings of Dangerous Side Effects, Infections

Consumers Union petitions FDA to require clearer warnings on DTC device ads


WASHINGTON, DC - December 17 -- 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’re 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.

Click here to read the full petition to the FDA.

In light of the rising rate of MRSA and other hospital-acquired infections for surgical patients, CU is requesting device advertisements disclose the potential risk of infection and urge patients to ask their doctor and hospital about infection rates at the facility where the surgery will be performed. Nearly 100,000 people die each year from hospital-acquired infections, and CU is supporting national infection-reporting and prevention legislation (HR 1174, HR 4214 and S 2278).

The Centers for Disease Control infection surveillance report shows hip and knee prosthesis surgery to be a serious source of infection, in some cases a high-risk source, and in some of the reporting hospitals, the infection rate may run as high as 5 percent or more.

Another recent study of 2003 nationwide data for primary total, partial, and revision hip replacements found the rates of readmission for any cause within 90 days of surgery ran between 9 percent for total replacement to 21 percent for partial.

“We do not want to discourage those in pain and facing loss of mobility from seeking out medical advice on implants. But we do believe that unintended side effects, which can include death, can be minimized if the public is better educated to avoid facilities which are not practicing the highest level of anti-infection practices,” Vaughan said.

“Placing information about the danger of infection from surgery in device advertisements will speed the day that America’s surgical centers and hospitals address this life-and-death problem,” he added.