Medical device ads should require infection risk warnings

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Testimony of Ami Gadhia
Concerning the Direct-to-Consumer Advertisements
for Implantable Medical Devices
Special Committee on Aging
United States Senate
September 17, 2008

Good morning, Chairman Kohl, Ranking Member Smith, and members of the Committee. My name is Ami Gadhia, and I am Policy Counsel with Consumers Union, the non-profit publisher of Consumer Reports magazine. I am here today to testify about direct-toconsumer (DTC) advertisements for implantable medical devices and the safety and health concerns related thereto. Consumers Union commends the Committee for holding today’s hearing on this critical consumer safety issue.
I. INTRODUCTION
Most people are familiar with direct to consumer, or “DTC” advertisements for prescription drugs. We see them on television almost every day, marketing a broad array of pharmaceuticals. Now, DTC ads for implantable medical devices such as knee and hip replacement hardware and heart valves, are also appearing on our televisions. Unfortunately, injuries and deaths related to medical devices are also manifesting themselves. In a December 2007 article entitled, “Medical devices: Problems on the rise,” our publication Consumer Reports noted that “reports of deaths linked to medical devices are at an all-time high, with 2,712 fatality reports in 2006, more than double the number in 1997.”
The Consumer Reports article also notes that in September 2007, “FDA issued its own report for its fiscal year 2006, saying it had seen a 25 percent increase in adverse events linked to medical devices over FY 2005, including 2,830 deaths, 116,086 injuries, and 96,485 device malfunctions.”
A number of studies show significant injury, including healthcare-acquired infections (HAIs), following implant surgeries. Both HAIs and device failure can and do cause death or serious morbidity and expense.
These injury and death statistics point to the need for regulation of the claims made in, and the warning information transmitted through, the advertising of the devices. While FDA review and regulation of DTC prescription drug advertisements are still in their infancy, the agency currently conducts almost no oversight of DTC advertisements for implantable medical devices. Consumers Union thus strongly urges Congress to require FDA to conduct the same oversight and regulation of DTC ads for implantable medical devices as the agency is now authorized to do for DTC drug ads as well as expand their review of all of these ads. I will explain the scope of the problem with DTC advertising for medical devices, and then I will discuss CU’s recommendations to address the problem.
For the complete testimony, click here (PDF format).