Medical Devices and Consumer Safety

Imagine a country where air travelers, cell phone users, and cable tv customers are safer than patients who receive potentially life-saving medical devices. According to Dr. William Maisel, a prominent cardiologist, that country is the United States of America. In an article published in the New England Journal of Medicine, Maisel faults the FDA’s regulatory measures and zeroes in on Medtronic’s Sprint Fidelis heart defibrillator lead to illustrate his point. Maisel is particularly critical of FDA’s 2004 approval of Sprint Fidelis without adequate human testing. Medtronic’s lack of post-marketing data concerning Sprint Fidelis’ effectiveness and safety only exacerbated the problem. These factors coupled with the huge popularity of Sprint Fidelis among doctors meant that 90% of Medtronic defibrillators implanted since 2004 were Sprint Fidelis defibrillators. While Maisel focuses his attention on the Sprint Fidelis defibrillaor problem, the same problems exist with other medical devices such as the Kugel Mesh hernia patch whose recoil ring collapses and fails as well as Stryker Corporation’s Trident hemispherical and Trident PSL Shells hip replacement devices. These faulty medical devices cause untold human suffering because the companies don’t spend the time nor the money to test them adequately and the FDA has not been able to properly regulate them. In the end, consumer safety suffers.