Most people assume medical devices are rigorously tested by the Food and Drug Administration (FDA)— like new drugs are — before being approved for use. In fact, most high-risk devices are not. According to a new article, medical interventions “are now the third-leading cause of death in the United States, and devices play an increasing role in that statistic.”
Nearly 32 million Americans have at least one medical device implanted — surgical mesh, pacemakers, artificial joints, defibrillators, heart valves, implants, birth control devices, etc. So how is it possible these devices aren’t subject to clinical trials and tests? There are two reasons. Medical devices weren’t subject to FDA regulatory control until 1976. When regulation began, the FDA created the 510(k) provision that grandfathered all existing devices on the market. Today, when a manufacturer markets a new device, they aren’t required to undertake any clinical testing as long as the device is “substantially equivalent” to an existing device. Manufacturers also can avoid testing by claiming that they made a “minor change” to an approved device.
This has allowed faulty hip replacements (a Johnson & Johnson model can leak cobalt, which may harm muscles near the hip and throughout the body) to hit the market. Minor changes to the lead wires in a Sprint Fidelis defibrillator resulted in the wires fracturing and harming or killing patients. Even when it’s possible to replace a medical device with a different option, the surgery can be risky — leaving the patient to assume more risk.
These lax regulations have led to increases in medical device recalls — 117 in 2016. If you, or someone you love, has been affected by a faulty medical device, contact us. We can help you review your rights and work together to ensure you receive the compensation you deserve.
If you would like to learn more about this dangerous trend in the medical device industry, you can listen to this interview with Jeanne Lenzer, an investigative medical journalist, who recently published “The Danger Within Us.”
