Most medical devices are approved without a lot of evidence regarding whether they work and are safe. Many go through what is known as the 510(k) approval process, an accelerated procedure that allows manufacturers to avoid conducting safety studies if they say a device is substantially equivalent to another that is already on the market. When medical devices are found to cause harm, the U.S. Food and Drug Administration (FDA) typically calls for stronger warnings or restricted use but usually no recall, and the devices continue to be sold, no matter the injury they may have caused.
But media coverage of the shortcomings associated with medical devices on the market is having an effect regarding policing them, even when current regulations do not:
- Pressure coming from Facebook community pages regarding the dangers of the permanent birth control device Essure in which more than 20,000 women shared their negative experiences are believed to be part of the reason why an expert panel convened by the FDA to publicly examine the device, something more than 5,000 complaints to the agency did not do. After a study on Essure was released this month in the British Medical Journal (BMJ), news outlets such as Reuters, the Wall Street Journal, NBC, and the Philadelphia inquirer all ran stories, and a New York Times editorial called for the FDA to suspend sales of the device until more data is available.
- NBC recently ran a two part-series on the C.R. Bard Recovery filter, reporting that the filter could migrate through the body and perforate the heart, and had caused 27 deaths and 300 non-fatal medical issues. The NBC report included startling details, including how one employee refused to sign off on the FDA approval application because of unresolved safety issues.
- Hooman Noorchashm, a cardiothoracic surgeon, spent years trying to get the power morcellator off the market after his wife discovered that she has a rare form of uterine cancer thought to have been spread by the morcellator. He did not have much success until the Wall Street Journal ran a February 2014 report on the dangers of morcellation. Since the report, one manufacturer has pulled the product from the market and the FDA issued a black box warning, the strictest cautionary label a product can carry.
As the 21st Century Cures Act moves closer to becoming law, media vigilance over medical devices will be even more important, since under the Act, devices will get even less regulatory scrutiny than they get now.