The laws regarding the reporting of potentially defective medical devices are spotty at best. Doctors themselves are not required to report adverse events to the FDA. Their participation is completely voluntary. However, hospitals are required to report any adverse events, but according to a recent report, hospitals are grossly underreporting numbers. This leaves the issue of reporting up to the manufacturer, an entity far less likely to proactively admit its own device defects to a federal agency. The FDA is giving power back to patients with a new website where anyone can report adverse events related to medical devices through a completely online process.
The FDA has been criticized for being slow to react to issues stemming from defective medical devices like the power morcellator and the Essure contraceptive device, but it’s not entirely the FDA’s fault. In the case of power morcellators, the device was on the market for more than ten years before any doctor reported to the FDA that the device inadvertently spread cancerous cells throughout the body.
By the time the FDA started investigating the power morcellator, thousands of women had already suffered from the device’s cancer spreading side effects. A patient-based reporting website could have also helped in identifying the Essure contraceptive as a dangerous device. This past March, the FDA gave Essure a black box warning, the most severe warning issued for medical devices. Had the FDA issued the warning earlier, many women would have decided not to expose themselves to the risks associated with the device.
If patients are allowed to report adverse events and side effects themselves, the FDA will better understand the safety and efficacy of medical devices on the market. The new website will also allow patients to file complaints regarding other types of misconduct by device companies, including false advertising, illegal marketing, and failure to meet manufacturing standards, among others.