We write to ask to join us in the reintroduction of the Medical Device Guardians Act, legislation that will address medical device safety shortfalls and reporting processes failures that have allowed women across America to be devastated by a medical device known as the power morcellator.
The power morcellator is a device used for hysterectomies and to treat uterine fibroids by grinding them up, or morcellating them. The device was first cleared by the FDA for use more than two decades ago. But since its use in gynecological procedures, the blades of the morcellator would spread an undetectable fibroid cancer throughout the body, like shrapnel – taking Stage 1 cancers immediately to Stage 4. For hundreds, if not thousands of women, what was supposed to be a routine procedure ended with a death sentence.
Despite cancer being spread by the blades of this device, no one ever reported this deadly safety defect to the FDA, that is until Amy Reed, a mother of six, and a doctor, underwent morcellation and had cancer spread throughout her body. Her patient report to the FDA was the first adverse event report ever received by the FDA regarding morcellators, despite her same hospital having a patient harmed by a morcellator one year earlier. After that initial report, hundreds followed. Those reports ultimately led the agency to issue its strictest safety warning about the use of the device, and manufacturers stopped marketing morcellators and insurers stopped covering the unsafe device. Amy is struggling to survive and while other victims, like Bonnie Davis of Pittsburgh have tragically passed away.
This year, the GAO released a long-awaited report investigating the approval process for this device and the critical shortfalls in the medical device adverse reporting system that allowed procedures to continue without women knowing of the potential consequences of power morcellators. In retrospect, it should not have fallen on patients to get the FDA’s attention. Everyone in the chain of care should have a responsibility to inform the FDA of death and serious injury caused by devices – from the manufacturer who creates the device, to the hospital who oversees the procedure, to the doctor who ultimately uses the device.
Some may consider this bill too burdensome for doctors, or it opens them up to liability. Not true. This bill simply codifies an existing mandate of the American Medical Association’s Code of Medical Ethics, which recognizes that physicians are in the best position to identify and report unsafe devices.Today, reporting unsafe devices to the FDA is as easy as downloading an app on a smart phone. Additionally, the bill adds physicians’ reports to the list of groups, like hospitals, that are protected from having their reports to the FDA used against them in a civil case.
While it is too late to protect those harmed by morcellators, this reasonable fix can help protect thousands of other patients throughout the country by incorporating doctors into the medical device safety reporting system.