New legislation seeks to identify medical device problems as early as possible. Under the Medical Device Guardians Act of 2016, introduced by U.S. Reps. Louise Slaughter, D-N.Y. and Michael Fitzpatrick, R-Pa., physicians would be required to report medical device injuries and complications to the U.S. Food and Drug Administration (FDA). Federal regulations already require doctors to report adverse events related to medications, but only hospitals and manufacturers are required to report medical device issues.
The bill was introduced in light of safety concerns surrounding power morcellators, tools used mince up tissue in minimally invasive gynecologic procedures, such as a hysterectomy or myomectomy (uterine fibroid removal). In the past few years, it became public knowledge that power morcellators can spread an undetected uterine cancer, greatly advancing the cancer and worsening a patient’s prognosis. Evidence has suggested this risk since power morcellators were introduced in the 1990s, but the dangers were not well-known until husband-and-wife physicians, Hooman Noorchashm and Amy Reed, shared their own personal story in 2013.
In some women, a presumed uterine fibroid is actually a type of cancer known as a uterine sarcoma. Unfortunately, there is no way to reliably test for this cancer prior to surgery. At the time Amy Reed underwent her procedure, it was believed that the risk of a hidden uterine cancer was extremely rare; 1 in 10,000. In the aftermath, however, Amy and her husband conducted their own research and discovered that the risks are substantially higher. They have made it their mission to ban morcellators from the market and raise awareness about the possibility of advancing, or “upstaging” cancer through power morcellators.
In 2014, the U.S. Food and Drug Administration (FDA) warned that 1 in 350 women undergoing a procedure to remove uterine fibroids had an unsuspected sarcoma. The agency discouraged the use of power morcellators in these procedures, and placed a “black box” warning on the devices,
In introducing the legislation, sponsors say it should not have fallen on patients (referring to Amy Reed) to raise awareness about the safety risks of power morcellators. The Government Accountability Office has agreed to investigate power morcellators, in response to a request from Slaughter.
The new bill also protects doctors against civil action related to reports. It seeks to “require physicians and physician’s offices to be treated as covered device users required to report on certain adverse events involving medical devices, and for other purposes.” This means that physicians’ reporting of medical device hazards could not be used against them in a civil lawsuit.