Left to Their Own Devices: How the Dangers of Power Morcellators Went Undetected by FDA for Two Decades

摘要

The power morcellator, a device for cutting tissue, was once a mainstay of minimally-invasive gynecological surgery. The devices were cleared by FDA through the 510(k) process and remained on the U.S. market for over twenty years. In 2013, a deadly risk associated with power morcellators came to the attention of FDA: in women with hidden uterine cancers, the devices were disseminating cancerous tissues throughout their bodies, severely accelerating the disease and harming their chances of survival. Though FDA had been aware of this potential problem associated with the devices, the magnitude of the risk had been severely underappreciated, leaving hundreds of women exposed to a dangerous procedure without any disclosure by their physicians of the potential for spreading cancer. Subsequent investigations by the media and the Government Accountability Office uncovered weaknesses in FDA's regulatory approach, with significant deficiencies in postmarket reporting and data collection hampering the agency's ability to ensure the safety and efficacy of medical devices. However, these accounts did not consider two additional gaps that led to the morcellation crisis, both of which fall primarily on the physician side, rather than the regulatory side, of the medical device world: first, the failure by doctors to fulfill their obligation to report adverse events, and, second, potential deficiencies in the training of gynecologists that have led to overly siloed practices. In order to truly empower FDA to identify and address problems with medical devices while still permitting a robust flow of potentially life-saving medical devices to the U.S. market, a holistic approach bridging gaps on both the regulatory and clinical sides of the medical device world is necessary.