An insurance industry trade group has implied that the U.S. Food & Drug Administration (FDA) 510(k) clearance program may be partly to blame for the safety crisis involving power morcellators. America’s Health Insurance Plans (AHIP) is now asking Congress to reform the program, which has allowed morcellators and other medical devices to come to market without the benefit of human testing.
In November, the FDA warned that power morcellators should not be used in the majority of women who require hysterectomy and myomectomy surgeries, because of the risk that the devices might disseminate undetected uterine cancer cells as it shreds tissue and fibroids. According to The Wall Street Journal, the FDA was aware of this potential in 1991 when it cleared the first morcellator for sale in the U.S., but only recently has the true magnitude of this risk become apparent.
The power morcellators currently on the market were all approved for sale via the FDA’s 510(k) program, which does not require human testing for device that are shown to be “substantially equivalent” to a product that is already on the market.
In an April 14th letter to U.S. Senator Robert Casey (D-PA), the AHIP asserted that the power morcellator controversy reveals weaknesses in how devices are cleared for use and monitored once they are on the market.
“As Congress continues to explore ways to promote biomedical innovation, we urge discussion around strengthening the 510(k) process and post-marketing assessment of medical devices, including power morcellators,” the letter states. “Requiring post-marketing review will greatly improve our ability to identify adverse events and to act more rapidly when safety issues are identified. Had this been required for morcellators, safety issues would have been identified much sooner.”
The debacle involving power morcellators is just the latest medical device controversy to raise questions about the 510(k) protocols. Other worrisome products cleared through this program have included transvaginal mesh and metal-on-metal hip implants. In 2011, the Institute for Medicine even concluded that the 510(k) program should be eliminated because the system is incapable of ensuring that devices are safe and effective.
Like transvaginal mesh and metal hip implants, power morcellators are now the subject of lawsuits that claim the devices were not subjected to adequate testing. Morcellator lawsuits also take issue with the FDA’s 510(k) program.