An insurance industry trade group is pushing the U.S. Congress to take another look at medical device regulation, in the wake of mounting concerns over the use of power morcellators in uterine surgeries.

According to a letter sent by America’s Health Insurance Plans (AHIP) to U.S. Senator Robert Casey (D-PA), the current situation involving power morcellators has exposed “serious gaps in the device safety infrastructure and the critical need to strengthen the pre-and post-market review and approval process.” In particular, the letter calls on Congress to strengthen the U.S. Food & Drug Administration’s (FDA) 510(K) clearance program.

FDA and Power Morcellators

Power morcellators, which are used to cut tissue into small pieces during minimally-invasive hysterectomies and myomectomies, were first approved by the FDA under the 510(k) program. This process does not require that a device undergo human testing if a manufacturer can show it is “substantially equivalent” in design to another product that was previously approved by the agency.

In April 2014, the FDA issued a safety alert concerning power morcellators, which discouraged doctors from using the devices during hysterectomies and myomectomies because of the possibility that they might disseminate undetected uterine cancer cells throughout a woman’s body. Then in November, the FDA issued a second alert warning doctors not to perform uterine morcellation in the majority of women who require hysterectomy and fibroid removal surgeries.

This is not the first time the FDA’s 510(k) program has come under scrutiny. In 2011, the Institute of Medicine called for its elimination, after concluding that the program does not reliably screen devices for safety and effectivness. An investigative report published by ProPublica the following year also noted that a number of medical devices, including transvaginal mesh implants and certain metal hip devices, had been linked to serious safety concerns years after being cleared for sale via the 510(k) process.

Contact a Power Morcellator Lawyer Today

A number of morcellator lawsuits have been filed in U.S. courts on behalf of women who allegedly experienced the spread of uterine cancers due to these devices. If you or a woman you loved were diagnosed with uterine sarcoma, leiomyosarcoma, or any other gynecological cancer after undergoing a morcellator hysterectomy or myomectomy, you may be entitled to file your own claim. To learn more, please call 1-877-779-1414 for a free, no-obligation review of your case.

Published April 20, 2015 by