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# Power Morcellator Controversy a ‘Reminder’: Sharfstein
- URL: https://www.fdaweb.com/power-morcellator-controversy-a-reminder-sharfstein/
- Published: 2017-06-29T12:00:00.000Z
- Updated: 2026-09-14T22:32:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139064

Former FDA associate commissioner **Joshua Sharfstein** says the controversy involving power morcellators and the risk of unexpected uterine sarcoma “serves as a reminder that every procedure and medical device has the potential for both benefit and harm.” [Writing](http://jamanetwork.com/journals/jama/fullarticle/2642831?amp;utm%5Fsource=JAMAPublishAheadofPrint&utm%5Fcampaign=29-06-2017&ref=fdaweb.com) in the *Journal of the American Medical Association*, Sharfstein and two other researchers review FDA’s actions in first issuing a safety communication discouraging use of the devices for the removal of fibroids and then issuing a Boxed Warning on the devices.

The authors note that some critics said FDA should have removed the devices from the market altogether, while others said that patients should be given an opportunity to weigh the risks of power morcellators versus alternative surgical approaches.

“The dispute reveals, in part, that there remain competing views about how regulatory decisions should be made about the use of medical products as evidence emerges on safety risks,” the article says. “But it also indicates how such ideological disagreements become more prominent when there is a lack of evidence on risks and benefits at the time of approval, coupled with a lack of ongoing data collection to address key questions….In the setting of uncertainty over power morcellators, FDA shared its best judgment and advice with patients and clinicians, discouraging use of the device while leaving room for individual patients to be able to access the technology. Like many positions by the agency, this action reverberated across the healthcare industry and raised concerns among many on both sides of the policy question.”

The researchers say that physician and patient frustration should not only be directed at FDA. They note that the agency does not bear sole responsibility for the current situation of lack of sufficient data to support and inform use of many high-risk and implanted devices such as the power morcellator. Responsibility is shared with the clinical community, they write, which often resists requirements to report data; with manufacturers, which often oppose strong premarketing and postmarketing requirements; and with payers, which often do little with the major data assets they control.

The article opens with a statement that significant changes are coming to FDA as a result of the 21st Century Cures Act, appointment of a new commissioner, and the context of a White House administration intent on reducing regulations. It concludes that “every system is perfectly designed for the results that it achieves. Until a postmarketing surveillance approach for medical devices is established that can answer essential questions quickly, clinical medicine will remain in data purgatory, vulnerable to the next dispute over the safety of a new device or medical technology. Escaping this state requires recognizing that a common ground exists beyond ideological debates about regulatory decision making: strong data requirements that benefit patients, physicians, and industry alike.”