Temporarily setting aside partisan politics to pursue the common goal of protecting Americans from highly dangerous medical practices, 12 members of Congress recently demanded that the U.S. Government Accountability Office (GAO) investigate a gynecological surgical device that spreads cancer in an alarming percentage of women. In the words of the letter’s authors, which include Representative Mike Fitzpatrick (R., Pa.) and Representative Louise Slaughter (D., N.Y.), “Hundreds, if not thousands of women in America are dead because of a medical device known as the laparoscopic power morcellator.”
FDA action, but was it timely?
The letter comes on the heels of a Food and Drug Administration warning that women who undergo morcellator-related procedures have an estimated 1 in 350 odds of carrying the type of cancer that the device can spread throughout the body. As a result of this risk, the FDA instituted a black-box announcement, its strongest warning, in November 2014, after which the largest manufacturer of the device, Johnson & Johnson, actually withdrew its morcellator device from the market. In the wake of this warning, scores of hospitals have reduced or eliminated morcellator-based procedures.
Approvals despite evidence?
Shockingly, the FDA has approved no less than 10 power morcellator devices in the last 24 years, notwithstanding evidence that the federal agency was aware that morcellators were capable of spreading potentially deadly cancerous cells. In its defense, the FDA claims that the extent of the risk was only recognized in late 2013.
So wrong for so long
The members of congress who signed the recent GAO letter, however, believe the FDA should have acted much more quickly to save lives, noting that the FDA’s warning came only “decades after some studies were already pointing to a serious problem.” The authors of the letter openly questioned, “How did [the FDA, the medical device industry, and many gynecologists] get it wrong for so long?” Only time will tell whether the GAO will heed their call and get to the bottom of a frightfully lax regulatory environment in which this risky surgical device was sold for close to a quarter of a century.