The U.S. Government Accountability Office said it would investigate the controversy stemming from wide use of power morcellators, gynecological devices now known to spread undetected cancers during hysterectomies and myomectomies.
The GAO’s Sept. 4 move comes after 12 members of Congress wrote a letter requesting an investigation.
“Hundreds, if not thousands, of women in America are dead because of a medical device known as a laparoscopic power morcellator,” the legislators said in the letter Aug. 7. “This device can take a Stage 1 treatable cancer immediately to a Stage 4 terminal cancer. For too many women, this routine procedure ended with a death sentence.”
The letter was signed by Reps. Mike Fitzpatrick (R-Pa.), Louise Slaughter (D-N.Y.), Ralph Abraham (R-La.), Rosa DeLauro (D-Conn.), Bill Pascrell, Jr. (D-N.J.), Lou Barletta (R-Pa.), Doug LaMalfa (R-Calif.), Anna G. Eshoo (D-Calif.), Jan Schakowsky (D-Ill.), Chris Smith (R-N.J.), Stephen Lynch (D-Mass.), and Rick Larsen (D-Wash.).
FDA severely limited the use of power morcellators in November 2014, a year after patient advocates Amy Reed and Hooman Noorchashm launched a vigorous campaign that drew FDA’s attention to the issue (The Cancer Letter, ).
The GAO investigation comes on the heels of an FBI probe in May. The FBI is reportedly trying to establish whether Johnson & Johnson—one of the largest manufacturers of power morcellators—knew as early as nine years ago that the gynecological device can disseminate uterine cancers (The Cancer Letter, ).
It’s not publicly known whether a formal FBI investigation has been launched.
The 12 lawmakers appear to be asking the same questions:
“Despite the long history of this device, only recently has the FDA put out guidance that the use of laparoscopic power morcellators increases the risk of spreading unsuspected cancers in women to as high as 1 in 352 cases,” they wrote in the letter to GAO. “As of the date of this letter, the morcellator remains on the market.
“It is unclear exactly how many women may be dead as a result of an unsuspected cancer having been spread by this device. FDA’s warning came decades after some studies were already pointing to a serious problem.
“Despite these studies, as late as last year, the FDA, the medical device industry, and many gynecologists pointed to the risk of a hidden cancer as being low, only one-in-10,000.
“How did they get it wrong for so long?
“In light of these concerns we respectfully request you investigate the root cause failure that ultimately led to the FDA’s black box warning on the use of laparoscopic power morcellators in Nov. 2014—over two decades after it was first approved.”
The legislators asked GAO to consider four questions:
1. Did the FDA’s reliance on the 510(k) approval policies and procedures sufficiently identify risks of adverse events before the laparoscopic power morcellator was allowed to enter the market?
2. Were the medical device reporting regulations (21 CFR 803) appropriately followed to protect patient safety in the case of the laparoscopic power morcellator by manufacturers, importers, user facilities, and the FDA?
3. What activities or training did manufacturers provide to clinicians and what professional society standards, if any, apply to training on the use of these devices?
4. What steps is the FDA taking after issuing the black box warning to further determine whether the laparoscopic power morcellator is safe to remain on the market?
The work requested by the members of Congress falls within the scope of GAO authority, a GAO spokesperson said to the Wall Street Journal. The investigation should begin in about five months, and FDA has agreed to cooperate.