American Recall Center
Oct. 30, 2014
Dr. Hooman Noorchashm, an outspoken critic of the use of power morcellators in gynecological operations, recently published an open letter calling for the resignation of Dr. William Maisel, the deputy director and chief scientist at the FDA’s Center for Devices and Radiological Health (CDRH). Dr. Noorchashm, a cardiothoracic surgeon at Brigham & Women’s Hospital and surgical lecturer at Harvard University, accuses Dr. Maisel of a conflict of interest.
As it pertains to the deadly hazard of gynecological morcellators in the United States and abroad, your primary stated mission as a strong industry advocate represents a clear conflict of ethical interest in guaranteeing patient safety. Under your leadership, the CDRH has failed to call for a ban on power morcellators, nearly two months after the data was clearly delineated and the victims presented at the FDA advisory – nearly one year after we raised an alarm from Boston, MA.1Dr. Noorchashm has been a central figure in the fight to ban power morcellation. When the FDA issued a safety communication recommending that patients talk with their doctors about power morcellation, Dr. Noorchashm criticized the FDA for not going far enough, arguing that a forced recall of power morcellators should be issued rather than simply advising people to talk with their doctors. To date the FDA has not issued such a mandatory recall, although Johnson & Johnson did voluntarily withdraw its Ethicon morcellation devices from the market, and several insurance providers have stopped covering morcellators as a surgical tool.
In his latest communication, Dr. Noorchashm accused the FDA of deliberately dragging its feet on a potential power morcellator ban.
It is now our understanding that the FDA may be delaying a final statement. This delay in a ban on power morcellators by the FDA is occurring despite the overwhelming evidence of deadly hazard. And many industry advocates appear to have been assured that FDA will not be banning the power morcellators from market.Dr. Noochashm has called for Dr. Maisel “to do right by all those women harmed, resign from the CDRH and relinquish the responsibility to protect the public’s health to those of your colleagues at FDA with capacity and patient safety foremost in their highest priority.” The letter appeared as part of Dr. Noorchashm’s larger effort to build awareness about health risks related to power morcellation, which includes a petition on Change.org.
[It seems] increasingly clear that this lethargy in FDA action to protect the public is directly related to industry lobby to which you, as a CDRH leader, have clearly stated your loyalty in the press.
For Dr. Noorchashm, the power morcellation issue is both a matter of public health and one of personal interest. His wife, Amy Reed, an anesthesiologist at Beth Israel Hospital in Boston, received a morcellator-assisted hysterectomy in October 2013. A few days later, Dr. Reed learned that she had leiomyosarcoma, a rare form of soft-tissue cancer, and that the morcellation procedure may have worsened her prognosis. Since then, Dr. Noorchashm has been on a campaign to ban the use of power morcellators altogether.
Although it’s hard to predict how the FDA will respond to Dr. Nooschashm’s latest call for Dr. Maisel’s resignation—if the agency responds at all—the letter does seem to have drawn some attention to this important issue. Power morcellation has been discussed in recent days on popular shows like The Dr. Oz Show, and a number of articles have appeared in reputable publications like The Wall Street Journal and various health news outlets. Even if Dr. Maisel does not resign as Dr. Noorchashm wishes, at least more people are now talking about the potential problems of power morcellators.