The Cancer Letter’s Coverage
Of the Power Morcellation Controversy
|Harvard Physician, Whose Cancer Was Spread Through Morcellation, Seeks to Revamp FDA Regulation of Medical Devices|
On Oct. 17, 2013, a surgical instrument called a power morcellator tore into the uterus of Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center, pulverizing what were believed to be benign fibroids.
Reed’s “minimally invasive” hysterectomy, a routine procedure, was performed at the Brigham and Women’s Hospital, a teaching hospital of Harvard Medical School.
Alas, Reed’s uterus contained an occult sarcoma, which the morcellator proceeded to spread through her abdominal pelvic cavity. Over ensuing months, as Reed battled to stay alive, her husband, Hooman Noorchashm, a cardiothoracic surgeon and, at the time, a lecturer at Harvard, waged a national campaign to put an end to the practice of power morcellation.
|Conversation with The Cancer Letter|
Challoner: We Recommended FDA Replace 510(k) Clearance
The Cancer Letter asked David Challoner, emeritus vice president for health affairs at the University of Florida, to discuss FDA’s 510(k) medical device clearance process.
The process has come under scrutiny after laparoscopic power morcellation procedures were found to spread previously undetected sarcomas inside benign fibroids.
Challoner chaired an Institute of Medicine committee tasked by FDA and Congress in 2009 to review the 510(k) approval process.
|Bertagnolli: Why Brigham Stopped Making Morcellation Available Outside of a Registry Trial|
“We know that this improves patient care,” Bertagnolli said in an interview with Matthew Bin Han Ong, a reporter with The Cancer Letter.
“In a case such as this one, close communication between the oncology and general gynecology communities is a key requirement for reducing morbidity and deaths due to uterine sarcomas.”
In a heated two-day hearing, several members of an FDA advisory panel on medical devices expressed low confidence in power morcellation as a treatment for uterine fibroids, and focused on alternative methods for performing hysterectomies and fibroid removal.
There was no formal consensus on either an outright ban on power morcellators or issuance of a “black box” warning label.
GYN Group: Open Surgery Would Cost More Lives than Morcellation
More women would die from open surgery each year if the FDA decides to ban power morcellation, said Jubilee Brown, an associate professor at MD Anderson Cancer Center and a spokesperson of the American Association of Gynecologic Laparoscopists.
|J&J Withdraws Power Morcellators, Citing Risk of Disseminating Cancer|
Ethicon, the Johnson & Johnson subsidiary that manufactures nearly three-quarters of laparoscopic power morcellators on the market, has requested a withdrawal of the controversial devices.
“Immediately review inventory to determine if you have any Ethicon Morcellation Devices which are the subject of this market withdrawal,” the company wrote in a letter to hospitals worldwide.
“If you have provided Ethicon Morcellation Devices to any hospital within your system, you are responsible for notifying the appropriate parties immediately,” said the letter dated July 31.
|Device Maker Threatens Legal Action Against Doctor Who Launched Campaign to End Power Morcellation|
Setting decorum aside, Hooman Noorchashm has been haranguing FDA, Congress, and the gynecology and oncology profession into partial abandonment of the procedure. Though he hasn’t sued anyone, several law firms are looking for women harmed by the procedure who would be willing to take part in litigation.
As an apparent result of this campaign by Noorchashm and his wife Amy Reed, top institutions—including Brigham and Women’s Hospital, where Reed underwent the procedure—are moving away from routine use of morcellation, and some insurers are refusing to pay for the procedure.