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Ethicon has initiated a worldwide withdrawal of the company’s morcellation devices because of the uncertainty over the risk-benefit profile of these devices when used in hysterectomies and myomectomies for women with fibroids, the company announced in a letter on July 30.
The withdrawal – which is voluntary – is an expansion of the company’s suspension of worldwide sales of these devices in April, following the Food and Drug Administration (FDA) announcement recommending that the use of power morcellation during laparoscopic hysterectomy or myomectomy to remove uterine fibroids should be "discouraged," because the procedure could spread cancerous tissue in women with an unsuspected sarcoma.
David M. Jaspan
In its letter, Ethicon stated that the company believes that its morcellation devices "perform as intended and there are patients who can benefit from procedures using laparoscopic power morcellators."
However, the letter adds that "the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures remains uncertain," and the company believes that market withdrawal "is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk."
The Ethicon withdrawal was announced less than 3 weeks after the FDA held a 2-day meeting of its Obstetrics and Gynecology Devices Advisory Panel to discuss the benefits, risks, and clinical role of laparoscopic power morcellators (LPMs) in the treatment of women with uterine fibroids.
Panelists also discussed strategies that might reduce the risks of morcellation disseminating cancerous tissue into the pelvis and abdomen of women with an unsuspected uterine sarcoma or leiomyosarcoma (LMS). Two panelists said that LPMs should not be used for gynecologic indications until better data are available, and during the open public hearing, Dr. Hooman Nourchashm, a cardiothoracic surgeon, reiterated his call for a worldwide moratorium on all gynecological tissue morcellation devices and on the practice of intracorporeal uterine morcellation during minimally invasive hysterectomy. He and his wife, anesthesiologist Dr. Amy Reed, who was diagnosed in 2013 with stage IV LMS after undergoing a hysterectomy with morcellation at the age of 40 for what was thought to be benign fibroids, are leading a campaign calling for the ban.
