FDA restricts use of device blamed for spreading uterine cancer, after news of patient deaths
Robotic surgery, including the use of an instrument known as a laparoscopic power morcellator, made it possible for many women to undergo hysterectomies with minimal pain and scarring and make a rapid recovery.
But for Linda Interlichia, who turned out to have an aggressive form of cancer rather than the benign uterine fibroids her initial doctor diagnosed, cutting up her uterus into tiny pieces that could be removed through a keyhole incision was a disaster, the Wall Street Journal (sub. req.) reported in a lengthy article last week.
The procedure left tiny pieces of the leiomyosarcoma in her abdomen that embedded and grew there, explained a second physician, Dr. Christopher Awtrey, following exploratory surgery a little over two months after the hysterectomy. He is the gynecologic oncology director at Beth Israel Deaconess Medical Center in Boston.
“That tumor, once morcellated, appeared to be like a small fire with gasoline on it,” Awtrey told the newspaper.
Interlichia’s hysterectomy took place in October 2013 and the exploratory surgery was done at the end of December.
On October 31 of this year she died at age 55.
Spurred by news coverage of high-profile cases, the U.S. Food and Drug Administration issued a statement in April discouraging the use of morcellators and urging doctors and patients to consider other, potentially safer, options, as the Wall Street Journal (sub. req.) reported at the time. That led to a suspension of sales by the manufacturer.
“The fact that the FDA released this warning makes it more likely that a doctor who went against it will be held to have practiced in a way below the standard of care,” said I. Glenn Cohen, a Harvard Law School professor who focuses on health policy and bioethics, at the time. “Second, this increases the chance that a patient may succeed in suing for a failure to get informed consent.”
In July, a morcellator recall was announced, as another Wall Street Journal (sub. req.) article reported.
And on Monday the FDA upgraded its warning, saying that morcellators should not be used for hysterectomies or fibroid removal “in the vast majority of women,” due to the risk of spreading cancer, the Associated Press reported.
However, Dr. William Maisel said the FDA did not ban the use of the device entirely because its benefits may outweigh the risks in some cases, such as women of childbearing age who need to have painful fibroids removed, reports the Boston Globe. He serves as deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.
Roughly 1 in 350 women undergoing hysterectomies are thought to have undiagnosed cancer and in recent years about 50,000 such surgeries were performed annually using morcellators.
