More Scrutiny for Laparoscopic Power Morcellator Procedures | Medical Devices and Equipment | JAMA | JAMA Network
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News From the Food and Drug Administration
February 16, 2021

More Scrutiny for Laparoscopic Power Morcellator Procedures

JAMA. 2021;325(7):613. doi:10.1001/jama.2021.0923

In an updated safety communication, the FDA recommended that clinicians who perform laparoscopic power morcellation for gynecologic procedures should do so with a legally marketed containment system to prevent unsuspected cancer from spreading within the abdomen and pelvis.

The agency also issued final labeling guidance suggesting that manufacturers include a boxed warning to point out that the devices may spread cancer and decrease patients’ long-term survival.

In addition to avoiding laparoscopic power morcellator use in women with suspected or confirmed cancer, the FDA also recommended against using the devices for fibroid removal in postmenopausal women or women who are older than 50 years due to the increasing risk of cancer as people age. Use of the devices also is contraindicated in women who are candidates for en bloc tissue removal through the vagina or with a minilaparotomy.

If laparoscopic power morcellation is performed without a containment system, the FDA warned that the device also may spread benign uterine tissue such as parasitic myomas and disseminated peritoneal leiomyomatosis, which could necessitate additional surgery.

The FDA has grappled with morcellator guidance since 2014, when its Obstetrics and Gynecology Devices Advisory Committee met to address the devices’ cancer risk. The committee concluded then that a boxed warning would be a useful but insufficient step to protect patients from the risk of inadvertently spreading unsuspected cancer during fibroid removal.