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Hysterectomy Device Recalled Amid Cancer Warnings

Hysterectomy Device Recalled Amid Cancer Warnings

August 1, 2014 — Johnson & Johnson on Wednesday asked surgeons to stop using its laparoscopic power morcellator amid growing concerns about the device's potential to unintentionally spread deadly cancers during hysterectomies, the AP/USA Today reports (AP/USA Today, 7/31).

The company -- which suspended sales of the device in April after FDA advised doctors not to use it -- is sending customers a letter asking them to return the morcellators (Kamp/Levitz, Wall Street Journal, 7/30).

Background

Laparoscopic power morcellation was developed as an alternative to invasive surgery for women with symptomatic uterine fibroids, which are responsible for about 40% of the 500,000 hysterectomies performed each year in the United States. It uses a power device to grind uterine tissue so it can be removed through a tiny incision and is used in about 50,000 procedures annually in the United States.

The technique has come under fire for its potential to spread a type of cancer -- known as a uterine sarcoma -- within the body. A study published last week in the Journal of the American Medical Association estimated that one in 368 women undergoing morcellation had uterine cancer that was undetected until after the procedure.

Earlier this month, an FDA advisory panel said that there are no proven ways to use morcellation for hysterectomies and fibroid removal without risking the spread of malignant cancers to other parts of the body. FDA takes its panelists' recommendations into account when making regulatory decisions, but it has not announced a timeline for making a determination about the use of morcellation (Women's Health Policy Report, 7/24).

Details of J&J Recall

Johnson & Johnson's Ethicon unit, the world's largest manufacturer of laparoscopic morcellators, decided to pull the device from the global market because of the "continued uncertainty" surrounding its use, according to spokesperson Matthew Johnson.

"Ethicon believes that a market withdrawal of Ethicon morcellation devices 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," he says (Fay Cortez, Bloomberg, 7/31).

Smaller manufacturers of morcellators, which include German companies Karl Storz GmbH and Richard Wolf GmbH, have not announced plans for the devices (Wall Street Journal, 7/30).