Wednesday, July 9, 2014

FDA to scrutinize cancer risks of uterine surgical device

YouTube courtesy:Smith & Nephew Digital Communications
CANCER DIGEST – July 9, 2014 – Sale and use of a device used in a minimally invasive surgery to remove uterine fibroids, called myomectomy, and to perform hysterectomies has been suspended pending a FDA advisory committee meeting July 10 and 11. The committee will examine recent cases linking the device to the spread of a rare cancer. The device is a laparoscopic morcellator, which is used to cut fibroid and uterine tissue into small pieces that can be removed through a small incision. The device has been used since the early 1990s to perform more than 50,000 hysterectomies or myomectomies each year. In an alert issued in April, the FDA estimated that 1 in 350 women undergoing such procedures is found to have unsuspected uterine cancer. “If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma,” the alert stated, “there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.” Some hospitals have suspended the use of the device and Johnson & Johnson, the largest manufacturer of the device, has halted sales, distribution and promotion of the device until FDA’s investigation is completed and the role of the device in these procedures is redefined.

No comments:

Post a Comment