Uterine sarcoma (a type of cancer) is more common in women undergoing surgery for uterine fibroids (noncancerous growths in a woman's uterus) than previously thought, and it can be hard to distinguish between a uterine sarcoma and a uterine fibroid prior to surgery with available tests. When laparoscopic power morcellators are used for myomectomy or hysterectomy in women with presumed uterine fibroids that are actually uterine sarcomas, the surgical procedure poses a risk of spreading cancerous tissue beyond the uterus, worsening a woman's chance of long-term survival.
The FDA estimates that a hidden uterine sarcoma may be present in approximately 1 in 225 to 1 in 580 women undergoing surgery for uterine fibroids based on recent publications. The FDA also estimates that a leiomyosarcoma (a specific type of uterine sarcoma) may be present in approximately 1 in 495 to 1 in 1100 women undergoing surgery for uterine fibroids based on recent studies. Prior to 2014, the clinical community estimated uterine sarcomas to be present much less frequently, in as few as 1 in 10,000 women undergoing surgery for uterine fibroids.
Several studies show that using a laparoscopic power morcellator during gynecologic surgery in women with hidden uterine sarcomas is associated with lowering their chances of long-term survival without cancer. While these studies have limitations, women who have had fibroid surgery with a laparoscopic power morcellator later found to have a hidden uterine sarcoma, have lower disease-free survival (less time without any sign or symptom of cancer after surgery), when compared to women who were treated with manual morcellation or without morcellation. In addition, there is data to suggest an increase in rate of occult sarcoma for women undergoing surgery for presumed fibroids.
Uterine sarcomas and uterine fibroids may have similar signs and symptoms. At this time, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma.
The FDA recommends health care providers share this information with patients and warns against using laparoscopic power morcellators in gynecologic surgeries to treat patients with suspected or confirmed cancer, and in women over age 50 having a myomectomy or hysterectomy for uterine fibroids.
Health care providers and informed patients can work together to choose the best treatment approach based on known risk factors for uterine sarcoma (e.g., age, exposure to pelvic radiation therapy, prior use of the drug Tamoxifen, and race). For some patients, the benefits of minimally invasive surgery with a laparoscopic power morcellator may outweigh the risks. These patients may include some younger women who wish to maintain their fertility.