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Thursday, May 22, 2014
May News - Morcellator Warning from the FDA
The FDA has discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of currently available data, it poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.
Laparoscopic power morcellation is one of several available treatments for fibroids. It is a procedure that uses a medical device to divide the uterine tissue into smaller pieces or fragments so it can be removed through a small incision in the abdomen, such as during laparoscopy.
Uterine fibroids are non-cancerous growths that originate from the smooth muscle tissue in the wall of the uterus. According to the National Institutes of Health, most women will develop uterine fibroids at some point in their lives. While most uterine fibroids do not cause problems, they can cause symptoms, such as heavy or prolonged menstrual bleeding, pelvic pressure or pain, and frequent urination, sometimes requiring medical or surgical therapy.
Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, 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.
“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”
A number of additional treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, and laparoscopic hysterectomy and myomectomy without morcellation, as well as other non-surgical options.
The FDA will convene a public meeting of the Obstetrics and Gynecological Medical Devices Panel to discuss information related to laparoscopic power morcellation.
“Input from clinical and scientific experts will help provide valuable information and perspectives to clarify the proper clinical role for these devices,” said Maisel. “We anticipate the discussion will include whether a boxed warning related to the risk of cancer spread should be added to the product labeling for laparoscopic power morcellators to ensure patients and health care professionals are adequately informed of the risks.”
Uterine fibroids are noncancerous growths that develop from the muscular tissue of the uterus. Most women will develop uterine fibroids (also called leiomyomas) at some point in their lives, although most cause no symptoms1. In some cases, however, fibroids can cause symptoms, including heavy or prolonged menstrual bleeding, pelvic pressure or pain, and/or frequent urination, requiring medical or surgical therapy.
Many women choose to undergo laparoscopic hysterectomy or myomectomy because these procedures are associated with benefits such as a shorter post-operative recovery time and a reduced risk of infection compared to abdominal hysterectomy and myomectomy2. Many of these laparoscopic procedures are performed using a power morcellator.
A number of additional treatment options are available for women with symptomatic uterine fibroids including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, laparotomy using a smaller incision (minilaparotomy), deliberate blocking of the uterine artery (catheter-based uterine artery embolization), high-intensity focused ultrasound, and drug therapy. Evidence demonstrates that, when feasible, vaginal hysterectomy is associated with comparable or better results and fewer complications than laparoscopic or abdominal hysterectomy3.
From the American Cancer Society:
Sarcomas are cancers that start from tissues such as muscle, fat, bone, and fibrous tissue (the material that forms tendons and ligaments). Cancers that start in epithelial cells, the cells that line or cover most organs, are calledcarcinomas.
More than 95% of cancers of the uterus are carcinomas. If a carcinoma starts in the cervix, it is called a cervical carcinoma. Carcinomas starting in the endometrium, the lining of the uterus, are called endometrial carcinomas. These cancers are discussed in our other documents Cervical Cancer and Endometrial (Uterine) Cancer. This document is only about uterine sarcomas.
Most uterine sarcomas are put into categories, based on the type of cell they developed from:
Endometrial stromal sarcomasdevelop in the supporting connective tissue (stroma) of the endometrium. These cancers are rare, representing less than 1% (1 in 100) of all uterine cancers. These tumors are low grade -- the cancer cells do not look very abnormal and they tend to grow slowly. Patients with these tumors have a better outlook than those with other uterine sarcomas .
Undifferentiated sarcomas used to be considered a type of endometrial stromal sarcoma, but since they are more aggressive and are treated differently from low-grade tumors, they are now considered separately. These cancers make up less than 1% of all uterine cancers and tend to have a poor outlook.
Uterine leiomyosarcomasstart in the muscular wall of the uterus known as the myometrium. These tumors make up about 2% of cancers that start in the uterus.
Another type of cancer that starts in the uterus is called carcinosarcoma. These cancers start in the endometrium and have features of both sarcomas and carcinomas. They can be classified with uterine sarcomas, but many doctors now believe they are more closely related to carcinomas. These cancers are also known as malignant mixed mesodermal tumors or malignant mixed mullerian tumors. Uterine carcinosarcomas are discussed in detail in the American Cancer Society document Endometrial (Uterine) Cancer.