BALTIMORE — In light of the recent FDA black box label and increased awareness on the dangers of using power morcellators, world-renowned hospital Johns Hopkins has issued new protocols governing the use of morcellation in its facilities.
Johns Hopkins Hospital will no longer use power morcellators to remove uterine fibroids or conduct laparoscopic hysterectomies in women over 50. The hospital announced the new rules at a December American Association of Gynecologic Laparoscopists (AAGL) conference. Morcellators will also not be used in women who have other factors increasing their risk for cancer, such as tamoxifen use, pelvic radiation, hereditary cancer syndromes, and BRCA mutations.
This decision came days before the FDA announced the high risk of spreading cancer when using the device and warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids. One in 350 women undergoing such a procedure were found to have an unsuspected or previously undetected type of uterine cancer.
Reason for Johns Hopkins’ Decision
Johns Hopkins conducted its own review of morcellation over a nine-year period. Hopkins reviewed 424 cases from 2005 to 2014. Two women were identified to have uterine sarcoma after undergoing a uterine morcellation procedure. The first woman was 55 years old and her preoperative biopsy and CT scans were negative for cancerous cells. She had a morcellation procedure and was later found to have invasive cervical adenocarcinoma. The second case involved a 56-year-old woman who had uterine fibroids removed via morcellation. Afterwards she was found to have uterine sarcoma. Both patients had to undergo chemotherapy to remove the cancers.
Countless reports have come out documenting the dangers of using morcellators to remove uterine fibroids (harmless fibrous tissue in the uterus) or conduct procedures such as hysterectomies or myomectomies in women. The device shreds the tissue or fibroid so that it may be drawn out through a small incision. However, dangerously aggressive forms of sarcoma tend to be hidden within the fibroids or are difficult to differentiate from the fibroids. Metastatic Leiomyosarcoma is an example of the type of dangerous sarcomas found hidden in the uterus. It is an unpredictable form of uterine cancer that often remains dormant for many years and occurs primarily in women between 40 to 60 years old. The morcellator’s shredding allows the cancerous cells to migrate to other parts of the body, resulting in the cancer aggressively spreading and even killing women.
Because the FDA has not yet banned the device, it is important that major players in the health care industry, such as Johns Hopkins, take the necessary steps to limit the use of such a dangerous medical device.
If you or a loved one has received fibroid-related treatment, myomectomy, or a hysterectomy from a medical provider that has not banned the use of power morcellators, there is a chance you are in danger of more serious health complications or the risk of cancer being spread.