The U.S. Food and Drug Administration (FDA) issued a safety warning that advised against the use of laparoscopic power morcellation for the removal of the uterus or uterine.
The warning was prompted after current data showed that laparoscopic power morcellation for removing the uterus (hysterectomy) or uterine fibroids (myomectomy) poses a substantial and hidden risk of spreading unsuspected cancerous tissue, specifically uterine sarcomas, beyond the uterus.
What is power morcellation?
A power morcellator is a surgical tool used in several laparoscopic procedures. With Laparoscopic power morcellation being one of numerous treatments available for fibroids (non-cancerous tumors that develop in the uterus). During the procedure the device – which has rotating blades – is used to separate the uterine tissue into smaller pieces so it can be suctioned through a small incision made into the abdomen of the patient.
Most women develop uterine fibroids at some point, according to the National Institutes of Health. But in most cases fibroids don’t cause problems, but they can cause symptoms that can require medical and/or surgical therapy.
How is the cancer spread?
When reviewing the data, the FDA determined that an estimated 1 in 350 women undergoing hysterectomy or myomectomy for fibroid treatment have an unsuspected type of uterine cancer, uterine sarcoma. In these women, if power morcellation is performed, there is a risk that the procedure will spread the cancerous tissue into the abdomen and pelvis which can significantly exacerbate the cancer.
The manufacturers been instructed by the agency to review their current labeling for accurate risk information for patients as well as health care professionals. Below is information that patient’s should know and consider if they are undergoing this procedure.
FDA recommendations for Women:
All options should be addressed with a health care professional including all associated risks and benefits of having this procedure.
If a health care professional recommends laparoscopic hysterectomy or myomectomy, ask if power morcellation will be performed during the procedure and why that is the best choice. It is imperative that you do your research and ask questions.
When a patient undergoes a hysterectomy or myomectomy for fibroids, the tissue removed during the procedure is generally tested for cancer. For women who have already had a procedure where a power morcellator was used, it is crucial to follow up with your doctor, especially if there are persistent or recurring symptoms.
Agency recommendations for health care professionals can be found on the FDA Web site.
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