Power morcellation devices have come under the microscope ever since the FDA issued a safety warning in April 2014 that implicated their use in the spread of occult cancer (which is where the cancer doesn’t have a primary site in the body such as the heart or lungs).
This is a worrying development as occult cancers account for around 5 to 10% of all cancer cases and are usually incurable. The message coming from the FDA in April 2014 particularly highlighted the potential dangers of laparoscopic power morcellators which are typically used in myomectomy and hysterectomy procedures on women. The devices have been used where a patient has a tumor growing in the walls of her uterus (uterine fibroids). Although uterine fibroids are generally benign, they can grow from the size of a small seed to as large as a grapefruit.
The power morcellator is a bit like a nose hair trimmer for tumors. It has a rotating blade that is applied to fibroid tissues. This cuts up and cores those tissues so that they can then be removed by the surgeon.
The April 2014 FDA warning was intended to highlight cases of uterine sarcomas (which are cancerous) spreading beyond the uterus as a result of the use of the devices. The reason for this is that morcellation devices are used where tumors are benign, and so the action of cutting up the tumors is not problematic. However, the FDA found that in about 1 in every 350 cases of uterine fibroids, there is an undiagnosed cancerous tumor within the fibroid. In those cases, there is a significant risk of spreading cancer from the uterus out to the pelvis and abdomen.
For that reason the FDA issued a warning against the use of power morcellators in myomectomy or hysterectomy procedures to treat uterine fibroids.
In Nov 2014 the FDA issued a further warning advising manufacturers of the devices that they needed to include notices on the boxes of the devices indicating that their use on fibroid tissues may cause cancer to spread, and that morcellators specifically should not be used in certain conditions (such as where the woman undergoing the procedure was post-menopausal). They also restated the previous 1 in 350 sarcoma statistic for problem cases. This indicates that in the six months following the first warning the FDA’s concerns had stood up to closer scientific examination.
The significance of these warnings needs to be set against a backdrop of the large numbers of women who have been treated with power morcellators, especially prior to the first April 2014 warning. The devices have been licensed for use in gynecological procedures since 1995 and have been commonly used in myomectomy and hysterectomy procedures ever since. An article in the Wall Street Journal in April 2014 estimated that there are almost half-a-million hysterectomies performed in the United States every year, and that of this number around 11% used morcellation devices during the procedure. According to those figures then there may have been 55,000 hysterectomy procedures annually where the devices were used, of which 1 in 350 (or around 157 cases every year) which may have wider medical and legal implications due to their use.