What is a Power Morcellator?
A power morcellator is a medical device that looks similar to a drill or hand-held blender. It features sharp, rotating blades attached to a long tube.
It is used in minimally invasive procedures to break up tissue so it’s easier to remove through a tube that has been inserted into a tiny incision. It has been used during laparoscopic procedures to remove uterine fibroids and hysterectomies. Doctors who advocate the use of the power morcellator believe it’s beneficial because it reduces healing time and some of the risks associated with surgery.
Despite the benefits of using a power morcellator, there is evidence these machines can cause cancer cells to spread outside of the uterus, which significantly worsens a patient’s long-term outlook.
Essentially, a power morcellator can turn an as-yet-undiagnosed but manageable occurrence of cancer into late-stage cancer that has a high risk of being fatal.
Why is Power Morcellators Dangerous?
Power morcellators have been used in a variety of different procedures, including gallbladder and spleen surgeries. Before the FDA warning that was issued in 2014 about the safety of the devices, approximately 60,000 women had undergone hysterectomies and uterine fibroid removal with the assistance of the machines.
In the majority of cases, the procedures went as planned. However, there is a moderate risk that fibroids in the uterus could be a sarcoma – a type of cancer – which cannot be known until they are removed and biopsied.
It is in these instances – about one in every 350 surgeries – that the risk is present for cancer to be spread. The undiagnosed sarcoma would be blasted into pieces with the rest of the fibroid tissue, which makes it easier for cancer cells to move into the abdomen or pelvic area.
By the time doctors realize what has happened, a previously manageable form of cancer has advanced and requires aggressive treatment that is not guaranteed to work. Survival time following the accidental spread of cancer because of morcellation is only 24 to 36 months.
Women with not yet diagnosed cancer at the time of a power morcellation procedure are four times more likely to die than if they had not undergone the procedure.
FDA Power Morcellator Warning
Though the original thinking was that the risk of developing a late stage cancer because of the use of a power morcellator was quite low, it has since been determined that the risk is much higher than previously believed.
As a result, the FDA issued a safety communication in 2014 to doctors warning not to utilize power morcellators in hysterectomy or fibroid removal procedures. They advised discontinuing the use of the device because there’s no reliable way to predict whether fibroids are a definite indication of uterine cancer.
Later that year, the FDA issued updated guidelines urging doctors to no longer use morcellators in uterine surgeries for most women. The agency also called on power morcellator manufacturers to add a warning to the products about the potential risk for spreading cancer.
Makers of power morcellators include:
- Blue Endo
- Cook Urological, Inc.
- Ethicon, Inc., and FemRx (both Johnson & Johnson subsidiaries)
- Karl Storz
- LiNA Medical
- Lumenis, Ltd.
- Olympus America Inc.
- Richard Wolf GmbH
Johnson & Johnson under FBI Investigation
Ethicon and Johnson & Johnson suspended the sale of power morcellators shortly after the safety communication was issued. The company stated it had always warned surgeons that the spread of malignant tissue as possible, but because the device was approved via the FDA’s fast track 510(k) process and didn’t undergo extensive clinical testing it’s not known exactly how the company determined there was a risk.
An FBI investigation was eventually launched in 2015 to assess how much Johnson & Johnson knew about the risks concerning its device and whether or not it made effort to alert doctors and patients. According to one doctor, the company updated its product instructions to include the cancer warning but made no actual concerted effort to warn surgeons or patients.
Johnson & Johnson, along with other power morcellator manufacturers are now facing legal action concerning their devices and the danger they pose.