The U.S. Food and Drug Administration has taken action to stop the use of a gynecological device that can spread pre-existing cancer in women. Laparoscopic power morcellators are used in the removal of the uterus, or to remove fibroids.
The device is used to destroy fibroids, which are then removed by key hole surgery. There is no way to know if the fibroids contain cancer cells. If they do, the destruction process may released some of those cells, allowing cancer to spread to other organs.
This can lead to more dangerous forms of cancer developing, which cannot be treated as easily.
In a press release,William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health said: “Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed.”
The FDA was made aware of the flaw with this device by surgeon Hooman Noorchashm. Dr Noorchashm’s wife, Amy Reed, had the procedure as a part of her hysterectomy and was diagnosed with stage 4 cancer. The use of the device had spread cancer cells throughout her body. Thankfully Amy is currently in full remission.
Whilst Dr Noorchashm was arguing for a complete ban on the device, the FDA was chosen to add a compulsory warning to the device. The warning indicates that the device may spread cancer cells throughout the body.
The FDA chose to only use a warning because younger women may still safely use the device in their procedures. That is due to the fact younger women are much less likely to have cancer cells in regions that can be spread. If the device is not used, fertility can be affected.
Some hospitals have already stopped using the device, well aware of the risk before the FDA decision. One of the companies that manufacture the device has also pulled it off the market, a sure sign that the risk of the procedure is well known.
So while this device might still play a role in certain surgeries, for older women with a higher chance of cancer, it is too risky.