Worldwide Recall for Medical Device Linked to the Spread of Uterine Cancer
Every year more than 50,000 women undergo hysterectomies to remove their uteri. The procedure is most commonly done due to cancer risks, sometimes as a preventative measure. However, they are also performed for severe issues with bleeding and debilitating pain for conditions like endometriosis or noncancerous growths called uterine fibroids. Hysterectomies for non-cancer reasons are done usually only after all other options have been exhausted.
Advances in medicine have allowed the procedure to be done in less invasive ways. Power morcellators have been used for about a decade to do this. The device cuts uterine tissue into small pieces, allowing them to be removed through a small incision. Morcellators are also used to remove uterine fibroids, a procedure that can also require extensive surgery.
Now the devices are being linked to the spread of uterine cancer.
An FDA panel reviewed the use of the device to treat uterine fibroids. They heard testimony from doctors, patients and families of women who had undergone procedures using the morcellator. A number of women had died of a uterine cancer. At the time of the hearing, there had been no indication how, or if, the device was linked. However, the anecdotal evidence was overwhelming. Many doctors were beginning to wonder if the device was worth the risk.
A study released last month suggests it is not.
The report published in the Journal of the American Medical Association found that women who underwent the minimally invasive procedure had high rates of uterine cancer. The risk of cancer increased depending on the age, with women over 50 being at a higher risk. Cancer is only detectable after surgery – meaning the doctors did not know the women had cancer prior to the procedure.
The study revealed that doctors have been drastically underestimating the number of women with aggressive and hard to detect cancers.
Fibroids are most often benign tumors. Most women have them at some point in their life, and they often disappear on their own. For many, however, the growths can be severe, causing severe pain, excessive bleeding and even affect fertility. Many undergo surgical removal of the tumors which can grow extremely large. It is only after removal that they can be tested for cancer, which is rarely discovered. There is no preoperative test to discover uterine cancer, which was not of great concern because of the belief that the risk of cancer was rare.
The researchers suggested that when the morcellator cuts the uterine tissue and fibroids, it spreads pre-cancerous and cancer cells that were previously undetected.
In April, the FDA had recommended that doctors stop using the procedure until further review could be done. At the time, the maker of the device, Johnson and Johnson, halted sales for use in treatment of uterine fibroids. This week, Johnson and Johnson went further and issued a worldwide product recall, and has asked doctors to stop using the device.
While the study does not conclusively link morcellation to the spread of uterine cancer, the Johnson and Johnson unit responsible for the power morcellator has decided to be proactive. They issued a statement saying, “Due to this continued uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk.”
They are also asking that all the devices currently on the market be returned immediately.