Power morcellators are controversial medical devices because of one very dangerous side effect: an aggressive type of cancer called leiomyosarcoma. A power morcellator is an electrically-powered device that is used to remove large amounts of tissue through a small surgical incision. It could be used to remove the gallbladder, a tumor, but most often is used in gynecological procedures.
Because of one very specific type of gynecological procedure and the fact that the tissue removed may include these dangerous cancer cells, a power morcellator can and has caused cases of aggressive, metastatic cancer in unsuspecting women. The issue is serious enough that it has led to recalls, lawsuits, and warnings from the FDA.
Power Morcellators and Surgery
Any type of surgery is inherently risky. It can cause any number of complications from excessive bleeding to infections to the formation of dangerous blood clots. The bigger the incision and the bigger the tools the surgeon must use, the riskier the surgery becomes and the greater the likelihood that the patient will experience complications.
Any time a surgery can be done in a way that is less invasive, it is desirable. Laparoscopic surgery, for instance, involves making a very small incision and inserting small tools, sometimes even remotely operated by the surgeon.
To remove a mass of tissue from the body requires a large incision, unless that mass can be cut up into smaller pieces before it is removed. This is where a morcellator comes in handy. Traditional morcellators are hand-operated by the surgeon. It is inserted through the incision, the surgeon cuts up the tissue to be removed, and pulls out the smaller parts.
Power morcellators made the process quicker and easier, using the same idea, but with a motored device. It can be used in any minimally invasive surgery that requires smaller pieces of tissue, but where it has been most controversial and has caused a terrible side effect in some women is in the removal of uterine fibroids.
Typical Side Effects
The side effect of cancer is not the most common potential complication of using a power morcellator. As with any type of surgery and any surgical device, there are side effects that may occur and unexpected things that can go wrong. A slip-up with a power morcellator can cause nicks and cuts that cause damage to organs and tissue and may even lead to excessive bleeding.
Other possible power morcellator side effects include infections being introduced to locations far from the incision site, pain from sore muscles or bruising, bowel obstructions, and even a recurrence of any malignant tissue that was being removed with the morcellator.
Cancer as a Side Effect
By far the most damaging side effect of the use of a power morcellator happens in some instances when a woman has uterine fibroids removed with the use of the device. Fibroids are largely benign growths that develop from muscle tissue. Fibroids in the uterus are called leiomyoma. A lot of women develop fibroids at some point in their lives, mostly before the age of 50. In the majority of cases they are not cancerous, but hiding in some of these fibroids, cancer cells may be hiding.
Fibroids don’t always have to be removed, but they can grow large enough to cause symptoms like pain and bleeding, frequent urination, and pain during sexual intercourse. They can also cause complications during pregnancy, so women may have them removed before trying to get pregnant. Until the recent side effect of cancer was discovered, a power morcellator was the tool of choice for removing fibroids.
The problem with using the power morcellator is that if there are cancer cells hiding in the fibroids, the device can spread them far and wide. Essentially the device speeds up the process of this cancer that tends to spread and metastasize on its own. Women have died because the power morcellator spread leiomyosarcoma when they never realized they had cancer cells in them.
The condition and the spreading of the cancer cells are rare. Only about one in 1,000 women have these cancer cells in their fibroid tissues. Although the risk is low, the side effect is considered serious and has caused controversy over the use of power morcellators because the effects for those who experience it are so devastating.
FDA Warns of Side Effects
The FDA became aware of the issue with power morcellators through reports collected in the agency’s adverse event reporting system. What followed was a 2014 warning about the risk of leiomyosarcoma. The FDA did not place any restrictions on power morcellators or force any recalls, but it did include a strong recommendation that surgeons not use them for any fibroid removal surgery. The FDA also recommended that packaging for power morcellators include the risks and the cancer side effect on the label.
Some of the manufacturers of power morcellators, of which there are several, responded to the FDA’s warning by downplaying it. Some suggested that the FDA had overreacted and that the risk was not very high. The FDA had stated that about 350 women having fibroid removal surgery with a power morcellator had cancerous cells and had been put at risk. The manufacturers doubted the accuracy of the number.
One maker of the device, however, took the warning and the side effect seriously. Johnson & Johnson issued its own recommendation that surgeons not use their power morcellators for removing fibroids or uterine tissue. The company also temporarily suspended the availability of some of its morcellators while it investigated the issue.
Some women paid the ultimate price for having had a power morcellator used to remove tissue. They suffered painful bouts with cancer and some even died from that cancer. Some of these women, or their surviving family members, are battling the manufacturers of power morcellators with lawsuits and pushes to get the devices banned entirely. If you or someone you love was affected by a power morcellator, you may want to join the cause and try to prevent other women from being harmed.