A power morcellator is a surgical device used to remove tissue from the body through a small, laparoscopic incision. The tool was designed to allow surgeons to perform minimally invasive surgeries even when large pieces of tissue or organs needed to be removed. One of the most common applications for morcellators is gynecological. The device has often been used to remove fibroid tissue from the uterus or to remove the uterus during a hysterectomy.
Only after this device had been in use for years did warnings come out from the U.S. Food and Drug Administration (FDA) that it could cause some serious health problems. Chief among these is the risk that it will spread cancerous cells. While the FDA has not yet issued an official recall, it has made serious warnings about the use of a power morcellator, and some manufacturers of the device have issued voluntary recalls.
Morcellation and the Benefits of Laparoscopic Surgery
A morcellator is not a new medical device, but electric power morcellators are more recent developments. A morcellator is a device that can be inserted into an incision and used to chop up tissue to be removed into smaller pieces. Older morcellators, and many that are still used today, are hand-powered by the surgeon. A power morcellator on the other hand is electrically powered.
Using a morcellator allows a surgeon to perform a surgery laparoscopically, or as a minimally invasive procedure. For instance, to remove the entire uterus during a hysterectomy, a surgeon may make a large incision to remove the entire organ, but larger incisions require more recovery time and put the patient at a greater risk for complications like infections.
With a power morcellator the surgeon can make a smaller incision, insert the morcellator, chop the organ up into smaller pieces, and then remove each piece through the small incision. With a smaller incision the patient should face fewer risks and have a shorter recovery period after the surgery.
Issues that Led to Power Morcellator Recalls
Just because the power morcellator was supposed to allow surgeons to perform less risky surgical procedures doesn’t mean it turned out that way. One particular type of surgery typically conducted with a power morcellator has proven to add to the risk for the patient. The surgery is to remove fibroid tissue from the uterus. Fibroids are tumors that grow in the uterus that are typically benign. They are also very common, so thousands of women have had fibroid removal surgery.
Although they are most often benign, fibroids can grow large enough to cause a woman abdominal pain, lower back pain, bleeding, frequent urination, and even complications during pregnancy. Removal relieves those symptoms. The only problem is that in some cases there may be cancerous cells harbored in those benign fibroids.
The type of cancer that is sometimes found in fibroids is called leiomyosarcoma and it is a highly malignant and aggressive cancer. If it metastasizes, or spreads throughout the body, it is often fatal. When a surgeon uses a power morcellator to chop up the fibroids for removal, the action can spread any of these cancer cells and cause a woman to develop a serious and deadly type of metastasized cancer.
Only about one out of one thousand cases of uterine fibroids contain leiomyosarcoma cancer cells, but for those that do, the use of a power morcellator can be devastating. Many women who underwent what was supposed to be routine and low-risk surgery for fibroid removal ended up with a deadly cancer because they had undetected cancerous cells in their fibroid tissue.
FDA Warnings, But No Recall
Many of the women who ended up with leiomyosarcoma because of surgery with a power morcellator have filed lawsuits against the companies that make them. In some cases the suits have been brought by family members of women who ultimately died from the cancer. They blame the manufacturers for selling defective products and of failing to warn them of the risks. Many have also called for all power morcellators to be recalled.
The FDA is well aware of the risks and has issued warnings, but has stopped short of demanding a recall of the devices. In 2014, years after the devices had been in use in thousands of surgeries the FDA issued a safety announcement that strongly warned surgeons against using power morcellators for removing the uterus or uterine fibroids. The warning was a recommendation, not a command or a recall. According to facts collected the FDA believes that one in 350 women who had uterine surgery with a power morcellator has ended up with leiomyosarcoma.
In addition to the strong warning that surgeons not use the devices for certain types of surgeries, the FDA also recommended that surgeons not use the device for any type of surgery if the presence of cancer is suspected at all. The agency also recommended that doctors discuss the use of a power morcellator with patients and talk about the risks of cancer versus the benefits of laparoscopic surgery.
Voluntary Power Morcellator Recalls
The FDA has not issued any mandatory recalls of power morcellators made by any companies. Some of the devices are designed to be used with a bag that contains the tissue so that it cannot be spread. These are considered to be much lower risk than those that do not come with a bag. The riskier power morcellators are made by several companies including LiNA Medical, Olympus, Lumens, Ltd., Cook Urological, Karl Storz Endoscopy America, Blue Endo, Richard Wolf GmbH, KSE America, and Ethicon, a division of Johnson & Johnson.
Ethicon has been the only company to voluntarily recall its power morcellators because of the risk of spreading cancer in patients. At first the company temporarily suspended them, but then issued a full recall of the Morcellex Sigma Tissue Morcellator System, the Gynecare X-tract Tissue Morcellator, and the Gynecare Morcellex tissue Morcellator. Johnson & Johnson and its Ethicon division weighed the evidence and found it to be compelling enough to make a full recall.
Although it made this move Johnson & Johnson has still had to face lawsuits over its power morcellators, as have other companies. In 2016 the company settled a multidistrict litigation case in Kansas, although the settlement amount was not released. With one in 350 women undergoing surgery with this device at risk, it is no wonder that at least one company issued a recall. Other companies still refuse to acknowledge that there is an issue with their products and the FDA has not forced them to commit to a recall. Unfortunately more women may suffer as a result and these companies may be facing future lawsuits.