Surgeons use a power morcellator, an electrical medical device, to chop up and remove tissue from the body during minimally-invasive surgery, also known as laparoscopic surgery. These devices allow surgeons to perform surgeries with small incisions, which in the past would have required larger incisions, greater risks of blood loss and infection, and a longer recovery time. Most often used in gynecological surgery, morcellators may also be used for surgery on other organs.
In recent years, new information has come to light about the risks of using power morcellators. Among other things, this tool and surgical technique can spread cancerous cells throughout the body and lead to a greater risk of death or early death for patients with cancer. The U.S. Food and Drug Administration (FDA) has issued warnings and restrictions for morcellators, but lawsuits have also been filed by people whose cancer spread because of the devices.
What is Morcellation?
Laparoscopic surgery is a modern development in surgical techniques that allows surgeons to make repairs, insert devices, or remove organs or tissue by making only very small incisions. Before the development of laparoscopy, surgeons had to make large incisions, which put patients at a greater risk for complications like infection and bleeding. With a smaller incision, patients have lower risks and are able to recover more quickly after a procedure.
In order to be able to remove large pieces of tissue or organ through a small incision during minimally-invasive surgery, surgeons must have a way of chopping that tissue into smaller pieces. A morcellator is a device that can be inserted into a small incision, and chop up an organ or tissue to be removed. Early morcellators were hand-operated, but those that have been in use since the early 1990s are electric.
Types of Morcellators
The newer power morcellators are electric and have spinning blades that chop up tissue. The FDA first approved these power devices in 1991. The first to come on the market was the Cook Tissue Morcellator. Because it was similar to morcellators already on the market, the FDA did not require rigorous testing for approval. Power morcellators are approved through the agency’s 510(k) process of expedited approval.
There are two main types of morcellators. The laparoscopic device, a power morcellator, is inserted into the small incision made for laparoscopic surgery to chop up tissue. That tissue is not contained in any way and small pieces of it may scatter in the body and are not collected. A hysteroscopic morcellator is used for hysterectomies, the removal of the uterus. This device uses a pouch to surround the tissue to be removed before it is chopped into pieces. This restricts the scattering. It uses mechanical energy, rather than electrical to chop tissue.
Uses for a Power Morcellator
A hysteroscopic morcellator is used for removing the uterus during a hysterectomy. Power morcellators may be used for a number of different types of laparoscopic surgeries. One of these is a myomectomy, or the removal of fibroids from the uterus. Other examples of the use of morcellators in minimally-invasive surgery are to remove the gallbladder or spleen or parts of the liver.
For many patients being able to undergo surgery with a small incision reduces the risk of complications and side effects. On the other hand, the use of a power morcellator introduces certain unique risks. The use of the device can cause bleeding, infections, damage to other organs close to the one being removed, pain at the site of the incision or internally, muscle soreness, bruising, obstruction of the bowel, and in the case of surgery to remove fibroids, the recurrence of the fibrous masses.
One of the most common uses for the power morcellator is to remove fibroids from the uterus. Fibroids are muscle tumors that grow on the inside of the uterus. Fibroids are also known as leiomyoma. Most often they are benign, or not cancerous. Fibroids are very common, with anywhere from 20 to 80 percent of women having these growths before the age of 50.
Fibroids do not always cause symptoms, but as they grow larger they may cause heavy bleeding, lower back pain, pain during sex, frequent urination, and pregnancy complications. Another potential problem with fibroids is that they may be cancerous or have cancerous cells in them. If symptoms are uncomfortable, surgical removal using a power morcellator is an option.
Only about one in 1,000 cases of fibroids are cancerous. Although not common, all fibroids have the potential to be cancerous. The most controversial possible complication of using a power morcellator is the spread cancerous fibroid tissue during laparoscopic removal. Malignant fibroids are not very common, and doctors test women for cancer before doing this surgery.
The problem is that fibroids may harbor a few cancerous cells that are almost impossible to detect. The morcellator shreds the fibroids and may cause those cells to be spread further into the body, where malignant tumors may grow. Even when there are no cancerous cells, some chunks of tissue may get attached to other organs and develop into growths that need to be surgically removed later.
The type of cancer that may be hiding in fibroids is called leiomyosarcoma. It is a particularly malignant type of cancer and if it spreads throughout the body it can become fatal. Patients with metastatic leiomyosarcoma do not have very good survival rates.
The FDA became aware of the risks of the spread of leiomyosarcoma by power morcellators and responded with a safety announcement in 2014. The agency did not recall the devices or prohibit them, but strongly discouraged surgeons from using power morcellators for the removal of uterine fibroids or for the removal of the uterus. The FDA estimated that one in 350 women undergoing a hysterectomy or fibroid removal with a power morcellator had undetected leiomyosarcoma cells.
The warning included several recommendations. In addition to recommending that the devices not be used for uterus and fibroid removal, the agency also recommended that the device not be used in anyone suspected of having cancer, that different treatment methods be considered for women with fibroids, and that doctors discuss the risks and benefits with patients. The FDA also recommended, but did not require, that manufacturers of power morcellators include a boxed warning on the label regarding the possible risk of spreading cancer.
Johnson & Johnson Morcellators
Although the FDA did not require a recall of the devices, Johnson & Johnson voluntarily removed its power morcellators from the market completely after a temporary suspension. The devices were made by the Ethicon division of the company. The suspended products included the Gynecare Morcellex Tissue Morcellator, the Gynecare X-tract Tissue Morcellator, and the Morcellex Sigma Tissue Morcellator System.
Both the FDA and Johnson & Johnson considered the evidence regarding the spread of cancer powerful enough to recommend that these devices not be used on uterine tissue. Other companies still make and sell morcellators, though, and some surgeons have suggested that the agency has overreacted and misinterpreted evidence. They say that the risk is not as high as one in 350 women.
While some may believe the risks are low, the women who have suffered the results of metastatic cancer because of surgery with a power morcellator know just how real the risks are. Women and the loved ones of those who died from cancer have filed lawsuits against the manufacturers of power morcellators and some are waging campaigns to get these devices banned for uterine surgeries.
If you have experienced the devastating consequences of metastatic cancer because of surgery with a power morcellator, you have an opportunity to recover damages and to make a difference for other women. Let a lawyer tell you what your options are and how you could file a lawsuit to seek compensation.