A power morcellator is a medical device that is used to remove tissues from the body during a surgical procedure. Several manufacturers of medical devices make these, but in recent years troubling details about how harmful they can be have arisen and led to a number of lawsuits. Although the devices were designed to reduce the risk of complications by allowing laparoscopic, or minimally invasive, removal of tissue, for some patients the opposite happened.
The biggest issue with power morcellators has proven to be the spread of cancerous tissue. One of the most common uses for the device is to remove the uterus in a hysterectomy, but many women with undetected cancer ended up in a worse health situation after the device spread those cancerous cells. Warnings have been issued regarding the dangers, but no forced recalls have yet occurred. Instead, many patients have opted to file lawsuits.
What Is a Power Morcellator?
A power morcellator is a device that allows surgeons to remove tissues from the body laparoscopically. There are also morcellators that are hand-powered. Before the invention of morcellators, if a surgeon needed to remove tissue, a large incision had to be made and the patient was at risk for dangerous blood loss, infections, and other complications. Minimally invasive surgery reduces those risks.
To be able to remove tissue through only a small incision, a special tool is needed. A surgeon can insert a morcellator and use it to chop up the tissue into small pieces that can then be removed. Early versions of morcellators were powered manually, but most of those in use since the 1990s have been electrically-powered morcellators.
A power morcellator may be used in any type of surgery in which large chunks of tissue need to be removed. Examples include gallbladder removal, spleen removal, or the removal of parts of the liver. Some of the most common uses for the device are gynecological. Fibroid removal, also called myomectomy, is a common use for a power morcellator, and the main source of complications and lawsuits.
What Are the Risks?
One of the major uses for power morcellators has also caused the most problems. Fibroids are benign tumors that often grow in the uterus. Although they are not cancerous, they can cause uncomfortable symptoms like bleeding and pain. Uterine fibroids are fairly common, so thousands of women have had surgery with a power morcellator to have them removed.
The risk of doing this procedure with a power morcellator is that sometimes fibroids and other uterine tissues contain cancer cells that have not yet been detected. The morcellator acts a little bit like a blender, chopping up tissue. Although surgeons work to contain it, pieces of tissue may escape collection and end up spreading outside of the uterus.
Fibroids rarely contain these cancerous cells, but when the do it is serious. The kind of cancer that can develop in this tissue is called leiomyosarcoma and it is aggressive and malignant and when it spreads to other parts of the body becomes very difficult to treat. The risk with the morcellator is that it will spread these undetected cancer cells and doom a woman to a fatal type of cancer.
Companies that Make Power Morcellators
There are many companies that make this device, or have made it, and they all come with some level of risk of spreading cancer cells unless they are used with a bag. The bag is used to enclose the part of the abdominal cavity that is to be treated with the morcellator. This contains the tissue to be removed and should reduce the risk that any cancerous tissue will spread to other parts of the body.
The companies that make power morcellators that were not designed to be used with a bag include Blue Endo, Cook Urological, LiNA Medical, Lumenis, Ltd., Olympus, Richard Wolf GmbH, KSE America, Karl Storz Endoscopy America, and of course the Ethicon division of Johnson & Johnson. Any of these companies may be vulnerable to lawsuits started by women whose cancer spread because of the use of a power morcellator.
Power morcellators had been in use for many years before the U.S. Food and Drug Administration finally became aware of the risks of spreading leiomyosarcoma during fibroid removal. In 2014 the agency issued a warning about the risks. The warning did not ban the use of the device, but recommended that surgeons not use a power morcellator for fibroid removal or hysterectomies and be especially cautious of using it in any patients who may have cancer.
According to FDA estimates, one in 350 women who had fibroid removal surgery or a hysterectomy with a power morcellator had leiomyosarcoma cells. The agency did not require recalls or bans of the product, and it did not even require a new label on the device. It only recommended that a new warning be placed on the label. Women who experienced devastating cancer because of a power morcellator did not believe that the FDA went far enough.
Power Morcellator Lawsuits
Hundreds of women have filed lawsuits over the damage caused to them by power morcellators. In one case a woman who had a hysterectomy and fibroid removal surgery in 2013 ended up with a shortened life expectancy when the device spread endometrial stromal sarcoma cells throughout her abdominal cavity. This rare, but often fatal cancer had been undetected before the surgery, but after doomed the woman to a lower quality of life and a shorter life. She blamed the device maker, Karl Storz Endoscopy America for not making her or her doctor aware of the full risks.
Another patient, a doctor herself, named Amy Reed, similarly was harmed by a Karl Storz morcellator. She developed leiomyosarcoma after having surgery with the device. Reed and her husband, also a doctor, now claim that the device caused her cancer to spread and put her in the battle for her life. She claims that no one informed her that a power morcellator would be used for her surgery or that the risk of cancer was possible. They are now fighting for Reed’s life and have even been threatened by Karl Storz with legal action.
Women like these are suing the companies that made power morcellators because they believe they did not adequately warn patients and doctors of the risks of spreading fatal cancers throughout their bodies. While some companies are fighting back, others are recognizing the flaw and agreeing to settlements.
Johnson & Johnson Moves to Settle Power Morcellator Lawsuits
One of those companies is Johnson & Johnson, the parent company for Ethicon, which is the maker of several devices targeted in power morcellator lawsuits. Many of those suits were consolidated into a multidistrict litigation case in Kansas in 2015. Early in 2016 the company announced that it would settle, although an exact amount has not been reached. Johnson & Johnson also voluntarily recalled its Ethicon power morcellators because of the dangers they pose.
If you or someone you care about developed cancer after a procedure with a power morcellator, you may be able to make a strong case before a judge or jury. Battling cancer is painful, upsetting, and expensive. The money from a settlement may help to ease those concerns. Let a lawyer help you decide what steps to take next.