In America, about 500,000 women have a hysterectomy (surgery to remove the uterus) each year. About 40% of hysterectomies are performed to treat uterine fibroids, which are non-cancerous growths on the uterus. Howvere approximately 0.2% of fibroids are actually uterine sarcoma, an aggressive type of cancer that includes leiomyosarcoma.
Laparoscopic power morcellators have grown rapidly popular for use in performing hysterectomies. Power Morcellators are simpler to use than the traditional scalpel. It is a long, tube-shaped blade used to cut up uterine tissue into smaller pieces that are easier to remove from the body. Many doctors prefer this tool because of the simplicity and low recovery time it brings.
The problem with morcellators is that they often leave behind tiny pieces of tissue. If the pieces contain cancerous cells and are left behind, aggressive cancer can spread by the morcellator throughout a woman’s abdomen and significantly increase her risk of death.
These cancers may include:
- Leiomyosarcoma (LMS)
- Uterine cancer
- Endometrial stromal sarcoma
- Uterine sarcoma
The risk of spreading cancer can be reduced by surgeons using a protective surgical bag, and only morcellating in the bag. However, the bags are cumbersome, flimsy, and difficult to use, which is why many surgeons do not use them.
Many women allege that they were never warned that morcellators could increase their risk of cancer or that they are even being used in the procedure. Recently, hospitals have started requiring surgeons to use bags when morcellating or avoid using the devices altogether.
Evidence linking morcellators and cancer has been growing for years. In 2011, researchers from South Korea presented data from a study, which showed that women who had uterine tumors fared far worse when a morcellator was used to remove their uterus — 44% died after 39 months, compared to just 19% after 63 months for women who had their uterus removed whole.
In April 2014, the U.S. Food and Drug Administration (FDA) published warnings against using morcellators for hysterectomies or surgery to remove uterine fibroids (myomectomy). “If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
Again in November 2014, the FDA issued an update to its safety communication from April 17, 2014, warning against the use of LPMs for hysterectomies and myomectomies “in the vast majority of women.” Furthermore, the FDA recommended that manufacturers of LPMs update their product labeling with a boxed warning about the risks of cancer spread and “decrease [in] the long-term survival of patients.” Such boxed warnings – also known as black box warnings – are the strongest type of safety measure short of taking a medical device off the market. The FDA guidance also asked manufacturers to update their labeling with statements contraindicating the use of LPMs when “the tissue to be morcellated is known or suspected to be cancerous” or can be removed intact without morcellation, and for all women who are approaching, are going through, or have gone through menopause.
List of Morcellators and Manufacturers
- FemRx – Diva Morcellator
- Hologic – MyoSure
- Lumenis Inc. – VersaCut Morcellator
- Ethicon Gynecare – X-Tract
- Ethicon Gynecare – Morcellex Tissue Morcellator
- Ethicon – Morcellex Sigma
- Interlace Medical – Hysteroscopic Morcellator
- Smith & Nephew – Trueclear Hysteroscopic Morcellator
- Olympus – PlasmaSORD
- Olympus – Gyrus PKS PlasmaSORD
- Nouvag – Morcellator TCM3000BL
- Blue Endo – MOREsolution Tissue Morcellator
- LiNA Medical – Xcise Cordless Laparoscopic Morcellator
- Karl Storz – Rotocut G1, G2, Steiner, and Sawalhell Supercut Morcellator
- Richard Wolf – Morce-Power 2306 Electronic Morcellator
Do I have a Morcellator Lawsuit?
Jinks, Crow & Dickson, PC is currently accepting morcellator induced injury cases. If you or somebody you know was injured by cancer after a hysterectomy, you should contact our lawyers immediately for a free case consultation. Jinks, Crow & Dickson is here to serve you and help in any way they can to get you the legal relief you deserve. Our attorneys will work with you to develop a plan and determine the best course of action for you and your case. Please call us today for a free consultation at 888-297-9592.