Morcellation is a procedure used by surgeons to remove fibroids embedded in the uterus. Morcellators—the devices that are used in morcellation—are also used during partial or total hysterectomies. In a recently released warning from the U.S Food and Drug Administration, it was revealed that there may be a link between the use of power morcellators and the spreading of cancerous tissue.
If you suspect that you may have been injured due to this medical process, Peterson & Associates, P.C. has a team of experienced defective medical device lawyers in Kansas City that are currently accepting inquiries into this potentially lethal device.
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FDA Morcellation Cancer Warnings
The Journal of the American Medical Association estimates that 1 in 350 women who undergo procedures involving hysterectomies for fibroid removal have Uterine Sarcoma. As such, the risk that the procedure will spread cancer is very real. Uterine sarcoma is a particularly aggressive brand of cancer with low survival rates, especially when it is spread throughout the abdominal cavity.
In April 2014, the Food and Drug Administration (FDA) released a cautionary decision about the risks posed by the use of morcellation. The FDA found that laparoscopic power morcellation may spread undiscovered cancerous tissue outside of the uterus into the abdomen and pelvis.
Are There Alternative Medical Procedures That Do Not Pose A Risk?
Laparoscopic power morcellation is only one of several different treatment options for removing the entire uterus or fibroids in the uterus. For instance, a standard hysterectomy does not pose a cancer-spreading risk. In a standard hysterectomy, the entire uterus and all of the fibroids are removed intact. Although a standard hysterectomy is a more invasive surgical procedure, it would greatly reduce the likelihood that the cancer, if any, would spread.
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Who Is Legally Responsible?
Depending on the type of the lawsuit and the injury, victims of Uterine Sarcoma and their families may be entitled to financial compensation. The medical device manufacturers, surgeons, and hospitals may all carry different levels of responsibility. Although certain large companies such as Johnson & Johnson have pulled their power morcellators off the market, other companies have not and hospitals and surgeons continue to perform the surgery.
Johnson & Johnson, accounting for 70% of the global sales in the power morcellator market, were warned about the risk to women undergoing morcellation procedures as early as 2006. Though Johnson & Johnson did not respond to the initial warning, the FDA’s April 2014 decision did cause the company to respond. Spurred by the concern expressed by the FDA, Johnson & Johnson announced a voluntary worldwide market withdrawal of all of the company’s morcellators during July 2014. Though they did not recall the tools, they did announce that they will be asking all doctors to return the devices.
Manufacturers of Power Morcellators
If the manufacturers knew or should have known about the risks posed by the use of power morcellators, there may be tens of thousands of American women who have been harmed by the surgical devices which have been on the market for 20 years.
The most popular manufacturers of power morcellators as well as the brand names under which the power morcellators are marketed and sold are listed below:
- Blue Endo: MOREsolution
- Cook Urological, Inc.: Cook Tissue Morcellator
- Ethicon, Inc.: Gynecate Morcellex, Morcellex Sigma, Gynecare X Tract
- Ethicon of FemRX: Diva
- LiNA Medical: Xcise
- Lumenis, Ltd.: VersaCut + Tissue Morcellator
- Karl Storz Endoscopy America: KSA Steiner Electromechanic Morcellator
- Karl Storz GmbH & Co.: ROTOCUT G1, G2, Swalhe || Supercut Morcellator
- Olympus: PKS PlasmaSORD, VarioCarve Morcellator
- Richard Wolf GmbH: Morce Power Plus
- Smith & Nephew: TRUCLEAR Morcellation System
If you or a loved one has gone through a hysterectomy, ovarian cyst, or uterine fibroid morcellation surgery, please contact the Kansas City defective medical device attorneys at Peterson & Associates, P.C. by calling 816-888-8888.