The Morcellex Sigma, the Gynecare X-Tract and the Gynecare Morcellex are power morcellators that are acknowledged to be among the best engineered morcellators in the market. Besides ensuring optimum performance and reliability, these medical devices from Ethicon, Johnson & Johnson’s power morcellator manufacturing unit, also guarantees faster performance and smoother and more efficient tissue morcellation (the cutting up of large masses of tissues into tiny pieces).
The US Food and Drug Administration began approving the use of morcellators in laparoscopic surgical procedures (such as hysterectomy, which is the removal of the uterus, and myomectomy, or the removal of uterine fibroids or myomas) in 1995. And, because the device allowed for the performance of a minimally invasive surgery, which meant very tiny incisions on the abdomen (four 0.5 – 1cm long incisions, actually), less pain and less blood, and wounds that would heal fast, surgeons began preferring to use it and perform laparoscopic surgeries, rather than the longer, more bloody and much more painful traditional procedures, which included vaginal hysterectomy and abdominal hysterectomy, which specifically required 5 to 7 inches abdominal incision.
About 600,000 hysterectomies are performed in the US every year; more than 50,000 of these are laparoscopic surgeries. A hysterectomy is performed to treat the following conditions: pelvic inflammatory diseases; cervical cancer, ovarian cancer or uterine cancer; uncontrollable vaginal bleeding; chronic pelvic pain; uterine prolapse; adenomyosis; and, endometriosis.
According to the website of Williams Kherkher, despite the many benefits provided by a morcellator, the FDA found it necessary to discourage surgeons, through a safety notice that it released on April 17, 2014, from further using it in laparoscopic surgical procedures, especially in myomectomy. This notice is based on a medical literature report that linked the morcellator with the spread of cancerous tissues, namely uterine sarcoma, beyond the uterus. With no device capable of detecting these cancer-bearing tissues, surgeons are not able to determine whether or not a female patient, who will undergo myomectomy, is infected with it. Thus, during the process of mincing the uterine fibroids, the sarcoma tissues, if there are any, get minced as well. However, as all minced tissues (fibroids and sarcomas) are suctioned out of the uterus, the removal of everything is often not guaranteed. And it is these left behind tissues that cause the greatest harm, which is the development of leiomyosarcoma, a rare yet aggressive cancer.
About two weeks after FDA’s safety warning, Ethicon responded by voluntarily withdrawing from the market its three celebrated devices and suspending the devices’ distribution and the worldwide sale. Many, however, believe that harm may already have been inflicted by Ethicon’s morcellators, as well as by those from other manufacturers. Prior to April 2014, a number of lawsuits have already been filed by women already diagnosed with leiomyosarcoma; many lawsuits are still expected to be filed.