Uterine Sarcomas and Morcellators

The use of a power morcellator is the key factor that differentiates a laparoscopic surgery or minimally invasive surgery, such as hysterectomy (which is the removal of the uterus) and myomectomy (or the removal of uterine fibroids), from traditional hysterectomy procedures. A power morcellator is a medical device that is made capable of mincing or dividing large masses of tissues into tiny shreds for easy removal through small incision sites. Compared to Abdominal hysterectomy, one particular traditional procedure that requires a long incision on the abdomen (about 5 – 7 inches long), a laparoscopic surgery, however, due to the use of a power morcellator, only needs (four) 0.5 – 1cm tiny incisions, just enough opening to allow certain devices to be inserted into the body.

One major reason for a laparoscopic surgery is for the removal of uterine fibroids, which grow in the uterus. Now, according to the US Department of Health and Human Services’ Office on Women’s Health, up to 80% of women, especially those aged between 40 and 50, will develop fibroids.

These uterine fibroids, also called leiomyomas or myomas, are actually non-cancerous tissues, and most of which do not even have symptoms. However, according to the website of Williams Kherkher, potential symptoms may include pelvic pressure or pain, prolonged or heavy menstrual bleeding, rectal pressure, and frequent urination, making medical or surgical therapy quite a necessity.

Based on analysis of available data, the US Food and Drug Administration found that 1 in 350 women undergoing myomectomy or hysterectomy can possibly be infected with uterine sarcoma, which is a cancerous tissue. The problem with uterine sarcoma, however, is that its actual presence cannot be detected due to the lack of a method reliable enough to do so. Thus, during a laparoscopic surgical procedure, as the fibroids are morcellated or minced, the uterine sarcoma tissues get minced too and made to spread in the abdomen and pelvis, causing the further growth of cancer.

With alternative ways of removing fibroids (through traditional procedures) and the risks posed by the use of a power morcellator, the FDA decided to discourage surgeons, through the safety alert it issued on April 17, 2014, from further using the device in laparoscopic surgical procedures.

Surgeons began using power morcellators in 1995, after the device was approved by the FDA for use in laparoscopic surgeries. From the different brands that were made available in the market, three were highly acknowledged due to their great engineering design and capability to ensure optimum performance and reliability: the Gynecare X-Tract, the Gynecare Morcellex and the Morcellex Sigma – all from Ethicon, the power morcellator manufacturing unit of Johnson & Johnson.

Ethicon was actually the first manufacturer to respond to the FDA’s notice, which other manufacturers and some surgeons seemed to have ignored as there were some who still continued using the device. In the same year that the alert was issued, a number of women had already been diagnosed with an advanced stage of leiomyosarcoma, the type of cancer that developed from the spread of uterine sarcoma. While lawsuits have already been filed by these women, many others are expected to follow, considering the fact that more than 50,000 laparoscopic surgeries are performed all across the nation every year.

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