The Gynecare Morcellex (mechanical) Tissue Morcellator

On April 17, 2014, the US Food and Drug Administration released a safety alert that warned of the further use of power morcellators in laparoscopic(minimally invasive) surgeries, such as myomectomy, or the removal of uterine fibroids (also called myoma), and hysterectomy, which is removal of the womb or uterus. This alert is based on reports that power morcellators can cause the spread of minced or divided (morcellated) tissue on the abdominal structures and organs, which can result to: fibroids, adenomyosis and endometriosis (adenomyosis is a condition wherein the inner linings of the uterus or womb would protrude through the muscle wall of the uterus, while endometriosis is the growth of the inner lining of the uterus in the abdomen, which can cause bleeding and intense pain). Though these conditions are bad enough, as these can require further surgery, the real worst result of the use of the identified device is the risk of the development of a rare, yet deadly, cancer, like leiomyosarcoma, due to the spread of a tissue, called uterine sarcoma.

A power morcellator is a medical device that is able to cut large pieces of tissues into small sizes to allow these to pass through the tiny incisions on the abdomen. Since the introduction of these devices in the early 1990s, many doctors have preferred laparoscopic hysterectomies and myomectomies (which make use of morcellators) over the traditional abdominal (an open surgery that requires a 5–7-inch incision on the abdomen) and vaginal hysterectomies. This preference is due to the many advantages of laparoscopic surgery (over traditional surgeries), which include tiny (four 0.5-1cm)incisions that heal much faster, shorter hospital confinement, lesser risk of complications and infection, less pain and less blood loss.

Due to the FDA’s safety alert, Ethicon, the power morcellator manufacturing division of Johnson & Johnson, stopped all sales and promotion of their devices (beginning April 30, 2014), which included the Morcellex Sigma, the Gynecare X-Tract and the Gynecare Morcellex.

Johnson & Johnson’s Gynecare Morcellex (mechanical ) Tissue Morcellator, specifically, was engineered to provide optimum performance and reliability. It enables surgeon to morcellate tissues smoothly and efficiently, and it eliminates many of the difficulties often associated with surgical procedures, including laparoscopic urologic procedures, laparoscopic general surgical procedures and laparoscopic gynecologic procedures.

Due to its design to perform four times faster than previously manufactured power morcellators, the Gynecare Morcellex is able to significantly reduce the length of the surgical procedures; it is also enabled to ensure ultimate safety and precision in tissue cutting and removal, and minimize any risk of hernia development.

Despite its unquestionable performance and great sales, however, Ethicon found it wiser to stop its sale, withdraw it from the market, and ask hospitals to return it, along with its other power morcellators, in compliance with the FDA alert.

With more than 50,000 laparoscopic hysterectomies and myomectomies performed every year, the chances of further increase in the number of lawsuits against manufacturers of power morcellators is definitely possible.

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