Laparoscopic Power Morcellation amongst Most Dangerous Medical Procedures

April 3, 2016, 8:00AM. By Gordon Gibb

Milwaukee, WIAbout a year ago we shared with you the story of Dr. Amy Reed, 42, an anesthesiologist and mother of six who is currently battling for her life after a diagnosis of leiomyosarcoma, a ferocious uterine cancer that spread through her body. She learned of the cancer about a week after she underwent Laparoscopic Power Morcellation on her uterus.

According to an update of her story recently published in the Philadelphia Inquirer (2/15/16), Reed had been dealing with severe bleeding during menstruation. Following a decision to limit the size of their family to six children, and with both Reed and her husband busy with careers in medicine, it was decided that she would undergo a hysterectomy, which is one of the treatments for fibroids.

Reed had inquired about traditional invasive surgery, where the uterus would be removed in one piece. Instead, Laparoscopy was recommended, a minimally invasive procedure that would result in smaller incisions, faster healing and minimizing blood loss.

In reality, Power Morcellation was used to section the uterus while still in Reed’s abdomen, and subsequently removed in sections. Uterine cancer cells that might have been contained had the uterus been removed intact, were instead spread throughout Reed’s abdomen through laparoscopic uterine surgery via power morcellator.

Now Reed, as she fights her aggressive cancer with standard and experimental treatments, is embroiled in a crusade with her cardiac surgeon husband to have laparoscopic uterine surgery via power morcellators banned. The US Food and Drug Administration (FDA) has only gone so far as to recommend that Laparoscopic Power Morcellation not be used, and certainly not the first option - but rather the option of last resort.

Some hospitals have since decreed that only sealed bags surrounding the uterus be employed to entrap both uterine tissue and any potentially cancerous fibroids. Other hospitals have discontinued the procedure altogether. Johnson & Johnson withdrew its leading brand of power morcellator from the market a few years ago.

Ovarian cancer is but one of a number of health concerns affecting women: the onset of menopause, the potential for a hysterectomy, are all things that lay in most women’s future and the safest treatments for fibroids and other health concerns are top of mind for women, their families, and their health care providers and advocates.

Power morcellation has evolved substantially since it was first approved by the FDA in 1995 at the forefront of minimally invasive laparoscopic surgery. From an initially promising medical procedure, laparoscopic power morcellation myomectomy and related procedures are now listed by many amongst the more dangerous medical procedures out there.

The statistics appear to be getting progressively troubling: once thought of as a risk to one in 10,000 women, the FDA now acknowledges that the spread of undetected sarcomas during hysterectomy or fibroid removal is more like one in 350.

Meanwhile, according to the Philadelphia Inquirer, the Federal Bureau of Investigation (FBI) and the Government Accountability Office are investigating why it took 20 years for the FDA to warn about the risks.

The value of those warnings is compelling. The Inquirer reported that three women, who steadfastly refused power morcellation after reading about Reed’s plight, found out later that they turned out to have sarcomas that were removed intact through traditional surgery.

Meanwhile, it has been reported that Johnson & Johnson has begun the process of settling power morcellation lawsuits. Those lawsuits, in kind, keep coming. It was recently reported that Babette Davis, a plaintiff from Wisconsin, filed a power morcellation lawsuit against Johnson & Johnson and Ethicon, amongst other defendants. Davis alleges in her action that the Gynecare power morcellator, manufactured by the Ethicon unit of Johnson & Johnson, was responsible for the spreading of uterine cancer throughout the plaintiff’s abdomen and pelvis.

Davis filed her power morcellation lawsuit on January 27 of this year, Case No. 2:2016-cv-00101 in US District Court for the Eastern District of Wisconsin. Defendants are Ethicon Inc., Ethicon Endo-Surgery Inc., Johnson & Johnson Services, Johnson & Johnson, Venton Medical Inc., Venton Medical Acquisition Co, and Venton Medical Holdings Inc.