Debate escalates over morcellation of uterine and fibroid specimens in Minimal Invasive Surgeries after FDA permits the marketing of PneumoLiner!

According to a press release today the US Food and Drug Administration (FDA) permitted the marketing of the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer.

"PneumoLiner is intended to contain morcellated tissue in the very limited patient population for whom power morcellation may be an appropriate therapeutic option - and only if patients have been appropriately informed of the risks," FDA deputy director William Maisel said in a news release.

"This new device does not change our position on the risks associated with power morcellation. We are continuing to warn against the use of power morcellators for the vast majority of women undergoing removal of the uterus or uterine fibroids," Dr Maisel added

The recently approved container bag, PneumoLiner  encase the morcellator, inside the abdominal cavity enabling collection and removal of all the morcellated tissue.But, FDA requires the manufacturer to warn patients about the potential risk of spreading unsuspected cancerous tissue.

The labeling for PneumoLiner will include a prominent warning that "the use of this containment system has not been clinically demonstrated to reduce the risk" of spreading an unsuspected uterine cancer.

In April 2014, FDA issued a warning against the use of power morcellators concluding that "a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas." A review of medical literature has shown that unintentional spread of cancer cells occurs in one of every 350 procedures involving power morcellation. Till now, there exists no reliable means to determine preoperatively whether the women with fibroid have uterine sarcoma.

This warning came in the wake of campaign launched in late 2013 by anesthesiologist Amy Reed and her husband, cardiac surgeon Hooman Noorchashm, began campaigning to ban electric morcellators. Reed's undetected sarcoma was spread by the device during a hysterectomy at Brigham & Women's Hospital in Boston. A subsequent operation confirmed that morcellation and its tissue-scattering action had advanced the cancer to stage IV, Dr Noorchashm said.

The morcellators were introduced in 1993, but the whole procedure is under heightened scrutiny regarding patient selection and pre-operative investigation in light of recent warnings against power morcellation issued by the US FDA. In the last year alone US FDA has received dozens of complaints about seeding of cancers due to power morcellation

It is estimated that 600,000 women will undergo myomectomy or hysterectomy for symptomatic uterine fibroid in the year 2016; the most common indication being uterine fibroid amounting to 40% of all surgeries.  During the last 10 years, abdominal hysterectomies are increasingly being replaced by minimally invasive hysterectomies that use power morcellators routinely. About 50% of hysterectomies are performed laproscopically.  However, based on demographic research, about one woman will be diagnosed with Uterne Leiomyosarcoma (ULMS) out of every 500-1000 who undergo hysterectomy or myomectomy for a uterine mass.

In the meantime, FDA offered four recommendations to healthcare professionals about information on laparoscopic power morcellators:

• The agency discourages use of the devices during treatment for uterine fibroids.
• Do not use laparoscopic power morcellators in women with suspected or known uterine cancer.
• Consider all treatment options available for women with symptomatic uterine fibroids.
• Discuss with patients the risks and benefits of all treatments.

In response to the FDA advisory, the American College of Obstetricians and Gynecologists (ACOG) issued a statement noting that the organization is conducting its own review of the evidence on power morcellation and the risk of spreading cancer. In 2016 ACOG issued a statement advocating development of technology and training for surgeons, and urging the FDA to establish national prospective morcellation surgery registry to establish a large data base.

Many researchers advocate the use of bagged morcellators; however, power morcellation performed within a bag is not well studied and has several limitations that potentially increase the risk of the procedure. Others advocated open surgeries in patients that are at increased risk for leiomyosarcoma, namely increasing age, long-term tamoxifen use, and pelvic radiation.

Meanwhile a recent study published in the Journal of Obstetrics and Gynecology  in March, 2016 aimed to estimate the incidence of occult uterine sarcoma and leiomyosarcoma in hysterectomies for leiomyomas and the risk associated with their morcellation.

Out of 34,728 hysterectomies performed for leiomyomas, 125 specimens were identified as uterine sarcomas. The incidence of occult uterine sarcoma and leiomyosarcoma was 1 of 278 surgeries. The risk of death at 1 year increased for power and no power morcellation as compared to no morcellation.

The study concluded that women with occult leiomyosarcoma have decreased 1 year survival, but lacked power to establish the risk of power morcellation.

Two other recent reviews also advocated that spread of malignancy is a real risk following the tissue morcellation, but also admitted the paucity of enough data to draw a firm conclusion.

Many hospitals and healthcare systems in US have revised the guidelines regarding the informed consent for morcellation procedure so that patients can have more choices and information. All options have to put on table and  patients deserve full disclosure about the treatment.

References:

http://www.ncbi.nlm.nih.gov/pubmed/26673851

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494650.htm

http://sarcomahelp.org/articles/uterine-morcellation.html

http://journals.lww.com/greenjournal/Abstract/2016/01000/Occult_Uterine_Sarcoma_and_Leiomyosarcoma_.7.aspx

http://articles.philly.com/2013-12-29/news/45677981_1_traditional-surgery-surgeon-patients