Myomectomy & Hysterectomy with Morcellation

In a medical review of more than 200,000 patients, one out of every 368 women treated with a power morcellator during hysterectomy or myomectomy had undiagnosed uterine cancer found during or after their treatment. Published in the Journal of the American Medical Association (JAMA), the review also indicated that older age was the only predictive factor associated with underlying uterine sarcoma or endometrial hyperplasia.

The FDA has already weighed in on hysterectomy morcellation surgery and fibroid tumor removal, advising doctors to stop using power morcellators in the laparoscopic procedures because the device can spread undetected cancer cells beyond the uterus. However, despite this instructive FDA warning, gynecological surgeons are still using this tool in uterine fibroid removal surgery, highlighting the limits of the agency’s influence into clinical practice.

In 2013, The Society of Gynecologic Oncology (SGO) urged doctors and patients to openly discuss the supposed benefits and inherent risks of morcellation before deciding to use the tool in a gynecological procedure.

Myomectomy & hysterectomy with power morcellation

Fibroid tumor removal, or a myomectomy, is a surgery that removes benign fibroids while leaving intact healthy uterine tissue. The procedure is indicated for women who plan on having children later, or who prefer to maintain their uterus due to other factors. Research suggests that a myomectomy has less risk of complications compared to a traditional hysterectomy, in which the uterus and other reproductive organs are removed.

Patients can opt to either have a laparoscopic myomectomy or an abdominal myomectomy, where the fibroids are removed through an incision just below the pubic hairline.

Laparoscopic uterine fibroid removal is performed on an out-patient basis under general anesthesia and has become the preferred surgery due to its swift recovery and short hospital stay. The advantages of such a minimally invasive surgery are less blood loss, smaller incisions and virtually undetectable scars. Several small incisions are made below the bikini line and instruments, including a power morcellator, are passed through the opening to help break down the tumors into smaller pieces before extracting them from the body.

The risk lies in how the electric morcellator’s spinning blades work, by disseminating pieces of fibroid tissue throughout the abdomen and pelvis. If the patient has uterine neoplasms of “uncertain malignant potential,” these cells can be spread by the device’s sharp blades, putting the patient at increased risk for uterine leiomyosarcoma.

It is estimated that almost 70 percent of women who undergo treatment for this deadly form of uterine cancer have a high rate of recurrence, since the disease metastasizes quickly. The FDA says that one out of every 350 women undergoing a myomectomy procedure with morcellation may have undetected sarcoma at the time of the surgery, which can set the stage for a leiomyosarcoma diagnosis. Though laparoscopic and robotic myomectomies can preserve a woman’s fertility if done correctly, the risks of future uterine cancer may outweigh any perceived benefits.

Morcellator hysterectomy cancer is also a source of growing concern among the OBGyn medical community. A hysterectomy, or surgical removal of the uterus, can be performed through an abdominal incision, or laparoscopically with electric morcellation.

A laparoscopic hysterectomy, much like the myomectomy, allows the surgeon to make tiny incisions through which small instruments are inserted. Depending on preexisting factors, the surgeon may choose to remove the uterus and cervix, or leave the cervix in place (Supra-cervical hysterectomy). The power morcellator, which slices the uterus into small bits, makes this laparoscopic approach feasible, with the goal of leaving patients with less post-op pain. But just like a myomectomy with morcellation, laparoscopic hysterectomies aided by power morcellators carry the risk of spreading cancerous cells outside of the uterus.

It remains challenging to estimate the exact number of gynecologists that are still using morcellators in such procedures, as these numbers aren’t tracked by the American College of Obstetricians and Gynecologists.

FDA yet to ban morcellators

Health officials at the FDA regulate medical devices and pharmaceutical products, but the agency doesn’t supervise medical practitioners, leaving doctors wide latitude in their choice and methodology of treatments. In April the FDA calculated that one in 350 women develop cancer with uterine fibroid removal surgery – pinpointing a danger far greater than originally thought.

The FDA morcellation cancer warning has prompted some doctors to explore alternative, minimally invasive options.

Johnson & Johnson voluntarily recalled its power morcellators this past July, and while it was the largest maker of the devices, several other manufacturers design and distribute morcellators for use in hysterectomies and myomectomies.

U.S. Senators Chuck Schumer and Kirsten Gillibrand have petitioned the FDA to ban all power morcellators from the American market “until additional risk assessments and patient and clinician education can be performed.”

Morcellators have been launched via the agency’s 510(k) program, a premarket notification system that has come under intense fire as of late. Through this 40-year-old system, new medical devices are cleared without substantive clinical trials as long as “substantial equivalents” of the devices are already on the market.

“Unfortunately, the sad saga of the evolution and modification of morcellation devices for gynecologic use under 510(k) clearance adds yet another example to the need to reconsider the safety and public health protection of this process,” wrote Dr. David R. Challoner, chairman of the Institute of Medicine Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process.

Morcellator hysterectomy cancer litigation

A cancer of the smooth muscle cells, leiomyosarcoma has a relative five-year survival rate of between 16 percent and 63 percent, depending on stage and location. The best outcome occurs in women who detect it early, and have the cancer surgically removed with wide margins, before it spreads.

At the heart of emerging power morcellator lawsuits is that patients who underwent hysterectomy or myomectomy with the device were not properly informed that the treatment could spread undetected cancer. Even though the medical community and manufacturers have known of this uterine cancer risk for years, it has been greatly underestimated until now.

At the very least, gynecologists are now discussing morcellator risks with their patients, though this important disclosure has come too late for several unfortunate women, who died from uterine cancer after hysterectomy morcellation surgery. Many morcellator product liability lawyers and medical professionals believe that morcellation cancer litigation will continue to swell in the coming months.

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