Uterine Leiomyosarcoma

Regulatory agencies, physicians and consumer watchdog groups alike are sounding the alarm about the potential dangers posed by gynecological procedures involving the use of medical devices known as power morcellators. Though these tools have gained widespread acceptance as being a safe and effective part of many types of minimally-invasive surgery, their use in laparoscopic uterine fibroid removal procedures (myomectomy) and hysterectomies has been called into serious question in recent months.

The concern revolves around growing evidence that when used in such operations, power morcellators can spread cells throughout the body that ultimately prove to be cancerous and often deadly.

Power morcellators and uterine cancer risk

Morcellators first gained approval from the U.S. Food and Drug Administration in 1995 and were designed to facilitate minimally-invasive procedures including myomectomy surgery and hysterectomies. The tools use rotating blades to break fibroids into small pieces for easier removal through small incisions. Surgery of this type saw dramatic gains in popularity over the past several years, largely due the convenience and quick recovery times for patients, but concerns about safety were not far behind.

Increasing numbers of physicians and medical advocates began to warn that power morcellators can actually disperse uterine and fibroid tissues throughout the abdominal and pelvic region, causing them to stick internally and develop new areas of growth. When the cells being spread through the body are malignant in nature, the outcome can be grave. Unfortunately, it can be extremely challenging, if not utterly impossible, to determine whether a fibroid slated for removal is indeed cancerous prior to undertaking such a procedure. Women who have undergone morcellation procedures and who ultimately discover that they have cancer often face an extremely dire prognosis and reduced quality of life.

Uterine leiomyosarcoma and morcellator cancer

Among the most serious types of cancer linked to the use of power morcellators in gynecological surgery is uterine leiomyosarcoma. This disease is a fast-growing, soft-tissue cancer springing forth from smooth muscle cells. Uterine leiomyosarcoma is quite rare, representing a mere 1 percent of all uterine cancer cases. Sadly, tumors of this type are known for being highly metastatic, meaning that they frequently spread to other regions of the body, including the liver and lungs. Statistics indicate that roughly 7 out of 10 leiomyosarcoma patients who have undergone surgical removal of their tumors will have their cancer return in a matter of months.

The prognosis for those diagnosed with uterine leiomyosarcoma is discouraging, with 8 out of 10 patients who experience a recurrence of their cancer evidencing metastasis that results in staging of III or IV. Individuals whose leiomyosarcoma has not metastasized have a 50% five-year survival rate, though patients whose cancer has metastasized have a five-year survival statistic of 4-16 percent.

While patients considering fibroid removal surgery are screened for uterine cancer in advance, leiomyosarcoma often goes undetected. This type of cancer tends to be diagnosed following surgery, when a pathologist examines the tissues masses removed during the operation. However, if the cancer-containing fibroid was broken apart with the help of a power morcellator, the deadly cells may have already been widely dispersed in the pelvic and abdominal regions, ultimately resulting in a rapid upstaging of the cancer diagnosis.

FDA, Ethicon reactions to morcellation hysterectomy cancer

In response to research suggesting that approximately one out of every 350 laparoscopic fibroid removal and hysterectomy patients may in fact have undiagnosed uterine cancer that can easily be disseminated through the body by a power morcellator, in April of 2014 the U.S. Food and Drug Administration (FDA) recommended that all physicians stop using the devices in such procedures. The agency pointed to several available alternative treatments for the conditions that posed far less risk to patients as part of its admonition.

The mounting concern about power morcellators and cancer risk prompted Johnson & Johnson and its Ethicon subsidiary to announce in April that all sales of the firm’s devices would be halted pending additional study. The company sat atop the morcellator market, having sold over 70% of the devices in use. In July of 2014, J & J/Ethicon issued a power morcellator recall, requesting that physicians return any and all Morcellex Sigma, Gynecar X-Tract and Gynecare Morcellex devices straight away. Company representatives stated that the danger of uterine cancer resulting from the use of morcellators was much more serious than previously thought and simply could not be dismissed. However, several other device manufacturers have continued selling morcellators despite the controversy.

FDA issues stark warning on power morcellator use

On November 24, 2014, the FDA took the very serious step of calling for a so-called “black box” warning for power morcellators. This represents the agency’s strongest possible product labeling mandate and is indicative of its belief that the devices pose a real threat to a defined segment of the population. While the agency has not endorsed a comprehensive ban on the device, the wording of the newly-required warning is so stark that that there are few patients on whom practitioners would be likely to use it.

Morcellator cancer litigation starts to emerge

Lawsuits are beginning to be filed by women who have been diagnosed with cancer from uterine fibroid removal surgery or a laparoscopic hysterectomy involving power morcellation. Thus far, plaintiffs in such cases are alleging that morcellator manufacturers designed, marketed and sold defective products and did not sufficiently warn physicians and consumers of known risks. Many argue that had they been made aware of the dangers, they would have opted for one of the many alternative treatments available to address their conditions. With over 50,000 procedures performed per year involving the use of these devices, it appears likely that morcellator cancer lawsuits will continue to escalate.

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