The FDA warns that power morcellators, surgical devices used in minimally invasive surgeries for women, may also spread a deadly cancer called metastatic leiomyosarcoma.
Medical professionals and the FDA express growing concern about the safety of gynecological surgical procedures that use power morcellators. These devices are effective when used for minimally invasive surgeries that can reduce recovery time. But when used in certain kidney and spleen surgeries or to break up uterine fibroid tumors, they also spread cells that develop into malignant tumors in women and men.
One of these cancers that can develop in women is metastatic leiomyosarcoma, a type of uterine cancer.
In response to reports of how this cancer developed and how it is associated with laparoscopic power morcellation, the FDA issued a safety alert in April 2014. That alert discourages use of the instruments for removing of fibroids or the uterus in women.
Use of the tool during the procedure poses a risk of spreading undetected cancerous tissue in women with unsuspected cancer can reduce their likelihood of long-term survival significantly.
Doctors use power morcellators in hysterectomies and other minimally invasive procedures to remove uterine fibroids, called myomectomies. Surgeons make small incisions and morcellate, or chop up, fibroids and tissue, cutting it into smaller pieces. They then vacuum the residue out of the pelvic or abdominal cavity.
Ideally, this involves less time in the operating room, less blood loss and a shorter recovery time. Initially, this was the selling point of the procedure for many women.
The concern is that power morcellators or electric morcellators can disseminate bits of uterine or fibroid tissue through the abdomen and pelvis, sprayed about by the centrifugal force of the spinning blades. These bits of tissue can adhere to other tissues and organs, seeding new growths.
When that tissue comes from benign fibroid tumors, the consequences of the resulting growths can be pain, infection or bowel obstruction. However, in some cases, malignant cancer cells can be present in the uterus, and their dissemination can have much more serious consequences.
Causes of Uterine Cancer
Uterine cancer occurs when cells within the uterus begin to grow abnormally, multiplying rapidly to form tissue masses known as tumors. It is the fourth most common cancer among women, behind breast cancer, lung cancer and colorectal cancer. About 95 percent of uterine cancers are cancers of the endometrium, the inner lining of the uterus. Endometrial cancer is one of the most curable cancers, with five-year survival rates of more than 80 percent. The remaining 5 percent are tumors of the outer muscular lining, called sarcomas, which are much more aggressive.
While the exact causes of uterine cancer are not known, a number of risk factors have been identified that can increase a woman’s chances of developing the disease. Among these are high levels of estrogen in the body, being over age 40, obesity and a family history of the disease. Some drugs may increase risk as well, including those used in hormone replacement therapy and some medications used in the treatment of breast cancer.
What are Uterine Cancer Symptoms?
Prior to a morcellation procedure, an undiagnosed uterine cancer might be in Stage I. A woman could have symptoms – no hint that she has cancer. However, shredding the fibroid can spread hidden cancerous cells and upstage the disease, making it worse by making it possible for the cancer to grow in new and dangerous areas. The procedure actually seeds the cancer. And after surgery, the cancer can go from Stage I to Stage IV quickly.
A tumor is considered Stage IV when it has spread to the lymph nodes, bladder, rectum and/or distant organs. Uterine cancer upstaged by morcellation, such as leiomyosarcomas, are aggressive. Some patients had the cancer spread to their spine or lungs.
Oncologists say that these tumors are difficult to treat, in large part because they are resistant to chemotherapy and radiation. Some symptoms that could signal upstaged cancer after morcellation, include:
- Vaginal bleeding or spotting, between periods or especially after menopause
- Vaginal discharge
- Pelvic or abdominal pain or a mass
- Pelvic or abdominal swelling
- Weight loss
- Nausea or vomiting
If tumors affect other organs or bones such as the spine, symptoms could include back pain or nerve issues.
What is Leiomyosarcoma (Uterine Cancer)?
Leiomyosarcoma is an aggressive, soft-tissue sarcoma that develops from smooth muscle cells, typically in the uterus or gastrointestinal tract. These tumors often spread and, depending on the stage, the 5-year survival rate ranges from 14 to 63 percent.
Uterine leiomyosarcoma (ULMS) arises from the muscular part of the uterus, and occurs primarily in women 40 to 60 years of age. A rare form of cancer, uterine leiomyosarcoma accounts for just 1 percent of patients with uterine cancer. However, these tumors have high metastatic potential, with nearly 70 percent of patients who have undergone treatment for the disease – which consists of surgical removal of tumors – seeing a recurrence within eight to 16 months, even in cases of stage I or II, in which the disease is still confined to the uterus.
In nearly 80 percent of patients who do have a recurrence, it has metastasized (spread) to other areas of the body, such as the ovaries, lungs or liver. When this happens, it is called metastatic leiomyosarcoma and is classified as either stage III or IV. Patients with non-metastatic leiomyosarcoma have a five-year survival rate of about 50 percent, while the 5-year survival rate for those with metastatic leiomyosarcoma has been estimated at between 4 and 16 percent.
Morcellation of Fibroids
Power morcellators are frequently used in the treatment of women diagnosed with symptomatic fibroids. While fibroids are benign growths, they can cause symptoms that include heavy uterine bleeding, pelvic pain, and infertility in many women. In these cases, fibroids may be treated with a surgical procedure called myomectomy, which removes the fibroid masses from the uterus, or hysterectomy, a procedure that removes the entire uterus.
The FDA reports the following risks of morcellating unsuspected tumors:
- For morcellating uterine sarcoma: 1 in 352.
- For morcellating uterine leiomyosarcoma: 1 in 498.
Minimally invasive procedures are the preferred course of treatment for uterine fibroids, and many of these procedures include the use of power morcellators to enable the extraction of fibroids or the uterus through incisions of less than 2 centimeters in size.
Surgery for Uterine Cancer
Because fibroids can contain cancer cells, women who will have them removed are pre-screened for signs of uterine cancer. While endometrial cancer is typically detected, leiomyosarcoma is often missed during routine preoperative testing because it may closely resemble fibroids in medical imaging. In fact, leiomyosarcoma is most frequently diagnosed after surgery, when extracted tissue masses are routinely examined by a pathologist.
If undiscovered leiomyosarcoma exists, as is, according to the FDA, the case in about 1 of every 350 women undergoing a fibroid removal procedure, cancer cells can be scattered throughout the pelvic and abdominal cavity, setting the stage for the development metastatic leiomyosarcoma.
Many women who have had laparoscopic power morcellation were not informed that the procedure carries a risk of spreading undetected cancer, despite the fact that it has been known – if greatly underestimated – by the medical community and device manufacturers for decades. As evidenced by recent high-profile cases, women who have been diagnosed with metastatic leiomyosarcoma after laparoscopic power morcellation or their families do have legal options, and given the life-threatening nature of this particular complication, should not hesitate to act.
Minimizing the Risk of Spreading Leiomyosarcoma Cancer
In a pivotal study by Dr. Jason D. Wright and colleagues published in the September 2014 issue of JAMA, authors stressed the importance of screening hysterectomy or myomectomy patients for any history of cancer before laparoscopic power morcellation. Women with any history of cancer should not undergo morcellation.
For instance, Anita Austin had laparoscopic power morcellation surgery to remove a uterine fibroid. Doctors told Austin that the procedure would be less invasive and she would recover faster, but they did not inform her of the cancer risk, even though she had previously had thyroid cancer. Her cells were only stage 1, but the procedure sprayed the cells all over her abdomen, effectively advancing the cancer to a higher stage.
“The big issue for me is that no one mentioned cancer,” she told Fred Hutch News. “Not at all. And I question things. I’d had thyroid cancer [in the early ‘80s], and I would have probably done something different. Given my history, honestly, I should have been advised not to do it.”
MRIs, CT scans and even biopsies are not 100 percent reliable in detecting these hidden cancer cells. But, endometrial cancers are easier to find than more aggressive forms like leiomyosarcoma. Before undergoing surgery, women should have a biopsy of the uterine lining.
The risk of uterine cancer rises with age. Women over age 65 had the most risk. The FDA does not recommend power morcellation for women in this age group.
Morcellation in a bag is also an option. The surgeon will insert a bag through a small incision in the abdomen. All morcellation occurs in the confines of the bag, preventing the spread of any undetected cancer.
Power Morcellator Lawsuits & Litigation
They lived in different parts of the country. But the deaths of Eva Cohn Galambos, Donna Burkhart and Esther Arama share a common thread. They died from cancer after undergoing power morcellator procedures. Their spouses filed suits in separate cases, all alleging the women had no signs of cancer before the treatments and they were not informed of the cancer threat from power morcellators. Burkhart said wife Donna Burkha had no evidence of metastatic cancer before undergoing a morcellated hysterectomy in March 2012. Less than a year later, she died of metastatic leiomyosarcoma. His attorneys last year reached a settlement with power morcellator makers LiNA Medical APS, Kebomed AG and LiNA Medical US. Terms were not disclosed. Eva Cohn Galambos underwent a procedure Jan. 20, 2011 called a total laparoscopic hysterectomy. A biopsy showed she had “endometrial stromal sarcoma/leiomyosarcoma,” says a suit against power-morcellator maker Ethicon, Inc. She died from cancer on April 19, 2015. Esther Arama’s husband filed suit after she died, alleging a morcellator fatally spread hidden cancer in her body in 2014. Tumors later removed from her body were deemed “metastatic high-grade leiomyosarcoma,” the suit says.
The exact cause of leiomyosarcoma is unknown. However, Annie Achee, president of the National Leiomyosarcoma Foundation, said possible links include toxins, chemicals and trauma.