Government alerts and an onslaught of personal injury attorneys’ advertisements on the dangers of using power morcellators in the removal of uterine fibroids have signaled a public health concern that could disproportionately impact African-American women.
Uterine fibroids, noncancerous growths that develop from the muscular tissue of the uterus, are quite common but overwhelmingly so among Black women.
“I see patients with fibroids every day, and of my African-American patients over the age of 30, having fibroids with or without symptoms is more the rule than the exception,” said Dr. Caren Craig, an obstetrician and gynecologist that just joined the staff at the Greater Baltimore Medical Center.
“African-American women are three times more likely to develop uterine fibroids and at an earlier age than other women…and we’re not sure why,” added Dr. Estella Parrott, medical officer in the Gynecologic Health and Disease Branch at the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
Similarly, Parrott said, research has not been able to uncover the causes of uterine fibroids, though some evidence suggests a combination of genetic, hormonal, and environmental—such as the lack of vitamin D—factors. All that is known is that it occurs during a woman’s reproductive years, and while it usually presents without symptoms, it could cause heavy or prolonged bleeding leading to anemia; pelvic pain, including pain with intercourse; pelvic pressure, bladder symptoms, and even back ache.
Many afflicted women choose to undergo laparoscopic hysterectomy (removal of entire uterus) or myomectomy (removal of fibroids) because these procedures are associated with benefits such as a shorter post-operative recovery time and a reduced risk of infection.
The minimally-invasive procedures usually involve the use of morcellators, medical devices that cut the fibroids into smaller fragments and remove them through small incision sites.
About 60,000 of those procedures are performed every year. But now, the Food and Drug Administration and other experts are warning that the devices can significantly spread undetected uterine cancer cells, “upstaging” the disease and worsening the patient’s prognosis.
The FDA estimates that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma (LMS), a very aggressive form of cancer.
African-American women are twice as likely to be diagnosed with LMS, according to the American Association of Gynecologic Laparoscopists.
“If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival,” the FDA’s safety alert read. “For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
It is estimated women who have accidental morcellation of their uterine sarcoma cancer are four times more likely to die than those who didn’t have the procedure, with an average life span of only 24-36 months. And, that 85 percent of women who have leiomyosarcoma (LMS) that has spread (stage 4) die five years after diagnosis.
The deadly consequences are evident in lives of people like Dr. Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center in Boston, whose Stage I uterine cancer was upstaged to Stage 4 after a uterine hysterectomy seeded cancer cells throughout her abdomen.
Her husband Dr. Hooman Noorchashm has since launched a petition on Change.org calling for a halt to the use of morcellation in the removal of uterine fibroids.
“This is an avoidable disaster,” the petition read. “Women should be told the truth and the practice should stop.”
Dr. Craig said the situation has similarities with the controversy surrounding the use of transvaginal mesh, which the FDA may now reclassify as a “high-risk” device after thousands of reported injuries and deaths.
“A bit of overuse and poor informed consent” is what has fuelled the growing morcellation crisis, Dr. Craig said.
“I think the answer is to have greater restrictions and better scrutinization of morcellating. Total banning is probably not a good thing,” she said.
The doctor agreed with the AAGL which warned that medical advancements do not occur without missteps and mishaps.
“With any surgical technology or intervention, unanticipated risks may not be realized for years after
implementation. Thus, surgical innovation should be linked with ongoing safety evaluation,” the organization stated in an advisory to its members.
“Medicine is evolving,” Dr. Craig agreed, “and as it does, we are all striving toward excellence in patient care.”
Parrott said her agency is continuing to support research that can provide more answers about fibroids with an eye to mitigating its incidence and impact. Given the disproportionate impact of the condition on Black women, too few of them are involved in that research or in clinical trials.
Meanwhile, though the FDA has stopped short of banning the use of power morcellators, it has urged doctors and their patients to be more thoughtful in sharing and garnering all information pertinent to treatment of fibroids, including the risks.
“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” said Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, in a statement. “Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”
552 total views, 5 views today