New Studies Confirm Dangers Posed by Power Morcellators
A recent study has revealed the number of doctors using laparoscopic morcellation to remove uterine fibroids is on the decline. Another new study suggests that women have lower survival rates when a morcellator is used during their myomectomy or hysterectomy procedure. Both were published in a December 2015 issue of the medical journal Obstetrics & Gynecology.
Researchers from Kaiser Permanente published the study on morcellation survival rates, “Occult Uterine Sarcoma Leiomyosarcoma: Incidence of and Survival Associated With Morcellation.”
The other study, “Association of the U.S. Food and Drug Administration Morcellation Warning With Rates of Minimally Invasive Hysterectomy and Myomectomy,” revealed that doctors are following FDA recommendations to stop performing these minimally invasive procedures.
Power morcellators pose cancer risk
Power morcellators experienced a surge in popularity over the past decade, as the device allows doctors to cut up and remove the uterus or uterine fibroids through a laparoscopic procedure. Patients often favor these minimally invasive surgeries as they offer a shortened recovery period and reduce the risk of complications, such as developing an infection. However, the medical community has largely halted the use of morcellators since discovering the overwhelmingly high cancer risk the device poses to women.
The study published by the Kaiser Permanente researchers found that women had a greater chance of death if morcellation is used as part of their procedure, as doctors cannot detect hidden cancers that the device could spread throughout the body.
“The unadjusted 3-year probability of disease-free survival for no morcellation, power and nonpower morcellation was 0.54, 0.19, and 0.51, respectively,” stated the researchers. “Morcellation is associated with decreased early survival of women with occult leiomyosarcomas.”
In April 2014, the U.S. Food and Drug Administration issued a statement estimating that roughly 1 in 350 women going through a hysterectomy or a myomectomy for fibroids has an undetected uterine sarcoma. However, the agency does advise that morcellation may be a good choice for younger women who want to have children, as it allows the uterus to remain intact. Either way, the FDA urges doctors to inform their patients of the risks and benefits associated with all potential treatment options.
In the “Association of the U.S. Food and Drug Administration Morcellation Warning With Rates of Minimally Invasive Hysterectomy and Myometomy” study, researchers examined six operating rooms in Florida, finding a 5.8% decrease in laparoscopic hysterectomies and a 19% drop in minimally invasive myomectomies in the eight months after the FDA issued the warning.
Morcellators get highest FDA cautionary warning
The FDA hasn’t banned morcellators from the market, but they now come with a black box warning — the agency’s strongest advisory. It is also encouraging the medical community to develop innovative ways to detect uterine cancers, to stop the spread of these diseases by laparoscopic morcellation entirely. Regardless, many hospitals feel that power morcellators are too risky and have discontinued use entirely.
In August 2014, 12 Congress members wrote a letter to the U.S. Government Accountability Office, asking the agency to investigate the reason it took the FDA so long to issue a warning on morcellators, as they have been on the market since 1991. The lawmakers also want to know if the expedited FDA 510(k) approval process inadvertently overlooked the cancer risk. GAO agreed to an examination of the device, but has yet to report its findings.
- U.S. Food and Drug Administration, FDA Warns Against Using Laparoscopic Power Morcellators to Treat Uterine Fibroids http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm424435.htm
- MedScape, Federal Watchdog Agency Will Probe Power Morcellators http://www.medscape.com/viewarticle/850590
- The Wall Street Journal, Surgical Tool Gets Strongest Warning http://www.wsj.com/articles/fda-adds-new-warning-to-labels-for-laparoscopic-power-morcellator-1416842439