The FDA issued a safety advisory asking surgeons to stop using power morcellators during uterine surgery in April, 2014, as the practice presents a risk spreading cancerous tissue. EmpowHER reported on this situation at that time.
Since then, many hospitals put moratoriums on the tool, and some insurers stopped covering its use. Johnson & Johnson issued a voluntary recall of their power morcellators due to the cancer risk.
However, in spite of the FDA warning, many doctors are still using power morcellators.
Laparoscopic techniques make it possible to perform uterine surgery through very small incisions. This allows for less blood loss and scarring, and a faster recovery.
Using a power morcellator, larger tissues are cut into smaller ones that are then pulled through the small incisions. In April, 2014 the FDA estimated this surgery was performed roughly 50,000 times a year.
This procedure creates a substantial and hidden risk to the patient, according to the Jewish Journal. Women with undetected cancers are at the greatest risk.
About 1 in 350 women have cancerous tissues in or around their uterine fibroids. When the morcellator cuts up the fibroids, it also cuts up the cancerous tissues, and can leave some behind to migrate to other areas, where they can re-seed new cancerous tumors.
The FDA warning sharply divided doctors.
Robert Graebe MD, the Department of Obstetrics and Gynecology chairman at New Jersey’s Monmouth Medical Center, first thought the FDA had overreached but now agrees with the safety advisory. He thinks power morcellators should be shelved until proven safe.
He told Wall Street Journal (WSJ), "People want to fight back, but it's not putting patients' safety first. It's not worth playing Russian roulette with the patient."
Others believe that the unknown cancer risks are overblown and that patient treatment has no room for government interference.
Dr. Jeffrey Thurston, a Dallas obstetrician and gynecologist who has practiced for three decades, told WSJ, "it is none of their business." Thurston performs 80 percent of his hysterectomies with a morcellator.
Thurston asks patients undergoing power morcellation to sign an informed-consent document that describes the cancer-spreading risk and puts the undetected cancer risk at between 1 in 300 and 1 in 1,000.
The American College of Obstetricians and Gynecologists argue that with more stringent patient selection, the device remains an important tool.
The FDA acknowledges the limited evidence that morcellation spreads hidden cancer. But the FDA also stresses the consistency across small studies showing a worsened prognosis when hidden cancers are cut up inside the body.
The FDA recommends that women considering uterine surgery discuss all options with their doctors. If laparoscopic techniques are the only available choice, be sure to ask if a power morcellator will be used.
If you are a woman who has already had a procedure done with a power morcellator, it is crucial to follow up with your doctor.
Sources:
Cohen, Judy. "Power Morcellation and women’s health: What you should know | Bloggish." Jewish Journal News. N.p., n.d. Web. 3 Oct. 2014.
http://www.jewishjournal.com/bloggish/item/power_morcellation_and_womens_health_what_you_should_know
"FDA: Doctors, Change the Way You Perform Uterine Surgery - ...." FDA: Doctors, Change the Way You Perform Uterine Surgery - N.p., n.d. Web. 3 Oct. 2014.
https://www.empowher.com/sexual-health/content/fda-doctors-change-way-you-perform-uterine-surgery
Levitz, Jennifer, and Jon Kamp. "Gynecologists Resist FDA Over Popular Surgical Tool." The Wall Street Journal. Dow Jones & Company, n.d. Web. 3 Oct. 2014.
http://online.wsj.com/articles/gynecologists-push-back-on-fdas-caution-about-cancer-when-using-morcellation-in-hysterectomies-1411358341
Luhana, Roopal. "New York, New York." New York Personal Injury Lawyer RSS. N.p., n.d. Web. 3 Oct. 2014.
http://newyork.legalexaminer.com/defective-dangerous-products/prominent-doctor-urges-fda-to-revise-510k-in-light-of-morcellator-debate
Reviewed October 9, 2014
by Michele Blacksberg RN
Edited by Jody Smith