In late 2017, the FDA released an updated assessment of laparoscopic power morcellation (LPM) that discouraged the use of LPM devices in hysterectomy and myomectomy procedures as they may increase the risk of spreading uterine tissue that may contain unsuspected cancer. According to the FDA, an estimated 1 in 225 to 1 in 580 women undergoing gynecological surgery for uterine fibroids may have an unsuspected uterine sarcoma, or cancerous uterine fibroid. The results of the assessment were “generally consistent” with the FDA’s estimates from a previous review in 2014.
Motley Rice medical attorney Carmen Scott represents women who have suffered complications and was appointed in 2015 to the Plaintiffs’ Steering Committee for the multidistrict litigation In re Power Morcellator Products Liability Litigation MDL No. 2652 in the District of Kansas under Judge Kathryn H. Vratil.
Motley Rice is reviewing claims involving women who received a cancer diagnosis after gynecological surgery that involved the use of Laparoscopic Power Morcellation.
If you or someone you know has been diagnosed with leiomyosarcoma cancer (cancerous uterine fibroids), a gynecologic cancer or occult malignancy (a cancer from an unknown source) following a gynecological surgery that used laparoscopic power morcellation, you may have a claim, you may contact Motley Rice women’s medical attorney Carmen Scott by email or call 1.800.768.4026.
About Laparoscopic Power Morcellation (LPM)
Surgeons began using LPMs in the mid-1990s as an alternative to more invasive procedures used to remove uterine fibroids during either a myomectomy or a hysterectomy. An LPM procedure involves the use of a thin, lighted tube equipped with a camera called a laparoscope, and a power morcellator, which uses a small blade inside of a hollow cylinder to fragment and remove tissue through the tube.
On Nov. 24, 2014, the FDA updated its safety communication regarding the laparoscopic power morcellation procedure. The statement discourages the use of power morcellators due to an increased risk to women with uterine fibroids, and recommends that a new boxed warning be included in all product labeling to inform health care providers and patients that "Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”
The safety alert also includes two contraindications—or situations in which the LPM procedure should not be used—that comprises the majority of women undergoing surgery for uterine fibroids.
A special report released by the American College of Obstetricians and Gynecologists (ACOG) in May 2014 estimates that, of the approximately 600,000 hysterectomies done in the U.S. each year:
less than 30 percent are performed laparoscopically in women
younger than 40
less than 44 percent in women ages 40 to 49, and;
16 percent in women ages 50 to 59.
It adds that “the most common indication for hysterectomy is uterine leiomyomas [uterine fibroids], accounting for an estimated 40% of hysterectomies.”
The Potential Spread Of Cancerous Tissue Due To Morcellators
On July 30, 2014, Johnson & Johnson, one of the largest manufacturers of the power morcellator device, voluntarily withdrew its power morcellators from the market and requested that customers return the devices. J&J had previously suspended sales of the device in April 2014 following an FDA safety communication regarding the risk of spreading cancerous tissue when using the LPM device.
In April 2014, the FDA issued a safety communication discouraging the use of LPM, stating that “if laparoscopic power morcellation is performed in women with unsuspected uterine scarcoma [leiomyosarcoma], 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. 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.”
In 2013, after the discovery of cancerous uterine fibroids in a patient who received the LPM process at Brigham and Women’s Hospital in Boston, the hospital warned its staff “that morcellation of an occult tumor may occur in between one in 400 and one in 1000 women who have this procedure—a risk at least ten times higher than previously assumed.”
In 2012, a study published in the Public Library of Science (PLOS.org) found that the LPM process could inadvertently spread cancerous tissues if the uterine fibroids were found to be malignant. The rate of unsuspected cancerous fibroids was “9-fold higher than the rate currently quoted to patients during pre-procedure briefings, and this rate may increase over time.” Additionally, the data found that the malignant tissue was likely to spread through the peritoneal, or genital, area 64.3 percent of the time following power morcellation.
Law360 (Dec. 14, 2017): Usage of Uterine Device Down Since Warning, FDA Says
Med Page Today (Aug. 25, 2016): Morcellation-Cancer Controversy Still Unresolved
Philly.com (Sep. 5, 2015): GAO to investigate medical device implicated in cancers
Philly.com (Aug. 12, 2015): Deadly harm: The result of regulatory failure by FDA
Bloomberg (Nov. 24, 2014): Hysterectomy Device Shouldn't Be Used By Most Women: FDA
Democrat & Chronicle (Oct. 9, 2014): FDA mum on hysterectomy surgery option
Wall Street Journal (Aug. 19, 2014): Senators want more companies to pull surgical device from market
Wall Street Journal (July 30, 2014): Johnson & Johnson Pulls Hysterectomy Device From Hospitals
Wall Street Journal (July 23, 2014): Study Finds New Cancer Risk from Hysterectomy Device
New York Times (March 17, 2014): A Surgical Procedure’s Risks, Unmentioned
The Lancet (February 2014): Patients safety must be a priority in all aspects of care