Power morcellators—medical devices resembling hand-held blenders that are used for minimally-invasive surgical procedures—may spread and worsen cancer in women.
Johnson & Johnson and other manufacturers are facing lawsuits alleging that power morcellators harmed women by spreading cancer.
Morcellators chop up tissue into smaller pieces that can be more easily extracted from the body through a small incision. Commonly used to perform the removal or uterine fibroids (myomectomy) or removal of the uterus (hysterectomy), morcellators can improve surgical outcomes but may also disperse undetected cancer beyond the uterus, significantly worsening a patient’s likelihood of long-term survival.
About Power Morcellators
In medical terms, “morcellation” refers to the dividing of tissue into smaller pieces.
Power morcellators are shaped like drills, with sharp, rotating blades at the end of a long tube that grind up tissue. The blade end of the device is inserted through a small incision in the abdomen to perform “laparoscopic” (minimally invasive) hysterectomies and myomectomies. Once the tissue to be removed is chopped up, it’s vacuumed from the body through the tube.
Compared to traditional hysterectomy or myomectomy surgery, which require a much larger surgical incision, minimally invasive procedures are associated with fewer surgical complications and a faster recovery.
Prior to the FDA’s warning in 2014, power morcellators were used in around 60,000 hysterectomies and myomectomies annually. The devices are used in other types of surgeries as well, including minimally invasive spleen and gallbladder procedures.
How Power Morcellators Can Spread Cancer
Most women develop noncancerous growths called “uterine fibroids” at some point in their lives. While fibroids typically cause no symptoms, they occasionally lead to complications (including bleeding and pain) that necessitate surgical removal. Many women opt for fibroid removal using a power morcellator due to the surgical benefits of minimally invasive morcellation.
But approximately 1 in 350 women undergoing hysterectomy or myomectomy for fibroid treatment actually have uterine sarcoma—a type of cancer—and NOT benign fibroids. When women with undiagnosed sarcoma undergo power morcellation, bits of cancerous tissue can be dispersed within the abdomen and pelvis, inadvertently spreading and worsening the cancer.
Previously, the rate of undetected sarcoma in women was estimated to be low (1-in-10,000) but an FDA analysis of currently available medical literature found the actual rate to be much higher.
FDA Warns About Morcellators
The FDA urged doctors not to use power morcellators in hysterectomies or myomectomies “in the vast majority of women.”
The Food and Drug Administration first warned about the risk of spreading cancer with power morcellators in an April 2014 safety communication that stated, “the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.”
According to the FDA, it is better to avoid altogether laparoscopic power morcellation for these patients because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma.
Women with symptomatic uterine fibroids have a number of surgical options that do not involve power morcellation.
Following up on its April 2014 warning, FDA issued new guidelines for power morcellators in November 2014 that urged doctors not to use power morcellators in hysterectomies or myomectomies “in the vast majority of women.” FDA also recommended that device manufacturers provide warnings on product labels about the risk of spreading cancerous tissue with power morcellators.
In lawsuits filed against device manufacturers patients allege that they were never warned a power morcellator could spread and worsen undetected cancer and that had they known of the risk, they would have opted for an alternative surgical procedure.
Power Morcellator Manufacturers
The following medical device manufacturers sell laparoscopic power morcellators:
- Blue Endo
- Cook Urological, Inc.
- Ethicon, Inc. (a Johnson & Johnson subsidiary)
- FemRx (J&J subsidiary)
- Karl Storz
- LiNA Medical
- Lumenis, Ltd.
- Olympus America Inc.
- Richard Wolf GmbH
J&J Suspends Morcellator Sales
Shortly after FDA’s April 2014 warning about morcellation, Johnson & Johnson—the company with the largest share of the morcellator market—suspended sales worldwide of its power morcellators.
The J&J products covered under the suspension are the Gynecare Morcellex Tissue Morcellator, the Morcellex Sigma Tissue Morcellator System, and the Gynecare X-Tract Tissue Morcellator.
Physician Couple Campaigns for an End to Morcellation
Amy Reed, a Boston-based anesthesiologist, was diagnosed with Stage 4 sarcoma after undergoing uterine morcellation. Reed, along with her physician husband Dr. Hooman Noorchashm, launched a campaign against morcellation that seeks to halt use of the surgical technique.
According to Reed and Noorchashm:
- The typical survival time following accidental morcellation of sarcoma is only 24-36 months.
- Women with sarcoma who undergo power morcellation are roughly 4 times more likely to die from sarcoma than if they had not been morcellated.
Dr. Noorchashm believes that J&J’s decision to suspend morcellator sales didn’t go far enough. He also says that the FDA’s warning is inadequate.
“Why are you leaving these devices on the shelves?” said Noorchashm. “We congratulate the FDA for acting, but they clearly could pull these devices off the market, and they haven’t.”
Morcellators Cleared Through Controversial FDA Program
Through the 510(k) program, the FDA allows new medical devices to be cleared for sale without first being tested on human subjects.
According to Johnson & Johnson instructions for its morcellation devices have always warned about the possible spread of malignant tissue. It’s not certain how the manufacturer arrived at this finding since its morcellators—and every other power morcellator on the market—never underwent clinical testing.
Through an approval process known as 510(k), FDA allows new medical devices to be cleared for sale without first being tested on human subjects, provided that the new device is “substantially equivalent” to an already-approved device.
Over a period of two decades, according to the Wall Street Journal, the FDA cleared at least 10 morcellators from several companies via the 510(k) process, including devices made by J&J, Cook, LiNA Medical, and Olympus.
Dr. William Maisel, chief scientist for the FDA’s medical device center, admits that only a large clinical study could have uncovered early evidence of power morcellator cancer risks.
FDA first approved a laparoscopic power morcellator in 1991. Cook, the company seeking sales permission for the first power morcellator, cited as “substantially equivalent” predicate devices four different medical tools, including a manual morcellator and tissue-punch devices.
Based on approval of the Cook device, which was accompanied by no clinical trial results, subsequent devices were approved based on “substantial equivalence” to the Cook morcellator. These devices were in turn cited as the basis of approval for new morcellators, and so on and so on, with the end result being that none of the power morcellators now in use were approved based on high-quality evidence of safety and efficacy.
FDA did not begin evaluating the cancer risks of morcellation until 2013.
FBI Investigates J&J Over Devices
In May 2015, the FBI began investigating what J&J knew about the cancer hazards of power morcellators prior to pulling its devices off the market, according to The New York Times.
The Times reports that it spoke with Dr. Robert W. Lamparter, a retired pathologist interviewed by the FBI, who said he warned J&J in 2006 about the potential for morcellators to spread undetected cancer. J&J allegedly updated product instructions in response to the doctor’s concerns, but the doctor called this a “legal fig leaf” and said that “I’ve come to believe that the morcellator, as it is used now, is just a bad idea.”
J&J, Other Morcellator Manufacturers Facing Lawsuits
Several power morcellator manufacturers are named in lawsuits claiming that the devices spread undetected cancer and harmed women. J&J’s Ethicon unit—the most frequently named manufacturer—faces about 100 morcellator lawsuits in federal courts in addition to state court cases.
J&J is reportedly moving quickly to settle the cases.