Some women have claimed they developed cancer after undergoing hysterectomies (removal of the uterus) or myomectomies (removal of uterine fibroids) performed via a special surgical technique known as “morcellation.”
Although the U.S. Food and Drug Administration as recently as 2014 was discouraging the use of laparoscopic power morcellation during surgeries — because it could spread undetected cancer cells throughout the body and significantly reduce the likelihood of long term survival for these patients — recent developments have uncovered something more troubling.
A recent Government Accountability Office study, released in February 2017, reported that for decades the FDA was aware of the cancer-spreading risk these morcellators posed, believing there was a low risk of cancer. The knowledge of the risk had been available to them as early as 1980, but they didn’t study it until 2013, according to the GAO.
In light of this information, our attorneys would like to hear from women who were diagnosed with cancer following one of these surgeries, as well as loved ones acting on their behalf.
What is Morcellation?
Morcellation is a surgical procedure that allows doctors to divide tissues into smaller pieces and remove them through a small incision. It can be performed by hand using a knife or with a morcellator, which is an electrical device with a spinning blade. A variety of surgeries previously used this technique due to its minimally invasive nature, though these new revelations have caused the use of morcellators to decline.
The Reported Problems with Morcellators?
Morcellators may spread cancer in women undergoing hysterectomies or myomectomies who are unaware that they have uterine sarcomas, which are highly malignant, cancerous tumors that doctors often have difficulty diagnosing. During these surgeries, doctors may mistake sarcomas for benign tumors known as fibroids or may not see the cancerous tumors in the uterine tissue. Using morcellation to break up and remove sarcomas may cause these cancer cells to be “sprayed” throughout patients’ bodies and land on their abdomen or pelvis, which can put patients at risk for advanced, potentially deadly forms of cancer.
FDA Discourages Use of Morcellators, Recommends Black Box Warning Cancer Risk
Controversy surrounding the risk of cancer spreading in patients undergoing surgeries using morcellators recently pushed the FDA to further investigate the prevalence of sarcomas in these patients. According to the FDA, data suggests that these cancerous tumors are much more prevalent than previously believed.
In 2012, the Wall Street Journal reported that doctors agree only between three and seven per 100,000 women have sarcomas; however, the FDA found that approximately 1 in 350 women undergoing hysterectomies and myomectomies using morcellators had unsuspected cancer cells in their uterine tissue.
Furthermore, a study published in the medical journal PLOS One found that rates of leiomyosarcoma, the deadliest form of the disease, were as high as 1 in 546 women, which is “much higher than the empiric rate of 1-in-10,000 typically quoted to patients during their pre-procedure briefing.”
In light of this information, the FDA said that since “there is no reliable way to determine if a uterine fibroid is cancerous prior to removal,” the agency is now discouraging the use of morcellators during these surgeries.
The knowledge of the risk had been available to them as early as 1980, but they didn’t study it until 2013.
In November 2014, the FDA updated its safety alert on these procedures to include recommendations that morcellator manufacturers add a black box warning and two contraindication warnings to the packaging for their surgical tools.
In 2015, however, members of Congress asked the GAO to investigate these morcellators. While the GAO did not take the FDA to task, it made it very clear in its recently released study that failing to act on their knowledge of the cancerous risks morcellators posed was a massive oversight that resulted in massive harm; a 2012 study that the GAO cited in their investigation said that the hidden cancer rate of morcellators was 9 times higher than the assumed 1 in 10,000 rate.
A spokesman for the GAO says that the FDA “has noted the shortcomings of the current passive postmarket surveillance system and has been taking steps to establish a better system to evaluate device performance in clinical practice.”
Have Morcellators Been Recalled in the Past?
Yes. Ethicon, a subsidiary of Johnson & Johnson and the largest supplier of morcellators, issued a worldwide withdrawal of its Morcelex device in July 2014. Ethicon originally suspended worldwide sales of its morcellators in April 2014 after the FDA published its initial alert about the procedure; however, after attending the FDA’s public meeting on the devices in July 2014, the company was reportedly persuaded that the risks these tools pose may not outweigh their benefits.
During that meeting, the FDA’s panel on obstetrics and gynecological medical devices discussed options for reducing the risk of spreading cancer cells in patients undergoing morcellation, including placing a “black box warning” on these tools. Just two weeks after the meeting, Ethicon sent a letter to doctors claiming that the company felt that at the time, they believed a total market withdrawal was the best action until the risk has been mitigated.
Despite Ethicon’s recall - and subsequent recalls since 2014, such as Lumenis’s 2015 recall of its VersaCut Tissue Morcellator - many major medical manufacturers continue to make and market power morcellators.