Women who suffer from painful uterine fibroids may have their uterus removed for relief. The most common hysterectomy procedure involves a 3-to-7-inch incision through which the entire uterus is removed intact. Surgeries that can be performed laparoscopically through a smaller incision offer less scarring, fewer complications and shorter recovery time. In order to remove the uterus through a smaller incision, it first has to be cut up into pieces. This is performed using a laparoscopic power morcellator. The device can also be used to remove fibroids only (called myomectomy) in a laparoscopic procedure.
On April 17, 2014, the Food and Drug Administration (FDA) issued a statement saying it “discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.” An advisory panel then provided a variety of recommendations, some going so far as to recommend completely banning the use of the device.
The issues surrounding the use of the morcellator can be examined in a Cause Map. The Cause Map allows a visual diagram of cause-and-effect relationships that include the impacts associated with a particular issue. In this case, the use of the power morcellator is found to increase the risk of spreading cancer, a clear impact to the patient safety goal. Concerns about the delay in determining the safety risk (morcellators have been used since the 1990s) can be considered an impact to the patient services goal. Sales of morcellators have been stopped, and as discussed above, the use of morcellators is being questioned by the FDA.
Beginning with the impacted goals, we can ask “Why” questions to determine the cause-and-effect relationships. The risk for spreading cancer results from undetected cancer in tissues that are then cut up inside the body. Uterine cancer is difficult to detect with available testing and can be difficult to distinguish from fibroids. Additionally, cases have been found where cancer was missed in testing prior to surgical treatment. Recent studies have shown that women who seek such surgeries have a higher incidence rate of uterine cancer (1 in 368 post-hysterectomy patients were found to have uterine cancer versus 1 in 10,000 for the general population).
The morcellator cuts up tissue so it can be removed laparoscopically in a minimally invasive hysterectomy or myomectomy for fibroids. Until recently, there was no data or warning indicating that morcellators weren’t safe to use. The device did not provide clinical trial data, which is not required for new products considered “substantially similar” to existing products that are already marketed. The FDA does not believe that the cancer risk would have been discovered even with a higher level of scrutiny. The FDA depends on a database of medical-device problems reported by doctors. However, doctors are not required to report issues. In addition, it’s not clear that many made the link from the spread of cancer after the use of the morcellator. Or, some healthcare professionals say they didn’t report it because they believed the undetected cancer – not the use of a device – was to blame.
The link over spreading cancer has now clearly been established. (Data is still being examined to see if the device worsens cancer as well.) The FDA is working to determine what – if any – restrictions will be placed on morcellator use. It’s pretty clear to some, especially given that this treatment for fibroids is considered elective and there are alternatives, including a traditional hysterectomy. Says Dr. Craig Shriver, surgical oncologist at Walter Reed National Military Medical Center, “There is at present no safe way to offer laparoscopic power morcellation as part of any minimally invasive surgery.”
However, others think the tool still has a place for minimally invasive surgery and that patients should be able to determine for themselves if the risk is worth taking. According to Dr. Jason D. Wright, the lead author of a study regarding morcellators published in the Journal of the American Medical Association study, “I don’t know that necessarily morcellation should be banned. But this data is important to allow people to make decisions.”
In the meantime, some facilities are attempting to enclose the uterus in a protective bag before morcellation to minimize the risk of tissue remaining in the body, but there is no evidence that this reduces the risk of cancer spread. Until the FDA’s final decision, each patient and healthcare facility will have to do their own risk assessment to determine whether or not the tool should be used.