By Anna E. Mazzucco, Ph.D.
2014
If you have uterine fibroids and are considering treatment or if you’ve heard about uterine morcellation in the news, this article will help you understand the issue.
What are power morcellation devices?
A power morcellation device is a small surgical tool which cut tissue into smaller pieces. This allows organs or other tissues to be removed through smaller incisions, making surgery shorter and leaving smaller scars behind. The front end of a power morcellator has a spinning blade that cuts the tissue into tiny pieces (pulverizes it), and the back end is connected to a tube which sucks the tissue through the device (see image below).
Power morcellation devices were originally designed for removal of the uterus (or the womb), but are currently used for many different types of surgical procedures because they make it easier for a physician to perform surgery using smaller incisions.
What is the controversy about morcellation devices?
In 2012, two Harvard doctors had their lives tragically affected by these devices. Dr. Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center, which is affiliated with Harvard Medical School, had surgery in the fall of 2013 to remove her uterus due to fibroids. After the surgery she was diagnosed with advanced (stage IV) uterine cancer, spread by the use of power morcellation during her surgery. The morcellation left behind tiny pieces of tumor throughout her pelvic cavity, which allowed the cancer to spread. While morcellation devices are sometimes used with a bag to contain the fibroid or tissue so that it won’t spread, the bags can be difficult to use so not all surgeons use them. Dr. Reed was never told that morcellation would be performed during her surgery, or about the potential risks.
As a result of this surgical procedure with morcellation, a small cancer that could have been easily and completely removed through surgery has been spread and is now considered fatal.
Dr. Reed, who is now undergoing aggressive treatment for her metastasized uterine cancer, and her husband, Dr. Hooman Noorchashm, who was a surgeon at nearby Brigham and Women’s Hospital (also affiliated with Harvard), began a campaign to raise awareness of this issue and prevent other patients from being harmed. As a result, Brigham and Women’s Hospital has since changed its policies on use of morcellation. Since their story came out, other similar stories have surfaced, confirming that cancer has been spread by these devices, that it is not a rare event, and that it can have fatal results. Moreover, many of these patients had not been told about these potential risks before their surgeries, and in some cases weren’t even told that morcellation would be used. In May 2015, the Wall Street Journalreported that the FBI is investigating whether information about the risks of morcellation was not reported by hospitals, doctors, and device makers, as required by law.
What are uterine fibroids?
Uterine fibroids are non-cancerous (benign) growths on the uterus. They are very common among women, especially during and after the reproductive years. In many women, they do not cause any noticeable symptoms or problems. But in some women, uterine fibroids can cause pain, discomfort during sex, and heavy bleeding. To read more about fibroids and treatment options for them, read our in-depth article here.
What are the risks and benefits of using power morcellators?
Morcellation can allow surgeons to do shorter, less invasive surgeries. This can reduce the chances of excessive blood loss and infection, and can reduce the amount of time spent in the hospital and result in an easier recovery afterwards. However, in the case of fibroids, there is no way to rule out the chance of hidden cancer which could be spread by morcellation. The Food and Drug Administration (FDA) estimates that 1 in 350 women receiving surgery for uterine fibroids has a hidden cancer that could be spread by morcellation. This is why the FDA released a warning in April 2014 recommending against morcellation for uterine fibroids.
On July 10-11, 2014, the FDA held a public meeting to discuss the risks and benefits of these devices. Our testimony before the FDA panel on uterine morcellation, is here.
On November 24, 2014 the FDA announced that they were issuing an immediate change in the label for power morcellation devices, which will now include a black box warning as follows:
“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.”
These tragic events involving power morcellation devices raise questions about how medical devices are approved and monitored, and how a tragedy like this can be prevented in the future. If larger studies had been done before the FDA allowed these devices to be used, and if cases of cancer being spread by morcellation had been reported to the FDA by doctors and companies, the FDA could have warned doctors and patients much earlier and prevented women from being exposed to these risks.
What do patients need to know?
If you are considering surgical treatment for uterine fibroids, be sure to discuss morcellation with your surgeon and make your wishes clearly known. Depending on your particular situation, there are alternative surgical procedures, such as vaginal hysterectomy, which can be done without morcellation. For any surgical procedure, make sure you have a clear and thorough discussion with your doctor about exactly how the procedure will be done, what choices you have, and what the risks and benefits of different options are. If you feel that you are not getting enough information from your doctor, consider getting a second opinion. Be sure to ask your doctor how often they perform the procedure you will have, because patients usually have a better outcome from surgery if the doctor performs the exact same surgery frequently. If the physician does not have many years of frequent experience with the surgery, seek out a doctor who does. For more tips on how to make smart decisions about medical treatments, especially use of medical devices, read our article here.