Last week, the FDA’s Obstetrics and Gynecology Devices Panel held a public meeting to discuss whether a procedure known as laparoscopic power morcellation should continue to be used during surgeries following reports that it can spread unsuspected cancer cells in women undergoing certain operations.
Morcellation is a procedure that allows surgeons to break up cells and tissues within the body and remove them through a small incision. It is often used to perform minimally invasive hysterectomies (removal of the uterus) and myomectomies (removal of presumed benign fibroids). In April 2014, the FDA said it was discouraging the use of morcellation during these surgeries, though, because if morcellation is used to break up an unsuspected cancerous tumor, it may cause cancer cells to spread throughout the body and advance-stage cancer may develop.
During the two-day public meeting, which took place on July 10 and 11, 2014, the FDA panel discussed possible solutions for reducing the spread of cancer cells in women undergoing these procedures.
According to reports, the panel seemed interested in implementing an informed consent form, which patients and doctors would be required to read and sign prior to surgery. A consent form would help ensure that patients fully understand the risks associated with morcellation, which was a concern of many members of the public who spoke at the meeting on behalf of loved ones who developed cancer after undergoing these surgeries.
In addition, the panel spoke about the importance of promoting alternatives to morcellation, such as vaginal hysterectomies and medical management of fibroids using birth control and other medications. Furthermore, the panel discussed the efficacy of surgical bags, which could be used during morcellation to safely contain potentially cancerous cells that are broken up during the procedure. Yet, many pointed out that these bags must be further tested for durability before they can be used for these procedures. The panel stressed that this may be an opportunity for the medical device industry to create new containment strategies or general solutions to morcellation.
The panel also discussed placing the FDA’s most serious warning, a “black box” label, on the tools used in these procedures, known as morcellators; however, the panel ultimately found that these labels would be insufficient, because patients rarely see the packaging for surgical tools before operations.
Morcellation initially came under fire in December 2013 when Drs. Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center and Harvard Medical School, and her husband Hooman Noorchasm, a surgeon, filed a petition to end the use of morcellation.
The couple appeared at the FDA’s public meeting last week to share their story and speak about the risks of morcellation, which they called “bad medicine.” Reed, who underwent a hysterectomy using morcellation in 2013, is currently battling stage-four cancer. She believes that her cancer was upstaged from morcellation and told the FDA panel that she would not settle for anything short of a ban on the procedure.
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