On the forefront of a heated debate concerning laparoscopic power morcellators (LPMs) in uterine fibroid surgery is Jubilee Brown, MD, Director of Oncology at the University of Texas MD Anderson Cancer Center. Dr. Jubilee Brown is in favor of LPMs used for minimally invasive surgery to remove fibrous growths from the uterus of affected women.
According to Dr. Brown, findings from the American Association of Gynecologic Laparoscopists (AAGL), show that mortality rates from open hysterectomy are 0.085% per year while mortality rates from laparoscopic hysterectomy using LPMs are 0.077%. Should LPMs be banned from the market, an additional 17 women would die from an open hysterectomy each year. “Let us improve, but not abandon, power morcellation,” said Dr. Brown in a news report.
On the opposing end of the argument is Amy Reed, MD, PhD, an anesthesiologist at Harvard Medical School’s Beth Israel Deaconess Medical Center: “Morcellation is bad medicine.” She rejects the statement that banning LPMs would require all women to undergo a full abdominal procedure. “Laparoscopic surgery involves opening a small incision. Morcellation is shredding up tissue. Other branches of surgery operate laparoscopically without morcellation. They do so by making an incision appropriate for the mass in question,” said Dr. Reed.
The two doctors were a part of a two-day meeting of the Obstetrics and Gynecology Devices Advisory Committee. The meeting was called after the Food and Drug Administration (FDA) voiced concern over the use of LPMs, suggesting greater restrictions on their use be put in place and to allow industry to create safer devices. The FDA’s concern is based on the chance that morcellation may inadvertently spread malignant tissue to upstage tumors and worsen a patient’s prognosis for their presumably benign fibroids.
Although the first LPM was FDA-approved in 1991, with the first gynecologic indication available in 1995, the FDA is now considering placing LPMs in a “black box” category. Before doing so, the FDA sought input from the panel called during the meeting.
The panel struggled with weak data showing a risk for cancer spread, but it was generally agreed that the risk of unsuspected cancer in women with uterine fibroids is greater than it was previously. Testimony from patients and family members brought to life the risk of tumor advancement following morcellation. Many of the patients who were treated were assured they did not have cancer and were not informed of the risk of morcellation.
Some of the discrepancy may originate from different perspectives of doctors. Said Robert Mattrey, MD, of the University of California, San Diego, “I think when a fibroid looks benign (i.e., dark, well circumscribed), it is benign. But the majority of the difficulty comes when fibroids don’t look that way. It’s not that we can’t diagnose leiomyosarcoma, it’s just that a good percent of fibroids could look like leiomyosarcoma, and to distinguish those two would be difficult.”
There was support for making LPMs safer by trying to identify risk factors, but no one factor should be relied upon to make a definitive judgment. Uterine sarcoma data from fifteen large population-based studies did identify some risk factors, but according to Nicolas Wentzensen, MD, PhD, from the National Cancer Institute Division of Cancer Epidemiology & Genetics, “the magnitude of those would not be useful for assigning risk categories.”
Although some panel members were in favor of using specimen bags to contain the tissue to be removed during morcellation, others were unconvinced. Keith Isaacson, MD, of the Newton-Wellesley Hospital Center for Minimally Invasive Gynecologic Surgery stated, “I think that if you’re going to morcellate, and it can be done safely in a bag, that should be encouraged,” while Craig Shriver, MD, of Walter Reed National Military Medical Center and the United States Army, believes, “There’s no evidence that bags or any containment devices prevent the outcome we’re trying to prevent.”
Regardless of the facts presented at the meeting, the panel seems to remain divided. The FDA stated the informed consent process regarding patient risk must occur when the need for morcellation was unknown before surgery. It would be best to include this documentation outside the LPM device packaging, as patients are unconscious when the sterile package is opened. “I think that would be a benefit, because it would make the surgeons think more carefully ahead of time who you’re going to use it in…. It would force everybody to think about it ahead of time,” said Dr. Brown.
No conflicts of interest were disclosed by presenting panel members, which will allow the FDA to unbiasedly decide the best course of action following the meeting.