SANTA MONICA, CALIFORNIA - Dozens of the country's leading experts in gynecology and related specialties are asking the Food and Drug Administration to rescind or revise a warning it issued severely restricting use of a device commonly employed in minimally invasive procedures to treat uterine fibroids.
Forty-eight gynecologists, gynecologic oncologists, surgical oncologists, department chairs and women's health advocates sent an open letter to the FDA yesterday saying they believe the agency's decision, although well-intentioned to protect against the spread of a very rare form of uterine cancer, was based on incorrect data, and it could require tens of thousands of women with benign fibroids to undergo major surgery with large abdominal incisions each year. The doctors point out that the more invasive operations have higher risks and require longer hospital stays and many more weeks for recovery than less invasive procedures.
In addition to its Dec. 7 plea to the FDA, the Leiomyoma Morcellation Study Group published a related article online Dec. 8, 2015 in Obstetrics & Gynecology, the journal of the American College of Obstetricians and Gynecologists. That paper presented statistics that support the group's objections and offered suggestions for clinical recommendations.
"We have to take into account all available data, including risk-benefit ratios, when establishing standards of patient care. In this case, the data supports using morcellation under specific circumstances in order to avoid much more invasive procedures," said Laurel Rice, MD, gynecologic oncologist and chair of the University of Wisconsin-Madison Department of Obstetrics and Gynecology.
Benign fibroids, also called leiomyomas, can be found in about 75 percent of all women at some point in their lives, resulting in an estimated 210,000 hysterectomies and 50,000 myomectomies – surgical fibroid removals – each year in the United States. Many of these operations are done laparoscopically and a small, electrical device called a power-morcellator is used to cut or break down the fibroids into tiny pieces that can be removed through the small incisions.
The FDA's concern is that if a presumed benign fibroid is later found to be a highly aggressive malignancy called a leiomyosarcoma, fragments of the cancer will be scattered by the power-morcellator, increasing the risk of spread.
Leiomyosarcoma, or LMS, is diagnosed in about 1,600 women in the U.S. each year and is difficult to identify prior to post-surgery laboratory analysis. When it is suspected prior to surgery, surgeons typically opt for open surgery using a large abdominal incision and try to remove the tumor intact. Even in its early stages and without morcellation, LMS advances quickly and is difficult to treat because its cells readily travel in the bloodstream and attach and grow elsewhere in the body.
But gynecology experts in the study group said the FDA's warning against power-morcellation was based on a flawed medical literature review and assumptions based on inconclusive evidence.
"The FDA's estimate that 1 in every 458 women having surgery for presumed fibroids actually has LMS appears to overstate the risk," said William Parker, MD, director of minimally invasive gynecologic surgery at UCLA Medical Center, Santa Monica.
He added that a recent and more rigorous analysis of 133 studies determined that the risk of finding a leiomyosarcoma among women having surgery for presumed fibroids was 1 in 1,960, or 0.051 percent. Another recently published large population-based study found 2 leiomyosarcomas among 8,720 women having surgery for fibroids, which equates to 1 in 4,360 or 0.023 percent.
The authors said they believe that restriction of any type of morcellation – whether by powered device or by hand using a scalpel – would severely restrict women's access to most procedures other than traditional abdominal surgery, which has more risks and complications.
Parker and his study group colleagues said that although it is difficult to distinguish between benign fibroids and LMS in preoperative exams, images and tests, there are some clues that can help doctors and patients make treatment decisions. For example, benign fibroids are more likely to cause symptoms in younger women, primarily those in their 40s, but LMS typically affects a more senior population; prevalence is 10 times higher in women older than 60 than in those younger than 50.
In the article, they offered six clinical recommendations for FDA consideration:
- Greater caution should be exercised before recommending morcellation procedures for post-menopausal women.
- Women 35 or older with irregular bleeding and presumed fibroids should have a biopsy of the lining of the uterus and normal Pap smear results.
- Certain ultrasound or MRI findings should increase suspicion of LMS.
- Women considering procedures involving morcellation for fibroids should be informed of the potential risk if LMS is found, and open surgery should be offered to all women considering minimally invasive procedures.
- Following morcellation, doctors should carefully inspect for retained tissue fragments and irrigate the pelvic and abdominal cavities thoroughly.
- Research projects should be initiated to find ways to noninvasively, preoperatively identify LMS and to discover how tissue fragments and cells are able to spread, implant and grow.
"In our view, the numbers do not support the FDA's estimated prevalence of LMS among women having surgery for presumed fibroids and those at risk for morcellation of a leiomyosarcoma, but the recent attention on hidden LMS may help improve the way we treat both benign fibroids and these cancers," Parker said.
All doctors signing the article and letter to the FDA affirm that they have no conflicts of interest.