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Regulatory News | 09 December 2015 | By Zachary Brennan
Leading gynecology experts sent an open letter to the US Food and Drug Administration (FDA) Tuesday calling on the agency to rescind or revise a warning it issued that restricted use of a device in minimally invasive procedures to treat uterine fibroids.
The warning on laparoscopic power morcellators (LPM) followed FDA concerns that if a presumed benign fibroid is later found to be a malignancy called a leiomyosarcoma, fragments of the cancer will be scattered by a LPM, increasing the risk of spread. The agency issued new restrictions in November 2014, outlined in its guidance document, Product Labeling for Laparoscopic Power Morcellators, to "promote the safe and effective use of LPMs when used for gynecologic surgeries.”
But now, 48 gynecologists, gynecologic oncologists, surgical oncologists, department chairs and women’s health advocates said in the letter that they believe the agency’s decision, although well-intentioned to protect against the spread of a 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 abdominal surgery each year.
In addition to the letter, the Leiomyoma Morcellation Study Group published a related editorial Tuesday in Obstetrics & Gynecology, and another study from the same journal notes that there was “a significant decrease in the proportion of minimally invasive hysterectomies and myomectomies performed during the 8 months after the FDA warning statement on the use of power morcellation.”
William Parker, the editorial’s lead author and director of minimally invasive gynecologic surgery at UCLA, said: “We believe the FDA failed to identify important information, leading to inaccurate results. We hope the agency will take a second look so that women will continue to have effective, minimally invasive treatment options for fibroids.
“The FDA’s estimate that 1 in every 458 women having surgery for presumed fibroids actually has LMS appears to overstate the risk,” Parker added, noting that a recent analysis of 133 studies determined that the risk of finding a leiomyosarcoma among women having surgery for presumed fibroids was actually 1 in 1,960, or 0.051 percent.
He also told Reuters that FDA’s recommendations “were not based on science, but rather on emotional and anecdotal information.”
The group also offered six clinical recommendations for FDA:
– 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 leiomyosarcoma.
– Women considering procedures involving morcellation for fibroids should be informed of the potential risk if leiomyosarcoma 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 leiomyosarcoma and to discover how tissue fragments and cells are able to spread, implant and grow.
Hal Lawrence, executive vice president and CEO of the American College of Obstetricians and Gynecologists, also put out a statement saying that the commentary largely reflects the positions of the group.
Association of the U.S. Food and Drug Administration Morcellation Warning With Rates of Minimally Invasive Hysterectomy and Myomectomy
U.S. Food and Drug Administration's Guidance Regarding Morcellation of Leiomyomas: Well-Intentioned, But Is It Harmful for Women?
ACOG Statement on FDA regulation of Morcellation
Tags: power morcellators, LPMs, FDA warnings, uterine fibroids, gynecology