Doctors decry FDA Morcellator Warning

morcellator uterine cancerSome doctors decry the latest FDA morcellator warning. At least 48 doctors decry an FDA morcellator warning for laparoscopic surgeries. The doctors  – the self-described ‘Leiomyoma Morcellation Review Group’ – have proclaimed that the FDA  erred in its warnings over power morcellators. In April 2014, the FDA first discouraged the use of power morcellators for minimally invasive surgery in women with uterine leiomyomas. The agency then wrote:

“Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”

Then FDA strengthened its power morcellator position to a warning on Nov. 24, 2014, writing:

“The FDA is warning against using laparoscopic power morcellators in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids. Health care providers and patients should carefully consider available alternative treatment options for the removal of symptomatic uterine fibroids.”

Doctors decry FDA Morcellator Warning

Now some medical practitioners have started to push back. Medscape and others have reported this week that the group of 48 doctors disagree with the methodology FDA used to determine the incidence rate of women “presumed to have benign leiomyomas and the subsequent restrictions placed on the use of the morcellator, which currently deny many women the benefits of minimally invasive surgery.”

The 48 gynecologists argue that banning morcellation would, each year, force tens of thousands of women with fibroids to undergo major surgery with large abdominal incisions. The doctors also noted that major surgeries require longer hospital stays, longer recovery times and greater risks of complications.

Leiomyoma Morcellation Review Group

The doctors’ statement was published in the commentary section of the Jan. 2016 issue of Obstetrics and Gynecology magazine. Its authors were William H. Parker M.D. and colleagues.

FDA issued its morcellator guidance over concerns that if a woman with undetected leiomyosarcoma had that cancer morcellated, the cancer could be spread to other parts of her body. The doctors say the FDA erred in focusing exclusively on leiomyosarcoma, failing to take into account more common surgical risks which, according to the doctors, the morcellator lowers.

The doctors claim in their letter that, “Reduced mortality and fewer complications represent well-established benefits of laparoscopic surgery.” The doctors say the FDA restriction on morcellation puts women at risk of more common complications.

ACOG backs Morcellator

The American Congress of Obstetricians and Gynecologists (ACOG) issued a statement on Dec. 8, 2015 that backed the statement from the 48 doctors. “The conclusions of the paper’s authors largely reflect conclusions that ACOG has reiterated,” said ACOG.

ACOG has also defended the use of transvaginal or pelvic mesh for stress urinary incontinence and pelvic organ prolapse. At least some of its members had and/or have financial ties to pelvic mesh makers who face at least 80,000 pelvic mesh lawsuits around the country filed by women who allege injury from the plastic mesh. ACOG conflicts of interest have been revealed by Mesh News Desk and others in ongoing pelvic mesh trials. ACOG disclosed no financial ties or other potential conflicts of interest with its statement critical of the FDA’s current morcellator stance, nor did the 48 doctors disclose any financial ties to any morcellator or its maker.

Stay tuned. . .



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