publication date: Sep. 12, 2014
Learning from the Power Morcellation Fiasco: Federal Government Must Do More to Regulate Devices
By Hooman Noorchashm
Following our discovery that my wife’s occult uterine cancer was morcellated using a gynecological power morcellator, we initiated a vigorous campaign to protect others from this avoidable harm. It is now increasingly clear that one in 350-500 women with symptomatic fibroids have occult or missed uterine cancer lurking in what a majority of gynecological surgeons have assumed to be benign tumors.
This assumption of benignity has proven deadly to many women for over twenty years because it allowed the upstaging of aggressive, but early stage and potentially curable, gynecological cancers. Additionally, morcellation, particularly power morcellation, is known to cause the spread of benign uterine tissues leading to highly morbid non-cancerous disease—so-called, parasitic leiomyomatosis and endometriosis. Of course this careless gynecological practice of morcellation rests at the core of a very high volume and revenue-rich procedure. Likely over 100,000 minimally invasive hysterectomy and myomectomy operations are performed using morcellation in the United States alone.
We reported the deadly oncological hazard of gynecological morcellation, and power morcellators, to the FDA and CDC for the first time in December 2013. Our alarm led to an FDA advisory issued on April 17, 2014 and a FDA hearing on July 10-11, 2014. Subsequently, Johnson & Johnson, the largest world-wide manufacturer of power morcellators, withdrew the device from market. And several large insurance carriers in the US have stopped covering the procedure. However, strikingly, the gynecological societies (ACOG, AAGL, and SGO) and a large number of individual gynecologists continue to defend the practice. And several device manufacturers have refused to withdraw their product from the market. In fact, the manufacturer whose device was used … Continue reading 40-34 Guest Editorial
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