During April 2014, the U.S. Food & Drug Administration (FDA), issued a warning to women and medical providers that may have come woefully late for some. The FDA’s warning of April 17, 2014, was a public message to discourage the continued use of laparoscopic power morcellation for removal of uterus or uterine fibroids because it could spread cancer into other parts of the body.
The FDA’s Safety Communication was issued along with the FDA NEWS RELEASE depicted above. The safety issue identified by the FDA identified a potential risk of spreading cancerous tissue through the use of a power morcellator. The FDA warned as follows: “[i]f laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.” The complete FDA Safety Communication is available here.
A laparoscopic power morcellator (pictured at the top of this post) is a medical device used during laparoscopic, or minimally invasive, surgery. In the case of the FDA’s Safety Communication, the morcellators are used to treat uterine fibroids, removal of the uterus (hysterectomy) or the removal of uterine fibroids (myomectomy).
Uterine fibroids are non-cancerous tumors growing within the wall of the uterus that can vary in size and symptoms. It is estimated that “most” American women will develop fibroids during their lifetime. As a result, morcellators pose a potential health risk to a vast number of girls and women. It is estimated that more than 200,000 hysterectomies are performed annually for uterine fibroids and that associated annual direct health care costs exceed $2.1 Billion. The potential public health risk from morcellators and associated health care costs arguably underscore the need for the recent FDA Safety Communication. More information on uterine fibroids from the U.S. Department of Health & Human Services is available here.
There has been an ongoing debate and groundswell of concern, including opposition to the use of morcellators and morcellation devices. The FDA’s Safety Communication marks a point in time where the FDA has acted but only after debate, groundswell and reports of adverse events. Regrettably, for some the warning comes only after other have fallen victim, or been exposed to an increased risk of cancer. By all indications the debate about the safety and use of morcellators will continue and is fueled by physicians interested in offering alternative treatments to their patients, manufacturers that make and promote use of the devices in question, as well as a lack of sufficient scientific data with which to silence critics on either side of the aisle.
The American College of Obstetricians and Gynecologists (ACOG) has authored a Special Report on the subject of morcellation entitled “Power Morcellation and Occult Malignancy in Gynecologic Surgery”, A Special Report, May 2014. Chronologically, this report followed the FDA’s Safety Communication and concluded by highlighting problems with morcellation under the current state of scientific knowledge. In the Patient Counseling and Informed Consent section the Special Report discusses a variety of risks, beyond the scope of this post, but that highlight how risky the procedure has been thru the present date. The Development of Technology and Training section calls for more studies to help identify pre-operative (pre-morcellation) uterine malignancies, development of special bags to be used in conjunction with the morcellators to basically “catch” tissues, credentialing of experts on morcellation with proven competency in use of the device and large population based studies to provide more accurate data on undiagnosed cancers in patients undergoing morcellation. Arguably, this report simply underscores the fact that there is little or not accurate data to support the continued use of morcellation in most women absent some compelling circumstances where the potential spread of cancerous tissue is warranted and the patient has consented to such a risk.
Earlier, in April 2014, ACOG had issued the following: ACOG Statement: FDA Issues Safety Communication on Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy.
Subsequently, the Special Report noted above was released, all the while many morcellators remained on the market until July 2014.
Johnson & Johnson publicly announced a market withdrawal, or recall, of the company’s Ethicon Morcellex Sigma Tissue Morcellator on July 31, 2014. It had reported suspended sales of the devices in April 2014, following the FDA’s Safety Communication. It was estimated as having been used in up to 50,000 U.S. uterine surgeries annually before the FDA Safety Communication as reported by Emily Wasserman in “Johnson & Johnson Pulls Power Morcellator Devices Amid Industry and Regulatory Backlash” here.
BLOOMBERG reported Michelle Fay Cortez reported in, “J&J Withdraws Hysterectomy Device Tied to Cancer Spread“, on how the device was being pulled from the global market amid growing concerns and continued debate about safety risks and the acceleration of undetected cancer growth following use of power morcellators. Her report cites the FDA as finding that 1 in 350 women who undergo morcellation may have a type of undetected cancer that can spread beyond the uterus, thus seeding malignant cells in the abdomen and pelvis while decreasing the woman’s chance of survival. As alarming is the fact that it is not known how many women undergo such procedures annually in the United States. How many women have been put at risk or have suffered as a result it not known and may never be known.
Based upon the history of morcellation devices and morcellators our office has initiated an investigation to assist victims. Please contact our office with any questions by using the link below to submit a contact request.
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