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AAGL Member Update: FDA Issues Safety Communication on Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy

Last week the Food and Drug Administration released a communication regarding the use of laparoscopic uterine power morcellation in hysterectomy and myomectomy:

FDA Communication: 
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm 

The AAGL recognizes the role of the FDA in regulating the use of medical devices and in protecting the interests of patients. We share the FDA’s concern for patient safety.  To this end, the AAGL recently convened a task force of experts to undertake a thorough and deliberate review of the scientific literature regarding uterine tissue extraction and alternative treatment options for uterine fibroids.  The task force’s extensive evidence-based report is in its final stages and will be available to our membership and the public in the coming weeks.

Earlier this month we sent a communication to the FDA encouraging them to use the AAGL as a resource as they evaluated data on complications related to power morcellation. We have yet to be contacted by them; however, we plan to participate in the public meeting of the Obstetrics and Gynecological Medical Device Advisory Committee the FDA is convening to address surgical options for uterine fibroids. We will continue to make the AAGL available to the FDA and any other organization or society as they address this challenging issue.

The AAGL is committed to advancing safe minimally invasive procedures for the benefit of women. The benefits of minimally invasive surgery are well known and include decreases in numerous highly morbid post-operative complications including deep venous thrombosis and pulmonary embolism, infection and sepsis, fascial dehiscence, and bowel obstruction.

While it is of paramount importance that our patients are counseled appropriately about the dissemination risks associated with intracorporeal morcellation, specifically, and tissue extraction in general, it is also important for our patients and the public to recognize the benefits provided to the vast majority undergoing minimally invasive surgery. It is theshared responsibility of the physician and patient to weigh the risks and benefits of alternative approaches to surgery based on individual circumstances.

Methods of tissue extraction include bagged or un-bagged approaches through mini-laparotomies or the vagina, laparoscopically via power morcellation, or through laparotomy incisions. We believe all of these approaches have merit in appropriate patients and we disagree with restrictions on any of these approaches. As these options are considered, we encourage individualized patient care to provide the maximum benefits while achieving the best outcomes.

The AAGL remains engaged in educating our membership of over 7000 gynecologists on the safe and appropriate use of all methods of tissue extraction. We encourage future research and development and anticipate continued improvement in safety for all our patients.


Filed under "Association News".

AAGL – Elevating Gynecologic Surgery
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