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FDA ISSUES AN UPDATED SAFETY COMMUNICATION AND INDUSTRY GUIDANCE ABOUT THE RISKS OF LAPAROSCOPIC POWER MORCELLATORS

FDA ISSUES AN UPDATED SAFETY COMMUNICATION AND INDUSTRY GUIDANCE ABOUT THE RISKS OF LAPAROSCOPIC POWER MORCELLATORS

November 24, 2014 - The FDA issued a major update to its safety communication from April 17, 2014, warning against the use of laparoscopic power morcellators (LPMs) for hysterectomies and myomectomies "in the vast majority of women."

FDA's decision to update its safety communication was prompted by the significant risk of cancer tissue spread "within the abdomen and pelvis" associated with LPMs that could "significantly [worsen] the patient's long-term survival." The FDA reiterated its "estimate that approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma." The safety update further notes that, "[w]hile the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood."

The updated recommendations were also informed by "the availability of alternative surgical options for most women." The safety update encourages both healthcare professionals and patients to "consider available alternative treatment options for the removal of symptomatic uterine fibroids." Such alternative options include "traditional surgical hysterectomy... and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, and laparotomy using a smaller incision (minilaparotomy)."

Furthermore, the FDA issued an industry guidance, to take immediate effect, that "strongly urges" the manufacturers of LPMs to include new and significant safety information in their product labeling. More specifically, the guidance recommends that the manufacturers update the device labels with a boxed warning about the risks of cancer spread and "decrease [in] the long-term survival of patients." Such boxed warning - also known as a "black box warning" - is the strongest type of safety measure short of taking a medical device off the market. The FDA guidance also asks manufacturers to update their labeling with statements contraindicating the use of LPMs when "the tissue to be morcellated is known or suspected to be cancerous" or can be removed intact without morcellation, as well as for all women who are approaching, are going through, or have gone through menopause. Furthermore, the guidance instructs that "this [new safety] information should be shared with patients when considering surgery with the use of [LPMs]." Finally, the guidance urges the manufacturers to update their labels with the boxed warning and contraindications "[w]ithin 120 days of the publication of [the] guidance."

LPMs are medical devices often used during various types of minimally invasive surgeries. As their name suggests, LPMs are used to morcellate, or break down tissue into smaller pieces so that they can be removed via the incision or extraction site. Many women undergo hysterectomies (partial or complete removal of the uterus) and myomectomies (removal of uterine fibroids) that utilize LPMs. On April 17, 2014, the FDA issued its original safety communication about the health risks associated with the use of LPMs, in which it discouraged the use of LPMs during surgeries in women with uterine fibroids due to the risks of cancer spread and worsening "likelihood of long-term survival."

Sources:

FDA,

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm393809.htm

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM424123.pdf

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