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Local hospitals offer mixed response to FDA surgery alert

The Democrat & Chronicle, in an April 24 story, reported that the Rochester General Health System has halted the use of a procedure called "power morcellation" for surgical hysterectomies based upon an alert from the Food & Drug Administration. The halt affects Rochester General Hospital and Newark-Wayne Community Hospital. Unity Health Systems imposed a similar ban on April 21. The University of Rochester Medical Center, consisting of Strong Memorial Hospital and Highland Hospital, permits the procedure with restrictions that were placed in March.

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The Food & Drug Administration released a document titled "Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication" on April 17. It noted that the procedure holds the risk of spreading an undetected cancer in as many as one of every 350 women receiving it. The agency discourages the use of "laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids."

Laparoscopic power morcellation is a minimally invasive procedure that removes the uterus or uterine fibroids by cutting them into pieces so that they can be removed through the small incisions in the abdomen. The FDA notes that there are no methods for detecting some uterine cancers and that morcellation as currently preformed may spread undetected cancer.

The Democrat & Chronicle interviewed a a local woman who had the procedure in Sept. 2012 and was then found to have cancer. Brenda Leuzzi told the paper "It's dangerous, it's deadly, look what it's done to me."

Several physicians' groups have weighed in on the FDA action, and oppose any outright ban. AAGL issued a statement in response that says, in part:

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 the shared responsibility of the physician and patient to weigh the risks and benefits of alternative approaches to surgery based on individual circumstances.

The FDA will continue to evaluate the technique and the devices used. It recommends that patients:

Ask your health care provider to discuss all the options available to treat your condition and discuss the risks and benefits of each. If laparoscopic hysterectomy or myomectomy is recommended, ask your health care provider if power morcellation will be performed during your procedure, and to explain why he or she believes it is the best treatment option for you.

The FDA is examining product labeling and instructions for power morcellators to determine their accuracy in presenting the risks to the patient. They are convening a meeting of the Obstetrics and Gynecological Medical Device Advisory Committee to discuss the role of power morcellation in the treatment of uterine fibroids and the value of any changes in technique or equipment. The agency will also continue its follow up by reviewing documents such as adverse event reports and peer-reviewed studies.

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