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Alternatives to Power Morcellation

The FDA’s Obstetrics and Gynecology Devices Advisory Panel cautions against the use of power morcellators, recommending certain alternatives for treating fibroids. En-bloc resection is one technique for fibroid removal. However, this method has unique risks.

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As a result of the Federal Drug Administration’s (FDA) safety alert that discouraged the use of power morcellation during hysterectomy and myomectomy, the Obstetrics and Gynecology Devices Advisory Panel strongly advocates for the promotion of alternatives to laparoscopic power morcellation, despite the potential benefits of minimally invasive procedures to decrease morbidity and shorten recovery time.

At some time in their lives, up to 80% of women will develop uterine fibroids. Many of these cases will require medical intervention. Many non-surgical treatments exist for fibroids, including expectant management, pharmaceutical therapy, uterine artery embolization, and endometrial ablation.

Surgical Options for Fibroid Treatment

If surgery is required, a patient and her doctor will decide between a hysterectomy, removing the uterus completely, or a myomectomy, which targets the problematic fibroids only. There are many factors that need to be considered before making a decision, including age, desire to get pregnant, medical history of atypical cervical or endometrial cells, family history of cancer, and the risk of fibroids returning.

When used during myomectomies or hysterectomies for the treatment of fibroids or the removal of the uterus, power morcellation carries the risk of spreading benign or malignant tissue, leading to a host of potentially severe complications, including morbid growths and the upstaging of undetected uterine cancer. In addition, power morcellation can create significant problems in accurately staging any cancer that is discovered during postoperative histopathological analysis.

The FDA’s Obstetrics and Gynecology Devices Advisory Panel have highlighted several surgical procedures and alternative techniques that may circumvent the need for power morcellation.

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Traditional Options: Hysterectomy & Myomectomy

Among the traditional options for removing the uterus is total abdominal hysterectomy, which, according to the FDA, is the most common surgical choice. This procedure involves making an incision in the wall of the lower abdomen, and compared to laparoscopic hysterectomy, takes less time and produces fewer injuries to the urinary tract.

Under this same umbrella are supracervical, or subtotal, hysterectomy and total vaginal hysterectomy. Vaginal hysterectomy is, according to the American College of Obstetricians and Gynecologists, the overall preferred option of hysterectomy due to the benefits it provides in comparison to the alternatives. The FDA states that vaginal hysterectomy allows patients a faster recovery and induces fewer infections than abdominal hysterectomy.

When fibroids are removed in lieu of the entire uterus, an open abdominal myomectomy is a traditional option that involves an abdominal wall incision much like an abdominal hysterectomy and avoids the need for morcellation.

According to the FDA, when compared to vaginal hysterectomy, the laparoscopic alternative may cause more complications during surgery, more transfusions, and a longer time spent in the operating room.

Risks of Laparoscopic Treatment

According to the FDA, when compared to vaginal hysterectomy, the laparoscopic alternative may cause more complications during surgery, more transfusions, and a longer time spent in the operating room. Laparoscopic hysterectomy uses multiple small incisions in the abdomen wall along with gas and visualization instruments. It is during these kinds of procedures that surgeons often opt to use power morcellators to allow large tissue to be extracted.

The types of laparoscopic hysterectomy include laparoscopic-assisted vaginal hysterectomy, total laparoscopic hysterectomy, and laparoscopic supracervical hysterectomy. Each of these types may, at some point during the procedure, require some form of morcellation to allow for complete uterine removal.

In minimally invasive laparoscopic myomectomy, power morcellation or the extending of incisions are ways of removing the cut fibroids. Morcellation may also be used during hysteroscopic myomectomy, which is a transvaginal procedure that does not require an incision in the abdomen, for fibroids found within the endometrial cavity and inner myometrium.

Alternative Surgical Techniques

In an effort to promote surgical techniques that would mitigate the risks of power morcellation, various options have been suggested as potential ways to prevent the dissemination of tissue while maintaining the claimed benefits of minimally invasive procedures.

En-bloc resection techniques involve removing tissue completely intact in an attempt to avoid power morcellation and the risk of spreading tissue fragments. To accomplish this, methods such as minilaparotomy, a surgically enlarged ancillary port, or transvaginal extraction may be used. However, each of these procedures comes with its own set of possible complications, and it is unclear whether or not the risk of tissue dissemination is alleviated.

Containment Bags and Other Strategies

Some industry representatives argue that if power morcellators are left on the market, competition will drive companies to find new solutions that will strive to mitigate the risks. Some proposed methods include vaginal morcellation and transvaginal extraction, but most common were techniques involving various types of containment bags.

“In bag morcellation” techniques have been suggested as a means of reducing the risk of tissue dissemination. However, after examining the permeability, integrity, and ability to execute various morcellation techniques within various surgical bags and other “containment strategies,” the FDA could not verify the efficacy of these methods to effectively reduce the morbid and cancer-spreading risks of power morcellation due to a lack of definitive data.

  1. US Food and Drug Administration. FDA Executive Summary: Laparoscopic Power Morcellation during Uterine Surgery for Fibroids. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM404148.pdf. Accessed on: July 14, 2014.
  2. The American College of Obstetricians and Gynecologists. Power Morcellation and Occult Malignancy in Gynecologic Surgery. Available at: http://www.acog.org/Resources_And_Publications/Task_Force_and_Work_Group_Reports/Power_Morcellation_and_Occult_Malignancy_in_Gynecologic_Surgery. Accessed on: July 20, 2014.
  3. American Association of Gynecologic Laparoscopists. Morcellation During Uterine Tissue Extraction. Available at: http://www.aagl.org/wp-content/uploads/2014/05/Tissue_Extraction_TFR.pdf. Accessed on: July 14, 2014.