The Morcellation Controversy: A Timeline

Stephanie Cajigal

Disclosures

April 24, 2014

When Amy Reed, MD, an anesthesiologist at Beth Israel Hospital in Boston, was diagnosed with fibroids in October, her physician recommended what has become a routine procedure: hysterectomy with morcellation. The minimally invasive approach should have meant less recovery time for this mother of 6, but as reported by The Wall Street Journal , things didn't go as expected. Dr. Reed learned a few days after the surgery performed at Brigham and Women’s Hospital that she had a uterine leiomyosarcoma and the morcellation may have worsened her prognosis by spreading the cancer around her abdomen.

Since then, Dr. Reed's husband, cardiothoracic surgeon Hooman Noorchashm, MD, PhD, has led a campaign calling for a ban on morcellation. The medical community has responded in various ways, culminating with the US Food and Drug Administration (FDA) announcing on April 17 that it discourages the use of laparoscopic power morcellators in most hysterectomy and myomectomy procedures because of the risk of spreading unsuspected cancerous tissue.

Here is a summary of major events leading up to the FDA announcement.

1995: The FDA approves the first laparoscopic power morcellator with a gynecologic indication for use through its 510(k) process. Since then, the agency has cleared about 2 dozen such devices for use in gynecology.

2009: The American College of Obstetricians and Gynecologists (ACOG) issues a statement recommending vaginal hysterectomy as the best route of removal in most cases of benign disease. According to the statement, "Evidence demonstrates that, in general, vaginal hysterectomy is associated with better outcomes and fewer complications than laparoscopic or abdominal hysterectomy."

ACOG reaffirms this statement in 2011.

2012: Researchers review the medical records of 1091 women who underwent morcellation for uterine masses presumed to be fibroids at Brigham and Women's Hospital in Boston from 2005 to 2010. The results, published in PLOS ONE , show the rate of unexpected leiomyosarcoma to be 0.09%, 9-fold higher than the 1-in-10,000 rate typically quoted to patients during their preprocedure briefings.

"These data suggest uterine morcellation carries a risk of disseminating unexpected malignancy with apparent associated risk of mortality much higher than appreciated currently," they write.

October 2013: Boston-based anesthesiologist Amy Reed undergoes minimally invasive surgery with power morcellation at Brigham and Women’s Hospital. She later finds out that the mass is cancerous.

Dr. Reed's husband, cardiothoracic surgeon Hooman Noorchashm, launches a campaign against morcellation.

December 2013: The Wall Street Journal publishes its first article about Dr. Reed's case, igniting a debate about the true risk-benefit profile of power morcellation. Robert Barbieri, MD, the chair of obstetrics and gynecology at Brigham and Women's, tells the WSJ that Dr. Reed's case and another in the past 14 months have prompted discussions at the hospital's top levels. He says the hospital issued a note to medical staff in early December warning that morcellation of an occult tumor may occur in 1 in 400 to 1 in 1000 women who have this procedure.

The Society of Gynecologic Oncology (SGO) publishes a statement that says morcellation shouldn't be performed in patients with premalignant conditions and that patients should be informed of the procedure's risk prior to surgery.

The FDA begins to review data on morcellators used in gynecology.

January 2014: In a letter to members, the medical society AAGL: Advancing Minimally Invasive Gynecology Worldwide (formerly known as the American Association of Gynecologic Laparoscopists) announces that it is creating a task force to examine the risks involved in power morcellation. The letter asks members to submit descriptions of tissue extraction methods to TissueExtraction@aagl.org.

February 2014: Temple University Hospital requires that a bag be used during morcellation and that fibroids larger than 7 inches must be removed through a large incision.

The Lancet publishes an editorial calling the SGO's position on morcellation "soft." "This problem needs urgent attention, not only because hysterectomy is extremely common and a 1 in 400 risk of morcellating an occult tumour is unacceptable, but also because these techniques are used in a wide range of settings," the editorial states.

March 2014: Brigham and Women's and Massachusetts General hospitals tell their surgeons they'll only be allowed to use power morcellators inside a surgical bag.

JAMA publishes a viewpoint in which authors Kimberly A. Kho, MD, MPH,and Ceana H. Nezhat, MD, suggest the creation of a nationwide registry of gynecologic surgeries that would include data on outcomes and complications associated with devices such as power morcellators.

April 2014: SGO President Barbara A. Goff responds to The Lancet editorial, pointing out that "morcellation allows a procedure that would have needed an exploratory laparotomy to be done via minimally invasive methods." Unlike with open surgery, minimally invasive surgery carries less risk of blood loss, surgical-site infection, and venous thrombosis, and reduces length of stay and postoperative pain, she notes.

According to Dr. Goff, "weighing the risk of these common and sometimes deadly complications to the 0.1-0.25% risk that morcellating a fibroid uterus will result in spread of a leiomyosarcoma should be considered, especially given that these sarcomas have a very poor prognosis even if they are removed intact."

The FDA announces that, after reviewing the current literature, it concludes that the risk of morcellating an unsuspected uterine sarcoma is 1 in 352 and the risk of morcellating an unsuspected uterine leiomyosarcoma is 1 in 498. The agency recommends that laparoscopic power morcellators no longer be used for hysterectomy or myomectomy in most women with uterine fibroids.

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