Restriction of Morcellation Procedure For Fibroid Excision

Philadelphia Hospital Restricts 'Morcellation' Procedure
By
Jon Kamp and
Jennifer Levitz

Updated Feb. 20, 2014 11:01 a.m. ET
WSJ.com

The medical community is moving to tighten rules involving a common gynecological procedure that may spread cancer in rare cases. Dr. Amy Reed and her husband Dr. Hooman Noorchashm join the News Hub with details of their fight to limit the procedure called morcellation.

BOSTON—Temple University Hospital has issued what appear to be the tightest restrictions yet on a common gynecological surgical procedure used during many hysterectomies, which has come under close scrutiny because of the potential to spread cancer in rare cases.

In a memo obtained by The Wall Street Journal, the top gynecologist at the Philadelphia hospital said so-called morcellation—a method of cutting up the uterus and growths called fibroids so they can be removed through small incisions—can be done only in certain cases and with serious safety precautions, such as using protective bags to keep harmful cells from spreading in the abdominal cavity.

Following the old protocols "is no longer acceptable," Enrique Hernandez, who heads the Department of Obstetrics, Gynecology and Reproductive Sciences at the Temple University School of Medicine, said in an interview. He said the new rules mark a major shift and will apply to 40 to 50 gynecologists at Temple University Hospital as well as satellite facilities.

Temple's move is the latest response to rising concerns about these minimally invasive procedures, which have become increasingly popular in recent years. The issue gained a national stage after Amy Reed, a Boston-area anesthesiologist who had surgery in October to remove her uterus, learned she had advanced-stage cancer. Her hospital, Boston's Brigham and Women's, said the morcellation process potentially worsened her prognosis. Dr. Reed and her husband, Hooman Noorchashm, a cardiothoracic surgeon, have launched a campaign against morcellation.

Leaders at AAGL—an organization for gynecologists who perform minimally invasive surgery that was previously known as the American Association of Gynecologic Laparoscopists—said they respect Temple's decision, but declined to say whether they agreed with the moves. The organization has stressed the benefits of minimally invasive surgery compared with open surgery, from smaller scars to faster recovery and shorter hospital stays, and said these need to be weighed against the risks.

AAGL has been working on its own statement about the issue.

"We as an organization certainly think this is absolutely worthwhile to look into" in hopes of advancing patient safety, said Jubilee Brown, a member of AAGL's board of trustees and a faculty member in the Department of Gynecologic Oncology at MD Anderson Cancer Center in Houston. She said "at this point we believe morcellation remains a valuable approach."

The increasing limits on morcellation could have broad implications for the way many patients are treated for symptomatic fibroids—common uterine growths that experts estimate affect between 20% and 40% of women over the age of 35. Fibroids, which are usually benign, are among the most common reasons for hysterectomies.

Of the nearly 500,000 hysterectomies performed annually in the U.S., at least 11% of them, or 55,000, involve morcellation, estimates the American Congress of Obstetricians and Gynecologists. Estimates from doctors at Columbia University Medical Center and Northwestern University put the figure at closer to 80,000 annually.

Boston-area doctors Amy Reed and her husband, Hooman Noorchashm, launched a campaign against morcellation after Dr. Reed learned she had cancer and the procedure potentially worsened her prognosis. Hooman Noorchashm

The cancer in question is relatively rare, and women who are at a greater risk with this procedure have the cancer before their hysterectomy. The concern is that using a powered device to grind up undetected, cancerous tissue within the abdomen—and without any protective measures—raises the risk of malignant cancer cells embedding in other tissue and elevating the cancer to a more dangerous stage, studies have shown.

The type of cancer currently raising concern, known as a uterine sarcoma, cannot be detected for certain before surgery. Some experts say there are also risks of spreading another type of malignancy, endometrial cancer, which can be tested, but is sometimes missed. In addition, studies have shown that morcellation can cause benign tissue to implant in the abdominal cavity, potentially requiring major surgery.

Brigham and Women's and other medical centers nearby, including Massachusetts General Hospital and Beth Israel Deaconess Medical Center, have either tightened or are working on new rules on morcellation. In general, the hospitals are requiring doctors to tell patients of the cancer risk before surgery, while trying to put some limits on which patients are candidates for the minimally invasive approach.

At Temple, Dr. Hernandez's memo set rules for how doctors should handle performing hysterectomies based on the size of a fibroid-laden uterus, which is correlated to the average size of a fetus based on weeks of pregnancy. When the uterus is smaller than a 10-week size, he said doctors should remove the uterus through the vagina without morcellation. If the uterus is larger, up to an 18-week size, Dr. Hernandez said doctors have two options: morcellate inside a protective bag to keep problem tissue from spreading or make larger incisions to take the uterus out intact. He recommended a specific bag that he said has tough material, which should assuage concerns about bags ripping.

For the largest cases, in which the uterus exceeds an 18-week size, Temple now requires an open procedure with a large incision.

"Above this size, we're not doing minimally invasive surgery," Dr. Hernandez said.

He said Temple's changes are in direct response to newly highlighted concerns about the risks of morcellating in an unprotected manner. He doesn't believe the hospital policy will hinder patients or doctors, although he acknowledged "it's a big change" that some doctors will have to adjust to.

"We have a firm stance, we'd like to be the leaders in this and say listen, this is wrong and [using a bag] is an alternative," he said.

Meantime, the memo said morcellation without protective bags is possible in hysterectomies for problems other than fibroid removal, such as pelvic pain, but only after certain tests and precautions. If doctors morcellate, they have to advise patients that if they have cancer, grinding up the tissue may hinder the ability to accurately detect the stage, the memo said. Additionally, the memo said doctors performing fibroid-removal in procedures that preserve the uterus should also morcellate in bags.