March 29, 2014 — -- Two Boston hospitals have made changes to a controversial surgical procedure after questions arose about its safety.
The technique, called morcellation, is characterized by a surgeon shredding tissue, usually fibroids or the uterus during a laparoscopic hysterectomy, that is then usually removed through a small incision in the abdomen.
Both Massachusetts General Hospital and Brigham and Women’s Hospital in Boston are changing guidelines about when to use morcellation just months after learning of at least two medical cases where women had undetected cancer spread into their abdomen following the procedure.
The most high-profile case involved Dr. Amy Reed, an anesthesiologist at Beth-Israel Hospital in Boston, who had a laparoscopic hysterectomy with morcellation. Reed, 41, had undetected cancerous cells that were spread throughout her abdomen after the procedure. She is now being treated for Stage IV cancer.
Two medical articles questioning the safety of the technique were also published in the Journal of American Medical Association earlier this year.
After reviewing the cases, both Brigham and Women’s Hospital and Massachusetts General Hospital will allow morcellation only in cases where there is a very low chance of a cancer occurrence.
At Brigham and Women’s Hospital, no morcellation will be allowed without the tissue first being encased in a bag that will then be removed from the abdomen.
At Massachusetts General, only in very rare cases will morcellation be used without a containment system. Dr. Isaac Schiff, chief of Obstetrics and Gynecology at Massachusetts General Hospital, said there are some cases where a women has a hysterectomy for a reason other than fibroids and that there would be no reason to suspect cancer. In those rare cases, morcellation will be allowed without using the bag to encase tissue.
The plastic bag used to contain tissue as it is removed has not been FDA approved for this purpose, but has been used during other surgeries to remove tissue. While the bag can protect against cancerous cells getting into the abdomen, there is also a chance that the plastic bags can rip if they snag on the morcellation device.
If tissue is cancerous, the morcellation can spread the cells throughout the abdomen as they are shredded to be removed from the body. It is unclear from recent studies how prevalent the problem is.
After two cases, including Reed’s, occurred at Brigham and Women’s Hospital within 14 months, the chief of obstetrics and gynecology, Dr. Robert Barbieri, issued a memo to medical staff that said the best estimate for how often cancerous or atypical cells are spread through the procedure is "as many as 1 in 400 cases or as infrequently as less than 1 in 1,000 cases."
A 2012 study published in the Public Library of Science found that in 1,091 morcellation procedures performed at Brigham and Women's over five years, only one woman was found to have leiomyosarcoma, the same virulent undetected cancer as Reed's.
However, that study did find that the rate of finding unexpected cancer after the morcellation procedure was 0.09 percent. While small, that percentage is "nine-fold higher than the rate currently quoted to patients during pre-procedure briefing," according to the study.
Reed and her husband, Dr. Hooman Noorchashm, a cardio thoracic surgeon, have created a campaign to stop the morcellation technique in laparoscopic procedures, including starting a Change.org petition.
Noorchashm said he is not happy that the morcellation technique is continuing in any capacity and has talked to other women who have ended up in a similar position as his wife.
“The primary purpose of surgery has to be safe removal of tissue form the body. Especially when it comes with cancer,” said Noorchashm. “This device needs to go away. It’s not a safe device. “
Noorchashm also thinks the U.S. Food and Drug Administration should review the device again and ban it.