Brigham and Women’s and Massachusetts General hospitals are largely abandoning a common surgical technique used nationwide for years to perform many hysterectomies, prompted by two recent cases where the procedure dangerously spread undetected cancer.
Leaders at the two influential academic medical centers said they decided after several months of discussion to shift to a new method for performing hundreds of laparoscopic hysterectomies annually that they believe will better protect patients.
A few hospitals already have made a similar change, and the shift by the Harvard Medical School teaching hospitals could galvanize others to drop the procedure now performed on up to 150,000 women a year in the United States.
The procedure is usually employed during minimally-invasive hysterectomies to remove painful growths called fibroids that are not believed to be cancerous. To remove the uterus and masses through small incisions, an electric device called a morcellator shreds the tissue. But in rare cases, a hidden cancer can lurk in fibroids, as happened with the two women who had surgery at the Brigham, and in such instances the device can scatter the disease throughout the abdomen and worsen the patient’s prognosis.
Starting Monday, the Brigham will ban so-called open power morcellation during hysterectomies for uterine masses. Surgeons will be allowed to use the device only inside a bag, which is inserted into a patient to surround the fibroids before they are minced, said Dr. Robert Barbieri, chairman of obstetrics and gynecology. The prohibition also applies to the removal of fibroids alone.
“The two cases in close proximity is the trigger,’’ said Barbieri, adding that he is “no longer reassured’’ about the safety of the open procedure.
Mass. General will make a similar shift, said Dr. Isaac Schiff, that hospital’s chief of obstetrics and gynecology. Gynecological surgeons at both hospitals have been training in the new technique for several weeks, and while some doctors resisted the change at first, their bosses said the bag procedure will not be optional for removing fibroids.
“We have to do everything to make sure this doesn’t happen again,’’ Schiff said.
The safety of performing morcellation in a bag has not been studied, however, and the Brigham, Mass. General, Johns Hopkins Hospital, and Dr. K. Anthony Shibley, a Minnesota surgeon who invented a technique to perform morcellation in a bag, are collaborating on a study that will track patient results and complications.
Morcellation is not allowed, even with a bag, when cancer is suspected.
The procedure has grown over the past decade into the standard of care across the country. It has enabled doctors to move away from traditional surgery, using a long incision across the belly, to laparoscopic surgery, which requires several much-smaller cuts and allows patients to recover more quickly with less pain and fewer infections.
But in the past few years, a small community of pathologists, gynecologists, and oncologists have begun studying the impact of morcellation and raised safety concerns, including several at the Brigham. Researchers at the hospital published a paper in 2012 that found two cases of undiagnosed sarcoma in women who had undergone morcellation from 2005 to 2010. One of those was leiomyosarcoma, a rare and aggressive cancer — a risk of about 1 in 1,000. On follow-up exploratory surgery, neither of the two women’s cancer had been spread by morcellation.
The researchers also reported on an additional seven women who likely had morcellation at outside hospitals and were later diagnosed with cancer or potential cancer. On follow-up surgery, four of these women, all with leiomyosarcoma, had their cancer spread.
The risk identified in the study was much higher than previously thought, the researchers wrote, but many doctors continued to view it as an acceptable trade-off for avoiding major surgery.
The issue took on urgency last fall, when Dr. Amy Reed, a Boston anesthesiologist, underwent a hysterectomy at the Brigham in October to treat what she was told were likely benign fibroids. During the laparoscopic procedure, the gynecologist used a morcellator.
Follow-up tests done on the removed tissue found that Reed had uterine leiomyosarcoma. Later imaging tests showed that the cancerous tissue had been spread throughout her abdominal cavity during the surgery, giving her stage 4, advanced cancer. Reed, 41 and the mother of six children, is now undergoing aggressive chemotherapy.
Reed’s misfortune occurred at about the same time another woman, who also had her hysterectomy at the Brigham, died of leiomyosarcoma that had been spread around her abdomen during morcellation.
The timing led Barbieri to worry that the risk of spreading cancer with morcellation was higher — maybe as high as 1 in 300 cases.
In December, both the Brigham and Mass. General began requiring doctors to inform patients about the risk of spreading cancer from morcellation — Reed had never been told this was a possibility. Barbieri said his hospital moved to change its surgical practice when doctors learned about Shibley’s technique in January. He inflates the bag with carbon dioxide to prevent the morcellator from cutting the bag.
At least two other hospitals — the University of Rochester Medical Center in upstate New York and Temple University Hospital in Philadelphia — have recently prohibited morcellation outside of a bag, driven in part by an advocacy campaign by Reed’s husband.
Dr. Hooman Noorchashm, a cardiothoracic surgeon at the Brigham, started an online petition and has written hundreds of strongly-worded letters and e-mails to medical journals, government officials, doctors, and media organizations charging that morcellation is fundamentally unsafe and should be banned. He has urged a complete stop to morcellation, saying bags can break.
But so far, no hospital has been willing to go that far, citing the advantages of laparoscopic surgery.
Even though the risk of undetected uterine cancer has been known for years, the knowledge that such cancer could be unwittingly spread by a woman’s gynecologist during surgery is more recent.
Dr. Michael Seidman, the lead author on the 2012 Brigham paper, recalls seeing his first case as a pathology intern at the hospital in 2009. A surgeon asked him to evaluate four or five tiny pieces of tissue that were found scattered around the abdomen of a woman after her hysterectomy. He found that they all contained the same potentially malignant cells as her original mass.
“I did not have a clue how this happened,’’ he said. When he spoke with the surgeon, Seidman learned the patient had undergone morcellation, and he began to gather data for the research. Spreading an aggressive cancer such as leiomyosarcoma “is a very significant adverse sent. It’s a horrific thing,’’ he said. “Are we making [the cancer] a little bit worse? Yes, maybe.’’
Shibley, the Minnesota surgeon, began using inflated bags for morcellation more than two years ago. In the past several months, as Amy Reed’s story was told in newspapers nationwide, and other women have come forward with similar experiences, surgeons at dozens of hospitals have contacted him for information on his approach using an inflated bag, he said.
Normally “the bag is right next to the specimen, and [doctors] would cut the bag and debris would spill out. Technology was focused on making a stronger bag, but none of those have held up to sharp instruments,’’ he said.
Shibley said that he has performed morcellation in a bag on three women with undetected cancer, and that none had their cancer spread.
Though the safety of Shibley’s technique hasn’t yet been firmly established, doctors at the Brigham and Mass. General say they have added improvements and decided they had enough information to act.
“We didn’t wait for 100 cases, we didn’t wait for a major study, we said how could we prevent this from happening,’’ Schiff said. “In medicine on the one hand, you don’t change everything you do based on one case. On the other hand, if you don’t try to learn from one case you are not going to learn.’’