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- FDA warns against procedure to remove uterine fibroids; says it could spread hidden cancer
FDA warns against procedure to remove uterine fibroids; says it could spread hidden cancer
By Brady Dennis,
The Food and Drug Administration on Thursday took the rare step of urging doctors to stop performing a surgical procedure used on tens of thousands of women each year to remove uterine growths, saying the practice risks spreading hidden cancers within a woman’s body.The procedure, known as power morcellation, has long been used in laparoscopic operations to remove fibroid tumors from the uterus, or to remove the uterus itself. It involves inserting an electric device into the abdomen and slicing tissue in order to remove it through a small incision. The surgery is far less invasive than traditional abdominal operations.
But the FDA on Thursday agreed with a growing chorus of researchers and clinicians who oppose the procedure, saying that it can recklessly spread undetected cancers throughout the body and make the disease more lethal in the process. The agency is not seeking to ban the practice or the roughly two dozen FDA-approved devices used to perform it, but hospitals and gynecologists are likely to abandon the procedure because of potential liabilities.
The FDA said its analysis determined that an estimated 1 in 350 women who undergo morcellation have an unsuspected form of uterine cancer called uterine sarcoma.
“The existence of the risk is not new,” said William Maisel, chief scientist at the FDA’s Center for Devices and Radiological Health. “What is new is that the magnitude of the risk appears to be higher than was appreciated by the clinical community.”
Maisel acknowledged that the agency was spurred to action — or at least moved more quickly — because of a high-profile campaign waged in recent months by a Massachusetts couple, both doctors, for a moratorium on the practice.
Anesthesiologist Amy Reed, a mother of six who last spring treated Boston Marathon bombing victims as well as one of the suspected bombers, underwent what was supposed to be a routine procedure last fall to end bleeding from fibroids. The procedure spread undetected, cancerous tumor fragments throughout her abdomen. Now she is battling stage-four leiomyosarcoma, a rare and aggressive form of uterine cancer.
Her husband, Hooman Noorchashm, a Harvard-affiliated cardiothoracic surgeon, responded by launching a campaign to ban the widely used procedure. He has e-mailed numerous regulators, doctors and lawmakers, written to medical journals and lobbied hospitals. The couple started a Change.org petition to end the practice.
Noorchashm said Thursday that he appreciated the FDA’s relative speed in addressing the problem. “You don’t even have to be a doctor to recognize that if tissue or a tumor has malignant potential, you should not mince it up inside someone’s body,” he said. “That’s just bad medicine.”
Many women develop uterine fibroids — benign growths that originate in the muscle tissue in the wall of the uterus. Although many fibroids do not cause problems, others can result in frequent urination, prolonged menstrual bleeding and pelvic pain.
Of the more than 500,000 hysterectomies performed in the United States each year, about 11 percent, or more than 50,000, involve morcellation, according to the American Congress of Obstetricians and Gynecologists. Some doctors advocate performing a morcellation only when using an “isolation bag” in an effort to minimize the spread of tissues, but that method is not foolproof, as the bags can break.
“When you consider what the benefit is, which is a shorter hospital stay and less pain, then consider what the risk is — this could kill you — most women would not choose that risk if they really understood what is at stake,” said Diana Zuckerman, president of the Cancer Prevention and Treatment Fund.
Even before Thursday’s announcement by the FDA, the push to limit uterine morcellations had gained traction.
In February, Temple University Hospital issued guidelines instructing surgeons not to perform the procedure on fibroids over a certain size. Doctors may use the procedure for smaller fibroids only after informing patients about the risks and, in most cases, using isolation bags. Even before that, prompted by Noorchashm’s campaign, Massachusetts General Hospital and Brigham and Women’s Hospital in Boston took similar measures.
On Thursday, the heads of obstetrics and gynecology at both Boston hospitals promptly notified their staffs to suspend use of power morcellation until further notice.
Margaret Jacobson, the medical director of Whatcom Hospice in Bellingham, Wash., cried upon hearing of FDA’s action on Thursday.
In March 2012, her sister, Elizabeth Jacobson, had a hysterectomy by morcellation. Elizabeth Jacobson did not want to miss much work, and the promise of a minimally invasive procedure appealed to her.
But inside the large fibroid that a doctor shredded lurked malignant cells that spread throughout her abdomen, her sister said. Soon, Elizabeth Jacobson was diagnosed with aggressive uterine cancer. She then had a second surgery, rounds of chemotherapy and long stretches of misery. She died Jan. 8, 2013.
“She suffered terribly,” Margaret Jacobson said. “It devastated our family.”
Thursday’s news brought a measure of relief, she said, that other women might avoid the same fate, especially given that safer surgical alternatives already exist.
“It’s a victory ,” Jacobson said. “It’s not okay to tolerate these deaths. . . . My sister’s life was extraordinary; she was beautiful and loving. She does not deserve to be an easily dismissed statistic.”
© The Washington Post Company
http://www.washingtonpost.com/national/health-science/fda-warns-against-procedure-to-remove-uterine-fibroids-says-it-could-spread-hidden-cancer/2014/04/17/f9fe53cc-c64a-11e3-bf7a-be01a9b69cf1_story.html?wpisrc=nl%5Feve
4/17/2014 10:54 PM EDT
Uterine fibroid embolization. Not every hospital does it and many obstetricians don't even tell you about it, but it worked for me. It cuts off the blood flow to fibroids. I had almost instantaneous relief - others have more gradual relief. I highly recommend that women look into it.
Last April I was scheduled to have a partial laparoscopic hysterectomy using the method described in this article, to relieve me of side effects of multiple uterine fibroids. My insurance company would not approve the procedure until I had a biopsy done on my uterine lining. My GYN performed the procedure, which was quite uncomfortable, but in fact saved my life! I was diagnosed with uterine papillary serous carcinoma - at age 42 - my GYN said she had NEVER seen it in a woman younger than 60! This is a rare and aggressive form of cancer.
Had a full hysterectomy via da Vinci - still removed everything, but intact, without cutting it up, and without cutting into me. Post-op pathology showed that the cancer cells were entirely contained in the uterus - no spread, and I was declared cancer-free one year ago next Thursday.
My GYN has now changed her procedures in recommending biopsies, and I would encourage EVERY woman considering this procedure to ASK for a biopsy beforehand. Or ask for the entire, intact removal. My heart hurts for every woman who went thru this procedure and the subsequent treatment. Let's hope these new changes and new laws will better protect and prevent this kind of horrible chain of events from happening again.
Had a full hysterectomy via da Vinci - still removed everything, but intact, without cutting it up, and without cutting into me. Post-op pathology showed that the cancer cells were entirely contained in the uterus - no spread, and I was declared cancer-free one year ago next Thursday.
My GYN has now changed her procedures in recommending biopsies, and I would encourage EVERY woman considering this procedure to ASK for a biopsy beforehand. Or ask for the entire, intact removal. My heart hurts for every woman who went thru this procedure and the subsequent treatment. Let's hope these new changes and new laws will better protect and prevent this kind of horrible chain of events from happening again.
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