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As a therapy matures from experimental to alternative to traditional there is less and less news about it. So this page has become more a historical archive than an active news-feed.Articles, videos and/or links to news stories about UFE are found in this section. Additional news can be found at the Society of Interventional Radiology's UFE page.
September 2008American College of Obstetrics and Gynecology (ACOG) revises its position on UFEIn the August 2008 Practice Bulletin of the American College of Obstetrics and Gynecology, the ACOG changed its position from the lukewarm recommendation it took in February 2004 to recommending it as an alternative for women with bothersome fibroids who wish to avoid hysterectomy. The following is a quote from pages 8 and 9 of that document: "The following recommendations and conclusions are based on good and consistent scientific evidence (Level A)Based on long- and short-term outcomes, uterine artery embolization is a safe and effective option for appropriately selected women who wish to retain their uteri."The ACOG was appropriately conservative and skeptical, but there is no refuting solid data. I applaud the College for revising their position. I do wonder what they were thinking when they wrote "women who wish to retain their uteri". Are there many women who do not wish to keep their uteri?
January 2, 2008Long-Term Effectiveness of UFE is Demonstrated90% of women who underwent UFE in this registry of patients from all over the United States were able to avoid hysterectomy.
November 18th, 2004 Condoleezza Rice undergoes UFE
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 | Brigham and Women's Hospital in Boston, MA |
| The Johns Hopkins Hospital in Baltimore, MD |
| Mayo Clinic in Rochester, MN |
| University MRI in Boca Raton, FL |
| Tower Beverly Radiology - Radnet in Beverly Hills, CA |
| Virtua Health in Voorhees, NJ |
| The Lahey Clinic in Burlington, MA |
South Texas Radiology Group has met with InSightec, the ExAblate manufacturer, and they now konw that we are very interested in acquiring the system. We have many years of tumor ablation experience with other types of ablating equipment, expertise in image guidance, ultrasound, and MRI, and are the most experienced radiology group in South Texas in treating women with symptomatic fibroids. We will begin offering this new alternative soon. We will make public announcements so that women know it is available and we will notify area physicians when it is ready.
August 2004
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New procedure gives women option to
hysterectomy
Web Posted: 08/27/2004 05:00 PM CDT
Hysterectomies are one of the most common surgeries for women. Yet, some experts say many of those who undergo the operation may benefit from a less invasive alternative. Jamie Turner works as a nurse at Methodist Hospital. For years, she had such heavy periods that she became anemic and weak. "I was very lethargic because I was bleeding a lot. I had a lot of heavy bleeding. That was one of my biggest problems. And I had a lot of cramping," Turner said. Turner had uterine fibroid tumors — non-cancerous growths that are often removed by a hysterectomy. Now, some patients with this condition are being treated with a non-surgical method in a radiology room under conscious sedation. The procedure starts when a doctor snakes a catheter through a small cut in the groin. He threads the catheter into the uterine artery. Then, the doctor releases tiny plastic spheres into the blood stream that plug the uterine artery and cut off blood supply. This causes the fibroid to shrink and died. The beads, made of a material similar to soft contact lenses, stay in the body forever. San Antonio interventional radiologist John Thomas performs the uterine fibroid embolization at Methodist Hospital. "It can completely control the symptoms of the fibroids and you don't have to have surgery," Thomas said. "You don't have to have an organ removed. The recovery is much faster than after a hysterectomy." Thousands of women have this procedure each year, but many specialists say thousands more could benefit. Turner is relieved that her symptoms are gone, and she didn't lose weeks of her life recovering from major surgery. "I feel like a whole new person," Turner said. "I can actually do things now and I don't have to plan my activities around my cycle. I just plan my activity and my life." Thomas says if more doctors mentioned this option, more women would choose it. “If the gynecologist doesn't tell you, 'Oh, by the way, here's an alternative,' you might want to go talk to these physicians who do this," Thomas said. An estimated 13,000 women living in Bexar County between ages 35 and 50 suffer from fibroid tumors.
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August 2004
February 2004
From the abstract of the ACOG Committee Opinion on Uterine artery embolization.
As appears in the publication: Obstet Gynecol. 2004 Feb;103(2):403-4
"Uterine artery embolization for the treatment of symptomatic uterine leiomyomata has become increasingly popular. Based on current evidence, it appears that uterine artery embolization, when performed by experienced physicians, provides good short-term relief of bulk-related symptoms and a reduction in menstrual flow. Complication rates associated with the procedure are low, but in rare cases can include hysterectomy and death." ABSTRACT
Dr. Thomas says: This committee previously opined that UFE should be considered experimental, a position that allowed OB/GYNs to ignore the procedure during "informed" consent. Now any OB/GYN would be remiss if the option of UFE is not presented while obtaining consent for hysterectomy as a therapy for symptomatic uterine fibroids.
March 30, 2003
The results of this trial were presented at the Society of Interventional Radiology annual meeting in Salt Lake City, Utah. The results are from the Ontario UFE trail. Trial director is Gaylene Pron, PhD.
There were 19 pregnancies in 17 women, 14 have delivered children, 3 miscarried, and 2 are still pregnant. One of the women had suffered 9 miscarriages prior to her UFE and now finally has a healthy baby. 12 of the women had no children prior to UFE, and most of these women had been told to have a hysterectomy prior to UFE.
Dr. Thomas says: These are encouraging results but are still too preliminary to recommend UFE over myomectomy for preparing a fibroid uterus for pregnancy. But if you are not a good candidate for myomectomy or do not want to undergo myomectomy and you fibroids are keeping you from getting pregnant I now recommend UFE.
March 28, 2003
The results of this trial were presented at the Society of Interventional Radiology annual meeting in Salt Lake City, Utah. The trial director is Dr. Jim Spies of Georgetown University in Washington, D.C.
They found that hysterectomy patients stayed in the hospital twice as long as UFE patients and had to stay home from work 3 times as long as UFE patients (32 days vs. 11 days).
Patients were twice as likely to have a complication with hysterectomy.
UFE patients enjoyed marked reductions in bleeding during periods and were just as likely to recover from pelvic pain, pelvic discomfort, and urinary symptoms as hysterectomy patients.
November 25, 2002
New Technology Blocks Fibroid Growth without Surgery
ROCKLAND, Mass.--Nov. 25, 2002--There is good news for the millions of American women of reproductive age who suffer from symptomatic uterine fibroids. BioSphere Medical(TM), Inc.
(NASDAQ:BSMD) announced today that the U.S. Food and Drug Administration (FDA) has cleared Embosphere(R) Microspheres for use in treating symptomatic uterine fibroids. Embosphere(R) Microspheres are miniature beads used to block the growth of fibroids found in the uterus by cutting off their blood supply using a procedure called uterine fibroid embolization (UFE). BioSphere Medical's Embosphere(R) Microspheres are the first and only device to receive clearance from the FDA for this indication.
UFE is a non-surgical, uterus-sparing procedure in which tiny microspheres are injected into blood vessels to cut off the blood supply to fibroids. During U.S. clinical trials with 182 women,
Embosphere(R) Microspheres were shown to provide substantial improvement in major symptom categories including pain, excessive bleeding and bulk symptoms. These improvements were similar to those experienced by a group of patients treated in parallel by hysterectomy, the current gold standard treatment for uterine fibroids. The study also showed that significant adverse events were rare in the UFE group and overall adverse events were fewer, in number and severity, than the hysterectomy group. At six months follow-up, the size of the fibroids and uteri decreased substantially amongst the UFE treated group. More than 90% of the patients treated with UFE reported being satisfied with the procedure.
"This is a very important step in the development of this therapy as an alternative to hysterectomy." said James Spies M.D., Associate Professor of Radiology at Georgetown University Hospital in Washington DC. "This decision by the FDA clears Embosphere(R) Microspheres for UFE thereby enabling uterine fibroid embolization to serve as an alternative to hysterectomy, which is the standard therapy for symptomatic fibroids. The scientific data from the comparative study supporting this application will likely be a key to the acceptance of this therapy among gynecologists and insurers, and this is likely to help make this treatment available to more women."
"Today, hysterectomy is often the treatment for symptomatic uterine fibroids - almost half of the 600,000 hysterectomies performed in the U.S. each year are for fibroids," said noted gynecologist Dr. Linda Bradley, Director of Hysteroscopic Services at the Cleveland Clinic Foundation, "This clearance gives women and their health care providers a much needed, uterus-sparing option. UFE with Embosphere(R) Microspheres has been clinically proven to block the blood supply to fibroids, reducing or eliminating painful symptoms."
"BioSphere Medical is pleased that the FDA has granted
Embosphere(R) Microspheres clearance for UFE because the Company is committed to increasing and improving uterus-sparing treatments available to women with symptomatic fibroids," said Paul A. Looney, Chairman and CEO of BioSphere Medical. "This clearance permits Biosphere Medical to begin increasing awareness in the U.S. of the importance of managing uterine fibroids. It is an important step in enabling patients to be fully aware of their treatment options."
Looney continued, "BioSphere Medical's Embosphere(R) and
EmboGold(R) microspheres are the most widely used spherical embolic for many indications from brain tumors to liver tumors. They represent the latest technology in embolotherapy for tumor management."
Uterine fibroids are common benign tumors that grow from the muscular wall of the uterus. Fibroids may cause heavy bleeding, pelvic discomfort, pelvic disfigurement, anemia, and create pressure on other organs. According to a recent survey conducted by the Society of Interventional Radiology (SIR), 57 percent of women surveyed with fibroids ranked them as "highly problematic." And, one in five women with fibroids experiences symptoms that can become so severe and debilitating that her everyday life is greatly impacted.
Clinical study shows value of UFE
A multi-centered, controlled U.S. clinical trial was conducted that involved 182 patients. Analysis of the data, which compared women treated with the UFE procedure to those who underwent hysterectomy, indicated the following:
-- Greater than 85% of the UFE patients demonstrated a reduction
in excessive menstrual bleeding at six month follow-up
-- Better than 75% of the patients treated with UFE reported a
reduction in pelvic pain and discomfort
-- 99% of the patients were discharged from the hospital within
24 hours whereas the hysterectomy group averaged a stay of 2.3
days
-- UFE patients returned to daily activities more than three
times faster than those who underwent hysterectomy
"It is important for women to talk to their gynecologists or family physicians about uterine fibroids to determine the best treatment plan. In fact, data suggests that as many as one-third of women who have hysterectomies each year do so without discussing potential alternatives with their doctors," said Dr. Bradley. "Early diagnosis and close monitoring benefit women because it increases the number of treatment options available before hysterectomy is the only solution."
From health.yahoo.com
| New Treatment for Uterine Fibroids a Success |
| April 08, 2002 05:55:43 AM PST, HealthScout News |
| By Colette Bouchez HealthScoutNews Reporter |
| MONDAY, April 8 (HealthScoutNews) -- In the latest
study of fibroid treatments, which pitted the traditional hysterectomy
against a new-age radiological treatment called uterine fibroid
embolization, a winner seems ready to emerge.
Reporting at the annual meeting of the Society of Cardiovascular and Interventional Radiology in Baltimore today, radiologists from Georgetown University School of Medicine offer the most convincing evidence yet that the minimally invasive uterine fibroid embolization (UFE) could become the new gold standard for fibroid treatment and care. "Our studies showed that in a head-to-head comparison with hysterectomy, the safety and efficacy of UFE was well-demonstrated," says study author Dr. James Spies, vice chairman of radiology at Georgetown University Medical Center. "Not only did it effectively treat the fibroids, it did so without major surgery." Fibroid tumors are typically noncancerous growths that develop inside the uterus, usually during the latter part of childbearing years. Because the major symptom is heavy bleeding, the treatment of choice for decades has been a hysterectomy. The procedure, which removes the uterus, requires up to 10 days of hospitalization and weeks of recovery at home. By comparison, UFE is minimally invasive and has almost no complication rate. In this treatment, doctors make a tiny incision in the groin and insert a slim catheter. They inject tiny chemical particles into the tube, which travel to the blood vessels that feed the fibroid. The tiny grains block the vessels, cutting off the blood supply to the fibroid, causing it to shrivel and die. Doctors report patients are back on their feet in a week or less, with only minimal discomfort. "There's really no comparison in terms of how much less drastic this procedure is when compared to hysterectomy -- and with remarkably similar results," Spies says. That's precisely what the research demonstrated. In a study of 148 women diagnosed with fibroid tumors, 102 were treated with UFE, while the rest had a hysterectomy. Before their treatment, all the women were asked to complete a questionnaire designed to measure their physical and mental quality of life as it pertained to their fibroid symptoms. After each treatment and period of recovery, the women were asked to repeat the questionnaire. Doctors then compared the scores before and after treatment for each group, and compared the groups to each other. Using the number 50 or higher as an indication of "normal," here's how the two procedures stacked up: In women who had a UFE, physical well being increased from 45 before treatment to 52 after treatment. Women who had a hysterectomy went from 41 before surgery to 51 afterwards. In terms of mental well being, the UFE group went from 45 to 52, while those who had hysterectomy went from 41 before surgery to 50 afterwards. Finally, among patients who had UFE, 94 percent said they were satisfied three months after treatment, compared to 95 percent of hysterectomy patients. "The bottom line is UFE compared favorably to hysterectomy, in terms of alleviating symptoms, and it did a little better when it came to quality-of-life issues," Spies says. For gynecologist Dr. Ernst Bartsich, any procedure that can reduce what he calls an "outrageously high rate of hysterectomy" should be seriously considered by any gynecologist. "Any doctor who is truly interested in their patient's health and well being must explore every treatment option before they can help her decide which is the best treatment for her condition," says Bartsich, an associate professor of obstetrics and gynecology at New York Weill Cornell Medical Center . While he doesn't believe embolization is right for every woman, he's certain it's worthy of consideration by every doctor treating a woman for fibroids. "To automatically think hysterectomy every time you hear the word fibroid is to do women a great disservice, and that kind of thinking shouldn't be tolerated," Bartsich says. Spies agrees: "We're not saying that UFE is the answer for all women. What we are saying is that, when applicable, women should be given a choice." The new study also carries another important message, this one for the U.S. Food and Drug Administration. The results of this study are being submitted to the FDA to help secure approval for UFE as a recognized treatment for fibroid tumors, a move experts hope will encourage gynecologists to accept the procedure as an important treatment option. Currently, the FDA has approved embolization treatments for cardiac and other vascular conditions. |
01/08/2002 - Updated 11:55 AM ET
A hope against hysterectomy
By Kathleen Fackelmann, USA TODAY
When her doctor didn't have the information she wanted, Kimberly King logged
onto the Internet to find out more about a radical, relatively new treatment for
uterine fibroids.
In fact, King's gynecologist had just one recommendation to remove the
non-cancerous tumors: a hysterectomy. There's no doubt that this surgical
removal of the uterus would "cure" King's condition. Remove the uterus and you
remove the fibroids growing there, too.
But King wasn't about to get a hysterectomy.
Instead, she went online and found a doctor who performed a new, less invasive
procedure in October 2000.
The procedure shrank the large fibroid tumors in King's uterus. She is now free
of the heavy bleeding caused by the fibroids and she kept her uterus.
No one knows what causes fibroid tumors, which affect one out of three women in
the USA and up to half of all black women. For most women, the tumors cause
minor problems like bloating or no symptoms at all. But for some women, the
tumors can trigger very heavy menstrual periods and clots.
The procedure that King underwent is called uterine artery embolization. It's so
new that many gynecologists either don't know much about it or don't recommend
it. Yet it offers women a much-needed alternative to a hysterectomy, says John
Lipman, an Atlanta radiologist who does the procedure.
An estimated 200,000 women in the USA will get a hysterectomy this year as a
treatment for fibroids. Many of them probably didn't know about the new
procedure, Lipman and other radiologists say. That may be changing as news of
the procedure spreads. About 20,000 women in the USA have opted for the new
procedure since 1997, the year it was introduced here, says the Society of
Cardiovascular & Interventional Radiology in Fairfax, Va.
They say uterine artery embolization is safer and offers women a much shorter
recovery period compared with a hysterectomy or with another surgical procedure
for fibroids called a myomectomy that removes the entire tumor.
Less pain, less hospital time
Women undergoing a hysterectomy or a myomectomy must go to the operating room
where the gynecologist makes an incision in the abdomen and then either removes
the entire uterus or carefully cuts out the tumor. In either case, it means a
three- to four-day stay in the hospital and then six weeks of recovery at home.
In the new procedure, the radiologist makes a small nick in the skin at the top
of the leg and inserts a thin, flexible catheter. The doctor pushes the catheter
until it gets to the artery supplying the uterus and the fibroid with blood. The
radiologist then injects a solution of small plastic particles (each one about
the size of a grain of sand) into the blood vessel. These particles plug up the
vessel supplying the tumor with blood, but in most cases do not affect the blood
flowing to the uterus.
Without a blood supply, the tumor starts to wither away.
Women who undergo the new procedure usually go home the next day and resume
their usual activities within a week, Lipman says.
Experts say women with very large tumors may not be good candidates for the
procedure. "It's not a treatment for everyone, but it sure beats a
hysterectomy," says radiologist Paul Kiproff at Allegheny General Hospital in
Pittsburgh.
Heavy bleeding from fibroids led Yvonne Brandon to consider a hysterectomy, but
she wasn't eager to undergo that operation. She'd already undergone a myomectomy
in 1986, a procedure that left her doubled over in pain for weeks.
Even worse: Brandon's fibroids grew back. When Brandon found out about the less
invasive procedure over a year ago, she jumped at it. She had it done on a
Monday, and by Friday "I was out cutting the grass," she says.
Lipman, Kiproff and other doctors who perform uterine artery embolization are
interventional radiologists. They say that the procedure has ignited a turf
battle with gynecologists over patients with fibroids.
Michael Wysoki of Yale University School of Medicine in New Haven says many of
the women who turn to this procedure just aren't willing to go along with the
standard treatment.
In a small study of how women end up getting the procedure, Wysoki found that 19
out of 21 women had initially been told to get a hysterectomy by their
gynecologist. Of those 21 women, nine had a gynecologist that opposed the less
invasive option.
Sandra Carson, a gynecologist at Baylor College of Medicine in Houston, says
that many gynecologists simply don't know much about the procedure. She says
there's always a lag between the development of a new technology and widespread
acceptance of it.
The rank-and-file gynecologist often follows the lead of the American College of
Obstetricians and Gynecologists (ACOG) in Washington, D.C. That group still
calls the procedure experimental.
Radiologists have been doing this procedure for only a few years, says ACOG
spokesman Jimmy Moore. It has yet to be fully tested, he says.
Yet uterine artery embolization does show promise, he says.
A study in the July issue of Obstetrics & Gynecology by James Spies, a
radiologist at Georgetown University Hospital in Washington, D.C., suggests that
for most women the procedure works well — at least in the short term.
Spies and his colleagues studied 200 women who underwent the new procedure.
Their analysis showed that 90% of the women said their heavy bleeding had
improved a year later.
"Serious complications are very rare," Spies says. The team found only one in
their study — a blood clot that was treated before it could do any harm.
Some worries
That study, although a step in the right direction, doesn't really prove that
the procedure is safe, points out Amy Allina of the National Women's Health
Network in Washington, D.C. No one really knows the impact of this procedure
over the long run, she says.
For example, scientists don't know whether young women who get the procedure
will suffer from fertility problems, she says.
Some women have died of complications related to this procedure, adds Nora
Coffey, president of the HERS Foundation, an anti-hysterectomy group in Bala
Cynwyd, Pa. Her group recommends no treatment at all for women with mild fibroid
problems. For those with serious bleeding and other symptoms, Coffey recommends
a myomectomy.
Any medical procedure like this one involves some risk, experts say. But Spies
says just four women worldwide have died because of the procedure, a rate that
indicates the procedure is very safe, he says.
The Food and Drug Administration has approved the devices used in this procedure
for the treatment of tumors in other parts of the body, but it has yet to
specifically OK their use as a treatment for fibroid tumors.
The general approval, however, means doctors can and do use the procedure on
uterine fibroids — even though scientists have yet to fully prove that it works
safely, Allina says.
She says there are some important unanswered questions about this new procedure,
despite the enthusiastic reviews by doctors who perform it. For example, doctors
really don't know whether the fibroids will return five years down the road, she
says. Furthermore, they don't have any data that compares the new procedure with
a hysterectomy or a myomectomy.
Yet Allina says that women should consider this new procedure along with the
other treatments for fibroids. But for some women, the risks don't compare with
the benefits offered by the new, less invasive treatment for fibroids.
Brandon says she didn't want to spend six weeks in bed recovering from a
hysterectomy, yet felt she had to do something to control the heavy bleeding
that she suffered every month.
She said every month she battled fatigue and the fear that she wouldn't have
enough protection with her.
After getting the procedure, the fatigue and worries vanished. "It has literally
changed my life," she says.
© Copyright 2002 USA TODAY, a division of
Gannett Co. Inc.
Warning!! this video is 37mb, so do not follow link unless you have a high bandwidth internet connection.
For more information, please contact me by e-mail or by phone 210.616.7780.
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