Informação

"Tudo sobre Mioma" é um site dedicado a compilar as principais notícias e atualidades sobre os miomas uterinos.
A informações aqui contidas são de inteira responsabilidade dos produtores indicados na fonte.

quinta-feira, 8 de novembro de 2012

Acessa recebe a aprovação do FDA para tratamento dos miomas uterinos



Acessa™ by Halt Medical receives FDA approval for treating uterine fibroids

Published: Tuesday, Nov. 6, 2012 - 8:09 am
/PRNewswire/ -- Halt Medical, Inc. announced today at the opening session of the AAGL Global Congress on Minimally Invasive Gynecology that the FDA has cleared Acessa™, a revolutionary new medical technology for treating millions of women suffering from uterine fibroids.  "At last, a fibroid treatment that patients and physicians have been waiting for," said Dr. David Levine, former Board Member of the American Association of Gynecological Laparoscopists (AAGL). 
"Acessa is the first product cleared anywhere in the world that can be used by gynecologists to treat all fibroid symptoms and types," said Jeffrey Cohen, Halt Medical's Chief Executive Officer.
According to the Centers for Disease Control (CDC), fibroids are the leading cause for hysterectomy procedures worldwide.  "It's estimated that 97% of women with fibroids choose to suffer with their symptoms rather than having their uterus removed.  We're about to change all that," said Mr. Cohen. "Finally, gynecologists will have an alternative to hysterectomy for their fibroid patients."
Acessa is used in a minimally invasive same-day surgery procedure where a slender handpiece is used to deliver radiofrequency (RF) energy to the fibroid.  After treatment, the fibroid is re-absorbed by the surrounding tissue.
In traditional fibroid surgery, layers of healthy tissue are cut through to gain access to the tumor or to remove the uterus entirely.  This can lead to complications, significant pain, and long recovery times.  Acessa treats just the fibroids, preserving the normal function of the uterus. Patients typically go home the same day with little pain and are back to regular activities in 5 days or less. According to Mr. Cohen, "The high patient satisfaction and low re-intervention rates seen in our clinical studies provides the opportunity for the healthcare system to replace radical surgery and save billions of dollars."
Acessa is already being used to treat women at medical centers in Canada and Europe.  "With compelling results from three clinical studies, we have been anticipating this clearance from the FDA," said Russ DeLonzor, Halt's President and Chief Operating Officer. "We've been expanding our manufacturing operations near San Francisco and are ready to meet the increased demand for Acessa from doctors in the U.S. and abroad."
Two surgeons, Dr. Bruce Lee and Dr. Gordon Epstein, led the team of engineers at Halt Medical to develop Acessa to be the ideal treatment for uterine fibroids.  "The FDA clearance means we can now put this imperative new medical technology in the hands of gynecologists in the U.S., a major milestone for our company," said Mr. Cohen.
For information about Acessa, please visit www.haltmedical.com .

Read more here: http://www.sacbee.com/2012/11/06/4964646/acessa-by-halt-medical-receives.html#storylink=cpy

segunda-feira, 6 de agosto de 2012

Miomas no Sem Censura


O assunto "miomas" esteve em pauta no programa Sem Censura (TV Brasil) no dia 01/08/12. Foram abordados temas com fatores de risco e predisposição para o aparecimento dos miomas, sintomas dos miomas e tratamento dos miomas uterinos. 

Confira abaixo o vídeo com a entrevista do Dr. Michel Zelaquett:  




quinta-feira, 2 de agosto de 2012

Doenças do Sistema Reprodutor Feminino associadas aos Estrogênios Ambientais



Women's Risk of Reproductive Disease Linked to Environmental Estrogens


Chemicals that mimic the human hormone may increase the risk of uterine and ovarian diseases

Shortly after moving to Canada’s Okanagan Valley, Patricia Lee started experiencing severe irregularities in her menstrual cycle. She had one period that lasted two and a half months. The bleeding was so intense that at one point, doctors recommended a blood transfusion.
“I couldn’t sleep – it was excruciatingly painful and I grew quite weak,” said Lee, now 47. Her diagnosis: a fibroid, or benign tumor, the size of a ping-pong ball in her uterus, and two cysts in her ovaries.
At the time, Lee lived in a long, slender valley through the center of British Columbia that produces nearly all of the province’s tree fruits and grapes. Agriculture is intensive there, as is pesticide use.
Lee will never know what role, if any, her environment played in causing her uterine fibroids. But scientists have long suspected a link between hormone-disrupting chemicals in the environment and gynecological diseases.
Research investigating these links has had mixed results. Now, several new studies are adding to the evidence that estrogen-mimicking pesticides and industrial chemicals may increase women’s risk of uterine and ovarian diseases – helping to solidify a theory that emerged two decades ago.
“Our studies are beginning to corroborate the idea that environmental estrogen may be associated with endometriosis,” said Germaine Buck-Louis, director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s epidemiology division in Maryland.
Back in 1993, a connection between endometriosis and environmental chemicals was discovered. Rhesus monkeys fed food contaminated with dioxins – hormone-disrupting pollutants created by waste incinerators and other industries – developed endometriosis 10 years later.
Endometriosis, when uterine tissue grows in the ovaries or other parts of the body, often causes pelvic pain and infertility. An estimated 10 to 20 percent of reproductive-age women in the United States suffer from it, according to the Endometriosis Foundation of America.
In a major new study, two groups of women in the Salt Lake City and San Francisco areas – one group with pelvic pain and the other with no symptoms -- were more likely to be diagnosed with endometriosis if they had high blood levels of the estrogen-like pesticide hexachlorocyclohexane (HCH) than women with low levels. HCH has been banned as a crop pesticide in the United States but it builds up and persists in the environment, so it remains in some food supplies.
Calling the study “revolutionary,” Buck-Louis said that finding the link between the pesticide and endometriosis in both groups “is a pretty strong signal” that the connection is real.
Also, women in the same group with the highest levels of a sunscreen chemical, benzophenone, in their urine had a 19 percent higher risk of endometriosis than women with the lowest levels, according to research published in Environmental Science and Technology.
And in Italy, women had endometriosis more often if they had higher levels of two banned chlorinated chemicals that can disrupt hormones – polychlorinated biphenyls (PCBs) or residue of the insecticide DDT, according to a 2009 study of 158 women.
Recent research has uncovered links to other gynecological problems, too. Women in Greece diagnosed with polycystic ovary syndrome (PCOS) – which causes irregular menstrual periods, infertility, weight gain and excessive hair growth – were more likely to have higher blood levels of the estrogen-mimicking chemical bisphenol A than women without the disease, according to a study published last year.
“It’s certainly plausible that any outside source that alters estrogen levels, even slightly, could contribute to gynecological diseases,” said Dr. Megan Schwarzman, a family physician at San Francisco General Hospital and an environmental health scientist at the University of California, Berkeley.
Exposure to many hormone-disrupting chemicals starts in the womb, and some scientists suspect the timing may be important in determining reproductive disease risk later in life.
“We know from animal models that there are critical periods during early development when cells are rapidly dividing and forming the circuitry through which cells will communicate with each other to form various tissues of the body,” said Retha Newbold, a reproductive biologist at the National Institute of Environmental Health Sciences in North Carolina. “When chemicals alter this set-up, the changes may not be reversible.”
Future generations of females may be at risk, too, according to a new animal study by Washington State University scientists.
Female rats exposed in the womb to high doses of several chemicals – including pesticides and plasticizers – developed cysts resembling human polycystic ovarian syndrome and premature menopause, according to the study published in PLoS One in July. Those changes were passed down through three generations—great-granddaughters of the exposed rats also developed cysts and other ovarian problems, even though they were not directly exposed.
Seeking to learn how the chemicals were able to harm future generations, the Washington State researchers examined the DNA of the ones whose mothers were exposed to vinclozolin, an estrogenic fungicide commonly used in the wine industry. They found that the chemical had reprogrammed genes as the rat fetuses developed.
Other chemicals in the study that had the multi-generational effects were dioxins, a pesticide mixture including permethrin and DEET and a plastic mixture including BPA and two widely used phthalates.
“What we are seeing in animal models is sobering,” said John McLachlan, biomedical scientist at Tulane University in New Orleans. The gene mechanisms responsible for transmitting such harmful effects across generations are essentially the same in humans, he said.
In the case of uterine fibroids, the body’s natural estrogens turn on and off genes in the smooth muscle of the uterus that allow the tumors to grow, according to research by McLachlan and colleagues. They are now investigating whether estrogen-mimicking chemicals in the environment affect these same genes.
The danger of estrogen-like chemicals already has been well-documented with DES, or diethylstilbestrol, a drug that was prescribed to millions of women at risk of miscarriages between 1940 and 1971. Daughters and granddaughters of the pregnant women who took the potent estrogenic drug had an increased risk of endometriosis, uterine fibroids and rare reproductive cancers.
But pesticides, sunscreen ingredients and PCBs are less potent hormone mimics than DES. The effects on women’s health are not as clear.
Some studies have found no connection between women’s exposure to environmental chemicals and gynecological diseases. For instance, among several hundred women in Italy highly exposed to dioxins from a 1976 factory explosion, UC Berkeley scientists found no significant increase in endometriosis linked to their contaminant levels. And in Japan, there was no increased rate of the disease among 139 infertile women with higher exposures to hormone-disrupting compounds including PCBs and dioxins, according to a 2005 study.
Newbold said because decades can pass between exposure during fetal development or early childhood and the manifestation of the disease in adult life, it can be difficult to nail down a link.
“Only recently are studies starting to focus on developmental risk factors in relation to adult disease,” she said.
Endometriosis and fibroids are referred to as “benign uterine diseases,” characterized mostly by painful periods, according to McLachlan. “Because these growths are not life-threatening or malignant, traditionally, these diseases haven’t garnered the attention they should,” he said.
But the disorders sometimes are linked to fertility problems, and researchers also are beginning to realize that such symptoms can be a sign of serious diseases to come.
“Gynecological problems during the reproductive years may be a predictor of diseases, such as cancer, later in life,” said Barbara Cohn, a reproductive health scientist and director of Child Health and Development Studies at the Public Health Institute in Berkeley, Calif.
Endometriosis has been associated with an increased risk of some ovarian cancers. However, the risk remains small, according to a review published in Lancet Oncology in May. Women with endometriosis have a 1.5 percent lifetime chance of developing ovarian cancer compared with 1 percent in the general female population.
The research is less clear on a link between cancer and other gynecological diseases, such as uterine fibroids.
Lee was terrified that her fibroids and extreme menstrual periods were signs of cervical or ovarian cancer. Several doctors recommended she have her uterus removed – standard treatment for severe fibroids. But she refused.
“You wouldn’t cut your nose off because you got frequent nose bleeds,” said Lee. “No one seemed concerned with trying to figure out why I was having such heavy periods.”
Pesticides and other environmental chemicals may not have contributed to Lee’s gynecological problems, since other factors, such as age and genetic predisposition, also increase a woman’s risk.
Nevertheless, since leaving the Okanagan for Nova Scotia in 2010, Lee has seen a marked decrease in her symptoms. She now avoids processed foods and buys only organic produce. The fibroid is no longer growing. In fact, according to Lee, it has shrunk in size.
“I can no longer feel it, but I know it is still there,” she said. “I worry constantly what the health effects will be down the road.”
This article originally ran at Environmental Health News, a news source published by Environmental Health Sciences, a nonprofit media company.

quarta-feira, 1 de agosto de 2012

Embolização dos miomas falha mais em mulheres jovens

Fibroid embolization "fails" more in young women



Young women who have a minimally invasive treatment for uterine fibroids are more likely to have a recurrence than older women are, a new study finds.

Fibroids are non-cancerous growths that form from muscle cells and other tissue in the wall of the uterus.
In the new study, Italian researchers looked at long-term results from one fibroid treatment option: uterine artery embolization, in which tiny particles are injected into blood vessels leading to the uterus, cutting off the fibroids' blood supply and shrinking them.
They found that of 176 women treated with embolization, the "clinical failure" rate was 18 percent over seven years.
That meant that the women's symptoms came back after initially getting better -- typically after three years.
And women age 40 or younger accounted for a large share of those recurrences: They were almost six times more likely to see their symptoms come back, versus women who underwent embolization after age 40.
Dr. Giovanna Tropeano and colleagues at Catholic University of the Sacred Heart in Rome report the findings in the journal Obstetrics & Gynecology.
It's not surprising that younger women have more recurrences, according to Dr. James Spies, a professor of radiology at Georgetown University Medical Center in Washington, D.C., who was not involved in the study.
Women who have fibroids treated after age 40 are closer to menopause, when fibroids will usually shrink on their own. But younger women have a longer time period in which a recurrence can happen, Spies explained in an interview.
On top of that, fibroids that arise at a young age are typically more severe.
According to Spies, women who need fibroid treatment should talk with their doctor about all their treatment options. The "right" therapy, he said, will largely depend on where you are in your life.

FIBROID REMOVAL VS. EMBOLIZATION
Uterine fibroids are very common. In the U.S., it's estimated that up to 70 percent of white women and 80 percent of African Americans will develop fibroids at some point by age 50.
Often, the growths cause no problems. But at least one-quarter of women have symptoms like heavy menstrual periods, bleeding between periods, and abdominal or back pain. For some women, fibroids make it hard to get pregnant.
The most common treatment is a hysterectomy, or surgical removal of the uterus.
But women who want to avoid a hysterectomy have other options. Besides embolization, they can have a myomectomy, in which just the uterine fibroids are removed. There's also endometrial ablation, in which the lining of the uterus is removed (which, like hysterectomy, renders you infertile.)
"For women in their 30s who want to become pregnant, myomectomy should be considered first," Spies said.
That's because, at least in the first few years after treatment, women's fertility seems to be better after myomectomy versus embolization.
If a woman is done having children, though, embolization has the advantage of a shorter recovery time, Spies said.
As far as fibroid recurrence, the odds may be similar, or somewhat higher, with myomectomy. Spies pointed to one study of women who were part of a large Washington State HMO: Of 628 women who had a myomectomy, 23 percent needed a repeat procedure -- most often a hysterectomy -- after five years.
The 18 percent recurrence rate in the current study is actually a little lower than what's been seen in others. In his own study of 200 embolization patients, Spies found that 20 percent had a recurrence within five years.
When a woman has a fibroid recurrence, she can get a repeat embolization. "It works as well the second time around," Spies said.
In this study, though, nearly all of the women who had a repeat procedure had a myomectomy or hysterectomy. The authors did not respond to requests for comment.
The costs of the three procedures -- hysterectomy, myomectomy and embolization - vary depending on where you live, but they are fall within a similar range. In the U.S. all three range from between $6,000 and $7,000 at the lower end, to between $12,000 and $15,000.
"It's still the default in this country to offer hysterectomy," Spies said. He suggested that if you want to avoid that, ask your gynecologist about the other options.

SOURCE: bit.ly/MQekrg Obstetrics & Gynecology, August 2012.

segunda-feira, 30 de julho de 2012

Miomas atingem 80% das mulheres em fase reprodutiva

Útero miomatoso


As visitas periódicas ao ginecologista são um incômodo para a maioria das mulheres, mas cumprir esse ritual pelo menos uma vez ao ano é ainda o melhor meio de se evitar que um mioma uterino, tipo de tumor benigno, venha a evoluir e provocar riscos à saúde.
Apesar de ser encontrado em 80% das mulheres em idade reprodutiva, o mioma pode aparecer sem apresentar qualquer sintoma ou mesmo danos ao corpo. Devido a essa característica, o médico responsável pelo Ambulatório de Mioma Uterino da Clínica de Ginecologia do Hospital das Clínicas, Nilo Bozzini, alerta que entre 50% e 60% das portadoras do mioma podem passar a vida inteira sem saber do tumor.
Por isso, o médico salienta ser importante manter na rotina os exames ginecológicos e aconselha aquelas que descobrem a presença do tumor para “não sofrer com a notícia”.
Há casos, segundo o especialista, em que nunca será necessário mexer no tumor e outros terão indicação de cirurgia. Extirpar o mal por meio da histerectomia ou retirada do útero, normalmente, é uma opção adotada apenas para mulheres que já tiveram os filhos ou que já passaram da idade fértil, relatou.
Outro recurso é se administrar medicamento para reduzir o tamanho do tumor, o que será benéfico até mesmo se houver a necessidade de cirurgia, porque ajudará a tornar o procedimento menos invasivo.
As técnicas utilizadas para a retirada dos miomas são: a histeroscopia, referente ao mioma submucoso, que está no interior da cavidade do útero; a laparoscopia, para os miomas encontrados na superfície externa do útero e já se instalando na cavidade muscular; e a laparoscopia, para os tumores de volume maior espalhados pelo tecido uterino. Outro procedimento é a embolização, que bloqueia o fluxo de sangue que alimenta o mioma.
“Cada caso é um caso”, pontua Bozzini, para explicar que não existe nenhuma conduta básica a seguir. Caberá ao médico decidir sobre a melhor forma de tratamento, a depender da idade da paciente, do volume, localização e evolução do tumor que se desenvolve no tecido do útero. Além do exame físico, o acompanhamento pode passar pelas etapas de uma ultrassonografia ou ressonância magnética.
Entre os sintomas que caracterizam os miomas estão sangramento menstrual em volume acima do normal, dor na região pélvica, aumento do tamanho do abdômen, dificuldade para urinar ou evacuar e até mesmo infertilidade. A doença pode estar relacionada à presença dos hormônios ovarianos estrógeno e progesterona, responsáveis pelo desenvolvimento sexual da mulher e pelo ciclo menstrual.
Embora tenham ocorrido avanços na medicina, lembra o médico, os estudos que avaliam se fatores genéticos podem levar à doença “ainda engatinham nesse aspecto”. O que se sabe, conta ele, é que as mulheres da raça negra são mais suscetíveis, porém as explicações para tal constatação ainda estão sendo pesquisadas.

sexta-feira, 27 de julho de 2012

Proellex-V passa por importante fase para ser aprovado pelo FDA para tratamento dos miomas uterinos

Repros' Proellex(R)-V Clears Important Hurdle in Uterine Fibroid Program


  • Vaginal delivery of 12 mg Proellex exhibits the systemic drug exposure designed to optimize risk/benefit clinical profile
  • Encouraging preliminary signs of efficacy in first cohort dosed with 12 mg Proellex-V  
  • Animal studies indicate that greater fibroid size reduction will occur at much lower doses of Proellex-V than previously tested oral doses
  • On track for end of Phase 2 meeting with FDA at year end
THE WOODLANDS, Texas, April 30, 2012 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.®(Nasdaq:RPRX) today announced its Proellex-V, or vaginally delivered Proellex, for the treatment of uterine fibroids, has passed an important first hurdle on the road to registration. Repros is ultimately developing Proellex-V, which is currently in Phase 2 development, for significant fibroid size reduction and symptom elimination, with the goal of avoiding surgery. Approximately 20% of women of reproductive age in the U.S. have symptomatic fibroids, with roughly 300,000 hysterectomies performed annually as a consequence. There is no approved chronic drug therapy for treatment of this debilitating condition.
As agreed upon with the FDA, Repros vaginally dosed 6 women diagnosed with uterine fibroids for a period of 2 weeks to determine steady state pharmacokinetics in order to ensure that overall systemic drug exposure was less than that observed in the previous oral study (1-12 mg). In the oral study, all doses were well tolerated and reliable cessation of menses was induced at doses as low as 3 mg. In earlier clinical studies, cessation of menses has been shown to directly correlate to efficacy in treatment of both uterine fibroids and endometriosis. A vaginal dose of 12 mg achieved only a fraction of the maximum exposure of the ineffective 1 mg oral dose but resulted in cessation of menses in 3 of the women. Statistical significance (p<0.05) was seen in a pair-wise comparison of the 6 women from both the perspective of reduction in menstrual bleeding using the Pictorial Blood Loss Assessment Chart (PBAC) and a reduction in overall uterine fibroid symptoms as determined by the Uterine Fibroid Symptom Quality of Life Survey (UFSQOL). Given the overall low systemic exposure of the 12 mg dose, the Company believes, in those women that continued to menstruate, reduction of symptoms may further improve with longer exposure to the drug.
The Company has commenced enrolling women into the 3 and 6 mg arms of the study and based on the low exposure of the 12 mg dose has notified the FDA that it will add a fourth cohort at 24 mg to the study. Each arm of the study will enroll 12 subjects. The first three arms of the study should be fully recruited by the end of May with the 24 mg arm enrolled by the end of June. The Company expects to have results from the trial in the fourth quarter of this year. If the study is successful, the Company intends to request an end of Phase 2 meeting with the FDA to commence Phase 3 studies late this year or early next year.
In efficacy studies using oral Proellex for the treatment of uterine fibroids, women experienced a nearly 50% reduction in mean fibroid size at a 25 mg dose. When those women were then escalated to a 50 mg oral dose for an additional four months, fibroid size was reduced to approximately 25% of the initial volume. Based on the assessment of fibroid symptoms as scored by UFSQOL, women on oral Proellex were, in general, symptom free. The 12 mg vaginal dose of Proellex is expected to have greater activity than the oral 50 mg dose. Importantly, the 12 mg vaginal dose exhibited a maximum exposure of 1/100th of the 50 mg oral dose. Even with this low exposure after only 4 weeks of treatment, women are seeing significant improvement in their fibroid related condition.