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The St. Mary's MRgFUS Team
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Change in CE marking: MRgFUS now a treatment option for uterine fibroids in fertile womenIn October 2007, the European CE marking was changed to state that women planning future pregnancies should be advised that they should consult with their physicians before seeking treatment with ExAblate® 2000, which combines MRgFUS technology (high-intensity focused ultrasound) with MRI. "The non-invasive nature of ExAblate whereby only the uterine fibroids are ablated and there is no damage to healthy surrounding tissues suggests that MRgFUS should be a safe approach for women who want to preserve their fertility," said Professor Lesley Regan, MD, Head of Obstetrics and Gynaecology at St Mary's Hospital, Imperial College, London. The St. Mary's Hospital in London is one of the pioneers in using MR guided focused ultrasound and has been treating patients with this non-invasive treatment modality since 2002. The MRgFUS unit at St. Mary's hospital has also conducted a clinical trial in the administration of GnRH prior to treating patients who have large fibroids with ExAblate, See links to abstracts. The fertility factorFertility is a major consideration for patients needing treatment for uterine fibroids, noted Dr Sue Zaher, Gynaecology Research Fellow, Imperial College, St Marys. In the UK, nearly 20% of women are giving birth after the age of 40. "Since women are delaying pregnancy, they require a fertility-preserving treatment option for their fibroids." Accumulating clinical data from St Mary's Hospital and other MRgFUS centers has shown that women have been able to conceive and successfully deliver children after undergoing MRgFUS treatment for their uterine fibroids. To date, thirteen women have delivered healthy infants at term without complications and with an average birth weight of 3.4 kg. No treatment-related adverse events were reported. Fast recovery time influences decision-makingBecause most patients are working women, recovery time is a major factor when deciding upon a treatment. “The longer recovery time of alternative treatments is unacceptable to many of our patients, because they can't afford to be off work for long periods of time," according to Dr Zaher. "Because ExAblate is a completely non-invasive outpatient procedure, patients can return to work within 24 hours of treatment." This is a major advantage compared to other procedures such as myomectomy. Minimal risk, long-term efficacyAccording to Regan and Zaher, the minimal risk involved in MRgFUS is a major factor when recommending the treatment. "The doctor is assured of the safety of the procedure, particularly in cases where surgery might be technically difficult. There have been no emergency procedures associated with MRgFUS, compared to surgical alternatives," they said. "We welcome the change in the CE marking and believe it will provide many of our colleagues with the reassurance needed to refer most of their patients." The treatment has been proven effective in controlling symptoms for up to 24 months. If required, it can be safely repeated without any additional risks,. "We believe that women should discuss this option with their physicians and weigh the risks and benefits against other procedures," added Prof Regan. Since the treatment is currently not available to Arab women in the Middle East, women from the UAE, Bahrain , KSA, and Egypt , have come to St Marys to seek treatment. "These women have heard about this new treatment and are desperate for a chance to avoid the risk of losing their uterus," says Dr Zaher. To date, some 300 women have been treated with the ExAblate system at St. Mary's Hospital. Over 3,500 women have been treated worldwide. Founded in 1845, the world-class hospital is a leading specialist centre in the field of recurrent pregnancy loss and high risk obstetrics. It was at this same hospital in 1928 that Sir Alexander Fleming discovered Penicillin. The hospital continues its pioneering work by introducing cutting-edge technologies that improve the quality of healthcare provided to its patients. A recent study by researchers at the Mayo Clinic and other institutions, published in the Green Journal, found that focused ultrasound treatment of uterine fibroids provides long term symptom relief. The study evaluated several measures of the long-term outcome of MRgFUS for symptomatic uterine leiomyomata on 359 women over 24 months. The study of this innovative treatment approach also shows that the more completely fibroids are destroyed by focused ultrasound, the more durable the symptom relief. In addition, the incidence of severe side effects is low. Combined, these results provide a significant improved quality of life. According to the study, the results show the treatment's potential to improve patient care by decreasing the need for repeated fibroid-removal procedures and keep health costs down. (Treating uterine fibroids can be a significant expense if it involves major surgery such as hysterectomy or requires multiple repeat procedures of traditionally noninvasive therapies such as abdominal and laparoscopic fibroid removal, or uterine artery embolization.) "Up to one-third of women who undergo alternatives to hysterectomy to treat fibroids experience recurrence of fibroids, so demonstrating the durability of focused ultrasound is important. Our study does this by examining rates of subsequent surgery for fibroid tumor symptoms and other key outcomes such as uterine shrinkage. Our study demonstrates that the more completely you treat the fibroids, the better the outcomes are," according to Mayo Clinic reproductive endocrinologist Elizabeth Stewart, MD, the study's lead author. Evidence indicates that this novel technology, in the hands of experienced care-giving teams, is an effective, durable treatment for uterine fibroid tumors that safely produces sustained relief of symptoms. |
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