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PRESS RELEASE For immediate release

NICE Guidance on Uterine Artery Embolisation for Fibroid Treatment is Invalid

THE NEW NICE INTERVENTIONAL PROCEDURES REVIEW WILL JEOPARDISE WOMEN'S ACCESS TO A SAFER NON-SURGICAL TREATMENT FOR FIBROIDS TO AVOID HYSTERECTOMY

A new interventional radiology procedure, which has saved over 50,000 women world-wide from hysterectomy is unlikely to become more widely available, because the NICE's - the National Institute for Clinical Excellence - new Interventional Procedures review has ignored vital evidence. In fact, NICE failed to find 120 of the most recent clinical studies published in the last three years or any data on the comparative safety and efficacy of other established treatments for fibroids. Uterine Artery Embolisation [UAE] a non-surgical treatment, not requiring general anaesthetic, which has a very high success rate, could replace hysterectomy for many women who have fibroids. It is much safer than hysterectomy and has a much lower complication and death rate. There is a one-night hospital stay and return to work in 2-5 weeks. Women maintain their fertility and it is less expensive for women and the NHS.

FEmISA - Fibroid Embolisation: Information, Support & Advice - a volunteer patient group, challenges the guidance published today by NICE on UAE. NICE states that 'there is uncertainty about the safety and efficacy of uterine artery embolisation'. This uncertainty arises from NICE's failure to look for up-to-date clinical evidence. The evidence upon which this guidance is based was two to three years out of date and the most experienced interventional radiologists in this field were not given the opportunity to give evidence. A proper review of all the clinical evidence would show UAE is much safer than hysterectomy, the usual treatment for fibroids. UAE has a much lower short and long-term complication and death rate than hysterectomy and is much more acceptable to women.

FEmISA is concerned that gynaecologists will use this guidance as a reason not to inform women patients about embolisation as a treatment option for fibroids. Some gynaecologists have already refused to tell women about embolisation and the Royal College of Obstetrics & Gynaecology has declined to ask their members to tell women about embolisation. Hysterectomy is the second commonest operation in the private sector and only caesarean sections are more common on women in the NHS.

"Many new clinical papers have been published over the last three years with large numbers of patients, showing safety and efficacy. NICE chose to ignore them and only considered older, smaller trials, even though FEmISA and others sent the references to them and analysed them." said Ginette Camps-Walsh for FEmISA. "We would expect the advisory committee [IPAC] of eminent doctors, who advise NICE, to have had access to all the clinical literature and to be able to receive evidence from stakeholders, especially radiologists with the greatest experience in UAE. We feel that this new NICE Interventional Procedures review process doesn't work. It needs to be changed. There seems to be more concern to keep to NICE timetables than to reach valid guidance. There is no criterion to judge when a procedure is 'safe'. The old surgical procedures such as hysterectomy have never been reviewed for their safety and efficacy. Our concern is that it will be even more difficult for women to have access to embolisation. Many women find hysterectomy unacceptable. Embolisation is much safer, and recovery is much quicker, but women aren't told about it."

Three of the most experienced interventional radiologists in this field, one of whom has performed 1,000+, another 170+ and the third 160+ UAE procedures were completely unaware that this NICE review was going on, until FEmISA alerted them to it.

There are some positive recommendations from the guidance. FEmISA welcomes the fact that NICE is now carrying out a proper systematic review of the clinical evidence, but feels it would have been have been better to wait for this before publishing guidance.

The UK registry for UAE is a very good idea, it will enable clinical evidence to be amassed from all patients. It would also be useful to link up with other EU countries and the USA & Canada, where many UAE procedures are performed.

FEmISA also endorses the recommendation that interventional radiologists and gynaecologists should work together as a team, for the benefit of their women patients. They also believe that women should be told all the treatment options and all the possible risks and complications of each. This happens with embolisation, but women are rarely told the complications of hysterectomy and long-term side effects they will suffer such as pre-mature menopause, sexual dysfunction, urinary incontinence and depression.

The members of FEmISA are all delighted with the results of their embolisation treatment, but most learned about it from magazine or newspaper articles. We want other women to have access to embolisation through the NHS and be able to choose the treatment that is right for them. This NICE guidance will make this much more difficult.

ENDS

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For further information please contact:
FEmISA web site www.femisa.org.uk

For medical comment from experienced interventional radiologists in this field please contact -

  • Dr Nigel Cowan, Consultant Interventional & Urogenital Radiologists,
    Churchill Hospital, Oxford 01865 225955

Or

  • Dr Woodruff Walker, Consultant Interventional Radiology,
    Royal Surrey County Hospital Guildford 07771 857218


INFORMATION FOR EDITORS

FEmISA

FEmISA - Fibroid Embolisation: Information, Support & Advice is an independent patient group of volunteers created to inform and help women gain access to uterine artery embolisation - UAE, a non-surgical treatment for symptomatic fibroids. FEmISA was formed by a number of women who are so delighted and impressed with fibroid embolisation that they have wanted to help other women avoid hysterectomy by having this treatment.

FEmISA will be happy to put women in touch with the nearest hospital offering embolisation and give women non-medical advice and support.

NICE - National Institute for Clinical Excellence

The new NICE Interventional Procedures Review process was set up only in February this year. It is to ensure that new procedures are safe and efficacious for patients. NICE has taken over from the previously system called SERNIP - [Safety & Efficacy register for New interventional Procedures]

NICE does not inform the stakeholders about these interventional procedure reviews. It informs the Royal Medical Colleges and the Association of British Healthcare Industries expects them to in turn to inform clinicians and manufacturers respectively about the procedure. Other stakeholders, in this case private hospitals offering UAE/embolisation and patients groups were not informed. FEmISA found out about it by accident and tried to circulate as many other stakeholders as possible. The current communication process does not work.

Under the new process adopted by NICE for Interventional Procedures review there is no requirement to amass up-to-date clinical evidence for the Interventional Procedures Advisory committee [IPAC] made up of eminent doctors to review. There is also no requirement or opportunity for the most experienced clinicians in the field to give evidence. There is one special advisor from each clinical speciality who gives evidence.

FEmISA submitted a 45 page document of evidence to NICE on UAE. This contains a list of 120 clinical papers on UAE that they had missed. This literature search took them 10 minutes. It also included detailed analyses on the important clinical papers on UAE and on hysterectomy, myomectomy and drug treatment for fibroids. It gave comparisons on all the complications, side effects and death rates - morbidity and mortality of all the treatments.

FEmISA understands that the committee [IPAC] didn't see this evidence.


Incidence of Fibroids

Uterine fibroids or leiomyomata are the commonest benign tumours in women of reproductive age. Approximately 20-70% of women develop uterine fibroids (up to 80% at post-mortem [40],[41] with 25% developing symptoms that need treatment. [71] However a recent study showed that incidence was likely to be much higher >80% for black women and nearly 70% for white women. [72] The peak incidence occurs between 35 and 40 years old. [42]

Treatment Options

Until recently only surgical intervention was available for fibroid treatment. Unless the woman was particularly young and wanted a family only hysterectomy was offered and for fibroids the abdominal approach is normally used, making it a very invasive operation. It remains an effective treatment for the symptoms of fibroids and there is no recurrence.

For younger women, wishing to have a family myomectomy may be offered. This is surgical removal of the fibroids. Pregnancy is possible after myomectomy, but fibroid re-growth and adhesions mean that most will go on to have a later hysterectomy.

Drugs -Gonadorelin Analogues - GnRH Agonists stop the production of the female hormone oestrogen and but a woman into chemical menopause.

This is only a temporary treatment, normally used to shrink the fibroids prior to surgery. Fibroids will return to their original size 24 weeks after treatment stops. This treatment should only be used once for 6 months. There are very debilitating side effects and some gynaecologists do not therefore use this option. [5],[19],[20]

Many women are keen to avoid hysterectomy. It is a very invasive operation with a 5-10 day hospital stay, 6 weeks home care without lifting or driving and 2-3 months before returning to work - a long recovery time. Some women feel it robs them of their femininity and sexuality. There are between 9-60 deaths p.a. in the UK from hysterectomy for fibroids alone. [No-one knows the exact figure.] There are also significant complications including pain, surgical damage to the gut [up to 5%], bladder and urinary tract [up to 1.7%] and infection to the wound and urinary tract of [up to 25%].

Long term side effects are rarely discussed with patients but these are pre-mature menopause, [5 years earlier than normal], often requiring HRT, clinical depression, urinary incontinence [a women is 30 times more likely to have this if she has had a hysterectomy], and sexual dysfunction.

Embolisation

Uterine artery embolisation (UAE) was first performed by a group under the direction of French gynaecologist, Prof. Jaques Ravina, in the late 1980s, to stem post-surgical haemorrhage. Radiologists started to embolise patients with fibroids pre-operatively to reduce bleeding. Patients started to cancel their surgery as their symptoms improved and a reduction in the size of their fibroids and uteri were noticed. [51],[53]

To date well over 50,000 embolisations have been performed world-wide with very high patient satisfaction. There have been at least 50 pregnancies. This procedure can also be used to treat adenomyosis (see patient experiences on web site), although the evidence is less clear.

Over 43 hospitals in the UK now perform uterine artery embolisation.

This non-surgical technique is performed under conscious sedation. No general anaesthetic is required and it is carried out in an interventional radiology suite. It takes approximately one hour to perform, requires a hospital stay of one night and a convalescence period usually of around a month. Women can return to work in 2-5 weeks.

An MR (magnetic resonance) scan is carried out to diagnose the number, size and position of the fibroids.

A very small (1mm) catheter (tube) is inserted in the groin, into the femoral artery (the main blood vessel supplying the leg). Small particles are introduced through the catheter into the uterine artery, (the artery that supplies blood to the uterus/womb) and they block the blood supply to the fibroids. The fibroids thus starved of blood break down, shrivel and die over the next few months.

Many women will feel cramping pain immediately after the procedure, although some feel nothing at all. Most return home the next day. There is a discharge, which normally lasts about 4 weeks. Some patients will have flu-like symptoms. The average reduction in fibroid volume six months after the procedure is 60% (range 30%-100%).

Clinical studies have shown that there is significant improvement in symptoms. Menorrhagia (heavy or prolonged menstrual bleeding) reduced in up to 85% of patients, dysmenorrhea (painful periods) in nearly 80% and pressure symptoms in 78%. There have also been over 50 successful pregnancies.

Women have a very high satisfaction rate for the technique with more than 85% willing to undergo the procedure again if necessary, and with many recommending it to friends. Many experience a general improvement in their health and there is an overall success rate of up to 97%. Embolisation is also significantly safer than hysterectomy. No serious long-term side effects have been reported.

Embolisation offers a very effective treatment for women with symptomatic fibroids. It is particularly helpful for women wanting to maintain fertility and who wish to avoid hysterectomy. It is much less costly to the NHS and medical insurers, as well as patients and those they work for.

In a few patients (1-7%) the reduction in fibroid size is not sufficient to relieve symptoms and patients will then opt to have surgery. (If this happens there is be much less likelihood of haemorrhage.) 8% of patients have hysteroscopic resection (removal of the fibroid through a tube into the uterus) or transcervical evacuation of a dead fibroid.

As there is no surgery, recovery is much quicker and women return to work within 2-5 weeks. Fertility is maintained and a number of women have had successful pregnancies after embolisation. The uterus is still viable and women experience normal menstrual cycles and a normal life.

There have been 5 deaths to date world-wide in approximately 50,000 cases. Two were from pulmonary embolism, one of these was in a woman in her 60s who was not mobilised for some days, two from sepsis and one from migration of the embolisation material. The type of embolisation material used in this case in the Netherlands is not normally used in the UK. [29],[30],[31],[56],[60]

This compares well with the mortality rate for hysterectomy of 1 in 3,300. [15],[26] Much higher mortality rates have been reported - 1-2 in 1,000 (Martin & Benson 1987). This rate would give rise to 9-60 deaths per annum in the UK

This technique is safer than surgery as it is much less invasive and there is less risk of infection and other side effects, fertility is maintained and there are no serious long-term complications.