Essure implant use in the UK

Z. Tsjeng made this Freedom of Information request to National Institute for Health and Care Excellence

This request has been closed to new correspondence. Contact us if you think it should be reopened.

The request was partially successful.

Dear National Institute for Health and Care Excellence,

Under the Freedom of Information Act 2000, I would like to ask the following questions:

1. How many women have been fitted with the Essure implant on the NHS since NICE approved its use in 2009?

2. Can you also state the number of women who have reported complications arising from the implant?

3. Can you state the number of women who have had the implant removed after having it fitted?

4. How much money the NHS has spent on fitting women with the Essure implant since NICE approved its use in 2009?

5. What is the approximate cost of fitting a single patient with the Essure implant?

6. What is the approximate cost of removing an Essure implant from a patient?

7. When was the last time that the NHS updated their clinical guidelines on Essure?

I would prefer to receive this information electronically. If you need any clarification of this request please email me. If FOI requests of a similar nature have already been asked, could you please include your responses to those requests.

I would be grateful if you could confirm in writing that you have received this request, and I look forward to hearing from you within the 20-working day statutory time period.

Yours faithfully,
Z. Tsjeng

NICE Mail, National Institute for Health and Care Excellence

Dear Z. Tsjeng,

 

Our reference No: EH69179

 

FREEDOM OF INFORMATION ACT 2000

 

Thank you for your request, sent to our office on 28 April 2016, in which
you asked NICE for the following information:

 

1. How many women have been fitted with the Essure implant on the NHS
since NICE approved its use in 2009?

 

2. Can you also state the number of women who have reported complications
arising from the implant?

 

3. Can you state the number of women who have had the implant removed
after having it fitted?

 

4. How much money the NHS has spent on fitting women with the Essure
implant since NICE approved its use in 2009?

 

5. What is the approximate cost of fitting a single patient with the
Essure implant?

 

6. What is the approximate cost of removing an Essure implant from a
patient?

 

7. When was the last time that the NHS updated their clinical guidelines
on Essure?

 

 

Your request will now be considered and you will receive a response within
the statutory timescale of 20 working days as defined by the Act, subject
to the information not being exempt or containing a reference to a third
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I would like to take this opportunity to thank you for your interest in
NICE.

Yours sincerely,

Helen

 

Helen Crosbie

Communications Executive (Corporate Communications)

National Institute for Health and Care Excellence

Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BT | United
Kingdom
Tel: 0300 323 0141

Web: [1]http://nice.org.uk

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NICE Mail, National Institute for Health and Care Excellence

Dear Sir/Madam

 

Our reference No: EH69179

 

FREEDOM OF INFORMATION ACT 2000

 

Thank you for your request, sent to our office on 28 April 2016, in which
you asked NICE for the following information about the Essure implant:

 

1. How many women have been fitted with the Essure implant on the NHS
since NICE approved its use in 2009?

2. Can you also state the number of women who have reported complications
arising from the implant?

3. Can you state the number of women who have had the implant removed
after having it fitted?

4. How much money the NHS has spent on fitting women with the Essure
implant since NICE approved its use in 2009?

5. What is the approximate cost of fitting a single patient with the
Essure implant?

6. What is the approximate cost of removing an Essure implant from a
patient?

7. When was the last time that the NHS updated their clinical guidelines
on Essure?

 

Your request has been considered and the following response issued in
compliance with the Act.

 

Regarding questions 1 – 6. This information is not collected by NICE for
the purpose of guidance development. Our role is to produce guidance on
the best way to treat health conditions, and the use of drugs, devices and
interventions as part of the care pathway, however this does not extend to
collecting data on operations performed, the cost of operations and any
reported complications or adverse side effects. You may wish to contact
the following organisations who may hold the information that you are
looking for:

 

[1]Health and Social care Information Centre (HSCIC) – The HSCIC is the
national provider of information, data and IT systems for commissioners,
analysts and clinicians in health and social care. They collect, analyse
and publish national health and social care data. Please be aware that
from July 2016 the HSCIC will change its name to NHS Digital.

 

[2]Medicines and Healthcare products Regulatory Agency (MHRA) – The MHRA
is the regulator of drugs and medical technologies in the UK and are
responsible for licensing drugs and devices and for monitoring their
safety. They operate a [3]’Yellow card scheme’ that enables members of the
public and clinicians to report adverse reactions to healthcare products.
Reports can be made for all medicines including vaccines, blood factors
and immunoglobulins, herbal medicines and homeopathic remedies, and all
medical devices available on the UK market

 

I hope the above information has helped to explain why we are unable to
provide information to answer your request and to help signpost you to the
relevant organisations.

 

With regard to question 7 ‘When was the last time that the NHS updated
their clinical guidelines on Essure?’ Our response is provided below.

 

NICE produces a range of guidance and information products, including
clinical guidelines, which are recommendations on how healthcare and other
professionals should care for people with specific conditions. Our
clinical guideline topics are referred to us by the Department of Health
and NHS England. I can confirm that we have not been asked to develop a
guideline relating to the use of the Essure implant. However under a
different work programme (the interventional procedures programme) we have
developed guidance which evaluates [4]Hysteroscopic sterilisation by tubal
cannulation and placement of intrafallopian implants (IPG315).

 

This interventional procedures guidance does not make a specific
recommendation on the use of the Essure implant. Interventional procedure
guidance only assesses the safety and efficacy of a procedure rather than
a specific technology/device, since more than one technology/device may be
available to carry out a procedure.

 

The [5]Overview document for IPG315 contains the evidence behind the
recommendations, and this includes evidence obtained from studies
evaluating the Essure implant. However, it’s important for me to reiterate
that our interventional procedure guidance evaluates - and makes
recommendations on - a particular interventional procedure, rather than on
specific devices that may be used to carry out the procedure.

 

For your background information, our interventional procedures guidance
looks at whether particular procedures used for treating a patient or
diagnosing an illness are safe enough and work well enough for wider use
in the NHS. Based on this, NICE publishes guidance on whether or not
doctors should consider specific interventional procedures to treat or
diagnose their patients. This type of NICE guidance does not consider how
much the procedures would cost the NHS, or whether the NHS should allocate
funding for them. The decision on whether to fund this procedure are made
at a local NHS level and usually on a case-by-case basis.

 

There is a [6]frequently asked questions page on our website about
interventional procedure guidance that may be helpful to you.

 

IPG315 was published in September 2009. We are currently considering
whether a review and potential update of this guidance is needed and
expect to reach a decision within the next few weeks. Should we decide
that an update is warranted we will endeavour to schedule the update into
our work programme as soon as possible.

 

If you have any questions on this response you are welcome to call the
corporate communications team on 0300 323 0141 (weekdays 09:00 – 17:00).

 

If you are unhappy with this response and wish to ask for an internal
review relating to the handling of your request it must be made in writing
by letter, fax or email within 20 working days of the Institute’s response
to you and sent to: Associate Director, Corporate Office, National
Institute for Health and Care Excellence,10 Spring Gardens,  London SW1A
2BU Email: [7][email address]. If we receive your request for an
internal review, you will be sent an acknowledgement within five working
days. The Associate Director, Corporate Office, will review your request
and a full reply will be sent to you within 20 working days. If you are
not content with the outcome of the internal review, you may apply
directly to the Information Commissioner for a decision who can be
contacted at: The Information Commissioner’s Office, Wycliffe House, Water
Lane, Wilmslow, Cheshire SK9 5AF.

 

Kind regards

Janet

 

Janet Fahie

Communications Executive

Corporate Communications

National Institute for Health and Care Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BT | United
Kingdom

Tel: 0300 323 0141 | Fax: 0300 323 0149
Web: [8]http://nice.org.uk

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