Dear Medicines and Healthcare products Regulatory Agency,

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.

Your faithfully,
Z. Tsjeng

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,
 
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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 16/270
       
Dear Z. Tsjeng,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
       
Thank you for your enquiry which we received on 28 April 2016.
       
I confirm that your request is being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.
       
Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Sir,

Thank you for your recent email requesting information under our FOI scheme.

You have requested information held by the Medicines and Healthcare Products Regulatory Agency (“MHRA”) relating to Essure Implants medical device products. You have also requested other information which I have listed below.

This is a request for adverse events related to a specific named medical device and we are unable to provide the information requested.

This information is subject to the exemptions contained in section 44(1) (a) of the Freedom of Information Act (FOIA). In particular Section 237(2) of the Enterprise Act 2002 applies to specified information, which is defined in section 237(1) and section 238 (by reference to Schedule 14 and the regulations made under section 11 of the Consumer Protection Act 1987) to include information held by MHRA and relating to any business of an undertaking. Section 237(2) provides that such information must not be disclosed while the undertaking continues in existence. There are a number of exceptions to this general rule, in Part 9 of the Enterprise Act 2002. The MHRA’s position is that none of these exceptions apply to the information that you have requested.

As this is an absolute exemption it is not subject to a test of public interest.

With regards to your other requests:

2) we do not hold data related to numbers of devices implanted or related costs - I refer you to the national provider of information, data and IT systems for health and social care (HSCIC) www.hscic.gov.uk

3) we are not responsible for NHS clinical guidelines - please refer to NICE

If you have a query about this email, please contact MHRA Customer Services at [MHRA request email]. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write, within the next two months to the Communications Directorate, 4th Floor, Medicines and Healthcare products Regulatory Agency, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ at the above address quoting the above reference.

If you remain dissatisfied, you have the right to apply directly to the information commissioner for a decision. The information Commissioner can be contact at:

The Information Commissioner's Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours Sincerely,

Customer Services
Communications division
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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