FOI release

Freedom of Information request (FOI 22/1141)

Published 17 January 2024

FOI 22/1141

15th December 2022

Dear

Thank you for your information request, dated 23rd November 2022, where you asked for:

1. The total number of BIA-ALCL cases MHRA is aware of to date, please provide calendar year subtotals starting with the earliest case MHRA is aware of through to this year to date. As well as the total across all brands, if possible, please provide the data broken down by the number of BIA-ALCL cases for each brand of implant for each year.

2. The total number of BIA-ALCL cases MHRA is aware of to date involving PIP (Poly Implant Prothèse) implants, where patients have had PIP implants or still have them. As well as the total, please provide calendar year subtotals starting with the earliest case MHRA is aware of through to this calendar year to date.

3. The total number of adverse health incidents related to PIP implants that the MHRA is aware of to date, starting with the earliest incident the MHRA is aware of through to this calendar year to date. If possible, please provide the information broken down by nature of the event, for example: Eight instances of infection, ten of lump in lymph node, etc.

I can confirm that the MHRA does hold the information that you have requested. However, we have also determined that the information is exempt under Section 12 of the Freedom of Information Act and we cannot process your request any further.

Section 12 of the Act allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information.

The MHRA records information on the device problem and also reported clinical effect in the patient. However, prior to 2015, this information was not fully captured within structured database fields but as free text. In order to process your request and accurately provide the total number of adverse health incidents related to PIP implants we would need to conduct a manual review of incidents. We consider that this would take longer than 24 working hours to complete.

We advise that you narrow your request by selecting specific adverse health effects that you are interested in, for example, the number of adverse incident reports for PIP breast implants reported in association with infections.

In the meantime, I would like to advise you that information regarding BIA-ALCL, including a breakdown of reports up until December 2021, can be found on our website via the following link: https://www.gov.uk/guidance/breast-implants-and-anaplastic-large-cell-lymphoma-alcl

Please note that substantially similar requests made within 60 working days of an original request can be aggregated into one for the purposes of calculating a cost limit, meaning that section 12 could still apply.

If you have a query about the information provided, please reply to this email

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision.

Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely,

FOI Team

Safety & Surveillance