Freedom of Information request on adverse reports submitted regarding Atrium Medical Corporation’s hernia mesh products (FOI 22/768)
Published 21 December 2023
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FOI 22/768
11th July 2022
Dear
Thank you for your email of 20th June 2022 requesting to receive email copies of any adverse incident reports made to MHRA concerning Atrium Medical Corporation’s hernia mesh products (i.e. the ProLite mesh or the C-QUR mesh). You also stated that this request “only concerns adverse incident reports filed prior to 2014”.
Unfortunately, we cannot share information about specific manufacturers, makes or models of devices because of the confidentiality clause of the legislation that we work under. We can provide information about generic types of devices.
The information you have asked for is exempt from disclosure under Section 41 of the Freedom of Information Act 2000 (FOIA) as detailed below.
Section 41 – Information provided in confidence: information provided to us in confidence, with the expectation that it will not be released, is exempt from disclosure under the FOI Act. Information will be covered by Section 41 if: it was obtained by the authority from any other person; its disclosure would constitute a breach of confidence; a person or organisation could bring a court action for that breach of confidence; and that court action would be likely to succeed.
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for an internal review. It will be carried out by a senior member of the Agency who was not involved with the original decision. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk
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 online: https://ico.org.uk/make-a-complaint/official-information-concerns-report/official-information-concern/
Yours Sincerely,
Safety & Surveillance, MHRA