FOI release

Freedom of Information request on the Allergan Implant Recall (FOI 21-254)

Published 28 May 2021

Thank you for your information request, dated 12 March 2021, and further clarification on 31 March 2021.

You asked for: “The exact date you were informed of the Allergan Implant Recall, and, the exact date that you stopped implanting them in NHS patients.
Also when were private patients were no longer getting them? Could you also provide details about how this information was relayed to yourselves, the trusts & the hospitals. Could I also have specific information relating to Calderdale Royal Hospital; specifically what date they were asked to stop using the implants from, and how this information was relayed.”

You clarified your request as follows: “The specific implant I am concerned with is the is an Allergan Natrelle Inspira TRF415, however, there have been numerous models recalled worldwide. I have added some links to websites with the recall information. https://www.biocellinformation.com/affected-products https://www.gov.uk/government/news/mhra-statement-on-allergan.”

We do not hold information on the exact date these devices were stopped from being implanted into patients, or any information regarding specific hospitals as this is not in the MHRA’s remit. NHS and private hospitals make their own decisions about the implants that they use. The MHRA is not involved in this. You may wish to contact the Calderdale Royal Hospital to ask when they received information from the manufacturer.

Allergan, the manufacturer, sent a letter about BIOCELL textured breast implants (including Natrelle Inspira implants) and BIOCELL textured tissue expanders to its UK customers on 29 July 2019. You can find the letter here.

If you have further questions on how and when this information was sent, we suggest that you contact the manufacturer directly because, unfortunately, the information that the MHRA holds is exempt from release under Section 44 of the Freedom of Information Act, detailed below.

Section 44 – Prohibitions on disclosure: the release of information is exempt as its disclosure is prohibited by other legislation. In this case, section 237 of the Enterprise Act 2002 prohibits a public authority from releasing information which came to it in connection with the exercise of its functions, and which relates to the affairs of an individual or business.

The MHRA is satisfied that the information you have requested: • constitutes information which came to us in connection with the exercise of the Agency’s functions. The MHRA has a duty of consumer protection under the Consumer Protection Act 1987 which is listed as a specified function under Schedule 14 of the Enterprise Act 2002, and receives information while exercising consumer protection functions in its role as the regulator of medicines and healthcare products.
• relates to the affairs of Allergan, a business which continues to exist. On that basis we are satisfied that section 44 of FOI Act applies and the information is exempt from release.

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

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

MHRA Customer Service Centre