FOI release
Failure of Post-Market Safeguards and Patient Traceability Frameworks
Some or all of the information requested was not provided because we determined that the cost to do so would exceed the appropriate limit.
Case reference FOI2026/00732
Received 28 June 2026
Published 17 August 2026
Request
5. Requests for PIP-Specific Surveillance Data Please provide the following PIP-specific statistics from the current surveillance frameworks: a. The total number of PIP-specific adverse incident reports received by the MHRA to date, broken down by year and type of adverse event. b. The exact number of these reports that specifically involve rupture, gel leakage, silicone migration, lymph-node involvement, or systemic inflammatory/autoimmune symptoms, BIA-ALCL, other implant cancer, or malignancy, including BIA-SCC. c. The total headcount of historically PIP-exposed women currently recorded within the BCIR. d. The specific data fields held for those PIP-exposed entries in the BCIR (e.g., original batch, model numbers, current rupture status). e. A statement clarifying whether the current BCIR contains historical PIP records from before 2016/2017, does if it hold data from later revision surgeries? If it cannot map the historic PIP cohort, please clarify the answer to Question 7(a). 6. Clarification on "Multiple Exposure" and BIA-ALCL Tracking An MHRA presentation regarding Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) note that as of December 2023, 48 out of 117 confirmed UK cases occurred in women who had "previous breast implants". Please disclose how the MHRA records and evaluates these sequential histories: - What is the MHRA’s official operational definition of "multiple exposure" in its adverse event tracking? - If a woman had a PIP implant, underwent explantation, and later received a different textured brand (e.g., PIP > explant > Allergan), does the MHRA record this complete sequence? If the Agency only records the specific brand present at the time of cancer diagnosis, explain how multiple exposure risk is accurately assessed. - Out of the confirmed UK BIA-ALCL reports, how many of those patients had a documented history of prior PIP exposure?
Response
See attached
Documents
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