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I have been asked to present at the expert Implant removal meeting and wondered if you would be able to share up to date data of missing, deep, migrated nexplanons since publication of below articles. https://srh.bmj.com/content/familyplanning/early/2019/10/09/bmjsrh-2019-200338.full.pdf https://www.gov.uk/drug-safety-update/nexplanon-etonogestrel-contraceptive-implants-new-insertion-site-to-reduce-rare-risk-of-neurovascular-injury-and-implant-migration
Published: 24 October 2025
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I am writing to make a formal request under the Freedom of Information Act 2000 for access to documentation relating to an MHRA report concerning: Organisation: Cambridge University Hospitals NHS Foundation Trust Department: Addenbrookes Hospital Radio pharmacy Inspection Date: 26 - 27th March 2025 Background and Context I am a UNISON union rep representing Fung Tang, an employee of Cambridge University Hospitals NHS Foundation Trust who is currently facing serious disciplinary allegations of gross incompetence. These allegations are directly based on findings and outcomes contained within an MHRA report relating to the Radiopharmacy department of the trust. The Trust has provided a copy of what they identify as the relevant MHRA report, however, this has been significantly redacted. Given the severity of the allegations against my member - which could result in immediate dismissal and referral to professional regulatory bodies - it is essential that we have access to the complete evidence upon which these allegations are founded. Specific Information Requested Under the Freedom of Information Act 2000, I formally request: * Copy of the MHRA Post-Inspection Letter relating to Cambridge University Hospitals NHS Foundation Trust concerning Radiopharmacy department Inspection dated approximately 26 - 27th March 2025 * All supporting documentation that formed part of the MHRA's investigation and findings, including: 1. Investigation notes and records 2. Correspondence with the Trust 3. Expert assessments or technical evaluations 4. Any follow-up reports or monitoring documents * Explanation of any information that MHRA considers must remain redacted, including: Legal basis for such redactions * Whether redacted material contains any findings that could be relevant to individual staff performance assessments Public Interest Considerations This request is made in the public interest for the following reasons: Fair Process: An employee facing career-ending allegations based on an MHRA report has a legitimate right to see the complete findings that form the basis of those allegations. Transparency: The proper use of MHRA reports in disciplinary processes requires transparency about what the reports actually contain and conclude. Accountability: Public bodies should be held accountable for how they interpret and apply regulatory findings in employment decisions. Natural Justice: The principles of natural justice require that individuals have access to evidence being used against them in serious proceedings. Legitimate Interest I have a legitimate interest in this information as: * The authorised representative of the affected employee * The report is being used as primary evidence in disciplinary proceedings * My member's professional registration and career are at risk * We need to ensure the Trust's interpretation of the report is accurate and complete Format and Delivery I would prefer to receive this information electronically via email. If the information is extensive, please provide it in searchable PDF format or contact me to arrange alternative delivery methods. Data Protection I understand that you may need to consider data protection obligations in responding to this request. However, I would highlight that: * This information relates directly to disciplinary proceedings involving my member * We have a legitimate interest in accessing evidence being used against our member * Any third-party personal data could be redacted where genuinely necessary * The serious nature of the allegations justifies disclosure in the interests of fairness This request is made to ensure that serious disciplinary allegations based on MHRA findings are founded on complete and accurate information. The public interest in fair employment processes and the proper use of regulatory reports strongly supports full disclosure of this information.
Published: 24 October 2025
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Please disclose: 1. The date MHRA approved and licenced ETHICON’s PMM3 surgical mesh usage in the UK. 2. For what intended purpose MHRA approved and licenced ETHICON’s PMM3 surgical mesh. According to ETHICONS Instruction for use it’s expressly stated that:- “This mesh may be used for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result. It can be used in endoscopic procedure”. 3. The date when MHRA approved and licenced ETHICON’s PMM3 surgical mesh for ANY prolapse repair in the UK even the ETHICON has never claimed and requested such mesh to be approved and licenced for ANY prolapse repair. If MHRA has never approved PMM3 mesh for prolapse repair as this is a ‘hernia mesh’, just simply state that MHRA has never approved and licenced PMM3 meshes to be used for ANY prolapse repair.
Published: 24 October 2025
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I refer to the above subject and attach the following correspondence My request to DHSC by email dated 29 August 2025, and Response from DHSC in a letter dated 17 September 2025 You will note that I have been redirected to MHRA and would be grateful if you could provide the following information from your records. A copy of the Public Assessment Report [PAR] setting out the safety and efficacy of the combined measles, mumps, rubella and chickenpox vaccine to be rolled out in England and Wales from January 2026.
Published: 24 October 2025
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I require this information for external defibrillators used in clinical practice, not implanted or automated external defibrillators.
Published: 24 October 2025
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A colleague inadvertently recently left a plastic stiffener within a pigtail drain at thereby reducing its lumen and resulting in reduced drainage. In this instance the drain in question was an internal external biliary drain made by Cook medical G09498 ULT10.2-38-40-P-32S-CLB-RH 10.2 .038 40 but the same or similar configuration of plastic stiffener is common to other manufacturers. This is being treated as a Never Event by my hospital but I think there is a common system failure here. Unfortunately in this case the drainage bag was connected to the Luer lock of the hub of the plastic stiffener rather than to the hub of the drain itself. This reduced the lumen diameter and resulted in ineffective drainage. I recall this same error occurring more than 10 years ago. At some point after this Cook placed a paper label on the plastic stiffener stating "remove after catheter insertion" but this can become separated especially if the catheter becomes wet or it can be removed without the operator's knowledge by a scrub assistant. I note that a similar plastic stiffener with a Luer lock is present with the BARD Navarre universal drainage catheter eg. NNU8LPT but, in this case, with no warning label . By contrast the Boston Scientific Flexima APDL locking pigtail drain eg M001 271390 has a plastic stiffener but without a Luer lock hub thus making it impossible to connect a drainage bag with the stiffener still in situ. Perhaps this could be consider to be the universal standard? I would like to know how often this scenario has been reported to you over the next 10 years. I would also like to know whether you would consider reviewing this matter in terms of there being a system vulnerability.
Published: 24 October 2025
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Under the Freedom of Information Act 2000, I would like to request the following information held by the Medicines and Healthcare products Regulatory Agency, covering the period from 1 January 2023 to the present: 1. The total number of reports to the Yellow Card system (broken down by year) relating to Electronic Prescribing and Medicines Administration Systems (following the January 2023 Drug Safety Update: Electronic Prescribing and Medicines Administration Systems: report adverse incidents on a Yellow Card) 2. Of these reports, the total number of (1) serious reports (2) reports with a fatal outcome 3. A breakdown of these reports by age 4. Any information you are able to provide around the type of adverse events that were reported in relation to these systems.
Published: 24 October 2025
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I am writing to request information under the Freedom of Information Act regarding the product AndroFeme (testosterone 1% cream), specifically in relation to its marketing authorisation and regulatory assessment in the UK. Could you please provide the following information: 1. EPAR Availability * Is there a European Public Assessment Report (EPAR) or equivalent public assessment document available for AndroFeme? * If so, please provide a copy or link. If not, please explain why one is not available. 1. Legal Basis of the Submission * What was the legal basis of the application for marketing authorisation (e.g. full application under Article 8(3), hybrid application under Article 10(3), generic under 10(1), etc.)? 1. Regulatory Exclusivity * Has AndroFeme been granted any form of regulatory data exclusivity or market protection in the UK? * If yes, please indicate the exclusivity period and its basis. 1. Reference Products * Were any reference medicinal products (RMPs) used in support of the application for AndroFeme? * If so, please identify them, including name, MA holder, and authorising Member State (if applicable). I would appreciate receiving this information in electronic form. If any of this information is exempt from disclosure, please provide an explanation citing the applicable exemption(s).
Published: 24 October 2025
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The drugs, medical devises are attached and governed by its classification/licence/label (for their intended purpose) and NOT by its formulation/name or based on material properties alone. In the UK, all permanent medical devices must be approved and licensed by the MHRA (Medicines and Healthcare products Regulatory Agency) for their intended purpose before they can be legally implanted in a patient. This is both a legal and regulatory requirement. Please disclose and provide the list of: 1. Any prolene/polypropylene surgical mesh (permanent medical device) that was officially approved and licenced by MHRA for ANY prolapse repair in a urogynaecology departments in the UK by March 2017. 2. Any prolene/polypropylene surgical mesh that was officially approved and licenced by MHRA for ANY incontinence procedure in a urogynaecology departments in the UK by March 2017. 3. Any prolene/polypropylene surgical mesh that was officially approved and licenced by MHRA for ANY other urogynaecology procedure in a urogynaecology departments in the UK by March 2017. Please note that I am interested ONLY in the ETHICON (mesh manufacturer) meshes. I believe that it could be helpful to gather my requested information if I say that during the The Independent Medicines and Medical Devices Safety Review (‘Review’) in 2018, the Review asked all mesh manufactures to provide evidence. Below is from ETHICON written submission to the Review, I quote: Question 1. Please confirm the synthetic mesh products that you market or have previously marketed within the EU [including the UK] for use in urogynaecological surgery. Stress Urinary Incontinence (“SUI”) Products: Gynecare TVTTM (Tension-free Vaginal Tape) Gynecare TVTTM with Abdominal Guides Gynecare TVT-OTM Gynecare TVT-SecurTM Gynecare TVT-AbbrevoTM Gynecare TVT-ExactTM Pelvic Organ Prolapse (“POP”) Products: Gynecare Gynemesh PSTM Gynecare ProliftTM Gynecare ProsimaTM Gynecare Prolift +MTM Gynecare Gynemesh MTM ArtisynTM Y-shaped Mesh During the Review in the written submissions ETHICON confirmed that In May 2012 Ethicon made the decision to discontinue the following products: • Gynecare Prosima Pelvic Floor Repair System • Gynecare Prolift Systems • Gynecare Gynemesh M • Gynecare Prolift +M Pelvic Floor Repair System • Gynecare TVT Secur System 4. As Ethicon made decision to discontinue some of their meshes/devices, please disclose and list what surgical meshes were still approved and licenced by MHRA for ANY PROLAPSE repair in the UK that could be done in a urogynaecology department in the UK between May 2012- March 2017 NOTE: MHRA can find the Review evidence in the link below (scroll to page 19-20) https://www.immdsreview.org.uk/downloads/Evidence/FOR%20PUBLICATION%20-%20Manufacturers%20of%20Pelvic%20Mesh.pdf Thank you.
Published: 24 October 2025
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I am writing to make a formal request under the Freedom of Information Act 2000 for access to documentation relating to an MHRA report concerning: Organisation: Cambridge University Hospitals NHS Foundation Trust Department: Addenbrookes Hospital Radio pharmacy Inspection Date: 26 - 27th March 2025 Specific Information Requested Under the Freedom of Information Act 2000, I formally request: * Copy of the MHRA Post-Inspection Letter dated 28th March 2025, Case no: Insp GMP 12854/425537-0017 relating to Cambridge University Hospitals NHS Foundation Trust concerning Radiopharmacy department Inspection dated approximately 26 - 27th March 2025 Public Interest Considerations This request is made in the public interest for the following reasons: Fair Process: An employee facing career-ending allegations based on an MHRA report has a legitimate right to see the complete findings that form the basis of those allegations. Transparency: The proper use of MHRA reports/correspondence in disciplinary processes requires transparency about what the reports/letters actually contain and conclude. Accountability: Public bodies should be held accountable for how they interpret and apply regulatory findings in employment decisions. Natural Justice: The principles of natural justice require that individuals have access to evidence being used against them in serious proceedings. Legitimate Interest I have a legitimate interest in this information as: * The authorised representative of the affected employee * The letter is being used as primary evidence in disciplinary proceedings * Our member's professional registration and career are at risk * We need to ensure the Trust's interpretation of the letter is accurate and complete Format and Delivery I would prefer to receive this information electronically via email. If the information is extensive, please provide it in searchable PDF format or contact me to arrange alternative delivery methods. Data Protection I understand that you may need to consider data protection obligations in responding to this request. However, I would highlight that: * This information relates directly to disciplinary proceedings involving our member * We have a legitimate interest in accessing evidence being used against our member * Any third-party personal data could be redacted where genuinely necessary * The serious nature of the allegations justifies disclosure in the interests of fairness Timeline I understand that you have 20 working days to respond to this request under the FOI Act. Given the urgent nature of the ongoing disciplinary proceedings, I would be grateful for the earliest possible response. If you need any clarification regarding this request or require additional information to process it, please contact me immediately. This request is made to ensure that serious disciplinary allegations based on MHRA findings are founded on complete and accurate information. The public interest in fair employment processes and the proper use of regulatory reports strongly supports full disclosure of this information.
Published: 24 October 2025
