FOI release
surgical meshes that were approved for any urogynaecology procedure
Some or all of the information requested was not provided because we didn't hold it.
Case reference FOI2025/01000
Received 17 September 2025
Published 24 October 2025
Request
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.
Response
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