Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort study
Shelley Potter(North Bristol NHS Trust), Elizabeth J. Conroy(University of Liverpool), Ramsey I Cutress(University Hospital Southampton NHS Foundation Trust), Paula Williamson(University of Liverpool), Lisa Whisker(Nottingham University Hospitals NHS Trust), Steven Thrush(Worcestershire Royal Hospital), Joanna Skillman(University Hospitals Coventry and Warwickshire NHS Trust), Nicola Barnes(Manchester University NHS Foundation Trust), Senthurun Mylvaganam(New Cross Hospital), E.M. Teasdale, Abhilash Jain(Nuffield Orthopaedic Centre), Matthew Gardiner(Nuffield Orthopaedic Centre), Jane Blazeby(NIHR Bristol Biomedical Research Centre), Chris Holcombe(Royal Liverpool and Broadgreen University Hospital NHS Trust), Raj Achuthan(Royal Liverpool and Broadgreen University Hospital NHS Trust), Imadeddin Adwan, Shweta Aggarwal, Mohyadin Abdullahi Ahmed(Royal Liverpool and Broadgreen University Hospital NHS Trust), M Akelund(Royal Liverpool and Broadgreen University Hospital NHS Trust), Deepika Akolekar(Royal Liverpool and Broadgreen University Hospital NHS Trust), O Al-Jibury, M Amanita(Royal Liverpool and Broadgreen University Hospital NHS Trust), Darryn Appleton(Royal Liverpool and Broadgreen University Hospital NHS Trust), David Archampong(Royal Liverpool and Broadgreen University Hospital NHS Trust), Kristjan Asgiersson(University Hospitals Coventry and Warwickshire NHS Trust), Ruvinder Athwal, Alexandre Rossato Augusti, Soofiyah Ayaani, S. Bains, Benjamin Baker, Elizabeth A. Baker, S. Baldota, D. Banerjee(Royal Liverpool and Broadgreen University Hospital NHS Trust), Sarah Barker, Lester Barr, Peter Barry(Royal Liverpool and Broadgreen University Hospital NHS Trust), Naren Basu, Shalu Bathla, Nicholas E. Bishop, Genevieve M. Boland(Nuffield Orthopaedic Centre), Olivier A. Branford, Rachel Bright-Thomas, R. Brindle, Lisa Brock, Victoria Tzortziou Brown, F Bux(Royal Liverpool and Broadgreen University Hospital NHS Trust), Ged Byrne(Nuffield Orthopaedic Centre), Henry Cain, L J M Caldon, M Callaghan(Royal Liverpool and Broadgreen University Hospital NHS Trust), Antonino Carbone, R Carpenter, Simon Cawthorn, Leena Chagla, Tom Challoner, C Chalmers, Ritchie Chalmers, Susan Chambers, Manik Chana(Royal Liverpool and Broadgreen University Hospital NHS Trust), N. Chand, Vinod Chandran, M. Chandrashekar(Royal Liverpool and Broadgreen University Hospital NHS Trust), H Charfare, Jharna Chatterjee(NIHR Bristol Biomedical Research Centre), Shaunak Chatterjee, Rahul Chattopadhyay, Aasem Chaudry, Kian Chin(University Hospitals Coventry and Warwickshire NHS Trust), K Chong(University Hospitals Coventry and Warwickshire NHS Trust), Ashvin Chouhan, Christina Choy, Panagiotis Christopoulos(Royal Liverpool and Broadgreen University Hospital NHS Trust), Dayalan Clarke(Royal Liverpool and Broadgreen University Hospital NHS Trust), S. P. Clarke, Emily Clayton, R Clifford, Daniel Cocker(Royal Liverpool and Broadgreen University Hospital NHS Trust), Thomas Collin, Nicholas Collis, Frank Conroy(University of Liverpool), Christodoulos Constantinou, Alicia‐Marie Conway, James L. Cook(NIHR Bristol Biomedical Research Centre), Nathan Coombs, Karina Cox(University Hospitals Coventry and Warwickshire NHS Trust), Adam Critchley, M A Dakka(Royal Liverpool and Broadgreen University Hospital NHS Trust), Mohsin Dani(Royal Liverpool and Broadgreen University Hospital NHS Trust), R. Daoud, Lynn Darragh, Sajjad Ali Darvesh, Isabella Dash, Sunando Datta, E Davies, Suzanne Dawson, Edisa de Oliveira Sousa, Debasish Debnath(Royal Liverpool and Broadgreen University Hospital NHS Trust), Harjit S. Deol, Haresh Devalia, Rosa Di Micco, J.R. Dicks, Joanne M. Dickson(NIHR Bristol Biomedical Research Centre), Nia Dobner, Gary Dobson(Nuffield Orthopaedic Centre), N Dunne, Donna Egbeare(Royal Liverpool and Broadgreen University Hospital NHS Trust), D El Sharief(Royal Liverpool and Broadgreen University Hospital NHS Trust), Dalia Elfadl(Royal Liverpool and Broadgreen University Hospital NHS Trust), E. Eltigani, Davioglu Enver(Royal Liverpool and Broadgreen University Hospital NHS Trust), Ertan Erel, Adam B. Evans, Georgios Exarchos(Nuffield Orthopaedic Centre), Elena Fage, Hiba Fatayer, C. Fenn, Douglas Ferguson(Royal Liverpool and Broadgreen University Hospital NHS Trust), R Foulkes, J Franks(NIHR Bristol Biomedical Research Centre), Victoria Fung, M Galea(Royal Liverpool and Broadgreen University Hospital NHS Trust), Tasha Gandamihardja, Ashu Gandhi, C Garnsey, C. Gateley, J. Gattuso(NIHR Bristol Biomedical Research Centre), Suzanne Gawne, N Geerthan, A Ghattura, A Giaramadze, J. Gill(NIHR Bristol Biomedical Research Centre), AR Godden, S Goh, S. Govindarajulu, Sharad Goyal, T. Graja, Steven W. Granger, Michael Green(Royal Liverpool and Broadgreen University Hospital NHS Trust), Kartikae Grover(University Hospitals Coventry and Warwickshire NHS Trust), Gerald Gui(Nuffield Orthopaedic Centre), Rejina Gurung, Eleanor Gutteridge, Aishah Hakim, Anastassi Halka, W Hamilton-Burke(Nuffield Orthopaedic Centre), Ishrak Hamo, Claudia Harding-Mackean, Anita Hargreaves, S. Harries, Kristin Harris(University Hospitals Coventry and Warwickshire NHS Trust), Patrick G. Harris(Royal Liverpool and Broadgreen University Hospital NHS Trust), Sean Harrison, James Harvey(NIHR Bristol Biomedical Research Centre), Mohamed Hashem(Royal Liverpool and Broadgreen University Hospital NHS Trust), Umar Hassan, Joel Henderson(NIHR Bristol Biomedical Research Centre), J. Henton(NIHR Bristol Biomedical Research Centre), S. Hignett, Kathryn A. Hodgkins(University Hospitals Coventry and Warwickshire NHS Trust), Kieran Horgan(University Hospitals Coventry and Warwickshire NHS Trust), Samantha R. Horn, Jennifer Hu(New Cross Hospital), Azar Hussain, Julie Iddon(NIHR Bristol Biomedical Research Centre), Atif Iqbal, R Irri, Tracey Irvine, GW Irwin(Nuffield Orthopaedic Centre), Abdulkadir İskender, Ahmed Ismail, Charlotte Ives, Karen James(University Hospitals Coventry and Warwickshire NHS Trust), R James, Natasha Jiwa, Matthew Jobson(Royal Liverpool and Broadgreen University Hospital NHS Trust), Sandeep Joglekar, L Johnson, Richard S. Johnson, Richard S. Johnson, Liam Jones, Mark Hwang(Royal Liverpool and Broadgreen University Hospital NHS Trust), Vasileios Kalles, Kavitha Kanesalingam(University Hospitals Coventry and Warwickshire NHS Trust), Isabella Karat, Monika Kaushik(Royal Liverpool and Broadgreen University Hospital NHS Trust), Kevin F. Kennedy(University Hospitals Coventry and Warwickshire NHS Trust), E Khalifa, H Khan, Mustafa Khanbhai(Royal Liverpool and Broadgreen University Hospital NHS Trust), Sarwar Khawaja, Hazem Khout, Tamara Kiernan, Baek Kim, Katharine Kirkpatrick(University Hospitals Coventry and Warwickshire NHS Trust), Pasupathy Kiruparan(Royal Liverpool and Broadgreen University Hospital NHS Trust), Cliona Kirwan, M Kishore(Royal Liverpool and Broadgreen University Hospital NHS Trust), Peter Kneeshaw(Royal Liverpool and Broadgreen University Hospital NHS Trust), Andrew T. Knight, Stan Kohlhardt, Jarosław Krupa(NIHR Bristol Biomedical Research Centre), Katherine Krupa(University Hospitals Coventry and Warwickshire NHS Trust), Roncy Savio Kuruvilla, C Laban, LM Lai(University Hospitals Coventry and Warwickshire NHS Trust), Ian Laidlaw, K Lambert(University Hospitals Coventry and Warwickshire NHS Trust), Fiona Langlands(Royal Liverpool and Broadgreen University Hospital NHS Trust), Mark Lansdown(Royal Liverpool and Broadgreen University Hospital NHS Trust), Nicola Laurence, Siobhan Laws, Serena Ledwidge, Valentina Lefemine, Hannah Lennon, Richard Linforth, Kate Little(University Hospitals Coventry and Warwickshire NHS Trust), Aphiwat Luangsomboon, Jonathan N. Lund(NIHR Bristol Biomedical Research Centre), Joseph Maalo(NIHR Bristol Biomedical Research Centre), Louise MacLennan, R. Douglas Macmillan(Nuffield Orthopaedic Centre), Finlay Macneil(Royal Liverpool and Broadgreen University Hospital NHS Trust), TK Mahapatra, Evangelos Mallidis, Patrick Mallon(Royal Liverpool and Broadgreen University Hospital NHS Trust), Nikolaos Manoloudakis, Loaie Maraqa, Sekhar Marla, Sameer Masood, J. Massey(NIHR Bristol Biomedical Research Centre), Tahir Masudi, Pilar Matey(Royal Liverpool and Broadgreen University Hospital NHS Trust), Fayyaz Mazari(Royal Liverpool and Broadgreen University Hospital NHS Trust), Stephen J. McCulley, K. McEvoy(University Hospitals Coventry and Warwickshire NHS Trust), Jamie McIntosh(NIHR Bristol Biomedical Research Centre), Stuart McIntosh, S. McKenzie, Penelope McManus(Royal Liverpool and Broadgreen University Hospital NHS Trust), Jackie McNicholas(NIHR Bristol Biomedical Research Centre), I. Michalakis, Nicola Mills, Geraldine M. Mitchell(Nuffield Orthopaedic Centre), Sherif Monib, Michelle Mullan(Royal Liverpool and Broadgreen University Hospital NHS Trust), Claire V. Murphy, G Murphy(Nuffield Orthopaedic Centre), John Murphy(NIHR Bristol Biomedical Research Centre), B. V. S. Murthy, Salam Musa, Gagan Nagra(Nuffield Orthopaedic Centre), R. Nangalia, Sankaran Narayanan, Rabie Nasr, Channegowda Navin, R. W. Newton, Suellen Nicholson, Niyogushima Nuru, Rachel O’Connell, Joseph A. O’Donoghue(NIHR Bristol Biomedical Research Centre), Arikoge Ogedegbe, O.S. Olayinka, Sisse Olsen, Gary Osborn(Nuffield Orthopaedic Centre), Christina Osborne, Hisham Osman, Careena Otieno, F. Pakzad(Royal Liverpool and Broadgreen University Hospital NHS Trust), A‐La Park, Samuel Parker, Polly Partlett(Royal Liverpool and Broadgreen University Hospital NHS Trust), A. Parvaiz, Laila Parvanta, Gayatri Patel(Nuffield Orthopaedic Centre), A L G Peel, Lashan Peiris, Michael Pennick(Royal Liverpool and Broadgreen University Hospital NHS Trust), Antonella Peppe, Dexter Perry(Royal Liverpool and Broadgreen University Hospital NHS Trust), Simon Pilgrim, James B. Piper(NIHR Bristol Biomedical Research Centre), S Poonawalla, E Popa, Victoria Pope, Peter J. Pugh(Royal Liverpool and Broadgreen University Hospital NHS Trust), Dick Rainsbury(Royal Liverpool and Broadgreen University Hospital NHS Trust), Kelvin Ramsey(University Hospital Southampton NHS Foundation Trust), Tuabin Rasheed, Rathinasabapathy Rathinaezhil, Tim Rattay, D. Ravichandran(Royal Liverpool and Broadgreen University Hospital NHS Trust), Malcolm Reed(Royal Liverpool and Broadgreen University Hospital NHS Trust), S Refsum, Dionysios-Dennis Remoundos(Royal Liverpool and Broadgreen University Hospital NHS Trust), Kathryn Rigby(University Hospitals Coventry and Warwickshire NHS Trust), Stuart Robertson, A. Robinson, Joelle Robinson(NIHR Bristol Biomedical Research Centre), Nathalie Roche, PJ Roy(University of Liverpool), Mira Runkel(Royal Liverpool and Broadgreen University Hospital NHS Trust), Jennifer Rusby(NIHR Bristol Biomedical Research Centre), Sunita Saha, Zuhair Saidan(NIHR Bristol Biomedical Research Centre), M Salab(Royal Liverpool and Broadgreen University Hospital NHS Trust), Mahmoud Saleh(Royal Liverpool and Broadgreen University Hospital NHS Trust), Fathi Salem(Royal Liverpool and Broadgreen University Hospital NHS Trust), Amtul Sami, Suzette Samlalsingh, N Sarfraz, Rakesh Shah, Sadr‐ul Shaheed, Y. Sharaiha(NIHR Bristol Biomedical Research Centre), Geeta Shetty(Nuffield Orthopaedic Centre), Rohan Shotton, Tapan Sircar, E Skene, Sam Sloan, Brendan Smith, Janet Smith(NIHR Bristol Biomedical Research Centre), Ludka Soldanova, F Soliman(Royal Liverpool and Broadgreen University Hospital NHS Trust), Soni Soumian, Jennifer Stevens(NIHR Bristol Biomedical Research Centre), C. Steventon, Emma Stewart-Parker, Thomas Stringfellow, Rupesh Sutaria, Richard Sutton, Helen Sweetland, B Swiech, Sujatha Tadiparthi, Habib Tafazal, Nooshin S. Taheri, C Tait, Marcus G. Tan(Royal Liverpool and Broadgreen University Hospital NHS Trust), Sarah Tang, Anne Tansley, S. Tate, Salim Tayeh, Amanda Taylor, John V. Taylor(NIHR Bristol Biomedical Research Centre), P Thawdar(Royal Liverpool and Broadgreen University Hospital NHS Trust), Christopher Thomas, Stuart P. Thomas, Simon Thomson, A. Thorne, Rachel Tillett, Zoe Tolkien(NIHR Bristol Biomedical Research Centre), Abigail Tomlins, Ashley Topps, Flora Hau Fung Tsang(Royal Liverpool and Broadgreen University Hospital NHS Trust), EJ Turner, Philip Turton(Royal Liverpool and Broadgreen University Hospital NHS Trust), Sujatha Udayasankar, Federica Ugolini(Royal Liverpool and Broadgreen University Hospital NHS Trust), E Vaughan Williams, Raghavan Vidya, Badri Vijaynagar, Raman Vinayagam, Angela Volleamere, Velin Voynov, Shamaela Waheed, T.G. Walker, Una Walsh, R Warner, Ruth Waters, Alex Wilkins, K Williams(University of Liverpool), George D. Wilson(Nuffield Orthopaedic Centre), M Wiltsher(Royal Liverpool and Broadgreen University Hospital NHS Trust), Brendan Paul Wooler, Chloe Wright, M Wright(Royal Liverpool and Broadgreen University Hospital NHS Trust), Lynda Wyld, Mina Youssef(Royal Liverpool and Broadgreen University Hospital NHS Trust), Catherine Zabkiewicz, C. Zammit, Bashar Zeidan, Da Zheng(Royal Liverpool and Broadgreen University Hospital NHS Trust)
Cited by 199Open Access
Abstract
BACKGROUND: Use of biological or synthetic mesh might improve outcomes of immediate implant-based breast reconstruction-breast reconstruction with implants or expanders at the time of mastectomy-but there is a lack of high-quality evidence to support the safety or effectiveness of the technique. We aimed to establish the short-term safety of immediate implant-based breast reconstruction performed with and without mesh, to inform the feasibility of undertaking a future randomised clinical trial comparing different breast reconstruction techniques. METHODS: In this prospective, multicentre cohort study, we consecutively recruited women aged 16 years or older who had any type of immediate implant-based breast reconstruction for malignancy or risk reduction, with any technique, at 81 participating breast and plastic surgical units in the UK. Data about patient demographics and operative, oncological, and complication details were collected before and after surgery. Outcomes of interest were implant loss (defined as unplanned removal of the expander or implant), infection requiring treatment with antibiotics or surgery, unplanned return to theatre, and unplanned re-admission to hospital for complications of reconstructive surgery, up to 3 months after reconstruction and assessed by clinical review or patient self-report. Follow-up is complete. The study is registered with the ISRCTN Registry, number ISRCTN37664281. FINDINGS: Between Feb 1, 2014, and June 30, 2016, 2108 patients had 2655 mastectomies with immediate implant-based breast reconstruction at 81 units across the UK. 1650 (78%) patients had planned single-stage reconstructions (including 12 patients who had a different technique per breast). 1376 (65%) patients had reconstruction with biological (1133 [54%]) or synthetic (243 [12%]) mesh, 181 (9%) had non-mesh submuscular or subfascial implants, 440 (21%) had dermal sling implants, 42 (2%) had pre-pectoral implants, and 79 (4%) had other or a combination of implants. 3-month outcome data were available for 2081 (99%) patients. Of these patients, 182 (9%, 95% CI 8-10) experienced implant loss, 372 (18%, 16-20) required re-admission to hospital, and 370 (18%, 16-20) required return to theatre for complications within 3 months of their initial surgery. 522 (25%, 95% CI 23-27) patients required treatment for an infection. The rates of all of these complications are higher than those in the National Quality Standards (<5% for re-operation, re-admission, and implant loss, and <10% for infection). INTERPRETATION: Complications after immediate implant-based breast reconstruction are higher than recommended by national standards. A randomised clinical trial is needed to establish the optimal approach to immediate implant-based breast reconstruction. FUNDING: National Institute for Health Research, Association of Breast Surgery, and British Association of Plastic, Reconstructive and Aesthetic Surgeons.
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