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Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort study

Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort study
Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort study
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.
1474-5488
254-266
Potter, Shelley
77970724-8e7c-47cb-973c-d5a7c6bd783c
Conroy, Elizabeth J.
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Cutress, Ramsey
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Williamson, Paula R.
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Whisker, Lisa J.
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Thrush, Steven
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Skillman, Joanna M.
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Barnes, Nicola
8d8289ce-48da-43bc-af15-0109c2e95e25
Mylvaganam, Senthurun
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Teasdale, Elisabeth
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Jain, Abhilash
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Gardiner, Matthew D.
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Blazeby, Jane M.
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Holcombe, Christopher
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Breast Reconstruction Research Collaborative
Potter, Shelley
77970724-8e7c-47cb-973c-d5a7c6bd783c
Conroy, Elizabeth J.
d050f25a-4835-4a7b-a7a9-1c3a01abe2a7
Cutress, Ramsey
68ae4f86-e8cf-411f-a335-cdba51797406
Williamson, Paula R.
cef0b386-84e6-4f2e-8e9b-516c58a14e44
Whisker, Lisa J.
6cae5575-e545-407f-9b9d-7a6db1f2cd42
Thrush, Steven
54ed886c-690c-41e8-a7d6-6bc05d4b7dd6
Skillman, Joanna M.
9dcb124c-14c3-4f88-be59-5c802c573aad
Barnes, Nicola
8d8289ce-48da-43bc-af15-0109c2e95e25
Mylvaganam, Senthurun
69d44b29-5c5f-4dd6-976a-8cee876196c8
Teasdale, Elisabeth
00b98a54-cc03-44cd-bcc7-6e840ecbd2d1
Jain, Abhilash
c68ef4be-e2dd-4317-9d2e-f146a2ee9e4c
Gardiner, Matthew D.
eea0ad25-65ea-4867-a60c-311aac543eab
Blazeby, Jane M.
689d490e-fca3-4430-88de-f19ec6cebf58
Holcombe, Christopher
e10e54d6-3370-45be-a43f-59a381f4391c

Potter, Shelley, Conroy, Elizabeth J., Cutress, Ramsey, Williamson, Paula R., Whisker, Lisa J., Thrush, Steven, Skillman, Joanna M., Barnes, Nicola, Mylvaganam, Senthurun, Teasdale, Elisabeth, Jain, Abhilash, Gardiner, Matthew D., Blazeby, Jane M. and Holcombe, Christopher , Breast Reconstruction Research Collaborative (2019) Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort study. The Lancet Oncology, 20 (2), 254-266. (doi:10.1016/S1470-2045(18)30781-2).

Record type: Article

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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Accepted/In Press date: 12 October 2018
e-pub ahead of print date: 9 January 2019
Published date: February 2019

Identifiers

Local EPrints ID: 425848
URI: http://eprints.soton.ac.uk/id/eprint/425848
ISSN: 1474-5488
PURE UUID: 4d37d9d0-99b9-4022-b424-ae227a9e26d7

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Date deposited: 05 Nov 2018 17:30
Last modified: 26 Nov 2021 05:49

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Contributors

Author: Shelley Potter
Author: Elizabeth J. Conroy
Author: Ramsey Cutress
Author: Paula R. Williamson
Author: Lisa J. Whisker
Author: Steven Thrush
Author: Joanna M. Skillman
Author: Nicola Barnes
Author: Senthurun Mylvaganam
Author: Elisabeth Teasdale
Author: Abhilash Jain
Author: Matthew D. Gardiner
Author: Jane M. Blazeby
Author: Christopher Holcombe
Corporate Author: Breast Reconstruction Research Collaborative

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