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Cited by 73Breast Implant and ReconstructionDental Implant Techniques and OutcomesTissue Engineering and Regenerative Medicine

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Implant Based Breast Reconstruction With Acellular Dermal Matrix: Safety Data From an Open-label, Multicenter, Randomized, Controlled Trial in the Setting of Breast Cancer Treatment

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Lohmander, Fredrik, Lagergren, Jakob, Roy, Pankaj G., Johansson, Hemming, Brandberg, Yvonne, Eriksen, Catharina, Frisell, Jan·2019·Annals of Surgery
DOI 10.1097/sla.0000000000003054
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Abstract

Objective: To evaluate clinical outcomes of using acellular dermal matrix (ADM) with implant based breast reconstructions (IBBRs) in a randomized controlled trial. Summary Background Data: The use of ADMs in IBBRs is widespread, but link between ADM and complications remain a controversial topic. In view of reports concerning harm, we present 6-months safety data of ADM-assisted IBBR in the setting of breast cancer treatment. Methods: An open-label, randomized, controlled trial recruiting patients from 4 centers in Sweden and 1 in UK. Eligible were women with breast cancer planned for mastectomy with immediate IBBR. Participants were randomly allocated to IBBR with or without ADM (Strattice, Branchburg, NJ), with stratification by center in blocks of 6. Main primary endpoint was number of unplanned reoperations at 24 months, and safety expressed as the incidence of adverse events with a 6-month follow-up time for all participants. Analysis were done per protocol using Fisher exact test for complications and reoperations. Results: From start of enrolment on April 24, 2014, to close of trial on May 10, 2017, 135 women were enrolled, of whom 64 with ADM and 65 without ADM were included in the final analysis. Four patients (6%) in each group had reconstructive failure with implant loss, but IBBR with ADM exhibited a trend of more overall complications and reoperations (difference 0·16, 95% CI, −0·01 to 0·32, P = 0·070), and with higher risk of wound healing problems (P = 0·013). Conclusions: With 6-months follow-up for all participants, immediate IBBR with ADM carried a risk of implant loss equal to conventional IBBR without ADM, but was associated with more adverse outcomes requiring surgical intervention. Further investigation of risk factors and patient selection in a long-term follow-up is warranted.

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Research works printed but not linked: 23

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Metadata

Authors
Lohmander, F., Lagergren, J., Roy, P. G., Johansson, H., Brandberg, Y., Eriksen, C., & Frisell, J.
Affiliations
  • Karolinska University Hospital (SE)
  • Karolinska Institutet (SE)
  • University of Oxford (GB)
  • Stockholm South General Hospital (SE)
Corresponding author
Lohmander, Fredrik
ORCID
Venue
Annals of Surgery
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2019-05
Volume
269
Issue
5
Pages
836-841
ISSN
  • 0003-4932 (ISSN-L)
  • 1528-1140
DOI
10.1097/sla.0000000000003054
OpenAlex
W2896814255
Cited by
73
References
0
Citations by year
2026: 4 · 2025: 8 · 2024: 10 · 2023: 8 · 2022: 7 · 2021: 12 · 2020: 15 · 2019: 9
FWCI
9.42
Type
journal article
Language
en
Open access
Licence
Locations
  • Annals of Surgery (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
Funders
University of Oxford
Topics
  • Health Sciences › Medicine › Surgery › Breast Implant and Reconstruction
  • Health Sciences › Dentistry › Oral Surgery › Dental Implant Techniques and Outcomes
  • Health Sciences › Medicine › Surgery › Tissue Engineering and Regenerative Medicine
Keywords
implant-based breast reconstruction, acellular dermal matrix, Strattice, breast cancer, mastectomy, immediate reconstruction, implant failure, reconstructive failure, unplanned reoperation, wound complications, surgical complications, reconstructive outcomes
MeSH terms
Breast Neoplasms, Female, Humans, Mastectomy, Middle Aged, Prospective Studies, Reoperation, Mammaplasty, Treatment Outcome, Breast Implants, Acellular Dermis

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