title: Early complications and implant loss in implant-based breast reconstruction with and without acellular dermal matrix (Tecnoss Protexa®): a comparative study.
abstract: BACKGROUND
  Acellular dermal matrix (ADM) may improve outcomes in implant-based breast reconstruction, but recent evidence suggests complication rates may be higher when ADM is used. We retrospectively compared early complications and implant loss in implant-based breast reconstruction (BR) with and without ADM to evaluate the safety of the procedure in our centre.
  
  
  METHODS
  Case-notes of consecutive women undergoing implant-based BR from May 2011 to November 2012 were retrospectively reviewed. Data were extracted using a standardised pro-forma and the rate of early complications, major complications and implant loss compared between procedure groups.
  
  
  RESULTS
  Forty-six implant-based reconstructions were performed for malignancy (n = 31, 67.4%) or prophylaxis (n = 15, 32.6%) in 31 women over the 18-month study period. ADM (Tecnoss Protexa(®), Tecnoss S.r.l.) was used in 31 (67.4%) cases. There were no differences in patient age, BMI, co-morbidities, smoking or chemotherapy between groups, but patients receiving ADM were more likely to have received radiotherapy prior to their reconstruction (n = 6, 30% vs. n = 0, 0%, p = 0.043). The overall rate of early complications was 26.1% (n = 12) but there was no significant difference between procedure groups (standard-n = 4, 27.7% vs. ADM-n = 8, 25.8%; p = 0.950). There were 2 (4.3%) major complications none of which were associated with ADM use (standard-n = 2, 13.3% vs. ADM-n = 0, 0.0%; p = 0.038). There were 6 (13.0%) implant losses of which 4 were in the ADM group (standard-n = 2, 13.3% vs. ADM-n = 4, 12.9%; p = 0.968). All of these were associated with pre-reconstruction radiotherapy.
  
  
  CONCLUSIONS
  ADM-assisted implant-based reconstruction with Tecnoss Protexa(®) is safe and may improve outcomes for women by facilitating a single-stage procedure. Robust prospective evaluation is now needed to definitively evaluate the role of ADM in implant-based BR.
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom.
authors.forename: S
authors.initials: S
authors.lastname: Potter
authors.affiliation: Breast Care Centre, North Bristol NHS Trust, Southmead Hospital, Southmead Road, Bristol BS10 5NB, United Kingdom.
authors.forename: A
authors.initials: A
authors.lastname: Chambers
authors.affiliation: Breast Care Centre, North Bristol NHS Trust, Southmead Hospital, Southmead Road, Bristol BS10 5NB, United Kingdom.
authors.forename: S
authors.initials: S
authors.lastname: Govindajulu
authors.affiliation: Breast Care Centre, North Bristol NHS Trust, Southmead Hospital, Southmead Road, Bristol BS10 5NB, United Kingdom.
authors.forename: A
authors.initials: A
authors.lastname: Sahu
authors.affiliation: Department of Plastic Surgery, North Bristol NHS Trust, Bristol, United Kingdom.
authors.forename: R
authors.initials: R
authors.lastname: Warr
authors.affiliation: Breast Care Centre, North Bristol NHS Trust, Southmead Hospital, Southmead Road, Bristol BS10 5NB, United Kingdom. Electronic address: simon.cawthorn@nbt.nhs.uk.
authors.forename: S
authors.initials: S
authors.lastname: Cawthorn
mesh_terms: D062088:Acellular Dermis; D000328:Adult; D000368:Aged; D019928:Breast Implantation / Q000379:methods*; D018427:Breast Implants; D001943:Breast Neoplasms / Q000517:prevention & control / Q000601:surgery*; D020878:Device Removal / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D016462:Mammaplasty / Q000379:methods*; D008408:Mastectomy / Q000379:methods*; D008875:Middle Aged; D011183:Postoperative Complications; D065286:Prophylactic Surgical Procedures / Q000379:methods*; D011475:Prosthesis Failure; D012189:Retrospective Studies; D016896:Treatment Outcome
keywords: ADM; Breast reconstruction; Early complications; Implant loss; Retrospective; Tecnoss Protexa