title: The true incidence of near-term postoperative complications in prosthetic breast reconstruction utilizing human acellular dermal matrices: a meta-analysis.
abstract: BACKGROUND
  The use of human acellular dermal matrix (HADM) materials in prosthetic-based breast reconstruction has gained popularity in recent years. Questions remain, however, regarding the nature and incidence of postoperative complications associated with this technique. The results reported in the available literature vary widely. This meta-analysis examines this question further with a broad review of the available literature in an effort to better define the true nature and incidence of near-term complications associated with the use of HADM in prosthetic-based breast reconstruction. It does not aim to compare this method of reconstruction to others.
  
  
  METHODS
  A review of the available literature was performed in July 2009. The goal was to identify all previous works describing the placement of HADM at prosthetic-based breast reconstruction. Included were studies that documented the use of HADM for coverage of tissue expanders or permanent implants following therapeutic or prophylactic mastectomy. Excluded were studies that reported on the use of HADM in cosmetic breast surgery or studies that included the use of xenografts. Data collected included demographics as well as the nature and incidence of complications, with separate categories assigned for seroma, infection, flap necrosis, and "other." Data were analyzed using Comprehensive Meta-Analysis(®) software (Biostat, Englewood, NJ). Raw proportions, fixed-effect models, and random-effect models were used to assess the complication rates across studies.
  
  
  RESULTS
  Eleven published articles and one abstract that was later published as an article were identified. Within these 12 studies, a total of 789 breasts were identified that had undergone reconstruction with HADM. The mean follow-up was 13.7 months. Under the random-effects model, the total complication rate was 12.0%. The most common complications were flap necrosis (3.3%), seroma (3.3%), and infection (5.6%). All complications not included in these categories were set apart in a separate category, "Other," and totaled 3.0%
  
  
  CONCLUSIONS
  The true incidence of postoperative complications in the near term utilizing HADM in prosthetic-based breast reconstruction appears to be approximately 12%. The incidence of long-term complications such as capsular contracture remains unknown. However, as surgical experience with HADM grows, operative techniques designed at reducing risks will mature, strategies for managing complications will advance, and more advanced products designed to reduce the incidence of complications are likely to become available.
authors.affiliation: Department of Plastic Surgery, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd., Weston, FL 33331, USA. newmanm@ccf.org
authors.forename: Martin I
authors.initials: MI
authors.lastname: Newman
authors.forename: Kimberly A
authors.initials: KA
authors.lastname: Swartz
authors.forename: Michel C
authors.initials: MC
authors.lastname: Samson
authors.forename: Chris Brown
authors.initials: CB
authors.lastname: Mahoney
authors.forename: Khaled
authors.initials: K
authors.lastname: Diab
mesh_terms: D001672:Biocompatible Materials / Q000009:adverse effects / Q000627:therapeutic use*; D018427:Breast Implants / Q000009:adverse effects / Q000706:statistics & numerical data*; D001943:Breast Neoplasms / Q000601:surgery; D003094:Collagen / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D016462:Mammaplasty / Q000379:methods / Q000706:statistics & numerical data*; D011183:Postoperative Complications / Q000453:epidemiology* / Q000517:prevention & control; D012307:Risk Factors; D013524:Surgical Flaps; D013530:Surgical Wound Infection / Q000453:epidemiology; D015625:Tissue Expansion Devices / Q000009:adverse effects / Q000706:statistics & numerical data*; D014945:Wound Healing
chemical_list: D001672:Biocompatible Materials; D003094:Collagen