Macrotextured Breast Implants with Defined Steps to Minimize Bacterial Contamination around the Device: Experience in 42,000 Implants

Plast Reconstr Surg. 2017 Sep;140(3):427-431. doi: 10.1097/PRS.0000000000003575.

Abstract

Background: Bacteria/biofilm on breast implant surfaces has been implicated in capsular contracture and breast implant-associated anaplastic large-cell lymphoma (ALCL). Macrotextured breast implants have been shown to harbor more bacteria than smooth or microtextured implants. Recent reports also suggest that macrotextured implants are associated with a significantly higher incidence of breast implant-associated ALCL. Using techniques to reduce the number of bacteria around implants, specifically, the 14-point plan, has successfully minimized the occurrence of capsular contracture. The authors hypothesize that a similar effect may be seen in reducing the risk of breast implant-associated ALCL.

Methods: Pooled data from eight plastic surgeons assessed the use of macrotextured breast implants (Biocell and polyurethane) and known cases of breast implant-associated ALCL. Surgeon adherence to the 14-point plan was also analyzed.

Results: A total of 42,035 Biocell implants were placed in 21,650 patients; mean follow-up was 11.7 years (range, 1 to 14 years). A total of 704 polyurethane implants were used, with a mean follow-up of 8.0 years (range, 1 to 20 years). The overall capsular contracture rate was 2.2 percent. There were no cases of implant-associated ALCL. All surgeons routinely performed all 13 perioperative components of the 14-point plan; two surgeons do not routinely prescribe prophylaxis for subsequent unrelated procedures.

Conclusions: Mounting evidence implicates the role of a sustained T-cell response to implant bacteria/biofilm in the development of breast implant-associated ALCL. Using the principles of the 14-point plan to minimize bacterial load at the time of surgery, the development and subsequent sequelae of capsular contracture and breast implant-associated ALCL may be reduced, especially with higher-risk macrotextured implants.

Clinical question/level of evidence: Therapeutic, IV.

MeSH terms

  • Breast Implantation / methods
  • Breast Implants / adverse effects*
  • Breast Implants / microbiology
  • Breast Neoplasms / epidemiology*
  • Breast Neoplasms / etiology
  • Equipment Contamination / prevention & control*
  • Female
  • Follow-Up Studies
  • Humans
  • Implant Capsular Contracture / epidemiology*
  • Lymphoma, Large-Cell, Anaplastic / epidemiology*
  • Lymphoma, Large-Cell, Anaplastic / etiology
  • Middle Aged
  • Practice Patterns, Physicians' / statistics & numerical data*
  • Prosthesis Design*
  • Surface Properties