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

Adams, William P. Jr. M.D.; Culbertson, Eric J. M.D.; Deva, Anand K. F.R.A.C.S.; R. Magnusson, Mark M.D.; Layt, Craig F.R.A.C.S. (Plast); Jewell, Mark L. M.D.; Mallucci, Patrick M.D., F.R.A.C.S. (Plast); Hedén, Per M.D.

Plastic and Reconstructive Surgery: September 2017 - Volume 140 - Issue 3 - p 427–431
doi: 10.1097/PRS.0000000000003575
Breast: Original Articles
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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.

Dallas, Texas; Sydney, Toowoomba, and Gold Coast, Australia; Portland, Ore.; London, United Kingdom; and Stockholm, Sweden

From the Department of Plastic Surgery, University of Texas Southwestern Medical Center; Macquarie University and Integrated Specialist Healthcare; private practice; Oregon Health Science University; and Royal Free Hospital.

Received for publication January 3, 2017; accepted March 17, 2017.

Disclosure: Dr. Adams is an educational advisor for Allergan and Sientra, and was a clinical trial investigator for Allergan and Mentor. Dr. Deva is a consultant and research coordinator for Allergan, Mentor (Johnson & Johnson), and Acelity. Dr. Magnusson is a consultant for Allergan. Dr. Layt is an educational consultant for Allergan. Dr. Mallucci is an educational consultant for Allergan and a consultant for Sebbin and B-Lite. Dr. Hedén is a consultant and educational advisor for Allergan and a consultant for GC Aesthetics, Motiva/Establishment Labs, and B-Lite Implants. Drs. Culbertson and Jewell have no conflicts of interest to disclose.

William P. Adams, Jr., M.D., Department of Plastic Surgery, University of Texas Southwestern Medical Center, 6901 Snider Plaza, Suite 120, Dallas, Texas 75205, wpajrmd@dr-adams.com

©2017American Society of Plastic Surgeons