Enhancing Patient Outcomes in Aesthetic and Reconstructive Breast Surgery Using Triple Antibiotic Breast Irrigation: Six-Year Prospective Clinical Study

[BREAST: ORIGINAL ARTICLES]

Adams, William P. Jr. M.D.; Rios, Jose L. M.D.; Smith, Sharon J. R.N.

Dallas, Texas

From the Department of Plastic Surgery, Parkland Health and Hospital System, and the Department of Plastic and Reconstructive Surgery, University of Texas Southwestern Medical Center.

Received for publication September 16, 2004; revised December 20, 2004.

William P. Adams, Jr., M.D., 2801 Lemmon Avenue West, Suite 300, Dallas, Texas 75204, dr@dr-adams.com

Abstract TOP

Background: Capsular contracture remains one of the most commonly reported complications in aesthetic and reconstructive breast patients. Previous in vitro studies from the authors' laboratory have recommended a new triple antibiotic povidone-iodine irrigation (2000) and subsequently a triple antibiotic non-povidone-iodine-containing irrigant (2001) to optimize broad-spectrum coverage of various bacteria implicated in capsular contracture; however, the clinical efficacy of these in vitro studies remains unproven. The purpose of this study was to determine the clinical efficacy for the previously reported triple antibiotic breast irrigation. The cost-effectiveness of universal application of irrigation solutions in breast prosthesis surgery was analyzed as well.

Methods: Patients undergoing aesthetic and reconstructive breast implant procedures were treated with a standardized operative technique, including the use of triple antibiotic breast irrigation by a single surgeon. Capsular contracture was assessed using a simplified Baker scale and graded by two independent caregivers to maximize objectivity and consistency. Additional complications were also recorded, including reoperation. Patient charges for antibiotic irrigation and reoperation for contracture were determined and compared.

Results: A total of 335 patients operated on since 1997 were evaluated prospectively. They ranged in age from 18 to 86 years, and the mean follow-up was 14 months (range, 6 to 75 months). The rate of grade III/IV capsular contracture in the study groups was 1.8 percent for patients undergoing primary breast augmentation. Patients undergoing augmentation-mastopexy had a grade III/IV contracture rate of 0 percent. Breast reconstruction patients had a 9.5 percent rate of grade III/IV contracture.

Conclusions: Triple antibiotic breast irrigation is clinically associated with a low incidence of capsular contracture compared with other published reports, and its clinical efficacy supports previously published in vitro studies. Application of triple antibiotic irrigation is recommended for all aesthetic and reconstructive breast procedures and is cost effective.

Despite 40 years of problems, capsular contracture remains a significant complication in aesthetic and cosmetic breast surgery. The incidence of contracture has been reported to be as high as 50 percent in some series,1 and despite suggestions by some surgeons that contracture is no longer a problem, it is still a significant issue for aesthetic and reconstructive breast patients. The best and most controlled available data come from the implant manufacturers' premarket approval prospective trials, with rates of 9 percent for primary augmentation and up to 30 percent for breast reconstruction patients in the Mentor Corp. saline trial (2001), 9 percent for augmentation and 25 percent for reconstruction patients in the Allergan/Inamed/McGhan Corp. saline trial (2001), and 8 to 9 percent for the augmentation subgroup in Inamed's and Mentor's silicone gel implant premarket approval trial (2003 and 2005).2-4

Although the underlying etiology of capsular contracture has yet to be fully elucidated, there is a well-established correlation between capsular contracture and bacterial infection.5-10 The use of breast pocket irrigation with povidone-iodine as a means of preventing subclinical implant pocket infection, and subsequent capsular contracture, was championed by Burkhardt and colleagues11,12 and widely practiced by plastic surgeons for many years. Without any additional scientific data, many surgeons also opted to use various other antibiotic-containing solutions, such as double antibiotic solution (polymyxin B/gentamicin) for breast pocket irrigation.

A wide variety of organisms have been implicated in the development of capsular contracture.5,13 Adams et al.14 provided recommendations for optimal broad-spectrum antibacterial coverage of the organisms most likely to cause implant contracture and infections. A critical analysis of a variety of solutions revealed the ideal coverage was provided by a combination of povidone-iodine, gentamicin, and cefazolin. Despite the complete absence of any evidence that extraluminal povidone-iodine contributes to implant shell failure, the U.S. Food and Drug Administration prohibited the contact of povidone-iodine with breast implant prostheses.15,16 Subsequent in vitro investigations at our institution15 yielded an alternative solution of bacitracin, gentamicin, and cephalexin that provided antibacterial coverage comparable to that of the initial povidone-iodine-containing solutions.14 Despite the promising in vitro results, the efficacy of this triple antibiotic solution in the clinical setting had not been established.

The purpose of this study was to evaluate the incidence of capsular contracture in the practice of one surgeon (Adams) using the triple antibiotic solution recommended by the in vitro studies. We also performed a cost analysis of the universal application of pocket irrigation in patients undergoing breast implant placement.

Read more on this breast augmentation study.