DISCUSSION TOP

Breast augmentation is one of the most popular cosmetic procedures performed by plastic surgeons. According to the statistics from the American Society of Plastic Surgeons,19 236,888 breast augmentations were performed in 2002. In addition, more than 74,000 breast reconstruction procedures involving the placement of a breast prosthesis were performed in the same year. The reported rates of capsular contracture have been highly variable.19-21 The best data available from implant manufacturers' saline prospective trials were 9 percent after augmentation and 27 percent after breast reconstruction.2,3 Thus, estimates of the number of women experiencing grade III/IV capsular contracture yearly may range from 22,000 to 44,000.

The cause of capsular contracture has been debated for many years, and no theory has been universally accepted. The precise mechanisms involved have yet to be elucidated, but a correlation with bacterial infection has been established in multiple reports.5-10 Whether or not the presence of bacteria is responsible for a subclinical infection, or results in the initiation of an inflammatory cascade with a final common pathway leading to contracture, the potential role of micro-organisms is impossible to deny.

The effectiveness of antibacterial irrigation solutions has been reported for many years in the specialties of orthopedics, ophthalmology, obstetrics and gynecology, and general surgery.22-26 Use of an antibacterial irrigation solution during placement of breast prostheses is logical given current data on the infectious theory of capsular contracture; however, it continues to be disputed whether antibiotic irrigation exerts its effect through local decreases in bacterial counts or through its systemic absorption, although local effects seem most logical.

One must also understand that a wide variety of organisms (other than Staphylococcus epidermidis) have been cultured from the pockets of patients with capsular contracture. Thus, an optimal irrigation solution for use in breast implant surgery must provide broad-spectrum coverage of all these organisms. In 1997, we developed a special interest in this area, since the specific type of breast pocket irrigation used by many surgeons was anecdotal, with a variety of different solutions used. We decided to apply the scientific method to provide better practice guidelines for surgeons using breast implants.

A critical in vitro analysis of the antimicrobial effectiveness of a variety of irrigation solutions was reported by our group in 200014 and again in 200115 (after the U.S. Food and Drug Administration's ban on povidone-iodine use during placement of breast prostheses). The results of these studies were interesting and informative, but the correlation of the in vitro methodology to the clinical realm was purely speculative.

The current study was performed to evaluate the actual clinical efficacy of the optimal irrigation solutions as determined by our previous in vitro analyses. The capsular contracture rates are favorable in comparison to the most recent premarket approval data available from the two breast implant manufacturers.2-4 We chose the premarket approval data as an appropriate means for comparison since these data are well-controlled and the most currently available from multiple plastic surgeons across the country with a specific interest in breast surgery.

In this study, the incidence of contracture in the augmentation group was reduced four- to five-fold, and three-fold in the reconstruction group. These results are significantly lower than many previously reported rates, and the details of the surgical technique have been provided for reproducibility. Our findings indicate that very low rates of capsular contracture are achievable despite the findings of the recent prospective trials, and that the triple antibiotic irrigation is effective in vivo, supporting our previous in vitro studies.

Implant texture made no significant difference and showed no significant benefit in capsular contracture in this study. The indication for use of a textured implant in this trial was use of a shaped device (saline or gel). In the augmentation subgroup, all capsular contractures occurred with smooth saline implants (but the total number of contractures was very low and 78 percent of the augmentation implants were smooth). In the reconstruction group, contracture occurred in three of six patients with smooth implants and three of six with textured implants.

We also analyzed the cost-effectiveness of the universal application of triple antibiotic breast pocket irrigation during breast implant procedures. The average costs of triple antibiotic solution range from $2 to $154. As all components are generic, the lower values are more realistic. A total solution cost of $5 for the combination solution was used in the comparison. The total cost of reoperation for capsular contracture at our institution ranged from $7217 to $7667. Treatment of 100 primary augmentation patients with irrigation solution costs $500. Another $14,434 can be estimated for reoperations at a 2 percent contracture rate, for a total of $14,934. Assuming a contracture rate consistent with the most recent available data (9 percent), $64,953 would be spent on reoperations. The savings would measure over $50,000. It is important to note, however, that this figure does not include revenues lost from time off work, the morbidity of another operation, and the possibility of recurrent contracture. If these measures are taken into account, the savings would be much greater than we have calculated. Additional important operating room management issues include mixing of the solution by the operating room nurses before the procedure. We have found that this eliminates oversights and overcomplications encountered when this step is left to the discretion of the pharmacy.

Also cogent is the known shortage of bacitracin and the reluctance of surgeons to use povidone-iodine-containing irrigation solutions due to U.S. Food and Drug Administration restrictions. We do not disagree with many who find it illogical that the Food and Drug Administration has not reconsidered its strange decision to restrict povidone-iodine usage when there have now been multiple studies that have not found any detrimental implant effect of extraluminal povidone-iodine.15,16,27,28 Despite the bureaucracy of this process, keep in mind that the off-label use of povidone-iodine-containing breast irrigation is still permissible at the discretion of the operating surgeon. In this situation, the surgeon can disclose the intention to use povidone-iodine to the patient with appropriate background information, and we have found patients to be not only accepting but grateful that their physician is acting in their best interest. Alternatively, the povidone-iodine irrigation may be used if after a 5-minute contact time it is followed by a saline irrigation, which prevents contact of the implant with povidone-iodine (this must be dictated in the operative note). Either practice is sound and permitted.

In addition, some patients have systemic allergies to antibiotics. Our breast pocket irrigation recommendations for common antibiotic allergies are summarized in Table 4.

It is important to note that most capsular contractures present within 1 year of the procedure; thus, the mean follow-up of our series (14 months) is adequate. In fact, all contractures in every subgroup in this study occurred within 1 year from operation and all were clinically detectable within 6 months postoperatively. Thus, the majority of patients do form contractures within a year of operation, and we believe this is secondary to a subclinical bacterial contamination of the periprosthetic pocket. More perplexing are contractures that form years after implantation. Potential causes for late contracture include secondary infection from systemic bacteremia and chronic capsular maturation changes mediated by elastomer degradation or filler bleed.

The lack of a prospective, double-blind, randomized trial design is a weakness of our report. Acknowledging this fact, we are unsure whether the aforementioned type of trial is ethical in the current era. Given the available data on the association between contracture and the presence of bacteria, the significant morbidity and costs associated with capsular contracture and its treatment, and the minimal risks associated with antibiotic irrigation, randomization of patients to a nontreatment group (saline only) would be ethically unsound at best. Furthermore, we believe the etiology of capsular contracture is multifactorial, and there is no way to completely isolate an experience with triple antibiotic without other confounding variables, such as tissue trauma and bleeding, both of which may also increase the possibility for contracture. Our recommended surgical technique minimizes both tissue trauma and bleeding, and these ultimate study limitations warrant acknowledgment. Nevertheless, we would conclude that triple antibiotic breast irrigation (povidone-iodine/cefazolin/gentamicin or bacitracin/cefazolin/gentamicin) has proven efficacy in both vitro and in vivo clinical studies. Its use clinically with our recommended technique yields capsular contracture rates four to five times lower than other available prospective premarket approval data.

Our technique for the placement of breast prostheses has been standardized, and our recommendations for surgeons include the following:

* atraumatic pocket dissection under direct vision, avoiding blunt instrumentation;

* soaking of implants in irrigation solution during pocket dissection;

* irrigation of pocket with 120 to 150 ml of irrigation solution without any active evacuation;

* cleansing of skin surrounding the incisions with irrigation solution;

* glove change before implant handling;

* aseptic implant insertion; and

* minimal implant manipulation after insertion (gloves should be washed with antibiotic solution if further implant handling is required)

New methods for the delivery of drugs, such as antibiotics, are being investigated. In a recent publication, Darouiche et al. 29 reported the use of saline-filled implants impregnated with minocycline/rifampin in a rabbit model. The sustained delivery of these drugs resulted in a significant decrease in the rates of contracture in their model. It is foreseeable that implants may be manufactured with antibiotics impregnated within their shell, for optimal control of the bacteria most often associated with capsular contracture; however, enhanced implant technology will not replace meticulous technique and use of antimicrobial irrigation to minimize implant pocket contamination.

As we attempt to advance the science of aesthetic and reconstructive breast surgery, we have found the use of triple antibiotic irrigation integral in reducing the incidence of complications associated with these procedures and enhancing the patient's experience.

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