When breast erythema is noted after mastectomy and ADM use, the initial response should be to rule out infection. The incidence of surgical site infection in the setting of ADM ranged from 0% to 18.5% with a mean incidence of 5.5% in the 9 studies reviewed (Table 1). The initial evaluation requires a through history and physical examination and obtaining appropriate laboratory studies. Prior investigation has demonstrated that the primary hallmarks of infection are pain, redness, and swelling and that fever and leukocytosis are less common.33 In patients with RBS, fever, leukocytosis, and pain are uncommon; however, erythema is universal with or without breast pain or edema. The onset and duration of RBS is variable ranging from a few days to a few weeks and a few weeks to several months, respectively. The self-limiting aspect of RBS is postulated to be the result of angiolymphatic regeneration and the re-establishment of lymphatic flow, thereby resulting in the resolution of the inflammatory mediators responsible for the localized erythema.
In all cases of erythema, a trial of antibiotic therapy is recommended that may be administered orally if mild or intravenously if severe. Cellulitis will typically resolve with antibiotics or require operative exploration if progressive. RBS will usually be unaffected with antibiotic therapy but can progress to infection if there is a component of bacterial overgrowth. If there is no change after 1 week of therapy and the patient remains afebrile, RBS is presumed and the antibiotics are discontinued. Figures 6, 7 illustrate a patient with RBS of 9 months duration who eventually had explantation of the original implants and ADM followed by secondary reconstruction. The decision to convert from prosthetic to autologous reconstruction in the setting of protracted RBS is based on the quality of the reconstruction, patient concerns, and surgeon recommendation.
Several retrospective clinical studies have reviewed the incidence of RBS and attempted to determine its etiology without any physiologic explanations (Table 1). In one study comparing aseptic AlloDerm to sterile AlloDerm, it was demonstrated that the incidence of RBS decreased from 7.5% to 2.5%.3 In another study, the incidence of surgical site infection was 11.1% with aseptic and 7.7% with sterile AlloDerm.24 The difference between aseptic and sterile AlloDerm is that the aseptic AlloDerm is freeze dried and has a sterility assurance level (SAL) of 10−3, whereas sterile AlloDerm is terminally sterilized using radiation and has an SAL that is also 10−3. Given that the incidence of RBS was reduced but not eliminated with the sterile product, the authors recognized that the occurrence of RBS might be unrelated to the processing of ADM. Although other ADMs were not evaluated, the study implied that RBS could occur with any ADM. In another study using a mathematical model to evaluate the relationship of SAL to infection, it was demonstrated that there was no difference in the rate of infection when comparing ADM with an SAL of 10−3 and 10−6.34
The purpose of device or tissue sterilization is to reduce the bacterial count. Guidelines for sterilization set forth by the Food and Drug Administration (FDA) are that for a product to be considered sterile, a minimal SAL of 10−3 must be achieved using terminal sterilization techniques such as radiation and detergents. An SAL of 10−3 implies that the likelihood of finding a viable organism is one in a thousand, whereas an SAL of 10−6 would be one in a million. Standards for the sterilization of medical devices or tissues will depend on the nature of the material. Materials that are heat resistant such as metals are best sterilized to an SAL ranging from 10−6 to 10−9. This is in contrast to materials that are heat sensitive that are typically sterilized to an SAL of 10−3.35 Human acellular dermal matrices are thermally sensitive tissues that can be damaged by excessive radiation. The implantation of a damaged human ADM is far more likely to result in an inflammatory reaction as the body undergoes degradation processes to eradicate the material from the body. It is postulated that the refractory nature of the RBS may be the result of scarred interface between the ADM and the mastectomy skin flap compromising the flow of lymphatic fluid and resulting in protracted RBS.
There have been several comparative clinical outcome studies evaluating various ADM materials. In 1 publication comparing dual plane reconstruction using AlloDerm (Allergan Inc., Irvine, CA) to DermACELL (Stryker, Kalamazoo, MI), the authors concluded that RBS was increased with AlloDerm (26%) compared with DermACELL (0%).10 The primary explanation for this observation was that DermACELL was sterilized to an SAL of 10−6, whereas AlloDerm was sterilized to an SAL of 10−3. The authors concluded that RBS is an inflammatory response to ADM and that by aggressive sterilization of ADM, RBS would be eliminated. Their conclusion that RBS is due to the degree of ADM sterilization is not based on any physiologic explanation and represents conjecture. Their contention that RBS is inflammatory is accurate; however, the implication that it is minimized by increasing the SAL to 10−6 is without foundation and misrepresentative.
It is important to recognize that RBS is not product specific. It can occur with any ADM regardless of the degree of sterilization or the biologic source (Table 1). This has been demonstrated by the clinical studies and personal observation having used a variety of ADMs and having evaluated patients with RBS who have had different ADMs placed (Table 1). It is also important to appreciate that RBS is uncommon with a mean occurrence based on review of the 8 studies of 6.4%.
In conclusion, RBS is more likely to represent the rubor associated with lymphedema and lymphatic obstruction rather than the type of ADM used or the other possible etiologies mentioned. It is important to recognize that these conclusions are based on the best available evidence and is not intended to be absolute. Inflammation is multifactorial, but the clinical appearance and characteristics of RBS are constant. Understanding the possible mechanisms responsible for RBS is important, as we move forward with prosthetic breast reconstruction and ADM.
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