Preliminary Results of the Use of a Stabilized Hypochlorous Acid Solution in the Management of Ralstonia Pickettii Biofilm on Silicone Breast Implants.

BACKGROUND: Ralstonia Pickettii biofilms are associated with pocket infections following breast implant surgeries. Biofilm protects bacteria most topically applied antimicrobial irrigations. OBJECTIVES: To evaluate the effectiveness of four antimicrobial solutions on the planktonic form and established biofilm of Ralstonia Pickettii grown on 3 different types of silicone breast implants. METHODS: Time kill assays at clinical concentrations of chlorhexidine gluconate, povidone iodine, triple-antibiotic solution, and a 0.025% hypochlorous acid solution stabilized in amber glass were evaluated. Normal saline was the control. Three types of silicone implants, two with a textured surface and one smooth surface, were selected. Planktonic assays were performed after implants were soaked for one, five, 30, and 120 minute time points. Biofilm assays were performed after 5 and 120 minutes of implant soak time. Both tests evaluated cell-forming units (CFU/mL). RESULTS: Triple antibiotic solution had no effect on R. pickettii and was dropped from the study. Remaining solutions showed total kill of planktonic bacteria at one minute. Saline control showed no significant effect on biofilm as anticipated. Stabilized hypochlorous acid was the only solution tested capable of eradicating R. pickettii biofilm on all implant surfaces tested within the first five minute soak time. CONCLUSIONS: Noncytotoxic, 0.025% hypochlorous acid in normal saline, stabilized in amber glass, successfully eradicated Ralstonia pickettii in planktonic and mature biofilm on three types of silicone implants during initial five minute soak time and may be the preferred antimicrobial solution for pocket lavage. This preliminary study requires further investigation. Leaching and implant compatibility testing is currently in progress.

Plastic Expander-Related Gordonia Sputi Infection: Case Report and Literature Review.

Gordonia sputi causes rare bacterial infections resulting from a contaminated indwelling medical device. We report the case of a postoperative plastic expander abscess in a woman, with G. sputi identification by 16S ribosomal RNA sequencing. This report indicates that Gordonia spp. should be included in the list of organisms causing plastic implant infections.

Contamination in smooth gel breast implant placement: testing a funnel versus digital insertion technique in a cadaver model.

BACKGROUND: Overt infection and biofilm formation resulting from breast augmentation are rare but serious problems that can lead to contracture and a need for revision surgery. The Keller Funnel is a medical device composed of a rip-stop nylon sleeve with a hydrophilic inner coating. One claim of the funnel is that it facilitates a "no touch" technique, thereby limiting contamination. To date, there are no data to support this claim. OBJECTIVES: The authors evaluate skin and breast parenchyma contamination with standard implantation techniques and the Keller funnel. METHODS: Insertion techniques were tested in two fresh cadavers. Smooth, round, moderate-plus silicone gel implants were placed for each experiment. To quantify the amount of skin contamination, a 2% w/v fluorescein paste was painted onto the cadaver thorax. After implantation, the implants were soaked in 250 mL of sterile water, and the fluorescence emission of the resulting solution was measured with an ultraviolet-visible spectrophotometer. To qualify the potential contamination from breast parenchyma, the cadaver breast tissue was swabbed with methicillin-sensitive Staphylococcus aureus, and the implant surfaces were cultured postimplantation. RESULTS: The funnel resulted in a 27-fold decrease in skin contact for all smooth gel implants (P = .00059). The amount of skin contact and potential contamination increased incrementally with increasing implant volume when either the funnel or digital implantation techniques were used. Bacterial contamination from breast parenchyma was two times more likely with the standard digital insertion technique (P = .06). CONCLUSIONS: The Keller funnel appears to significantly reduce the amount of skin contact and potential parenchyma contamination.

Late hematogenous bacterial infections of breast implants: two case reports of unique bacterial infections.

Late infections of breast implants are rare occurrences. We present 2 cases of late infections of breast implants, resulting from hematogenous spread from bacterial infection from distant sites. The first case involves a late implant infection following development of a chronic foot sore, caused by Achromobacter xylosoxidans, an aerobic pathogen. The second case describes a late infection, after extensive dental treatment, caused by Streptococcus viridans, a bacterium that normally lives in close association with the teeth and gingiva. On the basis of these 2 cases and others in the literature, systemic antibiotic therapy should be considered in breast implant patients who are exposed to potential bacterial inoculation and bacteremia to prevent late breast infections and subsequent capsular contractures.

Implant Shell Characteristics: The Science Behind the Surface.

Modern breast implant design emphasizes the host response at the surface. Implant surfaces are characterized by their roughness, surface area, and potential for bacterial attachment. The future of implant design may lie in the ability of bioengineers to transform both the structure and chemical properties of the device surface and therefore affect potential long-term outcomes.

The effects of copper additives on the quantity and cell viability of adherent Staphylococcus epidermidis in silicone implants.

This in vitro study evaluated the antibacterial effect of copper additives in silicone implants. Specimens of a standard silicone material used in breast augmentation and modified copper-loaded silicone specimens were prepared and incubated in a Staphylococcus epidermidis suspension (2 h, 37 degrees C). After the quantification of adhering staphylococci using a biofluorescence assay (Resazurin), the viability of the adhering bacterial cells was quantified by live or dead cell labeling in combination with fluorescence microscopy. In the Resazurin fluorometric quantification, a higher amount of adhering S. epidermidis cells was detected on pure silicone (4612 [2319/7540] relative fluorescence units [rfu]) than on silicone with copper additives (2701 [2158/4153] rfu). Additionally, a significantly higher amount of adhering bacterial cells (5.07% [2.03%/8.93%]) was found for pure silicone than for silicone with copper additives (1.72% [1.26%/2.32%]); (p < 0.001). Calculations from live or dead staining showed that the percentage of dead S. epidermidis cells adhered on pure silicone (52.1%) was significantly lower than on silicone with copper additives (79.7%); (p < 0.001). In vitro, silicone material with copper additives showed antibacterial effects against S. epidermidis. Copper-loaded silicone may prevent bacterial colonization, resulting in lower infection rates of silicone implants.

The Efficacy of Breast Implant Irrigant Solutions: A Comparative Analysis Using an In Vitro Model.

BACKGROUND: Infections are challenging complications of implant-based breast reconstruction and augmentation. They pose a clinical challenge, with significant economic implications. One proposed solution is implant irrigation at the time of placement. There is no consensus on the optimal irrigant solution. METHODS: The authors tested the relative efficacy of 10% povidone-iodine, Clorpactin, Prontosan, triple-antibiotic solution, or normal saline (negative control) against two strains each of methicillin-resistant Staphylococcus aureus and Staphylococcus epidermidis. Sterile, smooth silicone implant disks were immersed in irrigant solution, then incubated in suspensions of methicillin-resistant S. aureus or S. epidermidis overnight. The disks were rinsed and sonicated to displace adherent bacteria from the implant surface, and the displaced bacteria were quantified. Normalized values were calculated to characterize the relative efficacy of each irrigant. RESULTS: Povidone-iodine resulted in reductions of the bacterial load by a factor of 10 to 10 for all strains. Prontosan-treated smooth breast implant disks had a 10-fold reduction in bacterial counts for all but one methicillin-resistant S. aureus strain. In comparison to Prontosan, triple-antibiotic solution demonstrated a trend of greater reduction in methicillin-resistant S. aureus bacterial load and weaker activity against S. epidermidis strains. Clorpactin reduced the recovered colony-forming units for only a single strain of S. epidermidis. Povidone-iodine demonstrated the greatest efficacy against all four strains. However, Clorpactin, triple-antibiotic solution, and Prontosan demonstrated similar efficacies. CONCLUSIONS: Povidone-iodine was the most efficacious of the irrigants at reducing methicillin-resistant S. aureus and S. epidermidis contamination. Given the recent lifting of the U.S. Food and Drug Administration moratorium, larger clinical studies of povidone-iodine as a breast implant irrigant solution are warranted. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.

Implant Surface Options and Biofilm Mitigation Strategies.

Two important topics in breast augmentation and reconstruction relate to device surface texture and practices to mitigate biofilm contamination of implants. Breast augmentation can be considered a manufacturing process where planning concepts of process engineering and quality can be used to produce great outcomes. This article reviews the options available for surgeons with regards to device surface texture selection and practices to mitigate biofilm contamination of implants at the time of surgery.

Modern Primary Breast Augmentation: Best Recommendations for Best Results.

LEARNING OBJECTIVES: After reading this article, the participant should be able to: 1. Develop a practical method for preoperative implant size selection. 2. List characteristics and examples of fourth- and fifth-generation silicone implants. 3. Recognize the differences in "profile" designations across implant manufacturers. 4. Recall updated statistics on breast implant-associated anaplastic large cell lymphoma and describe current guidelines on disease diagnosis and treatment. 5. Apply atraumatic and aseptic surgical techniques in primary breast augmentation. SUMMARY: Modern primary breast augmentation requires an intimate knowledge of the expanding breast implant market, including characteristics of current generation silicone implants and "profile" types. Optimal implant size selection requires balancing patient desires with tissue qualities. Evidence and awareness of breast implant-associated anaplastic large cell lymphoma continue to grow, and patients and surgeons alike should be informed on the most updated facts of the disease entity. Atraumatic surgical technique and aseptic adjuncts are critical in reducing periprosthetic inflammation and contamination, both of which are known instigators of capsular contracture and potentially breast implant-associated anaplastic large cell lymphoma.

Use of antibiotic beads to salvage infected breast implants.

PURPOSE: When an implant becomes infected, implant salvage is often performed where the implant is removed, capsulectomy is performed, and a new implant is inserted. The patient is discharged with a PICC line and 6-8 weeks of intravenous (IV) antibiotics. This method has variable success and subjects the patient to long-term systemic antibiotics. In the 1960s, the use of antibiotic-impregnated beads for the treatment of chronic osteomyelitis was described. These beads deliver antibiotic directly to the site of the infection, thereby eliminating the complications of systemic IV antibiotics. This study aimed to present a case series illustrating the use of STIMULAN calcium sulfate beads loaded with vancomycin and tobramycin to increase the rate of salvage of the infected implant and forgo IV antibiotics. METHODS: A retrospective analysis was performed of patients who were treated at Mount Sinai Hospital for implant infection with salvage and antibiotic beads. RESULTS: Twelve patients were identified, 10 of whom had breast cancer. Comorbidities included hypertension, smoking, and immunocompromised status. Infections were noted anywhere from 5 days to 8 years postoperatively. Salvage was successful in 9 out of the 12 infected implants using antibiotic bead therapy without home IV antibiotics. CONCLUSIONS: The use of antibiotic beads is promising for salvaging infected breast implants without IV antibiotics. Seventy-five percent of the implants were successfully salvaged. Of the three patients who had unsalvageable implants, one was infected with antibiotic-resistant Rhodococcus that was refractory to bead therapy and one was noncompliant with postoperative instructions.

Presence of Biofilms on Polyurethane-Coated Breast Implants: Preliminary Results.

Polyurethane-coated breast implants seem to be associated with lower medium- and long-term capsular contracture rates in comparison to textured or smooth implant surfaces. Although the etiology of capsular contracture is uncertain, bacterial biofilms have been suggested to trigger chronic peri-implant inflammation, eventually leading to capsular contracture. It is unknown whether polyurethane-coated implants are less prone to biofilm colonization than other implant surfaces. We extracted data from patient records included in a prospective cohort between 2008 and 2011. All patients who underwent removal of polyurethane-coated implants were included in this current study and screened for presence of biofilms by sonication. In addition, implant- and patient-related data were analyzed. Of the ten included polyurethane-coated breast implants, six had been inserted for reconstructive purposes and four for aesthetic reasons. The median implant indwelling time was 28.3 mo. Overall, sonication cultures were positive in 50% of implants. Propionibacterium acnes and coagulase-negative staphylococci were the predominant pathogens isolated from biofilm cultures. Like other implant surfaces, polyurethane-coated implants are prone to biofilm colonization. Further investigations are needed to determine why capsular contracture rates seem to be lower in polyurethane implants than in other implant surfaces. Notably, in this study, 40% of the implants were explanted from breasts with severe capsular contracture.

Microbial evaluation: 139 implants removed from symptomatic patients.

Possible adverse effects of microbial organisms have been implicated in symptomatic silicone implant patients. In the literature, numerous authors have investigated the possible role of infection with respect to implant problems. To date, various bacterial species have been reported, including Staphylococcus aureus, Staphylococcus epidermidis, peptostreptococci, and Clostridium perfringens. Infections in polyurethane-coated prostheses also have been shown to prolong morbidity. Antibiotic use has been relatively empirical in this regard. The purpose of this study was, first, to determine the frequency, type, and clinical relevance of microbial colonization on implant surfaces removed from symptomatic patients and, second, to determine possible effects of microbial colonization on implant integrity (gel bleed, rupture). A total of 139 implants from 72 symptomatic patients were entered into the prospective clinical study between February of 1993 and July of 1994 at the UCLA Medical Center. The implant shell types included smooth (79 percent), polyurethane (8 percent), textured (7 percent), and smooth and Dacron (6 percent). The implant locations were subglandular (71 percent), submuscular (28 percent), and subcutaneous (1 percent). Of the 139 implants removed, 69 percent were intact and 31 percent were ruptured. Forty-seven percent of 139 implants were culture-positive. Propionibacterium acnes was isolated most frequently (57.5 percent), followed by Staphylococcus epidermidis (41 percent), and then Escherichia coli (1.5 percent). No fungal infections were identified. Culture positivity was not significantly associated with systemic symptoms. Sixty-seven percent of the positive culture implants were intact; 33 percent were ruptured. The frequency (47 percent) and types (P. acnes and S. epidermidis) of microbial colonization are determined in symptomatic silicone implant patients.

Microbial growth inside saline-filled breast implants.

In vitro and in vivo experiments were conducted to determine whether intraluminal saline in breast implants can support the growth of common wound-infecting microorganisms over a prolonged period of time. The bacteria tested were Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Corynebacterium jeikeium, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa. Three fungal species also were tested: Aspergillus fumigatus, Paecilomyces variotii, and Candida albicans. In the in vitro study, four organisms survived in flasks of sterile saline for the 2 weeks in which serial cultures were performed: K. pneumoniae, C. albicans, A. fumigatus, and P. variotii. In the in vivo study, 61 white rabbits (122 implants) received both an experimental implant inoculated with one of the test organisms and a control implant containing only sterile saline. They were sacrificed at 1-, 3-, or 6-month scheduled endpoints. None of the control implants containing sterile saline had positive cultures. In contrast, the intraluminal saline was culture positive for 7 of the 10 inoculated organisms after varying lengths of time: S. epidermidis, E. coli, E. cloacae, K. pneumoniae, P. aeruginosa, A. fumigatus, and P. variotii. Samples of capsular tissue also were cultured. Of the 122 capsular tissue specimens, 21 (17 percent) had positive cultures and surrounded both inoculated and sterile implants. In most instances, capsules that were culture positive contained an organism different from the one that had been inoculated in the group. In only 3 cases was the same organism cultured from both the periprosthetic tissue and the intraluminal saline, and these may represent instances of the inoculated organism migrating through the implants filler valves. The data show that several types of bacteria (particularly gram-negative species) and fungi can grow and reproduce in a restricted saline environment for extended periods of time.

Optimizing breast pocket irrigation: an in vitro study and clinical implications.

Subclinical infections have been implicated in the etiology of capsular contracture. Intraoperatively, breast pocket irrigation with povidone-iodine or other antibiotic solutions has been popularized; however, detrimental effects on wound healing for these agents have been reported and their efficacy against common organisms found around breast implants has not been studied. The purpose of this study was to compare the in vitro efficacy of serial dilutions of povidone-iodine and two double antibiotic solutions DAB-1 (gentamicin/polymyxin B) and DAB-2 (gentamicin/cefazolin), against organisms most commonly found around breast implants. In phase I trials, serial dilutions of povidone-iodine and DAB were combined 1:1 with cultures of five common organisms found around implants. In phase II, povidone-iodine was serially diluted in DAB-1 rather than saline. In phase III, povidone-iodine was serially diluted with DAB-2. Efficacy for all phases was determined by plating the mixture onto agar plates and incubating at 37 degrees C for 48 hours. Povidone-iodine was 100 percent effective at a dilution of 12.5% against Staphylococcus epidermidis and 25% against Staphylococcus aureus but relatively ineffective against Escherichia coli and Pseudomonas, DAB-1 was found to be ineffective against S. epidermidis but effective against S. aureus, Propionibacterium acnes, E. coli, and Pseudomonas. In phase II trials, a concentration of 12.5% povidone-iodine in DAB was effective at killing all experimental bacteria. In phase III trials, 10% povidone-iodine in DAB-2 was effective at killing all bacteria tested. In conclusion, to maximize bacterial control of common breast implant organisms and to minimize the detrimental effects on wound healing, 10% povidone-iodine in gentamycin/cefazolin may be used with excellent results and its use clinically may reduce the incidence of capsular contracture.

Antimicrobial coating agents: can biofilm formation on a breast implant be prevented?

BACKGROUND: Numerous clinical studies have shown that biofilm formation by Staphylococcus epidermidis on the outer surface of a silicone breast implant is strongly associated with capsular contracture formation. Traditional administration of systemic antibiotics and antiseptic washing are not necessarily the most effective methods for the prevention of initial biofilm formation on implants in the clinical scenario. In this study an alternative or supplement was sought for preventing or delaying bacterial colonisation and adherence to the outer surface of a breast implant, by establishing an in vitro model for investigating this complex problem. The in vitro antimicrobial activity of several antimicrobial agents was investigated for inhibitory effects on biofilm formation by S. epidermidis. METHODS: The study consisted of two experiments. The first experiment consisted of two groups (A and B) of seven discs each whilst the second experiment was divided into three groups (C, D and E) of 14 discs each. Each group of 14 consisted of seven smooth and seven textured discs. Discs (biopsies) of each implant were individually coated with one of six different antimicrobial agents. Controls that received no agent were included in the various experimental groups. In the first experiment disc diffusion sensitivity testing was performed and inhibition zone sizes were measured. In the second experiment the discs were cultured in broth. The degree of biofilm formation was evaluated by scanning electron microscopy (SEM). RESULTS: In the first in vitro experiment, all six agents showed a measurable antimicrobial effect against the biofilm-forming strain of S. epidermidis when compared to the effect against the American Type Culture Collection strain. In the second in vitro experiment, discs coated with Chloramex, Fucidin and Terramycin did not allow biofilm formation to take place for at least 7 days. CONCLUSIONS: Staphylococcus epidermidis biofilm formation on the outer surface of a silicone breast implant was prevented in vitro for at least 7 days by coating with an appropriate antimicrobial agent. Further evaluation of the interaction between antimicrobial coating agents and S. epidermidis biofilm formation needs to be made before conclusions regarding the clinical scenario can be drawn.

[Titanium-coated silicone is not effective for preventing graft infection]. / Die Beschichtung von Silikonimplantaten mit Titan ist nicht effektiv zur Vermeidung von Infektionen.

AIM: Titanium-coated grafts for breast augmentation are available since 2001 and are used clinically. The titan surface is supposed to improve the tissue compatibility and to lower the infection rate. It was the aim of the present study to validate the antibacterial efficiency of titanium-coated silicone. MATERIAL AND METHODS: C3H/HcN mice were assigned to four different groups (n=6/group). Silicone without (group I and III) or with (group II and IV) titanium were implanted subcutaneously. Following this in groups III and IV a local contamination was induced with 2 x 10 (7) CFU/0.1 ml Staphylococcus aureus ATCC 25923. Groups I and II were not infected. 14 days after primary operation all animals were euthanized and the grafts harvested. Specimens were examined for signs of infections by macroscopy, histology and microbiology. RESULTS: In group I none of the grafts were infected (0/5). In group II (silicone, + titanium, no contamination) one infection was evident due to biting of the animal (1/6). In group III (silicone, no titanium, contamination) an infection was detected in all mice (6/6). The use of titanium, however, did not significantly reduce the infection rate in contaminated animals (group IV, 5/6). Interestingly, tissue integration of titanium-coated grafts was macroscopically reduced compared to non- titanium-coated grafts (group II vs. I). CONCLUSION: The titanium-coated silicone grafts were not effective in protecting infection in vivo. The decreased tissue integration of titanium-coated grafts, however, might reduce the rate of capsular contracture. This potential advantage of titanium needs to be validated in controlled clinical trials.