povidone-iodine and Implant-Capsular-Contracture

Breast implant-associated infection and capsular contracture are challenging complications that can result in poor outcomes following implant-based breast surgery. Antimicrobial irrigation of the breast pocket or implant is a widely accepted strategy to prevent these complications, but the literature lacks an evidence-based consensus on the optimal irrigation solution.. The objective of this systematic review was to compare clinical outcomes, specifically capsular contracture, infection, and reoperation rates, associated with the use of antibiotic, antiseptic, and saline irrigation.. A systematic review was performed in March 2020 based on the following search terms: "breast implant," "irrigation," "antibiotic," "bacitracin," "antiseptic," "povidone iodine," "betadine," "low concentration chlorhexidine," and "hypochlorous acid." Capsular contracture, infection, and reoperation rates were compared by analysis of forest plots.. Out of the 104 articles screened, 14 met the inclusion criteria. There was no significant difference in capsular contracture rates between antibiotic and povidone-iodine irrigation, although the data comparing these 2 groups were limited and confounded by the concurrent use of steroids. Antibiotic irrigation showed a significantly lower rate of capsular contracture compared with saline irrigation and a lower rate of capsular contracture and reoperation compared with no irrigation at all. Povidone-iodine was associated with lower rates of capsular contracture and reoperation compared with saline irrigation but there were no data on infection rates specific to povidone-iodine irrigation.. Our study supports the use of antibiotics or povidone-iodine for breast implant irrigation. Further research is required to better determine which of these 2 irrigation types is superior.

Topics: Anti-Bacterial Agents; Anti-Infective Agents, Local; Breast Implantation; Breast Implants; Humans; Implant Capsular Contracture; Povidone-Iodine; Therapeutic Irrigation

Capsular contracture is common and distressing after aesthetic breast augmentation. The precise cause of capsular contracture is not well established. This systematic review investigates current available evidence regarding perioperative povidone-iodine irrigation safety and efficacy in reducing capsular contracture.. PubMed/MEDLINE, Embase, and Scopus databases were searched for publications through December of 2014. Studies with the following criteria were included: (1) primary breast augmentation with implants; (2) perioperative povidone-iodine use; and (3) documentation of capsular contracture. Our primary outcome was incidence of Baker class III/IV capsular contracture. The methodologic quality of included studies was assessed independently. Trials were meta-analyzed to obtain a pooled odds ratio describing the effect of povidone-iodine irrigation on Baker class III/IV capsular contracture.. Nine studies with a total of 5153 patients undergoing aesthetic breast augmentation with implants were included. Only three comparative studies achieved high methodologic quality. The meta-analysis included four studies, with 1191 patients receiving povidone-iodine irrigation and 595 patients receiving saline irrigation. The meta-analysis favored povidone-iodine irrigation for decreasing Baker class III/IV capsular contracture (2.7 percent versus 8.9 percent; OR, 0.30; 95 percent CI, 0.18 to 0.50; p < 0.00001; I = 0 percent). The reported implant rupture rates for both saline implants and silicone implants were less than 1 percent.. Perioperative povidone-iodine irrigation reduces Baker class III/IV capsular contracture and is not associated with implant rupture. Low methodologic quality of included studies limits recommendations for perioperative povidone-iodine irrigation as the standard of practice. Additional high-quality trials are warranted to corroborate the findings of this meta-analysis.. Therapeutic, II.

Topics: Anti-Infective Agents, Local; Breast Implantation; Female; Humans; Implant Capsular Contracture; Incidence; Odds Ratio; Povidone-Iodine; Therapeutic Irrigation; Treatment Outcome

Capsular contracture (CC) remains the most common complication of implant-based aesthetic and reconstructive breast surgery. With subclinical infection proven to be the primary etiology, antimicrobial breast pocket irrigation has been recommended as the key step to reduce CC but has not been universally adopted.. The purpose of this study was to review the rates of CC observed when applying proven antimicrobial breast pocket irrigations.. Data from patients undergoing cosmetic breast augmentation were recorded prospectively from 1997 to 2017. The irrigation was performed with either a Betadine-containing (50% Betadine or "Betadine triple") or a non-Betadine triple antibiotic regimen. The database was assessed to determine the type of implant used, the incidence of CC, and possible contributing factors. The degree of CC was recorded according to the Baker classification.. A 20-year prospective data collection yielded 2088 patients with 4176 implants; of these patients, 826 had textured implants and 1262 had smooth implants. The incidence of Grade III/IV CC was found to be 0.57% in all patients undergoing primary breast augmentation (1.21% in textured implants and 0.16% in smooth implants).. This study constitutes the largest and longest review of CC in a controlled, single-surgeon setting. The incidence of CC is low and reinforces the efficacy/utility of antimicrobial breast pocket irrigation. Both the Betadine and non-Betadine antibiotic regimens were found to be effective, with the Betadine regimen being preferred. Universal adoption of Betadine-containing antimicrobial breast pocket irrigation is recommended to reduce CC and other device-associated infections.

Topics: Anti-Bacterial Agents; Anti-Infective Agents; Breast Implantation; Breast Implants; Follow-Up Studies; Humans; Implant Capsular Contracture; Povidone-Iodine

Capsular contracture (CC) has remained an unresolved issue throughout history. Strong evidence focuses on bacterial biofilm as its main source. A literature review revealed that more than 90% of bacteria found in capsules and implants removed from patients with Baker grade III-IV CC belong to the resident skin microbiome (Staphylococcus epidermidis, predominant microorganism). The use of an adequate preoperative skin antiseptic may be a critical step to minimize implant contamination and help prevent biofilm-related CC.. The authors sought to compare the effect of 2 different antiseptic skin preparations: povidone-iodine (PVP-I) vs chlorhexidine gluconate (CHG) on CC proportions after primary breast augmentation through a periareolar approach.. In June of 2014, The Society for Healthcare Epidemiology of America proposed to use CHG for preoperative skin preparation in the absence of alcohol-containing antiseptic agents as strategy to prevent surgical site infection. The clinical safety committee of a surgical center in Colombia decided to change PVP-I to CHG for surgical site preparation thereafter. The medical records of 63 patients who underwent to primary breast augmentation through a periareolar approach during 2014 were reviewed. In the first 6 months PVP-I was used in 32 patients, and later CHG was employed in 31 patients.. Pearson's chi-squared test to compare CC proportions between subgroups showed a statistically significant difference. The CC proportion was higher for patients who had antisepsis with PVP-I. CC was absent when CHG was employed.. CHG as preoperative skin antiseptic for primary breast augmentation surgery was more effective than PVP-I to help prevent biofilm-related CC.

Topics: Administration, Cutaneous; Adolescent; Adult; Anti-Infective Agents, Local; Biofilms; Breast Implantation; Chlorhexidine; Female; Follow-Up Studies; Humans; Implant Capsular Contracture; Microbiota; Middle Aged; Povidone-Iodine; Preoperative Care; Skin; Staphylococcal Infections; Staphylococcus epidermidis; Young Adult

Capsular contracture induced by chronic subclinical infection is a major cause of poor outcomes and reoperation in breast implant surgery. The use of pocket irrigation with antiseptic/antibiotic has been shown to reduce the incidence of contracture. A new formulation of hypochlorous acid solution PhaseOne has been proposed as potential agent for irrigation.. This study aimed to test the efficacy of hypochlorous acid solution PhaseOne for use in breast pocket irrigation as an alternative to povidone iodine solution Betadine.. The efficacy of PhaseOne, a hypochlorous acid formulated wound and skin cleanser, was tested in vitro against planktonic and biofilm Staphylococcus aureus with or without biological soil and in an implant attachment assay. Its activity was compared with Betadine containing 10% povidone iodine.. Our findings showed that PhaseOne was unable to eradicate planktonic and/or biofilm S. aureus in the presence of either tryptone soy broth or bovine calf serum (protein soil) in a variety of in vitro assays.. We advise that povidone iodine containing irrigants are superior to hypochlorous acid containing irrigants in the clinical setting and should remain the recommended solution for pocket irrigation to reduce bacterial contamination at breast implants surgery.

Topics: Anti-Infective Agents, Local; Biofilms; Breast Implantation; Breast Implants; Hypochlorous Acid; Implant Capsular Contracture; Povidone-Iodine; Staphylococcal Infections; Staphylococcus aureus; Surgical Wound Infection; Therapeutic Irrigation

In the fourth quarter of 2017, the US FDA reviewed and approved a request by one of the breast implant manufacturers for a change in the Directions for Use (DFU) that removed warnings regarding the use of Betadine (povidone-iodine [PI] 10% solution, 1% available iodine [Purdue Frederick Company, Stamford, CT], also available in generic formulations [Aplicare, Inc., Meriden, CT]). Previously, in 2000, there were concerns by the FDA that PI would degrade the silicone elastomer shell. This change in the DFU represents an important advance that will benefit patients through the permitted use of PI to reduce the risk of bacterial contamination of implant surfaces. What was formerly an off-label practice can be openly practiced by plastic surgeons as an anti-infective and biofilm-mitigation strategy. PI has an ideal spectrum effect for gram-positive and gram-negative organisms. Gram-positive organisms have been linked to capsular contracture and gram-negative Ralstonia picketti to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). R picketti is resistant to aminoglycoside antibiotics, but it is susceptible to at least a 50% solution of PI. We believe that the strategy of antisepsis and biofilm mitigation is an integral part of a contemporary approach for breast augmentation. This is beneficial regarding reduction of the risk of surgical infection, capsular contracture, and BIA-ALCL. Outcome data so far indicate that antibiotics/anti-infectives seem to reduce the incidence of these adverse events that lead to reoperation and increased costs. It behooves plastic surgeons to take all actionable steps that enhance the quality of breast implant outcomes and reduce the rate of reoperation.

Topics: Anti-Infective Agents, Local; Bacteria; Biofilms; Breast Implantation; Breast Implants; Drug Labeling; Equipment Contamination; Female; Humans; Implant Capsular Contracture; Incidence; Lymphoma, Large-Cell, Anaplastic; Off-Label Use; Povidone-Iodine; Silicone Gels; Surgical Wound Infection

Antibacterial lavage with topical antibiotics may reduce the occurrence of capsular contracture (CC) in breast augmentation.. The authors investigate the efficacy of povidone-iodine combined with antibiotic irrigation in reducing the CC rate.. The charts of 330 consecutive women who underwent cosmetic breast augmentation during 2 different periods (group A: 2004-2009, n = 165; group B: 2009-2010, n = 165) were retrospectively reviewed. All patients in the series underwent augmentation with the same surgeon (A.S.) via the inframammary approach and dual-plane pocket. In group A, patients received a single perioperative dose of 1.5 g of intravenous cephalothin and 750 mg of oral cephalexin twice a day for 7 days after discharge. In group B, patients perioperatively received 750 mg of intravenous cefuroxime, and each implant and pocket were irrigated with 25 mL of a 10% povidone-iodine solution mixed with 750 mg of cefuroxime and 80 mg of gentamicin diluted in 15 mL of 0.9% sodium chloride solution. After discharge, patients received 500 mg of oral levofloxacin once a day for 5 days. Postoperative complications included occurrence of infection, hematoma, seroma, and CC.. Mean (SD) postoperative follow-up in groups A and B was 24 (+/- 13) months and 22 (+/- 3) months, respectively. The postoperative superficial wound infection rate was 1.8% and 1.2%, the seroma rate was 1.8% and 1.2%, and the hematoma rate was 0.6% and 1.2% in groups A and B, respectively. Ten CC cases (Baker grade 3 or 4) in group A and 1 in group B were reported (6% vs 0.6%; P = .006).. Povidone-iodine and antibiotic irrigation in cosmetic breast augmentation yielded a lower CC rate than standard perioperative antibiotics in this series of patients.

Topics: Administration, Topical; Adult; Anti-Bacterial Agents; Biofilms; Breast Implantation; Breast Implants; Case-Control Studies; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Implant Capsular Contracture; Middle Aged; Postoperative Complications; Povidone-Iodine; Reference Values; Retrospective Studies; Risk Assessment; Therapeutic Irrigation; Treatment Outcome