Betadine and Breast Implants

Betadine and Breast Implants Abstract 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. 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]). Formerly, in 2000, there were concerns by the FDA that PI would degrade the silicone elastomer shell. In response to this, Adams developed a non-Betadine containing triple antibiotic solution (NB-TAB) (50,000 units bacitracin, 1 gm cefazolin, 80 mg gentamicin, 500 cc NS) as an alternative to the same authors original recommendation for Betadine Triple Antibiotic (Betadine-Triple) (50 cc Betadine solution, 50,000 units bacitracin, 1 g cefazolin, 80 mg gentamycin, 500 cc normal saline) or 50-50% Betadine solution and normal saline.1,2 With the recent change in DFU, the use of Betadine is once again permitted. We believe that 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 when utilizing breast implants and tissue expanders. Bacterial Contamination Risks All implanted devices are at risk for bacterial contamination.3 Bacterial surface contamination of implants (smooth and textured surfaces) has been implicated as a cause of infection, capsular contracture, double capsules, and late-term breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).3-18 Gram-positive organisms have been linked to capsular contracture and gram-negative R picketti to BIA-ALCL.6,19-21R picketti is resistant to aminoglycoside antibiotics, but susceptible to at least a 50% solution of PI.22,23 Methods to Reduce Capsular Contracture The concept of iodine as an antibacterial agent has existed for 150 years.24-26 There have not been reports of acquired resistance or cross-resistance to iodine.26 Iodine appears to have excellent efficacy as a biofilm-mitigation agent. The iodine inhibits vital bacterial structures and enzyme systems.26 Iodine has a broader range of antibacterial effect than antibiotics. Moreover, with iodine, there is an ideal spectrum effect for gram-positive and gram-negative organisms. PI is universally available and inexpensive, and it is ideal for applications such as breast implants and tissue expander surgery pocket irrigation. Credit must be given to Boyd Burkhart, MD, for describing in the 1980s the use of implant pocket irrigation with Betadine (PI) to reduce capsular contracture.27-30 Other investigators have found similar benefits.17,18 While these were not large-scale controlled studies, evidence regarding the benefit of pocket irrigation with PI was established. The senior author’s (M.L.J.) personal experience with this approach throughout his use of breast implants to the present (40 years) reveals zero perioperative infection incidence in primary breast augmentation patients and a low long-term capsular contracture incidence of <2.5%. Similarly, the combined experience of 8 surgeons who reviewed their experience with a comprehensive approach for 14 Point Plan biofilm mitigation (Betadine-Triple, NB-TAB, or at least a 50% solution of PI) in macrotextured implants demonstrated zero incidence of BIA-ALCL with a mean follow-up of 11.5 year in 22,000 patients.4 Credit also must be given to Thomas Wiener, MD, for being a tireless advocate of the use of Betadine (PI) to reduce capsular contracture.17-18,31-32 Despite numerous communications with the US FDA by Dr. Wiener circa 2005, the restriction on the use of Betadine and breast implants continued for another 12 years.31 While the use of PI as an antibacterial to reduce capsular contracture is nothing new, it has found use as a simple, cost-effective solution to manage surface contamination with both gram-positive and gram-negative organisms, including R picketti in both smooth and textured surface implants and expanders. It can be utilized as an irrigation solution or as a lubricant (gel formulation). PI is supplied in small bottles that are packaged in sterile surgical skin prep kits (solution, gel, or scrub). We believe that this approach of a one-time use of pre-packaged sterile PI is safer than decanting PI onto the surgical field from a bottle that has been opened multiple times. For PI to be effective, the concentration should be a 50% concentration in an irrigation solution.23 Full-strength PI in one report has been shown to inhibit 100% of fibroblasts in vitro.33 While some in vitro studies have suggested that PI may have a measure of cytotoxic effect, no consistent deleterious effects on various measures of wound healing have been demonstrated in in vivo studies, particularly at lower PI concentrations. PI showed gram-positive and gram-negative activity without fibroblast inhibition.34 To lower the PI concentration, surgeons have utilized PI-triple antibiotic (Betadine Triple Antibiotic) and Non-PI-Triple Antibiotic. These irrigations have been shown to lower capsular contracture tenfold.8,10,12 Concerns have been raised regarding the potential toxicity and negative wound-healing effects of PI-detergent formulation involving rabbit articular tissue.35 Data from other studies, pertaining to chronic wounds, do not show deleterious effects on wound healing.36,37 There has not been a definite study that has demonstrated that PI produces a negative clinical outcome with breast implants or tissue expanders. With breast implants and tissue expanders, PI is utilized as a one-time pocket irrigation rather than being chronically utilized in wound-management scenarios. Given the improved gram-negative coverage for R picketti with PI-containing irrigations, our preference is to utilize PI-TAB or a 50-50% mixture of PI in normal saline. PI appears effective in penetrating existing biofilms.26 PI should never be utilized within the lumen of saline-filled breast implants or tissue expanders, because it may produce delamination of the implant shell.38 There is no published data regarding how pocket irrigation with PI affects tissue integration with alloplastic soft tissue support materials. Stabilized hypochlorous acid is being studied as an antibacterial irrigation and biofilm-mitigation agent. PI has been shown to be superior to 0.025% hypochlorous acid (PhaseOne, Integrated Healing Technologies, Franklin, TN, USA, “HOCl”) for the inhibition and eradication of Staphylococcus aureus biofilm in an in vitro study.39 The authors theorized that the presence of blood or protein apparently reduced the effectiveness of HOCl. A second study by Brindle et al40 demonstrated that HOCl had excellent efficacy against planktotic and biofilm bacteria, including R picketti. We believe that the strategy of utilizing antibacterial agents for biofilm mitigation is an integral part of a contemporary approach for breast augmentation along with the other actionable steps that are outlined in The 14 Point Plan (Table 1). These steps are beneficial in reducing the risk of surgical infection, capsular contracture, and BIA-ALCL. Outcome data so far indicate that antibiotics/antibacterial agents 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 to enhance the quality of breast implant outcomes and reduce the rate of reoperation. Table 1. Surgical 14-Point Plan for Breast Implant Placement (reprinted with Permission from Wolters Kluwer Health, Inc.4) 1. Use intravenous antibiotic prophylaxis at the time of anesthetic induction  2. Avoid periareolar/transaxillary incisions; these have been shown in both laboratory and clinical studies to lead to a higher rate of contracture  3. Use nipple shields to prevent spillage of bacteria into the pocket  4. Perform careful atraumatic dissection to minimize devascularized tissue  5. Perform careful prospective hemostasis  6. Avoid dissection into the breast parenchyma  7. The use of a dual-plane pocket  8. Perform pocket irrigation with triple antibiotic solutions or Betadine (povidone-iodine [PI] solution) i. Perform entire pocket irrigation with precisely mixed PI-TAB solution or 50% (1:1 dilution) or stronger Betadine. Completely envelop the pocket, prep the skin around the incision, and preemptively dip and clean any instruments used in the pocket in the solution. ii. Do not use single-agent antibiotic (Cefazolin) irrigation or Bacitracin irrigation, because they do not work effectively (incomplete coverage spectrum) iii. Recommended irrigation (see Appendix A)  9. Take steps to minimize skin-implant contamination. There are multiple methods to minimize skin contamination including: i. Adequate incision size ii. Re-prep skin with antibiotic solution or skin prep iii. Skin barrier (eg, Tegaderm) iv. Use of an insertion sleeve  10. Minimize implant open time and replacement of implant or sizers  11. Change surgical gloves prior to handling and use new or cleaned instruments and drapes  12. Avoid utilizing a drainage tube, which can be a potential site of entry for bacteria  13. Use a layered closure  14. Use antibiotic prophylaxis to cover subsequent procedures that breach skin or mucosa  1. Use intravenous antibiotic prophylaxis at the time of anesthetic induction  2. Avoid periareolar/transaxillary incisions; these have been shown in both laboratory and clinical studies to lead to a higher rate of contracture  3. Use nipple shields to prevent spillage of bacteria into the pocket  4. Perform careful atraumatic dissection to minimize devascularized tissue  5. Perform careful prospective hemostasis  6. Avoid dissection into the breast parenchyma  7. The use of a dual-plane pocket  8. Perform pocket irrigation with triple antibiotic solutions or Betadine (povidone-iodine [PI] solution) i. Perform entire pocket irrigation with precisely mixed PI-TAB solution or 50% (1:1 dilution) or stronger Betadine. Completely envelop the pocket, prep the skin around the incision, and preemptively dip and clean any instruments used in the pocket in the solution. ii. Do not use single-agent antibiotic (Cefazolin) irrigation or Bacitracin irrigation, because they do not work effectively (incomplete coverage spectrum) iii. Recommended irrigation (see Appendix A)  9. Take steps to minimize skin-implant contamination. There are multiple methods to minimize skin contamination including: i. Adequate incision size ii. Re-prep skin with antibiotic solution or skin prep iii. Skin barrier (eg, Tegaderm) iv. Use of an insertion sleeve  10. Minimize implant open time and replacement of implant or sizers  11. Change surgical gloves prior to handling and use new or cleaned instruments and drapes  12. Avoid utilizing a drainage tube, which can be a potential site of entry for bacteria  13. Use a layered closure  14. Use antibiotic prophylaxis to cover subsequent procedures that breach skin or mucosa  View Large Table 1. Surgical 14-Point Plan for Breast Implant Placement (reprinted with Permission from Wolters Kluwer Health, Inc.4) 1. Use intravenous antibiotic prophylaxis at the time of anesthetic induction  2. Avoid periareolar/transaxillary incisions; these have been shown in both laboratory and clinical studies to lead to a higher rate of contracture  3. Use nipple shields to prevent spillage of bacteria into the pocket  4. Perform careful atraumatic dissection to minimize devascularized tissue  5. Perform careful prospective hemostasis  6. Avoid dissection into the breast parenchyma  7. The use of a dual-plane pocket  8. Perform pocket irrigation with triple antibiotic solutions or Betadine (povidone-iodine [PI] solution) i. Perform entire pocket irrigation with precisely mixed PI-TAB solution or 50% (1:1 dilution) or stronger Betadine. Completely envelop the pocket, prep the skin around the incision, and preemptively dip and clean any instruments used in the pocket in the solution. ii. Do not use single-agent antibiotic (Cefazolin) irrigation or Bacitracin irrigation, because they do not work effectively (incomplete coverage spectrum) iii. Recommended irrigation (see Appendix A)  9. Take steps to minimize skin-implant contamination. There are multiple methods to minimize skin contamination including: i. Adequate incision size ii. Re-prep skin with antibiotic solution or skin prep iii. Skin barrier (eg, Tegaderm) iv. Use of an insertion sleeve  10. Minimize implant open time and replacement of implant or sizers  11. Change surgical gloves prior to handling and use new or cleaned instruments and drapes  12. Avoid utilizing a drainage tube, which can be a potential site of entry for bacteria  13. Use a layered closure  14. Use antibiotic prophylaxis to cover subsequent procedures that breach skin or mucosa  1. Use intravenous antibiotic prophylaxis at the time of anesthetic induction  2. Avoid periareolar/transaxillary incisions; these have been shown in both laboratory and clinical studies to lead to a higher rate of contracture  3. Use nipple shields to prevent spillage of bacteria into the pocket  4. Perform careful atraumatic dissection to minimize devascularized tissue  5. Perform careful prospective hemostasis  6. Avoid dissection into the breast parenchyma  7. The use of a dual-plane pocket  8. Perform pocket irrigation with triple antibiotic solutions or Betadine (povidone-iodine [PI] solution) i. Perform entire pocket irrigation with precisely mixed PI-TAB solution or 50% (1:1 dilution) or stronger Betadine. Completely envelop the pocket, prep the skin around the incision, and preemptively dip and clean any instruments used in the pocket in the solution. ii. Do not use single-agent antibiotic (Cefazolin) irrigation or Bacitracin irrigation, because they do not work effectively (incomplete coverage spectrum) iii. Recommended irrigation (see Appendix A)  9. Take steps to minimize skin-implant contamination. There are multiple methods to minimize skin contamination including: i. Adequate incision size ii. Re-prep skin with antibiotic solution or skin prep iii. Skin barrier (eg, Tegaderm) iv. Use of an insertion sleeve  10. Minimize implant open time and replacement of implant or sizers  11. Change surgical gloves prior to handling and use new or cleaned instruments and drapes  12. Avoid utilizing a drainage tube, which can be a potential site of entry for bacteria  13. Use a layered closure  14. Use antibiotic prophylaxis to cover subsequent procedures that breach skin or mucosa  View Large The 14 Point Plan is compatible with process engineering methods such as the Toyota Production System and Lean Manufacturing as applied to breast augmentation, in which quality improvement is continuous and work is described as a series of interconnected steps.41 A previous study by Tebbetts and Adams42 described the process of breast augmentation as a series of connected events rather than just a single surgical procedure. Credit must be given to Dr. Adams for describing the four sequential steps that optimize the surgical outcomes. The process of breast augmentation is comprised literally of hundreds of steps. CONCLUSION For the future, we recommend that surgeons document their practices to manage biofilm contamination and its consequences both prior to surgery in preoperative discussions with patients and within the operative report. Outcome data collection regarding the quality of outcomes, reoperation, and patient satisfaction will be key to keeping breast implants available for patients. Moreover, it emphasizes that plastic surgeons are committed to solving the relationship between biofilm and BIA-ALCL. Supplementary Material This article contains supplementary material located online at www.aestheticsurgeryjournal.com. Disclosures Dr Jewell is a Consultant for Allergan and New Beauty Magazine; and is an Investigator for TDM Surgical and Cohera. Dr Adams is a Principal for GAAB and Peninsula Partners. Funding The authors received no financial support for the research, authorship, and publication of this article. REFERENCES 1. Adams WPJr, Conner WC, Barton FEJr, Rohrich RJ. Optimizing breast pocket irrigation: an in vitro study and clinical implications. Plast Reconstr Surg . 2000; 105( 1): 334- 8; discussion 339. Google Scholar CrossRef Search ADS PubMed  2. Adams WPJr, Conner WC, Barton FEJr, Rohrich RJ. Optimizing breast-pocket irrigation: the post-betadine era. Plast Reconstr Surg . 2001; 107( 6): 1596- 1601. Google Scholar CrossRef Search ADS PubMed  3. Deva AK, Adams WPJr, Vickery K. The role of bacterial biofilms in device-associated infection. Plast Reconstr Surg . 2013; 132( 5): 1319- 1328. Google Scholar CrossRef Search ADS PubMed  4. Adams WPJr, Culbertson EJ, Deva AK, et al.   Macrotextured breast implants with defined steps to minimize bacterial contamination around the device: experience in 42,000 implants. Plast Reconstr Surg . 2017; 140( 3): 427- 431. Google Scholar CrossRef Search ADS PubMed  5. Adams WPJr. Discussion: Subclinical (biofilm) infection causes capsular contracture in a porcine model following augmentation mammaplasty. Plast Reconstr Surg . 2010; 126( 3): 843- 844. Google Scholar CrossRef Search ADS PubMed  6. Adams WPJr. Discussion: bacterial biofilm infection detected in breast implant-associated anaplastic large-cell lymphoma. Plast Reconstr Surg . 2016; 137( 6): 1670- 1672. Google Scholar CrossRef Search ADS PubMed  7. Adams WPJr. Discussion: breast implant-associated anaplastic large cell lymphoma in Australia and New Zealand: high-surface-area textured implants are associated with increased risk. Plast Reconstr Surg . 2017; 140( 4): 663- 665. Google Scholar CrossRef Search ADS PubMed  8. Adams WPJr, Rios JL, Smith SJ. Enhancing patient outcomes in aesthetic and reconstructive breast surgery using triple antibiotic breast irrigation: six-year prospective clinical study. Plast Reconstr Surg . 2006; 117( 1): 30- 36. Google Scholar PubMed  9. Jacombs A, Allan J, Hu H, et al.   Prevention of biofilm-induced capsular contracture with antibiotic-impregnated mesh in a porcine model. Aesthet Surg J . 2012; 32( 7): 886- 891. Google Scholar CrossRef Search ADS PubMed  10. Blount AL, Martin MD, Lineberry KD, et al.   Capsular contracture rate in a low-risk population after primary augmentation mammaplasty. Aesthet Surg J . 2013; 33( 4): 516- 521. Google Scholar CrossRef Search ADS PubMed  11. Deva AK. Reply: chronic biofilm infection in breast implants is associated with an increased T-cell lymphocytic infiltrate: implications for breast implant-associated lymphoma. Plast Reconstr Surg . 2015; 135( 6): 1059e- 1060e. Google Scholar CrossRef Search ADS PubMed  12. Giordano S, Peltoniemi H, Lilius P, Salmi A. Povidone-iodine combined with antibiotic topical irrigation to reduce capsular contracture in cosmetic breast augmentation: a comparative study. Aesthet Surg J . 2013; 33( 5): 675- 680. Google Scholar CrossRef Search ADS PubMed  13. Hu H, Jacombs A, Vickery K, et al.   Chronic biofilm infection in breast implants is aAssociated with an increased T-cell lymphocytic infiltrate: implications for breast implant-associated lymphoma. Plast Reconstr Surg . 2015; 135( 2): 319- 329. Google Scholar CrossRef Search ADS PubMed  14. Allan JM, Jacombs AS, Hu H, Merten SL, Deva AK. Detection of bacterial biofilm in double capsule surrounding mammary implants: findings in human and porcine breast augmentation. Plast Reconstr Surg . 2012; 129( 3): 578e- 580e. Google Scholar CrossRef Search ADS PubMed  15. Tamboto H, Vickery K, Deva AK. Subclinical (biofilm) infection causes capsular contracture in a porcine model following augmentation mammaplasty. Plast Reconstr Surg . 2010; 126( 3): 835- 842. Google Scholar CrossRef Search ADS PubMed  16. Vickery K, Deva A, Jacombs A, et al.   Presence of biofilm containing viable multiresistant organisms despite terminal cleaning on clinical surfaces in an intensive care unit. J Hosp Infect . 2012; 80( 1): 52- 55. Google Scholar CrossRef Search ADS PubMed  17. Wiener TC. The role of betadine irrigation in breast augmentation. Plast Reconstr Surg . 2007; 119( 1): 12- 5; discussion 16. Google Scholar CrossRef Search ADS PubMed  18. Wiener TC. Relationship of incision choice to capsular contracture. Aesthetic Plast Surg . 2008; 32( 2): 303- 306. Google Scholar CrossRef Search ADS PubMed  19. Hu H, Johani K, Almatroudi A, et al.   Bacterial biofilm infection detected in breast implant-associated anaplastic large-cell lymphoma. Plast Reconstr Surg . 2016; 137( 6): 1659- 1669. Google Scholar CrossRef Search ADS PubMed  20. Kadin ME, Deva A, Xu H, et al.   Biomarkers provide clues to early events in the pathogenesis of breast implant-associated anaplastic large cell lymphoma. Aesthet Surg J . 2016; 36( 7): 773- 781. Google Scholar CrossRef Search ADS PubMed  21. Kadin ME, Morgan J, Xu H, Glicksman CA. CD30+ T cells in late seroma may not be diagnostic of breast implant-associated anaplastic large cell lymphoma. Aesthet Surg J . 2017; 37( 7): 771- 775. Google Scholar CrossRef Search ADS PubMed  22. Ryan MP, Adley CC. The antibiotic susceptibility of water-based bacteria Ralstonia pickettii and Ralstonia insidiosa. J Med Microbiol . 2013; 62( Pt 7): 1025- 1031. Google Scholar CrossRef Search ADS PubMed  23. Allergan: Data on file. 24. Gilmore OJ. A reappraisal of the use of antiseptics in surgical practice. Ann R Coll Surg Engl . 1977; 59( 2): 93- 103. Google Scholar PubMed  25. Parker MC, Ashby EC, Nicholls MW, Dowding CH, Brookes JC. Povidone-iodine bowel irrigation before resection of colorectal carcinoma. Ann R Coll Surg Engl . 1985; 67( 4): 227- 228. Google Scholar PubMed  26. Bigliardi PL, Alsagoff SAL, El-Kafrawi HY, Pyon JK, Wa CTC, Villa MA. Povidone iodine in wound healing: a review of current concepts and practices. Int J Surg . 2017; 44: 260- 268. Google Scholar CrossRef Search ADS PubMed  27. Burkhardt BR. Capsular contracture: hard breasts, soft data. Clin Plast Surg . 1988; 15( 4): 521- 532. Google Scholar PubMed  28. Burkhardt BR, Demas CP. The effect of Siltex texturing and povidone-iodine irrigation on capsular contracture around saline inflatable breast implants. Plast Reconstr Surg . 1994; 93( 1): 123- 8; discussion 129. Google Scholar CrossRef Search ADS PubMed  29. Burkhardt BR, Dempsey PD, Schnur PL, Tofield JJ. Capsular contracture: a prospective study of the effect of local antibacterial agents. Plast Reconstr Surg . 1986; 77( 6): 919- 932. Google Scholar CrossRef Search ADS PubMed  30. Burkhardt BR, Eades E. The effect of Biocell texturing and povidone-iodine irrigation on capsular contracture around saline-inflatable breast implants. Plast Reconstr Surg . 1995; 96( 6): 1317- 1325. Google Scholar CrossRef Search ADS PubMed  31. Wiener TC. Betadine and breast implants: an update. Aesthet Surg J . 2013; 33( 4): 615- 617. Google Scholar CrossRef Search ADS PubMed  32. Wiener TC. Reply, letters to the editor. Plast Reconstr Surg . 2007; 120( 7): 2116. 33. Lineaweaver W, McMorris S, Soucy D, Howard R. Cellular and bacterial toxicities of topical antimicrobials. Plast Reconstr Surg . 1985; 75( 3): 394- 396. Google Scholar CrossRef Search ADS PubMed  34. Rabenberg VS, Ingersoll CD, Sandrey MA, Johnson MT. The bactericidal and cytotoxic effects of antimicrobial wound cleansers. J Athl Train . 2002; 37( 1): 51- 54. Google Scholar PubMed  35. Faddis D, Daniel D, Boyer J. Tissue toxicity of antiseptic solutions. A study of rabbit articular and periarticular tissues. J Trauma . 1977; 17( 12): 895- 897. Google Scholar CrossRef Search ADS PubMed  36. Goldenheim PD. An appraisal of povidone-iodine and wound healing. Postgrad Med J . 1993; 69( Suppl 3): S97- 105. Google Scholar PubMed  37. Vermeulen H, Westerbos SJ, Ubbink DT. Benefit and harm of iodine in wound care: a systematic review. J Hosp Infect . 2010; 76( 3): 191- 199. Google Scholar CrossRef Search ADS PubMed  38. Brandon HJ, Young VL, Jerina KL, Wolf CJ, Adams WPJr, Watson ME. Mechanical analysis of explanted saline-filled breast implants exposed to Betadine pocket irrigation. Aesthet Surg J . 2002; 22( 5): 438- 445. Google Scholar CrossRef Search ADS PubMed  39. Hu H, Sleiman J, Johani K, Vickery K. Hypochlorous acid versus povidone-iodine containing irrigants: which antiseptic is more effective for breast implant pocket irrigation? Aesthet Surg J . 2017. doi: 10.1093/asj/sjx213. 40. Brindle CT, Porter S, Bijlani K, et al.   Preliminary results of the use of a stabilized hypochlorous acid solution in the management of Ralstonia pickettii biofilm on silicone breast implants. Aesthet Surg J . 2017. doi: 10.1093/asj/sjx229. 41. Jewell ML, Jewell JL. A comparison of outcomes involving highly cohesive, form-stable breast implants from two manufacturers in patients undergoing primary breast augmentation. Aesthet Surg J . 2010; 30( 1): 51- 65. Google Scholar CrossRef Search ADS PubMed  42. Tebbetts JB, Adams WP. Five critical decisions in breast augmentation using five measurements in 5 minutes: the high five decision support process. Plast Reconstr Surg . 2005; 116( 7): 2005- 2016. Google Scholar PubMed  © 2018 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Aesthetic Surgery Journal Oxford University Press

Betadine and Breast Implants

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Abstract

Abstract 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. 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]). Formerly, in 2000, there were concerns by the FDA that PI would degrade the silicone elastomer shell. In response to this, Adams developed a non-Betadine containing triple antibiotic solution (NB-TAB) (50,000 units bacitracin, 1 gm cefazolin, 80 mg gentamicin, 500 cc NS) as an alternative to the same authors original recommendation for Betadine Triple Antibiotic (Betadine-Triple) (50 cc Betadine solution, 50,000 units bacitracin, 1 g cefazolin, 80 mg gentamycin, 500 cc normal saline) or 50-50% Betadine solution and normal saline.1,2 With the recent change in DFU, the use of Betadine is once again permitted. We believe that 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 when utilizing breast implants and tissue expanders. Bacterial Contamination Risks All implanted devices are at risk for bacterial contamination.3 Bacterial surface contamination of implants (smooth and textured surfaces) has been implicated as a cause of infection, capsular contracture, double capsules, and late-term breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).3-18 Gram-positive organisms have been linked to capsular contracture and gram-negative R picketti to BIA-ALCL.6,19-21R picketti is resistant to aminoglycoside antibiotics, but susceptible to at least a 50% solution of PI.22,23 Methods to Reduce Capsular Contracture The concept of iodine as an antibacterial agent has existed for 150 years.24-26 There have not been reports of acquired resistance or cross-resistance to iodine.26 Iodine appears to have excellent efficacy as a biofilm-mitigation agent. The iodine inhibits vital bacterial structures and enzyme systems.26 Iodine has a broader range of antibacterial effect than antibiotics. Moreover, with iodine, there is an ideal spectrum effect for gram-positive and gram-negative organisms. PI is universally available and inexpensive, and it is ideal for applications such as breast implants and tissue expander surgery pocket irrigation. Credit must be given to Boyd Burkhart, MD, for describing in the 1980s the use of implant pocket irrigation with Betadine (PI) to reduce capsular contracture.27-30 Other investigators have found similar benefits.17,18 While these were not large-scale controlled studies, evidence regarding the benefit of pocket irrigation with PI was established. The senior author’s (M.L.J.) personal experience with this approach throughout his use of breast implants to the present (40 years) reveals zero perioperative infection incidence in primary breast augmentation patients and a low long-term capsular contracture incidence of <2.5%. Similarly, the combined experience of 8 surgeons who reviewed their experience with a comprehensive approach for 14 Point Plan biofilm mitigation (Betadine-Triple, NB-TAB, or at least a 50% solution of PI) in macrotextured implants demonstrated zero incidence of BIA-ALCL with a mean follow-up of 11.5 year in 22,000 patients.4 Credit also must be given to Thomas Wiener, MD, for being a tireless advocate of the use of Betadine (PI) to reduce capsular contracture.17-18,31-32 Despite numerous communications with the US FDA by Dr. Wiener circa 2005, the restriction on the use of Betadine and breast implants continued for another 12 years.31 While the use of PI as an antibacterial to reduce capsular contracture is nothing new, it has found use as a simple, cost-effective solution to manage surface contamination with both gram-positive and gram-negative organisms, including R picketti in both smooth and textured surface implants and expanders. It can be utilized as an irrigation solution or as a lubricant (gel formulation). PI is supplied in small bottles that are packaged in sterile surgical skin prep kits (solution, gel, or scrub). We believe that this approach of a one-time use of pre-packaged sterile PI is safer than decanting PI onto the surgical field from a bottle that has been opened multiple times. For PI to be effective, the concentration should be a 50% concentration in an irrigation solution.23 Full-strength PI in one report has been shown to inhibit 100% of fibroblasts in vitro.33 While some in vitro studies have suggested that PI may have a measure of cytotoxic effect, no consistent deleterious effects on various measures of wound healing have been demonstrated in in vivo studies, particularly at lower PI concentrations. PI showed gram-positive and gram-negative activity without fibroblast inhibition.34 To lower the PI concentration, surgeons have utilized PI-triple antibiotic (Betadine Triple Antibiotic) and Non-PI-Triple Antibiotic. These irrigations have been shown to lower capsular contracture tenfold.8,10,12 Concerns have been raised regarding the potential toxicity and negative wound-healing effects of PI-detergent formulation involving rabbit articular tissue.35 Data from other studies, pertaining to chronic wounds, do not show deleterious effects on wound healing.36,37 There has not been a definite study that has demonstrated that PI produces a negative clinical outcome with breast implants or tissue expanders. With breast implants and tissue expanders, PI is utilized as a one-time pocket irrigation rather than being chronically utilized in wound-management scenarios. Given the improved gram-negative coverage for R picketti with PI-containing irrigations, our preference is to utilize PI-TAB or a 50-50% mixture of PI in normal saline. PI appears effective in penetrating existing biofilms.26 PI should never be utilized within the lumen of saline-filled breast implants or tissue expanders, because it may produce delamination of the implant shell.38 There is no published data regarding how pocket irrigation with PI affects tissue integration with alloplastic soft tissue support materials. Stabilized hypochlorous acid is being studied as an antibacterial irrigation and biofilm-mitigation agent. PI has been shown to be superior to 0.025% hypochlorous acid (PhaseOne, Integrated Healing Technologies, Franklin, TN, USA, “HOCl”) for the inhibition and eradication of Staphylococcus aureus biofilm in an in vitro study.39 The authors theorized that the presence of blood or protein apparently reduced the effectiveness of HOCl. A second study by Brindle et al40 demonstrated that HOCl had excellent efficacy against planktotic and biofilm bacteria, including R picketti. We believe that the strategy of utilizing antibacterial agents for biofilm mitigation is an integral part of a contemporary approach for breast augmentation along with the other actionable steps that are outlined in The 14 Point Plan (Table 1). These steps are beneficial in reducing the risk of surgical infection, capsular contracture, and BIA-ALCL. Outcome data so far indicate that antibiotics/antibacterial agents 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 to enhance the quality of breast implant outcomes and reduce the rate of reoperation. Table 1. Surgical 14-Point Plan for Breast Implant Placement (reprinted with Permission from Wolters Kluwer Health, Inc.4) 1. Use intravenous antibiotic prophylaxis at the time of anesthetic induction  2. Avoid periareolar/transaxillary incisions; these have been shown in both laboratory and clinical studies to lead to a higher rate of contracture  3. Use nipple shields to prevent spillage of bacteria into the pocket  4. Perform careful atraumatic dissection to minimize devascularized tissue  5. Perform careful prospective hemostasis  6. Avoid dissection into the breast parenchyma  7. The use of a dual-plane pocket  8. Perform pocket irrigation with triple antibiotic solutions or Betadine (povidone-iodine [PI] solution) i. Perform entire pocket irrigation with precisely mixed PI-TAB solution or 50% (1:1 dilution) or stronger Betadine. Completely envelop the pocket, prep the skin around the incision, and preemptively dip and clean any instruments used in the pocket in the solution. ii. Do not use single-agent antibiotic (Cefazolin) irrigation or Bacitracin irrigation, because they do not work effectively (incomplete coverage spectrum) iii. Recommended irrigation (see Appendix A)  9. Take steps to minimize skin-implant contamination. There are multiple methods to minimize skin contamination including: i. Adequate incision size ii. Re-prep skin with antibiotic solution or skin prep iii. Skin barrier (eg, Tegaderm) iv. Use of an insertion sleeve  10. Minimize implant open time and replacement of implant or sizers  11. Change surgical gloves prior to handling and use new or cleaned instruments and drapes  12. Avoid utilizing a drainage tube, which can be a potential site of entry for bacteria  13. Use a layered closure  14. Use antibiotic prophylaxis to cover subsequent procedures that breach skin or mucosa  1. Use intravenous antibiotic prophylaxis at the time of anesthetic induction  2. Avoid periareolar/transaxillary incisions; these have been shown in both laboratory and clinical studies to lead to a higher rate of contracture  3. Use nipple shields to prevent spillage of bacteria into the pocket  4. Perform careful atraumatic dissection to minimize devascularized tissue  5. Perform careful prospective hemostasis  6. Avoid dissection into the breast parenchyma  7. The use of a dual-plane pocket  8. Perform pocket irrigation with triple antibiotic solutions or Betadine (povidone-iodine [PI] solution) i. Perform entire pocket irrigation with precisely mixed PI-TAB solution or 50% (1:1 dilution) or stronger Betadine. Completely envelop the pocket, prep the skin around the incision, and preemptively dip and clean any instruments used in the pocket in the solution. ii. Do not use single-agent antibiotic (Cefazolin) irrigation or Bacitracin irrigation, because they do not work effectively (incomplete coverage spectrum) iii. Recommended irrigation (see Appendix A)  9. Take steps to minimize skin-implant contamination. There are multiple methods to minimize skin contamination including: i. Adequate incision size ii. Re-prep skin with antibiotic solution or skin prep iii. Skin barrier (eg, Tegaderm) iv. Use of an insertion sleeve  10. Minimize implant open time and replacement of implant or sizers  11. Change surgical gloves prior to handling and use new or cleaned instruments and drapes  12. Avoid utilizing a drainage tube, which can be a potential site of entry for bacteria  13. Use a layered closure  14. Use antibiotic prophylaxis to cover subsequent procedures that breach skin or mucosa  View Large Table 1. Surgical 14-Point Plan for Breast Implant Placement (reprinted with Permission from Wolters Kluwer Health, Inc.4) 1. Use intravenous antibiotic prophylaxis at the time of anesthetic induction  2. Avoid periareolar/transaxillary incisions; these have been shown in both laboratory and clinical studies to lead to a higher rate of contracture  3. Use nipple shields to prevent spillage of bacteria into the pocket  4. Perform careful atraumatic dissection to minimize devascularized tissue  5. Perform careful prospective hemostasis  6. Avoid dissection into the breast parenchyma  7. The use of a dual-plane pocket  8. Perform pocket irrigation with triple antibiotic solutions or Betadine (povidone-iodine [PI] solution) i. Perform entire pocket irrigation with precisely mixed PI-TAB solution or 50% (1:1 dilution) or stronger Betadine. Completely envelop the pocket, prep the skin around the incision, and preemptively dip and clean any instruments used in the pocket in the solution. ii. Do not use single-agent antibiotic (Cefazolin) irrigation or Bacitracin irrigation, because they do not work effectively (incomplete coverage spectrum) iii. Recommended irrigation (see Appendix A)  9. Take steps to minimize skin-implant contamination. There are multiple methods to minimize skin contamination including: i. Adequate incision size ii. Re-prep skin with antibiotic solution or skin prep iii. Skin barrier (eg, Tegaderm) iv. Use of an insertion sleeve  10. Minimize implant open time and replacement of implant or sizers  11. Change surgical gloves prior to handling and use new or cleaned instruments and drapes  12. Avoid utilizing a drainage tube, which can be a potential site of entry for bacteria  13. Use a layered closure  14. Use antibiotic prophylaxis to cover subsequent procedures that breach skin or mucosa  1. Use intravenous antibiotic prophylaxis at the time of anesthetic induction  2. Avoid periareolar/transaxillary incisions; these have been shown in both laboratory and clinical studies to lead to a higher rate of contracture  3. Use nipple shields to prevent spillage of bacteria into the pocket  4. Perform careful atraumatic dissection to minimize devascularized tissue  5. Perform careful prospective hemostasis  6. Avoid dissection into the breast parenchyma  7. The use of a dual-plane pocket  8. Perform pocket irrigation with triple antibiotic solutions or Betadine (povidone-iodine [PI] solution) i. Perform entire pocket irrigation with precisely mixed PI-TAB solution or 50% (1:1 dilution) or stronger Betadine. Completely envelop the pocket, prep the skin around the incision, and preemptively dip and clean any instruments used in the pocket in the solution. ii. Do not use single-agent antibiotic (Cefazolin) irrigation or Bacitracin irrigation, because they do not work effectively (incomplete coverage spectrum) iii. Recommended irrigation (see Appendix A)  9. Take steps to minimize skin-implant contamination. There are multiple methods to minimize skin contamination including: i. Adequate incision size ii. Re-prep skin with antibiotic solution or skin prep iii. Skin barrier (eg, Tegaderm) iv. Use of an insertion sleeve  10. Minimize implant open time and replacement of implant or sizers  11. Change surgical gloves prior to handling and use new or cleaned instruments and drapes  12. Avoid utilizing a drainage tube, which can be a potential site of entry for bacteria  13. Use a layered closure  14. Use antibiotic prophylaxis to cover subsequent procedures that breach skin or mucosa  View Large The 14 Point Plan is compatible with process engineering methods such as the Toyota Production System and Lean Manufacturing as applied to breast augmentation, in which quality improvement is continuous and work is described as a series of interconnected steps.41 A previous study by Tebbetts and Adams42 described the process of breast augmentation as a series of connected events rather than just a single surgical procedure. Credit must be given to Dr. Adams for describing the four sequential steps that optimize the surgical outcomes. The process of breast augmentation is comprised literally of hundreds of steps. CONCLUSION For the future, we recommend that surgeons document their practices to manage biofilm contamination and its consequences both prior to surgery in preoperative discussions with patients and within the operative report. Outcome data collection regarding the quality of outcomes, reoperation, and patient satisfaction will be key to keeping breast implants available for patients. Moreover, it emphasizes that plastic surgeons are committed to solving the relationship between biofilm and BIA-ALCL. Supplementary Material This article contains supplementary material located online at www.aestheticsurgeryjournal.com. Disclosures Dr Jewell is a Consultant for Allergan and New Beauty Magazine; and is an Investigator for TDM Surgical and Cohera. Dr Adams is a Principal for GAAB and Peninsula Partners. Funding The authors received no financial support for the research, authorship, and publication of this article. REFERENCES 1. Adams WPJr, Conner WC, Barton FEJr, Rohrich RJ. 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A comparison of outcomes involving highly cohesive, form-stable breast implants from two manufacturers in patients undergoing primary breast augmentation. Aesthet Surg J . 2010; 30( 1): 51- 65. Google Scholar CrossRef Search ADS PubMed  42. Tebbetts JB, Adams WP. Five critical decisions in breast augmentation using five measurements in 5 minutes: the high five decision support process. Plast Reconstr Surg . 2005; 116( 7): 2005- 2016. Google Scholar PubMed  © 2018 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices)

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Aesthetic Surgery JournalOxford University Press

Published: Feb 14, 2018

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