Surgical Best Practices: 14-Point Plan

Transcription

1 Surgical Best Practices: 14-Point Plan William P. Adams, Jr., MD & Anand K. Deva, MBBS (Hons), MS BIA-ALCL Frequently Asked Questions Sientra Medical Affairs

2 SURGICAL BEST PRACTICES: 14-POINT PLAN William P. Adams, Jr., MD and Anand K. Deva, MBBS (Hons), MS Introduction The 14-Point Plan aims to reduce the number of bacteria present at the time of breast implant placement, thereby reducing the risk of associated infection. 1 Each of these steps outlined below is backed by evidence and cumulatively have been shown to reduce the risk of capsular contracture in patients following breast implant surgery. During breast implant placement, if bacteria attach to the surface of an implant and create a biofilm over time, the biofilm becomes almost impossible to remove. If the bacterial biofilm load reaches a certain threshold it can lead to chronic inflammation and known sequelae, including infection, capsular contracture, double capsule, and breast implant-associated ALCL (BIA-ALCL). 1, 2 We have performed extensive bench and clinical studies on this topic and are committed to educating plastic surgeons on proven steps that have been shown to reduce the bacterial biofilm load. 1 These simple steps have been shown to decrease the risk of developing capsular contracture ten-fold. 3-5 Additionally, a wealth of evidence has demonstrated a link between chronic inflammation from bacterial biofilm in the pathogenesis of BIA-ALCL, especially in textured devices where the increased surface area can result in an increased amount of bacterial biofilm. 2 A meticulous procedure will help minimize the known and likely sequelae of bacterial attachment including infection and chronic biofilm, which is implicated in the pathogenesis of both capsular contracture and BIA-ALCL. 14-Point Plan Translating sound research into clinical practice results in improved outcomes for our patients by reducing post-operative complications and the need for revision surgery. These technique-focused recommendations help minimize bacterial attachment at multiple points during the operation. 1 Use intravenous antibiotic prophylaxis at the time of anesthetic induction. It is recommended to use a cephalosporin antibiotic that specifically targets S. epidermidis. 6 Many surgeons advocate for the use of vancomycin to target methicillin-resistant S. epidermidis. 2 When possible use inframammary incisions shown in both laboratory and clinical studies to lead to a decreased rate of capsular contracture. 7-9 Periareolar and transaxillary incisions cross ductal tissue and sweat glands that are known to harbor bacteria. 3 Use nipple shields to cover the nipples and prevent spillage of bacteria onto the skin during the procedure as this can lead to bacterial contamination of the breast implant pocket Perform careful atraumatic dissection to minimize devascularized tissue. 1 Electrocautery is recommended to develop a precise plane and assist with careful and atraumatic dissection.

3 5 Perform careful prospective hemostasis. 1,12 6 Avoid dissection into the breast parenchyma. 8 7 The use of a submuscular and/or dual-plane pocket has significant anatomic advantages because both techniques do not enter the breast parenchyma. 1 This minimizes contact of the breast implant with bacteria in the breast ducts, thereby decreasing the risk of infection and chronic inflammation from bacterial biofilm. These techniques have been shown to decrease the rate of capsular contracture Perform irrigation of the entire breast implant pocket with precisely mixed triple antibiotic solution or 3, 16 50% (1:1 dilution) or stronger betadine (povidone-iodine) solution. The entire surgical field should be adequately cleaned with an antibiotic solution, including: Prep the skin around the incision, clean the entire breast implant pocket and all instruments that are introduced into the breast implant pocket with the antibiotic solution. Do not use single agent cefazolin irrigation or bacitracin irrigation because they do not work 14, 16 effectively against all bacteria. Recommended irrigations: 3, 14, 16 Triple Antibiotic Betadine Irrigation Triple Antibiotic Non-Betadine Irrigation Betadine Irrigation 50cc betadine, 1g cefazolin, 80mg gentamicin, 500cc normal saline 150cc per pocket, no active evacuation 50K units bacitracin, 1g cefazolin, 80mg gentamicin, 500cc normal saline 150cc per pocket, 5 minute contact time, no active evacuation 50% (1:1) or greater strength (out of bottle = 100%) Only dilute with no more than equal volume of saline 9 Take steps to minimize skin-to-implant contact, 1,15 including: Adequate incision size Re-prep skin with antibiotic solution or skin prep (eg, chlorhexidine) Skin barrier Use of a sleeve 10 Minimize the time of implant opening, repositioning and replacement of implant or sizers. 1 Leave the implant covered in the thermoplastic container until immediately prior to insertion. The tyvek cover can be slightly peeled back to introduce some antibiotic solution to bathe the implant while it is still covered. When possible avoid sizers and implant removal/replacement. Both passively increase potential bacterial contamination.

4 11 Change surgical gloves prior to handling the implant and clean all instruments with antibiotic solution or use new instruments that will come into contact with the breast implant. 1 This helps reduce any possible transfer of bacteria from the skin to the breast implant. Only one person should handle the implant and the surgeon s fingers should be dipped in antibiotic solution for skin re-draping maneuvers. 12 Avoid use of a drainage tube for primary augmentation; in revision and reconstruction cases, use proper technique when a drain is necessary Use a layered closure. 1,6 This protects the breast implant from bacterial access via the surgical wound during the early healing process. 14 Recommend that your patients, who have undergone breast surgery, take antibiotic prophylaxis prior to procedures that breach skin or mucosa (i.e. tattoos, piercings, and dental procedures). 1 This will help prevent the small risk of bacteremia that could lead to breast complications including infection and capsular contracture. Conclusion This paper provides a concise review of the 14-Point Plan with the aim of bringing awareness to surgeons regarding how to minimize bacteria at key points of breast implant surgery. The adoption of these standardized steps by you and your operative team is the key to optimizing their overall effectiveness. For more information on the 14-Point Plan and supporting evidence, please go to We encourage you to take the pledge to support the use of best evidence to reduce the bacterial contamination of breast implants. By incorporating these simple steps, it has been demonstrated that you will achieve improved surgical outcomes and a reduction in complications and reoperations. Sientra continues to drive peer-to-peer education of evidence-based medicine in order to achieve the safest outcomes for patients. References 1 Deva, A. K., Adams, W. P., Jr., & Vickery, K. (2013). The role of bacterial biofilms in device-associated infection. Plast Reconstr Surg, 132(5), doi: /prs.0b013e3182a3c105 2 Hu, H., Jacombs, A., Vickery, K., Merten, S. L., Pennington, D. G., & Deva, A. K. (2015). Chronic biofilm infection in breast implants is associated with an increased T-cell lymphocytic infiltrate: implications for breast implant-associated lymphoma. Plast Reconstr Surg, 135(2), doi: /prs Adams, W. P., Jr., Rios, J. L., & Smith, S. J. (2006). Enhancing patient outcomes in aesthetic and reconstructive breast surgery using triple antibiotic breast irrigation: six-year prospective clinical study. Plast Reconstr Surg, 117(1), Blount, A. L., Martin, M. D., Lineberry, K. D., Kettaneh, N., & Alfonso, D. R. (2013). Capsular contracture rate in a low-risk population after primary augmentation mammaplasty. Aesthet Surg J, 33(4), doi: / x Giordano, S., Peltoniemi, H., Lilius, P., & Salmi, A. (2013). Povidone-iodine combined with antibiotic topical irrigation to reduce capsular contracture in cosmetic breast augmentation: a comparative study. Aesthet Surg J, 33(5), doi: / x Paek, L. S., Giot, J. P., Tétreault-Paquin, J. O., St-Jacques, S., Nelea, M., & Danino, M. A. (2015). The impact of postoperative expansion initiation timing on breast expander capsular characteristics: a prospective combined clinical and scanning electron microscopy study. Plast Reconstr Surg, 135(4), Bartsich, S., Ascherman, J.A., Whittier, S., Yao, C.A., & Rohde, C. (2011). The breast: a clean-contaminated surgical site. Aesthet Surg J, 31(7): Wiener, T.C. (2008). Relationship of incision choice to capsular contracture. Aesthet Plast Surg, 32(2): Wiener, T.C. (2012). Minimizing capsular contracture in a clean-contaminated site. Aesthet Surg J, 32: ; author reply, Wixtrom, R.N., Stutman, R.L., Burke, R.M., Mahoney, A.K., & Codner, M.A. (2012). Risk of breast implant bacterial contamination from endogenous breast flora, prevention with nipple shields, and implications for biofilm formation. Aesthet Surg J, 32(8): Collis, N., Mirza, S., Stanley, P. R. W., Campbell, L., & Sharpe, D. T. (1999). Reduction of potential contamination of breast implants by the use of nipple shields. Br J Surg, 52(6), Maxwell, G. P., Scheflan, M., Spear, S., Nava, M. B., & Hedén, P. (2014). Benefits and limitations of macrotextured breast implants and consensus recommendations for optimizing their effectiveness. Aesthet Surg J, 34(6), Stevens, W. G., Calobrace, M. B., Harrington, J., Alizadeh, K., Zeidler, K. R., & d Incelli, R. C. (2016). Nine-Year Core Study Data for Sientra s FDA-Approved Round and Shaped Implants with High-Strength Cohesive Silicone Gel. Aesthet Surg J, 36(4), Adams, W. P., Jr., Conner, W. C., Barton, F. E., Jr., & Rohrich, R. J. (2000). Optimizing breast pocket irrigation: an in vitro study and clinical implications. Plast Reconstr Surg, 105(1), ; discussion Tebbetts, J. B. (2006). Achieving a zero percent reoperation rate at 3 years in a 50-consecutive-case augmentation mammaplasty premarket approval study. Plast Reconstr Surg, 118(6), Adams, W. P., Jr., Conner, W. C., Barton, F. E., Jr., & Rohrich, R. J. (2001). Optimizing breast-pocket irrigation: the post-betadine era. Plast Reconstr Surg, 107(6),

5 Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Frequently Asked Questions

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7 Summary BIA-ALCL is a condition that Sientra takes very seriously and has spent a tremendous amount of time investigating. Sientra continues to support all medical research, education and FDA initiatives to better understand BIA-ALCL and to provide women with the highest quality and safest implant options. For any questions, please contact your Plastic Surgery Consultant or Sientra at Important Information Sources ASAPS: ASPS: FDA: Recent Key BIA-ALCL Literature Understanding Rare Adverse Sequelae of Breast Implants: ALCL, Late Seromas, and Double Capsules (Clemens, et al; Gland Surg 2016): NCCN Consensus Guidelines for the Diagnosis and Management of BIA-ALCL (Clemens, et al; ASJ 2017): Bacterial Biofilm Infection Detected in BIA-ALCL (Hu, et al; PRS 2016): Biomarkers Provide Clues to Early Events in the Pathogenesis of BIA-ALCL (Kadin, et al; ASJ 2016): Understanding the Etiology and Prevention of Capsular Contracture: Translating Science into Practice (Chong, et al; Clin Plast Surg 2015): For questions from patients due to media pieces, the following report may be provided for more balanced and easier to understand information: Information for women regarding this potential risk is included in the Sientra Patient Informed Decision Brochure: Thompson PA, et al. Breast implant-associated anaplastic large cell lymphoma: a systematic review of the literature and mini-meta analysis. Curr Hematol Malig Rep. 2013; 8(3): Benjamin K, et al. Breast implant-associated anaplastic large cell lymphoma: updated results from a structured expert consultation process. Plast Reconstr Surg Glob Open. 2015; 3(1): e Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) FDA. US Food and Drug Administration. Web. 29 Mar Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) FDA. US Food and Drug Administration. Web. 29 Mar ASPS-ASAPS Update-BIA-ALCL Summary and Quick Facts ASPS. American Society of Plastic Surgeons. Web. 29 Mar Clemens MW, et al. NCCN consensus guidelines for the diagnosis and management of breast implant-associated anaplastic large cell lymphoma. Aesthet Surg J. 2017; 37 (3): Brody, GS, et al. Anaplastic large cell lymphoma occurring in women with breast implants: Analysis of 173 cases. Plast Reconstr Surg. 2015; 135(3); plastic surgery statistics report ASPS. American Society of Plastic Surgeons. Web. 29 Mar Feuer EJ, et al. The lifetime risk of developing breast cancer. J Natl Cancer Inst. 1993; 85(11): Carlson, RW Surveillance of patients following primary therapy In Diseases of the Breast, 5th edition (pp ). Philadelphia, PA: Lippincott Williams and Wilkins. 11 Stevens WG, et al. Nine-year Core study data for Sientra's FDA-approved round and shaped implants with high-strength Cohesive Silicone Gel. Aesthet Surg J. 2016; 36 (4): Clemens, MW. "Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL): by the numbers, and what they mean". ASPS. American Society of Plastic Surgeons Web. 29 Mar Joint ASPS & ASAPS statement on breast implant-associated ALCL ASPS/ASAPS. American Society of Plastic Surgeons/American Society of Aesthetic Plastic Surgeons. Web. 29 Mar Clemens MW, et al. Understanding rare adverse sequelae of breast implants: anaplastic large-cell lymphoma, late seromas, and double capsules. Gland Surg. 2016; "Member FAQs. Latest information on ALCL." ASAPS. American Society of Aesthetic Plastic Surgeons. Web. 29 Mar ASPS/ASAPS Update Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Quick Facts and FAQs ASPS/ASAPS. American Society of Plastic Surgeons/American Society of Aesthetic Plastic Surgeons. Web. 29 Mar Stevens WG, et al. Risk factor analysis for capsular contracture: a 5-year Sientra study analysis using round, smooth, and textured implants for breast augmentation. Plast Reconstr Surg. 2013; 132(5): Haws M, et al. "Sientra primary and revision augmentation rupture trending and analysis with magnetic resonance imaging. Aesthet Surg J. 2015: 35(S1): S33-S Schwartz, MR. Algorithm and techniques for using Sientra s silicone gel shaped implants in primary and revision breast augmentation. Plast Reconstr Surg. 2014: 134(S1): 18S-27S. 20 Hu H, et al. Bacterial biofilm infection detected in breast implant-associated anaplastic large-cell lymphoma. Plast Reconstr Surg. 2016; 137(6): Jacombs A, et al. In vitro and in vivo investigation of the influence of implant surface on the formation of bacterial biofilm in mammary implants. Plast Reconstr Surg. 2014; 133(4): 471e-480e. 22 FDA Advises Women With Breast Implants FDA. US Food and Drug Administration. Web. 29 Mar EXT-0029 R1