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Calcium sulphate vaco cap talk

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Rex Moulton-Barrett, MD
Rex Moulton-Barrett, MD

New method to treat capsular contractures of the Breast using a combination of capulotomy, capsulectomy with placement of calcium sulphate beads containing vancomycin and review of causes and treatments of capsular contracture with a critical review of the biofilm theory and how to utilize our knowledge of biofilms to prevent reformation of capsular contractures

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Vancomycin Calcium Sulphate Beads in the Prevention of Recurrent Capsular Contracture of The Breast - A Pilot Study Olivia Jackson B. Sc., U C Davis & Rex Moulton-Barrett, MD, FACS Plastic & Reconstructive Surgery, Alameda, California
Are the previous concepts on prevention, causation & treatment of capsular contractures: evidence based or medical fashion ?
U.S. Breast Implantation Statistics 2016U.S. Breast Implantation Statistics 2016 ASPS 2016 Plastic Surgery StatisticsASPS 2016 Plastic Surgery Statistics 290,567 Augmentations: no. 1 cosmetic surgery290,567 Augmentations: no. 1 cosmetic surgery 89,000/109,256 (89,000/109,256 ( 81%81% ) Breast Reconstructions) Breast Reconstructions 2011-20162011-2016 rate increaserate increase by +/-by +/- 3% / yr3% / yr 28,467 (28,467 ( 10%10% ) Augmentation) Augmentation implantsimplants removedremoved
Relevance of Capsular ContractureRelevance of Capsular Contracture After Breast AugmentationAfter Breast Augmentation The most common complication & reason for removal / reoperation >10 x more common than explantation for acute infection / extrusion Incidence after Breast Augmentation 3-29%: >= to Grade III +/-r II Headon, Kasem & Mokbel, 2015: Overall incidence 10.6%
Definition of Capsular ContractureDefinition of Capsular Contracture Baker Classification, 1976: Breast Augmentation I- Natural II- Minimal: palpable firmness noticed by surgeon only III- Moderate: Firmness noticed by patient IV- Severe: Obvious distortion of breast shape Spear and Baker, 1995: Prosthetic Breast Reconstruction Ia- Natural Ib- soft detectable by physical examination only II- mildly firm by examination, may be visibly detectable III- moderately firm, readily detectable visually, may be acceptable IV- severe, symptomatic, unacceptable esthetically, needs surgery
1. Older patient vrs young 2. Smooth vrs textured 3. Silicone elastomer vrs polyurethane shell 4. Subglandular vrs submuscular 5. Silicone vrs saline 6. Previous XRT vrs no XRT 7. Implantation < 6 -12 months after pregnancy / breast feeding 8. Incision: transglandular: mastopexy>periareola>= transaxillary vrs inframammary incision 9. Touch technique vrs no touch technique +/- nipple shields 10. Talc / Lap packing vrs talc-free gloves & no packing 11. No irrigation triple antibiotic +/- betadine 5-10% 12. Delayed replacement: deflated saline / ruptured silicone implant 13. Blood / hematoma in pocket vrs dry pocket dissection +/ -drain 14. No IV antibiotics vrs IV Vancomycin & Ancef +/-orals Clinical Factors Associated With Capsular Contractures after Primary Augmentation ( no randomized, controlled, blinded studies to date )
1. The Same Factors as for Primary Augmentation 2. Replacement of implant in the same pocket vrs neo-pocket 3. Neo-pocket adjacent vrs change to trans-pectoral : sub-muscular sub-glandular 4. Capsulotomy vrs sub total / total capsulectomy 5. No prolonged vrs prolonged oral antibiotics 6. No ADM vrs ADM grafting 7. Replace with same implant vrs new implant 8. No steroid injection vrs injection into the capsular bed 9. No BoTox injection vrs injection into the capsular bed 10. No fat grafting vrs peri-capsular fat grafting & capsulotomy 11. Prior reconstructive implantation vrs esthetic augmentation Clinical Factors Associated With Recurrent Capsular Contractures ( no randomized, controlled, blinded studies to date )
Incidence of Recurrent Capsular Contracture (CC)Incidence of Recurrent Capsular Contracture (CC) Wan & Rohrich, 2016 PRS: 137:826-841Wan & Rohrich, 2016 PRS: 137:826-841.. Incidence of recurrent CC % 24/461 articles up to 4/2015: 0-54% Capsulotomy vrs Capsulectomy conflicting data Partial vrs total Capsulectomy conflicting data Site change Neo +/- Trans Muscle 0-12 % vrs no site change: 0-54% Implant Exchange 0-26% vrs same implant 33-54% vrs No ADM 6 articles using ADM 0-2.6% +site change 3/6: 50% 0% + no site change 1/6: 16%
1. Early massage and superior compression 2. Closed capsulotomy- Dan Baker 1975: 75% resolution at 2 yrs 3. Ultrasound / Aspen randomized clinical study 2017-2018 4. Low Dose Laser randomized study: conclusions not helpful 5. Medication: Accolate Zafirlukast: leukotrine receptor antagonist: check LFTs Singulair Montelukast: minimal results at most Tamoxifen Myofibroblast: Block Er - receptors 鏝 Post Operative Factors: Prevention & / 0r Treatment of Capsular Contractures
Peri-Prosthetic Inflammation Fibroblast transient immortalization loss p53 senescence Macrophages TGF- 硫 Myofibroblasts: estrogen receptors ( Er - , 1/ )硫 stimulated by mechanical stress / tension Fibroblast collagen parallel layering texturing reduces Bacterial Colonization Bacterial Colonization also without capsular contracture Bacterial Biofilms - also without capsular contracture Multifactorial Pathophysiological Causes of Capsular Contractures
Implant Colonization with bacteria: Staphylococcus epidermidis 56%with CC vrs 18% with no CC Virden, et al, 1992. Aesthetic Plast Surg 16:173-179 Endogenous Bacterial Flora Cultured from Breast Tissue: Benign: not the same as skin flora & also different from malignancy (Bacillus>Acinetobacter,>Enterbacteriaeae>Pseudomonas,>Staphlococcus>Proprionibact) Malignant: Fusobacterium, Atopbium,Gluconacterobacter, Hydrogenophaga Lactobacillus Early Acute Infection: Staphloccus aureus, streptococcus, gram-negatives Late infection: Coagulase negative staph., Propionibacterium spp. Biofilm Producing bacteria from the capsule Propionbacterium acnes Staphylococcus epidermidis: 80% oxacillin resistant Bacteria cultured from textured implants associated with ALCL Ralstonia spp: in the water reservoirs Capsular Contracture and Bacterial Colonization
65 - 80% of human infections associated with biofilms 5 stages of a Biofilm Composition of Biofilms < = 97% water 2% microbial cells 2% Extracel Polymeric Substances ie protein enzymes 1-2% Polysaccharides adhesion + immune barrier 1-2% DNA / RNA Calcium Sulphate Beads with Vancomycin planktonic eradicate MRSA and Staph epidermidis biofilm formation prevention mature biofilm may reduce Biofilm of IV Staph Aureus requires a 4 X increase in antibiotic MIC (50) Rough surfaces and or foreign bodies are more susceptible to biofilms Nutrient / O2 / waste dormancy = reduced antibiotic susceptibility Relevance of Biofilms in Medicine
PMMA filler / beads: do not dissolve & beads need to be removed high levels of antibiotics 2-3 days surface area diffusion prolonged release below MIC may support biofilms Bioceramic Beads: dissolve and beads do not need to be removed Calcium Phosphate: Monocalcium: mono or anhydrous Dibasic calcium: anhydrous, hemihydrous Tricalcium: simple, and 硫 Hydroxyapatite: & calcium deficient Biphasic Tricalcium Tetracalcium Octacalcium Calcium Sulphate Anhydrous = anhydrate Dehydrate = gypsum = Plaster of Paris Hemihydrate: and 硫 Antibiotic Beads in Medicine
Calcium Sulphate: used since 1892, initially used as a bone graft gypsum: impure, acidic, inflammatory ( self limiting synovitis and post-op drainage ) hemihydrate with water exothermic reaction hemihydrate dissolves in 3-6 weeks soft tissue Medical Grade alpha hemi-hydrate 1997: Prevention & treatment osteomyelitis Preventive & treatment of infection in joint replacement Treatment of prosthetic vascular graft infections Deep diabetic foot infections Deep neck infections adjacent to the carotid artery Calcium Phosphate: longer resorption time 1 / water solubility resorption may be 6 months to 10 years can be made into a strong cement Polyphasic Ceramics: + Potassium Sulphate short & longer release Use of Antibiotic Bioceramics in Medicine
Commercially Available Antibiotic Beads Kits of Calcium Sulphate Hemi- Hydrate 3mm 4.8mm OsteoSet ( Wright Medical ) Gypsum derived: less hydrophilic 510(k) 2001: bone void filler 2 size beads 3, 4.8mm No 510(k) for + antibiotics 5ml rapid 5 min and 20 minute cure $1,100 Stimulan ( Biocomposites ) synthetic: hydrophilic mix 510(k) 2015: bone void filler 3 size beads 3, 4.8, 6mm No 510(k) for + antibiotics 5ml rapid 4 min and 12ml 8 min cures $1,000
1. 12mls of OsteoSet powder to bowl from kit 1.Add 500mg Vancomycin powder to the bowl 2. Add diluent from small bottle in kit, makes 5mls in total 3.Alow to sit for 1 minute without touching 4.Mix thoroughly with plastic spatula in kit for 45 seconds into paste 5.Press paste into the mold 3mm smaller side: makes 200 x 3mm beads 6.Fast Cure allow to sit 3-5 minutes ( regular kit = 15-20 minutes ) 7.Flex mold to remove beads How to Make Vancomycin OsteoSet Fast Cure 3mm Beads
Severe vascular or neurological disease Uncontrolled diabetes Severe degenerative bone disease Pregnancy Hypercalcemia Renal compromised patients Patients with a history of or active Potts disease Where intra-operative soft tissue coverage is not planned or possible Contraindications for the use of OsteoSet Beads
Hypercalcaemia: 2 case reports Kaliiala & Hadda, 2015: 15 pts s/p revision hip / knee surgery all 15 peri-prosthetic infections Stimulan 10mls + 1g vancomycin + 240mg gentamicin radiological absorption: 21-45 days 3/15 developed transient hypercalcemia maximum POD#5: 1/3 was symptomatic Carlson, et al, 2015: single case report hip replacement infection Osteoset beads unspecified amount + 2g Vancomycin, 3.6 g Tobramycin POD#6: 14.7 mg/dl max Returned to normal POD# 8 Potential Complications Related To Calcium Sulphate Beads
Increased Volume and Duration of Drainage: acidic elution Stimulan purported 0-3.2% drainage rates ( > 30mls beads ) Osteoset purported* 23-50% drainage rates * unsubstantiated competitor data Heterotopic Ossification: no reported cases for soft tissue 1-2%: avascular bed ( > 33mls beads ) Potential Complications Related To Calcium Sulphate Beads
Elution Profile of Calcium Sulphate / Vancomycin Beads Aiken et al, 2015: 900 mg Vancomycin bead immersed in 4ml saline 3mm Stimulan Beads Peak conc. 13.5 mg/L at 48 hrs 42 days later : 0.67 mg/L 6mm Stimulan Beads Peak conc. 10.4 mg/L at 48 hrs 42 days later : 0.59 mg/L MIC 90: planktonic MRSA is 1mg/L Vancomycin MIC90+: biofilm MRSA:15mg/L but only if + rifampicin or tigecycline
Albright, et al, 2016: Pilot Study, Retrospective n=14 Debridement of infected pocket +IV antibiotics PMMAplates/beads:2g Vancomycin+1.2gTobramycin Immediate Expander placed + drain Exchange for implant & removal plates / beads No reoperations for capsular contractures Mean follow-up 8.2 months Sherif, et al, 2017: Infected implant removed, partial capsulectomy n=12 6/12 culture +: Staph epidermidis, Staph aureus Enterobacter, yeast & Rhodococcus Stimulan + 1g Vancomycin, 1.2g Tobramycin Immediate new implant or expander replaced 75%,n=9 patients successful salvage of implant Off label Use of Antibiotic Beads in Breast Surgery 2016-2018
Kenna, et al, 2018: Preventive Study to Reduce Expander Infection 3 years: 127 submuscular breast reconstructions n=68 Retrospective, non randomized, 68 / 127 + beads 5ml Stimulan beads + 500mg vancomycin + 240mg gentamicin all patients with Alloderm : IMF to Pect Major drains kept up to 4 weeks infections: + Beads: Pseudomonas (1) No Beads: Pseudomonas (3), Staph epi (3), Escherichia coli (1) infections 1.5% +beads group vrs 11.9 % now using beads for all implant exchanges no mention of capsular contractures at all Off label Use of Antibiotic Beads in Breast Surgery 2016-2018
Can peri & intra - capsular placement of 5mls of OsteoSet 3mm Beads + 500mg Vancomycin prevent recurrent capsular contracture ? In conjunction with: IV antibiotics and 10 days of post-operative oral antibiotics Capsulectomy, partial capulectomy & or open capsulotomy Early superior compression and breast massage In office closed capsulotomy if indicated: Baker Grade II-III Purpose of Current Pilot Study
Pearl IRB re Study No. 17-RMB-101: IRB Exempt 10/18/17 Retrospective case review: chart and structured interview n = 14 implants & 10 patients Original Implantation: esthetic augmentation or reconstruction Indications for surgery: capsular contracture Baker III-IV Same surgeon and one post graduate student Follow-up to > 6 years: 2011-2018 Methods: Pilot Study CC with Antibiotic Beads
Methods: Pilot Study CC with Antibiotic BeadsMethods: Pilot Study CC with Antibiotic Beads Data collected included:Data collected included: Prior Procedure(s)Prior Procedure(s) Current SurgeryCurrent Surgery age, gravida, para date of last breast feeding esthetic or reconstructive surgical details: incisions, pocket numbers of surgery since then complications associated pre and final post op grade capsule date of surgery, follow up dates implants, incisions, drains / duration surgical details: capsulectomy/otomy use of simultaneous ADM complications of surgery
+ Retrospective review 50 primary augmentations ( 25 patients ) document post-operative Baker grade duration of follow-up implant texture and silicone vrs saline incision(s) used + Retrospective review 17 CC surgeries without antibiotic beads document Baker grade before vrs after surgery Methods: Additional Information
Surgery: outpatient IV Ancef was given within 30 minutes prior to surgery + 10 days po Keflex Incisions preexisting or new: inframammary, mastectomy, periareola, mastopexy Explantation followed by capsulotomy, partial / complete capsulectomy Pocket irrigations 5% betadine then triple: Vanco/Bacitracin/Gentamicin Osteoset 5ml rapid 3mm beads 500mg vancomycin in peri-capsule / pocket All pts received new implants and no lap packing in the pocket All cases s/p capsulectomy were drained with a 7-10mm Jackson Pratt No: transposition of the pocket to opposite side of pectoralis implant funnels , no-touch technique, nipple guards were utilized Methods: Operative Details
Frequency Capsular Contracture after Primary Augmentation n = 50 implants (25 patients) 14 Silicone: 4 Smooth & 10 Textured 36 Saline: 36 Smooth & 0 Textured Incision: 50 Superior peri-areola Final Grade: (48) I-II, (2) III, (0) IV Mean follow-up: 10.2 months CC rate (III-IV): 4% Results: Primary Augmentations
n = 14 implants (10 patients) Ages: (36-69) mean = 53 Para: (0-4) mean = 2.3 Prior Surgery Indication for first surgery: 9 esthetic, 5 reconstruction Prior XRT: 1/14 14 Implant used: 8 saline of which 5 textured, 6 silicone of which 4 textured Incision: 1 mastectomy, 0 anchor, 4 transaxillary, 4 periareola, 5 inframammary Number of previous surgeries for CC: 0-24, most common 0 (7/14) Baker Grade: 7 III, 7 IV Months from last surgery to current surgery: 4-396 Current Surgery Capsular work done: 5 open capsulotomy, 5 partial, 4 total capsulectomy Implants: 4 saline of which all 4 textured, 10 silicone of which 8 textured Drain & Duration in days: 14/14, (5-34) mean = 16 Incision: 1 mastectomy, 3 anchor, 0 transaxillary, 5 periareola, 5 inframammary Use of ADM- Alloderm: 1/14 Follow-up duration in months : (4-75) mean = 20.5 months Final Grade: (10) I-II, (1) III, (3) IV Complications: none Results: Antibiotic Beads Pilot Study Prior + Current Surgical Details
Case example: 62 yr lady 33 yr after silicone augmentation Mexico 10/16 1/17 2/18 Infra-mammary incision Bilateral total capsulectomy + 7mm JP 500mg Vancomycin in 200 3mm beads of 5mls OsteoSet implant replacement using Natrelle Inspira TRF 450
Implants Grade + Bead therapy _______ (I) ________ (II)______ _(III-IV)____ Prior to Surgery (n=14) 0 0 14 Bead Therapy (n=14 ) 10 0 4 71% improvement with surgery + beads Implants No Bead therapy _______ (I) ________ (II)_________(III-IV)____ Prior to Surgery (n=17) 0 0 17 After Surgery (n=17) 3 8 6 64% improvement with surgery + no beads Surgery & Beads versus no Bead Therapy Fishers Exact one tailed Test (p= 0.497) Results: Statistical Evaluation of Success of Antibiotic Bead Therapy
Summary Of ResultsSummary Of Results A Pilot Study was performed to determine the efficacy of OsteoSet & Vancomycin Beads with replacement of implant + capsulotomy / capsulectomy to prevent recurrent capsular contracture While 71% showed an improvement with the use of the beads so did 64% without using beads There was a 4% Grade III-IV capsular contracture rate for primary breast augmentation
1. The current results did not reach statistical significance, n= low sample size unable to show a difference between surgery with antibiotic beads vrs no beads 2. The surgical techniques used are in keeping with other current standards based on a 4% rate of capsular contracture after primary augmentation 3. Symptomatic hypercalcemia has been reported with 10mls of Ca Sulphate beads 4. The inflammatory reaction to a biofilm may be individual including the susceptibility of the biofilm to local immunity and antibiotic therapy 5. The 29% failure rate of surgery with Vancomycin beads may be a reflection of the inadequate dosage of Vancomycin +/- need for an additional anti-staphlococcal agent for biofilm producing bacteria, such as rifampicin ? 6. The results support further work, (n) & a prospective, randomized study Conclusions
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Calcium sulphate vaco cap talk

  • 1. Vancomycin Calcium Sulphate Beads in the Prevention of Recurrent Capsular Contracture of The Breast - A Pilot Study Olivia Jackson B. Sc., U C Davis & Rex Moulton-Barrett, MD, FACS Plastic & Reconstructive Surgery, Alameda, California
  • 2. Are the previous concepts on prevention, causation & treatment of capsular contractures: evidence based or medical fashion ?
  • 3. U.S. Breast Implantation Statistics 2016U.S. Breast Implantation Statistics 2016 ASPS 2016 Plastic Surgery StatisticsASPS 2016 Plastic Surgery Statistics 290,567 Augmentations: no. 1 cosmetic surgery290,567 Augmentations: no. 1 cosmetic surgery 89,000/109,256 (89,000/109,256 ( 81%81% ) Breast Reconstructions) Breast Reconstructions 2011-20162011-2016 rate increaserate increase by +/-by +/- 3% / yr3% / yr 28,467 (28,467 ( 10%10% ) Augmentation) Augmentation implantsimplants removedremoved
  • 4. Relevance of Capsular ContractureRelevance of Capsular Contracture After Breast AugmentationAfter Breast Augmentation The most common complication & reason for removal / reoperation >10 x more common than explantation for acute infection / extrusion Incidence after Breast Augmentation 3-29%: >= to Grade III +/-r II Headon, Kasem & Mokbel, 2015: Overall incidence 10.6%
  • 5. Definition of Capsular ContractureDefinition of Capsular Contracture Baker Classification, 1976: Breast Augmentation I- Natural II- Minimal: palpable firmness noticed by surgeon only III- Moderate: Firmness noticed by patient IV- Severe: Obvious distortion of breast shape Spear and Baker, 1995: Prosthetic Breast Reconstruction Ia- Natural Ib- soft detectable by physical examination only II- mildly firm by examination, may be visibly detectable III- moderately firm, readily detectable visually, may be acceptable IV- severe, symptomatic, unacceptable esthetically, needs surgery
  • 6. 1. Older patient vrs young 2. Smooth vrs textured 3. Silicone elastomer vrs polyurethane shell 4. Subglandular vrs submuscular 5. Silicone vrs saline 6. Previous XRT vrs no XRT 7. Implantation < 6 -12 months after pregnancy / breast feeding 8. Incision: transglandular: mastopexy>periareola>= transaxillary vrs inframammary incision 9. Touch technique vrs no touch technique +/- nipple shields 10. Talc / Lap packing vrs talc-free gloves & no packing 11. No irrigation triple antibiotic +/- betadine 5-10% 12. Delayed replacement: deflated saline / ruptured silicone implant 13. Blood / hematoma in pocket vrs dry pocket dissection +/ -drain 14. No IV antibiotics vrs IV Vancomycin & Ancef +/-orals Clinical Factors Associated With Capsular Contractures after Primary Augmentation ( no randomized, controlled, blinded studies to date )
  • 7. 1. The Same Factors as for Primary Augmentation 2. Replacement of implant in the same pocket vrs neo-pocket 3. Neo-pocket adjacent vrs change to trans-pectoral : sub-muscular sub-glandular 4. Capsulotomy vrs sub total / total capsulectomy 5. No prolonged vrs prolonged oral antibiotics 6. No ADM vrs ADM grafting 7. Replace with same implant vrs new implant 8. No steroid injection vrs injection into the capsular bed 9. No BoTox injection vrs injection into the capsular bed 10. No fat grafting vrs peri-capsular fat grafting & capsulotomy 11. Prior reconstructive implantation vrs esthetic augmentation Clinical Factors Associated With Recurrent Capsular Contractures ( no randomized, controlled, blinded studies to date )
  • 8. Incidence of Recurrent Capsular Contracture (CC)Incidence of Recurrent Capsular Contracture (CC) Wan & Rohrich, 2016 PRS: 137:826-841Wan & Rohrich, 2016 PRS: 137:826-841.. Incidence of recurrent CC % 24/461 articles up to 4/2015: 0-54% Capsulotomy vrs Capsulectomy conflicting data Partial vrs total Capsulectomy conflicting data Site change Neo +/- Trans Muscle 0-12 % vrs no site change: 0-54% Implant Exchange 0-26% vrs same implant 33-54% vrs No ADM 6 articles using ADM 0-2.6% +site change 3/6: 50% 0% + no site change 1/6: 16%
  • 9. 1. Early massage and superior compression 2. Closed capsulotomy- Dan Baker 1975: 75% resolution at 2 yrs 3. Ultrasound / Aspen randomized clinical study 2017-2018 4. Low Dose Laser randomized study: conclusions not helpful 5. Medication: Accolate Zafirlukast: leukotrine receptor antagonist: check LFTs Singulair Montelukast: minimal results at most Tamoxifen Myofibroblast: Block Er - receptors 鏝 Post Operative Factors: Prevention & / 0r Treatment of Capsular Contractures
  • 10. Peri-Prosthetic Inflammation Fibroblast transient immortalization loss p53 senescence Macrophages TGF- 硫 Myofibroblasts: estrogen receptors ( Er - , 1/ )硫 stimulated by mechanical stress / tension Fibroblast collagen parallel layering texturing reduces Bacterial Colonization Bacterial Colonization also without capsular contracture Bacterial Biofilms - also without capsular contracture Multifactorial Pathophysiological Causes of Capsular Contractures
  • 11. Implant Colonization with bacteria: Staphylococcus epidermidis 56%with CC vrs 18% with no CC Virden, et al, 1992. Aesthetic Plast Surg 16:173-179 Endogenous Bacterial Flora Cultured from Breast Tissue: Benign: not the same as skin flora & also different from malignancy (Bacillus>Acinetobacter,>Enterbacteriaeae>Pseudomonas,>Staphlococcus>Proprionibact) Malignant: Fusobacterium, Atopbium,Gluconacterobacter, Hydrogenophaga Lactobacillus Early Acute Infection: Staphloccus aureus, streptococcus, gram-negatives Late infection: Coagulase negative staph., Propionibacterium spp. Biofilm Producing bacteria from the capsule Propionbacterium acnes Staphylococcus epidermidis: 80% oxacillin resistant Bacteria cultured from textured implants associated with ALCL Ralstonia spp: in the water reservoirs Capsular Contracture and Bacterial Colonization
  • 12. 65 - 80% of human infections associated with biofilms 5 stages of a Biofilm Composition of Biofilms < = 97% water 2% microbial cells 2% Extracel Polymeric Substances ie protein enzymes 1-2% Polysaccharides adhesion + immune barrier 1-2% DNA / RNA Calcium Sulphate Beads with Vancomycin planktonic eradicate MRSA and Staph epidermidis biofilm formation prevention mature biofilm may reduce Biofilm of IV Staph Aureus requires a 4 X increase in antibiotic MIC (50) Rough surfaces and or foreign bodies are more susceptible to biofilms Nutrient / O2 / waste dormancy = reduced antibiotic susceptibility Relevance of Biofilms in Medicine
  • 13. PMMA filler / beads: do not dissolve & beads need to be removed high levels of antibiotics 2-3 days surface area diffusion prolonged release below MIC may support biofilms Bioceramic Beads: dissolve and beads do not need to be removed Calcium Phosphate: Monocalcium: mono or anhydrous Dibasic calcium: anhydrous, hemihydrous Tricalcium: simple, and 硫 Hydroxyapatite: & calcium deficient Biphasic Tricalcium Tetracalcium Octacalcium Calcium Sulphate Anhydrous = anhydrate Dehydrate = gypsum = Plaster of Paris Hemihydrate: and 硫 Antibiotic Beads in Medicine
  • 14. Calcium Sulphate: used since 1892, initially used as a bone graft gypsum: impure, acidic, inflammatory ( self limiting synovitis and post-op drainage ) hemihydrate with water exothermic reaction hemihydrate dissolves in 3-6 weeks soft tissue Medical Grade alpha hemi-hydrate 1997: Prevention & treatment osteomyelitis Preventive & treatment of infection in joint replacement Treatment of prosthetic vascular graft infections Deep diabetic foot infections Deep neck infections adjacent to the carotid artery Calcium Phosphate: longer resorption time 1 / water solubility resorption may be 6 months to 10 years can be made into a strong cement Polyphasic Ceramics: + Potassium Sulphate short & longer release Use of Antibiotic Bioceramics in Medicine
  • 15. Commercially Available Antibiotic Beads Kits of Calcium Sulphate Hemi- Hydrate 3mm 4.8mm OsteoSet ( Wright Medical ) Gypsum derived: less hydrophilic 510(k) 2001: bone void filler 2 size beads 3, 4.8mm No 510(k) for + antibiotics 5ml rapid 5 min and 20 minute cure $1,100 Stimulan ( Biocomposites ) synthetic: hydrophilic mix 510(k) 2015: bone void filler 3 size beads 3, 4.8, 6mm No 510(k) for + antibiotics 5ml rapid 4 min and 12ml 8 min cures $1,000
  • 16. 1. 12mls of OsteoSet powder to bowl from kit 1.Add 500mg Vancomycin powder to the bowl 2. Add diluent from small bottle in kit, makes 5mls in total 3.Alow to sit for 1 minute without touching 4.Mix thoroughly with plastic spatula in kit for 45 seconds into paste 5.Press paste into the mold 3mm smaller side: makes 200 x 3mm beads 6.Fast Cure allow to sit 3-5 minutes ( regular kit = 15-20 minutes ) 7.Flex mold to remove beads How to Make Vancomycin OsteoSet Fast Cure 3mm Beads
  • 17. Severe vascular or neurological disease Uncontrolled diabetes Severe degenerative bone disease Pregnancy Hypercalcemia Renal compromised patients Patients with a history of or active Potts disease Where intra-operative soft tissue coverage is not planned or possible Contraindications for the use of OsteoSet Beads
  • 18. Hypercalcaemia: 2 case reports Kaliiala & Hadda, 2015: 15 pts s/p revision hip / knee surgery all 15 peri-prosthetic infections Stimulan 10mls + 1g vancomycin + 240mg gentamicin radiological absorption: 21-45 days 3/15 developed transient hypercalcemia maximum POD#5: 1/3 was symptomatic Carlson, et al, 2015: single case report hip replacement infection Osteoset beads unspecified amount + 2g Vancomycin, 3.6 g Tobramycin POD#6: 14.7 mg/dl max Returned to normal POD# 8 Potential Complications Related To Calcium Sulphate Beads
  • 19. Increased Volume and Duration of Drainage: acidic elution Stimulan purported 0-3.2% drainage rates ( > 30mls beads ) Osteoset purported* 23-50% drainage rates * unsubstantiated competitor data Heterotopic Ossification: no reported cases for soft tissue 1-2%: avascular bed ( > 33mls beads ) Potential Complications Related To Calcium Sulphate Beads
  • 20. Elution Profile of Calcium Sulphate / Vancomycin Beads Aiken et al, 2015: 900 mg Vancomycin bead immersed in 4ml saline 3mm Stimulan Beads Peak conc. 13.5 mg/L at 48 hrs 42 days later : 0.67 mg/L 6mm Stimulan Beads Peak conc. 10.4 mg/L at 48 hrs 42 days later : 0.59 mg/L MIC 90: planktonic MRSA is 1mg/L Vancomycin MIC90+: biofilm MRSA:15mg/L but only if + rifampicin or tigecycline
  • 21. Albright, et al, 2016: Pilot Study, Retrospective n=14 Debridement of infected pocket +IV antibiotics PMMAplates/beads:2g Vancomycin+1.2gTobramycin Immediate Expander placed + drain Exchange for implant & removal plates / beads No reoperations for capsular contractures Mean follow-up 8.2 months Sherif, et al, 2017: Infected implant removed, partial capsulectomy n=12 6/12 culture +: Staph epidermidis, Staph aureus Enterobacter, yeast & Rhodococcus Stimulan + 1g Vancomycin, 1.2g Tobramycin Immediate new implant or expander replaced 75%,n=9 patients successful salvage of implant Off label Use of Antibiotic Beads in Breast Surgery 2016-2018
  • 22. Kenna, et al, 2018: Preventive Study to Reduce Expander Infection 3 years: 127 submuscular breast reconstructions n=68 Retrospective, non randomized, 68 / 127 + beads 5ml Stimulan beads + 500mg vancomycin + 240mg gentamicin all patients with Alloderm : IMF to Pect Major drains kept up to 4 weeks infections: + Beads: Pseudomonas (1) No Beads: Pseudomonas (3), Staph epi (3), Escherichia coli (1) infections 1.5% +beads group vrs 11.9 % now using beads for all implant exchanges no mention of capsular contractures at all Off label Use of Antibiotic Beads in Breast Surgery 2016-2018
  • 23. Can peri & intra - capsular placement of 5mls of OsteoSet 3mm Beads + 500mg Vancomycin prevent recurrent capsular contracture ? In conjunction with: IV antibiotics and 10 days of post-operative oral antibiotics Capsulectomy, partial capulectomy & or open capsulotomy Early superior compression and breast massage In office closed capsulotomy if indicated: Baker Grade II-III Purpose of Current Pilot Study
  • 24. Pearl IRB re Study No. 17-RMB-101: IRB Exempt 10/18/17 Retrospective case review: chart and structured interview n = 14 implants & 10 patients Original Implantation: esthetic augmentation or reconstruction Indications for surgery: capsular contracture Baker III-IV Same surgeon and one post graduate student Follow-up to > 6 years: 2011-2018 Methods: Pilot Study CC with Antibiotic Beads
  • 25. Methods: Pilot Study CC with Antibiotic BeadsMethods: Pilot Study CC with Antibiotic Beads Data collected included:Data collected included: Prior Procedure(s)Prior Procedure(s) Current SurgeryCurrent Surgery age, gravida, para date of last breast feeding esthetic or reconstructive surgical details: incisions, pocket numbers of surgery since then complications associated pre and final post op grade capsule date of surgery, follow up dates implants, incisions, drains / duration surgical details: capsulectomy/otomy use of simultaneous ADM complications of surgery
  • 26. + Retrospective review 50 primary augmentations ( 25 patients ) document post-operative Baker grade duration of follow-up implant texture and silicone vrs saline incision(s) used + Retrospective review 17 CC surgeries without antibiotic beads document Baker grade before vrs after surgery Methods: Additional Information
  • 27. Surgery: outpatient IV Ancef was given within 30 minutes prior to surgery + 10 days po Keflex Incisions preexisting or new: inframammary, mastectomy, periareola, mastopexy Explantation followed by capsulotomy, partial / complete capsulectomy Pocket irrigations 5% betadine then triple: Vanco/Bacitracin/Gentamicin Osteoset 5ml rapid 3mm beads 500mg vancomycin in peri-capsule / pocket All pts received new implants and no lap packing in the pocket All cases s/p capsulectomy were drained with a 7-10mm Jackson Pratt No: transposition of the pocket to opposite side of pectoralis implant funnels , no-touch technique, nipple guards were utilized Methods: Operative Details
  • 28. Frequency Capsular Contracture after Primary Augmentation n = 50 implants (25 patients) 14 Silicone: 4 Smooth & 10 Textured 36 Saline: 36 Smooth & 0 Textured Incision: 50 Superior peri-areola Final Grade: (48) I-II, (2) III, (0) IV Mean follow-up: 10.2 months CC rate (III-IV): 4% Results: Primary Augmentations
  • 29. n = 14 implants (10 patients) Ages: (36-69) mean = 53 Para: (0-4) mean = 2.3 Prior Surgery Indication for first surgery: 9 esthetic, 5 reconstruction Prior XRT: 1/14 14 Implant used: 8 saline of which 5 textured, 6 silicone of which 4 textured Incision: 1 mastectomy, 0 anchor, 4 transaxillary, 4 periareola, 5 inframammary Number of previous surgeries for CC: 0-24, most common 0 (7/14) Baker Grade: 7 III, 7 IV Months from last surgery to current surgery: 4-396 Current Surgery Capsular work done: 5 open capsulotomy, 5 partial, 4 total capsulectomy Implants: 4 saline of which all 4 textured, 10 silicone of which 8 textured Drain & Duration in days: 14/14, (5-34) mean = 16 Incision: 1 mastectomy, 3 anchor, 0 transaxillary, 5 periareola, 5 inframammary Use of ADM- Alloderm: 1/14 Follow-up duration in months : (4-75) mean = 20.5 months Final Grade: (10) I-II, (1) III, (3) IV Complications: none Results: Antibiotic Beads Pilot Study Prior + Current Surgical Details
  • 30. Case example: 62 yr lady 33 yr after silicone augmentation Mexico 10/16 1/17 2/18 Infra-mammary incision Bilateral total capsulectomy + 7mm JP 500mg Vancomycin in 200 3mm beads of 5mls OsteoSet implant replacement using Natrelle Inspira TRF 450
  • 31. Implants Grade + Bead therapy _______ (I) ________ (II)______ _(III-IV)____ Prior to Surgery (n=14) 0 0 14 Bead Therapy (n=14 ) 10 0 4 71% improvement with surgery + beads Implants No Bead therapy _______ (I) ________ (II)_________(III-IV)____ Prior to Surgery (n=17) 0 0 17 After Surgery (n=17) 3 8 6 64% improvement with surgery + no beads Surgery & Beads versus no Bead Therapy Fishers Exact one tailed Test (p= 0.497) Results: Statistical Evaluation of Success of Antibiotic Bead Therapy
  • 32. Summary Of ResultsSummary Of Results A Pilot Study was performed to determine the efficacy of OsteoSet & Vancomycin Beads with replacement of implant + capsulotomy / capsulectomy to prevent recurrent capsular contracture While 71% showed an improvement with the use of the beads so did 64% without using beads There was a 4% Grade III-IV capsular contracture rate for primary breast augmentation
  • 33. 1. The current results did not reach statistical significance, n= low sample size unable to show a difference between surgery with antibiotic beads vrs no beads 2. The surgical techniques used are in keeping with other current standards based on a 4% rate of capsular contracture after primary augmentation 3. Symptomatic hypercalcemia has been reported with 10mls of Ca Sulphate beads 4. The inflammatory reaction to a biofilm may be individual including the susceptibility of the biofilm to local immunity and antibiotic therapy 5. The 29% failure rate of surgery with Vancomycin beads may be a reflection of the inadequate dosage of Vancomycin +/- need for an additional anti-staphlococcal agent for biofilm producing bacteria, such as rifampicin ? 6. The results support further work, (n) & a prospective, randomized study Conclusions
  • 34. Rejoice while we are young