1. The document discusses various options for breast reconstruction after mastectomy, including immediate versus delayed reconstruction and the use of tissue flaps, implants, or a combination. 2. Skin-sparing mastectomy is described as oncologically safe based on studies finding local recurrence rates similar to conventional mastectomy and most recurrences detected within 3 years. 3. Autologous tissue reconstruction is discussed as having advantages like a natural appearance but also longer recovery, while implant reconstruction has shorter procedure time but risks like infection or capsular contracture.

1. Breast Reconstruction: Decision Making Surgical Planning Michael J. Miller, M.D. Professor of Surgery Director, Division of Plastic Surgery The Ohio State University

2. Lifetime Probability of Developing Cancer Source:DevCan: Probability of Developing or Dying of Cancer Soft ware, Version 5.1 Statistical Research and Applications Branch, NCI, 2003. http://srab.cancer.gov/devcan 1 in 59 Ovary 1 in 57 NH-Lymphoma 1 in38 Uterine corpus 1 in 18 Colon and rectum 1 in 17 Lung and bronchus 1 in 7 Breast 1 in 3 All Sites Risk Site

3. Why Breast Reconstruction?

4. Mastectomy/ No Reconstruction Advantages no further surgery needed shorter surgery time/hospital stay symmetry restored with prosthesis may consider reconstruction in future Disadvantages scar on chest wall asymmetry in clothing external prosthetic can: dislodge be uncomfortable be impractical for athletic activities

5. Breast Deformities Consequences: Aesthetic Functional Emotional Social Decreased Quality of Life

6. Reconstruction Options Immediate Delayed Timing Technique Tissue Tissue + Implant Implants alone

7. Delayed Reconstruction Advantages shorter hospital stay/ shorter recovery adjuvant therapy causes no complications to reconstruction allows patient time to consider reconstructive options Disadvantages soft tissue scar on chest wall requires additional surgery and recovery time difficult to reconstruct after scarring occurs

9. Immediate Reconstruction Advantages lowers psychosocial morbidity lowers surgical morbidity superior cosmetic results lowers cost of surgery No difference in development or detection of local recurrences No delays in adjuvant therapies Disadvantages mastectomy skin flap necrosis possible longer hospitalization/recovery additional scars coordination required between surgeons

10. Reconstruction Options Immediate Delayed Timing Technique Tissue Tissue + Implant Implants alone

11. Breast Reconstruction Methods UTMDACC 1990 - 2000

12. Implant Reconstruction Two-Stage Stage One: Tissue expansion Stage Two: Permanent implant placement One Stage Permanent implant placement Use of dermal matrix implants

13. Implant Reconstruction Tissue Expanders/Implants Advantages No additional scarring Shorter procedure/recovery Satisfactory shape in clothing Disadvantages Foreign body causing risk of infection Risk of rupture necessitating removal Risk of capsule formation and firmness Asymmetry Implant not permanent

14. Two-Stage Implant Reconstruction Pre-op Full Expansion Final Result

15. Acellular Dermal Matrix (AlloDerm ® ) Zienowicz RJ. Karacaoglu E. Plastic & Reconstructive Surgery . 120(2):373-81, 2007

16. Zienowicz RJ. Karacaoglu E. Plastic & Reconstructive Surgery . 120(2):373-81, 2007

17. Preminger BA. et. al. Annals of Plastic Surgery. 60(5):510-3, 2008.

18. “ Well, this is a fine mess …”

19. Q. 1 “How in the world did we get here?” “ Well, this is a fine mess …”

20. Q. 1 “How in the world did we get here?” Q. 2 “How do we avoid ever being back here again?” “ Well, this is a fine mess …”

21. Breast Implantation Autologous Tissue Contralateral breast (Verneuil, 1887) Lipoma (Czerny, 1895) Grafts and flaps of muscle, fascia, fat, and dermis

22. paraffin, ivory, glass balls, ground rubber, ox cartilage, Terylene wool, gutta percha, Dicora, polyethylene chips, Ivalon sponge (poly(vinyl alcohol-formadehyde)), Ivalon in polyethylene sac, polyether foam sponge (Etheron), polyethylene (Polystan) tape or strips wound into a ball, polyurethane foam sponge, teflon-silicone prosthesis. Breast Implant Devices

23. Breast Implantation Paraffin, Vaseline, “Organogen,” “Bioplaxm” Silicone oil + some combination of: ricinoleic acid, animal fatty acid, vegetable fatty acids, mineral oil, vegetable (castor) oil, olive oil, croton oil, peanut oil, concentrated vitamin D, snake venom, talc, beeswax, shellac, glazier’s puddy, epoxy resin, industrial silicone fluids Example: Sakurai (> 72,000 cases) Medical-grade silicone Direct Injections

24. Silicone Implant Alternatives Pain Skin discoloration, edema, ulceration, and necrosis Calcifications Granulomas Fluid migration Infection Cysts Axillary adenopathy Disfigurement Loss of the breast Liver dysfunction Pneumonitis/ARDS Pulomonary embolism Coma Death Complications

25. Pre-Silicone Implant Era Women wanted breast enhancement Many alternatives Many complications Ideal material not identified Non-rigorous trials… What was known:

26. Silicone Breast Implants 1950’s- shunts and joint replacements 1964- Cronin and Gerow Introduced silicone gel-filled breast implant Pre-clinical studies in dogs 1962-1968 Dow Corning- only manufacturer 1968-early 1990’s- Multiple manufacturers Dow Corning, Heyer-Schulte-Mentor, Cox-Uphoff International, Aesthetech Corp., Surgitek, Inamed-McGhan, Mammatech, foreign manufacturers, …

27. Silicone Breast Implants Early 1990’s, > 2 million women implanted!!

28. Prior to 1970’s: little regulation or oversight…

29. FDA Device Regulation 1976- Medical Devices Amendments General and Plastic Surgery Advisory Panel Implants required general controls and performance standards only. 1982- FDA proposes reclassification as Class III device requiring stringent controls 1988- Changed to Class III status requiring pre-market approval (PMA) applications. 1992- Withdrawn from the market

30. Clinical Value + = ?

31. Clinical Value Determined by: Affect on patient’s: Functional Status Risk Status Well being Cost Patient satisfaction and perceived benefit Clinical outcome Nelson EC. et al. Joint Commission Journal on Quality Improvement. 22(4):243-58, 1996

32. Clinical Value Affect on patient’s: Functional Status Risk Status Well being Cost Satisfaction/perceived benefit Clinical outcome Pre-1991 acceptable + Value Score

33. Clinical Value Affect on patient’s: Functional Status Risk Status Well being Cost Satisfaction/perceived benefit Clinical outcome Pre-1991 acceptable Post-1991 + Value Score acceptable ? ? ? ? ? ?

34. Clinical Value

35. Medical Device Safety Risk Benefit

36. Silicon Gel Breast Implants After all is said and done… Conclusions: Local complications are well described Systemic complications are not supported Patients must be informed 2006- Silicone Gel implants return to the U.S. market

37. “ How in the world did we get here?” “ How do we avoid being back here again?”

38. Reconstruction Options Immediate Delayed Timing Technique Tissue Tissue + Implant Implants alone

39. Skin Sparing Mastectomy

40. Skin Sparing Mastectomy The ablative surgeon begins the reconstruction!

41. Skin-Sparing Mastectomy Incisions only for: - Nipple and Areola - Access to the axilla - Biopsy scars - Skin areas “at risk”

42. Skin Sparing Mastectomy

43. Pre-op Post-op Skin Sparing Mastectomy

44. Skin Sparing Mastectomy Mastectomy skin flap necrosis

45. Oncologic Safety 51 breast cancer patients, Stages 0-II; 1991-1994 Median follow-up 45 months Local recurrence rate 2% Biopsies of incisions in 32 consecutive patients revealed no evidence of retained breast tissue Slavin, et al, Plast Reconstr Surg 1994; 93:1191-1204 Skin-Sparing Mastectomy

46. Oncologic Safety of SSM vs. CM Local Recurrence Rate (T2 tumors) Kroll 104/SSM 271/CM Carlson 327/SSM 188/CM Simmons 77/SSM 154/CM SSM CM 15% 12% 9% 6% 3% 0%

47. Skin Sparing Mastectomy Skin-sparing mastectomy with immediate breast reconstruction is oncologically safe and offers superior cosmetic results compared to conventional mastectomy Local recurrence rates are similar for skin-sparing and conventional mastectomies Most local recurrence are detected by physical exam within 3 years following skin-sparing mastectomy

48. Technically more demanding Oncological safety Superior aesthetic results Skin Sparing Mastectomy

49. Latissimus Dorsi + Implant

51. Latissimus Dorsi Flap + Implant Pre-op Post-op Donor site scar

52. LD flap- Endoscopic Harvest Post-op. ( 3/1/2005) Pre-op. ( 1/13/2004)

53. LD flap- Endoscopic Harvest Pre-op Post-op

54. Reconstruction Options Immediate Delayed Timing Technique Tissue Tissue + Implant Implants alone

55. Autologous Tissue Reconstruction

56. Pedicled TRAM

57. Pedicled TRAM Prone to venous insufficiency leading to fat necrosis Download illustrations from Moon and Taylor

58. Microvascular Tissue Transfer

59. Microsurgical Breast Reconstruction Donor site options Free TRAM Muscle-sparing free TRAM DIEP SIEA S-GAP I-GAP Other

60. Perforator Flaps DIEP flap Advantages Spares Muscle Minimizes Pain Less functional morbidity Disadvantages Technical challenge Increased operative time Variations in anatomy Increased fat necrosis

61. 5/13/2008

62. 5/29/2008

63. CT Angiogram Analysis

64. 7/23/2008 7/23/2008

65. 7/8/2008 7/23/2008 7/23/2008

66. CT Angiogram Analysis: Vessel Selection

67. 9/2/2008 9/2/2008 Autologous Reconstruction: I-Gap Candidate

68. CT Angiogram Analysis: I-Gap Planning

69. 9/18/2008

70. Autologous Tissue Reconstruction Advantages Natural breast shape and behavior Natural consistency “ Tummy-tuck,” “buttocks lift” No foreign body Lower costs long-term Less emotional trauma

71. Autologous Tissue Reconstruction Disadvantages Longer surgical procedure Donor site scarring/deformity Possible Complications Longer hospitalization Longer recovery Greater initial cost

72. Ideal Abdominal Tissue Candidate Healthy No previous abdominal surgery Multiparous Non-smoker No plans of radiotherapy Compliant patient

73. Adjunct Procedures Breast mound reshaping Contralateral modifications for symmetry Nipple reconstruction Nipple/areolar micropigmentation

74. “ Breast reconstruction- a process… not an operation.”

75. 5/29/2007 10/2/2007 1/29/2008

76. Nipple Reconstruction 3 cm 4 cm

77. Nipple Reconstruction 3 cm 4 cm

78. Nipple Reconstruction

79. Nipple-Areola Micropigmentation

80. Final Results Breast mound creation Revisions for shape Nipple Reconstruction Micropigmentation

81. Thank you! University Hospital James Cancer Hospital The Ohio State University Plastic Surgery … to restore and make whole

83. Skin-Sparing Mastectomy Frozen section control of margins

84. Oncologic Safety 51 breast cancer patients, Stages 0-II; 1991-1994 Median follow-up 45 months Local recurrence rate 2% Biopsies of incisions in 32 consecutive patients revealed no evidence of retained breast tissue Slavin, et al, Plast Reconstr Surg 1994; 93:1191-1204 Skin-Sparing Mastectomy

85. Local/Regional Recurrence*after Skin-Sparing Mastectomy Immediate Flap Reconstruction (Stage ll) * Median follow-up 5.4 years ** None with stage 0 or stage I breast cancer

86. Oncologic Safety of SSM vs. CM Local Recurrence Rate (T2 tumors) Kroll 104/SSM 271/CM Carlson 327/SSM 188/CM Simmons 77/SSM 154/CM SSM CM 15% 12% 9% 6% 3% 0%

87. Local Recurrences after Skin-Sparing Mastectomy and Immediate Reconstruction Group Number Pts. Local Recurrences (%) All 104 6.7 T1 61 3.3 T2 43 11.6 Black’s grade I* 31 12.9 Black’s grade II 48 6.3 Black’s grade III 6 0.0 *The lower the grade, the more anaplastic the tumor Ann Surg Oncol 4:193-197,1997

88. Regional recurrence after skin-spring mastectomy is a function of the biology of the tumor and stage of disease

89. Detection and Management of Local Recurrence Following SSM MDACC Experience 437 SSMs in 372 patients with invasive T1/T2 breast cancers, 1986-1993 Median follow-up 50 months 23/372 local recurrences detected Local recurrence rate = 6.2% Newman, Ann Surg Onc,1998

90. Local Recurrence Following SSM MDACC Experience Median time to recurrence: 25 months (3-98) Median size of recurrence: 1.5 cm Presentation - Palpable skin flap mass: 22/23 (96%) - Non-palpable, CXR finding: 1/23 (4%) Histology - Consistent w/primary tumor: 22/23 (96%) - Different histology; ? New primary: 1/23 (4%)

91. Imaging of Local Recurrence Mammography visualized: 3/5 Ultrasound visualized: 11/12 CT scan imaged: 3/3 MRI imaged: 1/1

93. Distant Relapse and Overall Survival Median follow-up 26 mos. (range 6-105) N = 23 Metastases: 39% - Synchronous 22% - Metachronous 17% Survival: - Alive without disease 61% - Alive with disease 9% - Dead with disease 30%

94. Local Control and Outcome by Treatment Treatment # Pts. Local Control Alive, NED Local only 3 100% 100% (Surgery or Surgery + RT) Systemic only 5 60% 40% Local and 15 86% 71% Systemic

95. Local Control and Outcome by Treatment Local Only Systemic Only Local & Systemic Local Control Alive, NED 100% 80% 60% 40% 20% 0%

96. Skin Sparing Mastectomy Skin-sparing mastectomy with immediate breast reconstruction is oncologically safe and offers superior cosmetic results compared to conventional mastectomy Local recurrence rates are similar for skin-sparing and conventional mastectomies Most local recurrence are detected by physical exam within 3 years following skin-sparing mastectomy

97. Treatment approach depends on extent of local recurrence and presence of synchronous metastases, but resection of the reconstructed breast is rarely necessary Multimodality therapy usually results in excellent local control of disease and prolonged disease-free survival Skin Sparing Mastectomy

98. MDACC Recommendations Minimize risk of positive margins following skin-sparing mastectomy: - Intraoperative inking of margins - Mammography of serial sections if microcalcifications are present - Resection of additional skin as necessary Consider XRT if postoperative margins are microscopically positive

99. MDACC Recommendations Management of local recurrence: - Evaluate for distant metastatic disease - Breast ultrasound and mammography to evaluate extent of recurrence - Multimodality therapy, including surgery for resectable disease

100. Reservations Regarding Skin-Sparing Mastectomy Technically more demanding: Yes Increased surgical morbidity: No Oncologic safety: Yes