Breast Reconstruction Patients Educational Brochure - Mentor

More documents

Recommendations

Info

48Table 6 ContinuedYear 3%Year 6%Other Complications Occurring in 1% or More of Patients 3Size Change - Patient Request 5.0 5.0Size Change - Physician Assessment Only 2.1 2.1Skin Lesion 1.1 1.8Suture Complication 1.7 1.7Tenderness/Soreness 0.5 1.4Wrinkling 4 3.3 4.01129 primary reconstruction patients experienced at least one or more complication or reoperation2Implant Rupture (based on the MRI cohort) was assessed by MRI at 1, 2, 4, and 6 years (results providedin Table 10); there were no cases of rupture reported through 6 years in the non-MRI cohort of primaryreconstruction patients (N=117).3The following complications occurred at a rate less than 1%: capsular contracture Baker Grade unknown,external injury not related to breast implants, muscle atrophy, necrosis, new diagnosis of breast cancer,nipple complication, palpability-implant, swelling (excessive), symmastia, wound opening.4Mild occurrences were not included5All causes of death were reported by the investigator to be unrelated to study procedure or device.6There were 3 diagnoses in 3 primary reconstruction patients: rheumatoid arthritis (10 monthspost implantation), other inflammatory arthritis (11 months post implantation), and othermechanical/degenerative condition (16 months post implantation).Revision-ReconstructionThe complications observed in women who had revision-reconstruction through 3 and 6years are presented in Table 7. The most common reported complication within the first 3and 6 years after revision-reconstruction surgery was reoperation (28% or approximately28 out of 100 through 3 years; and 45% or approximately 45 out of 100 through 6 years).
49Table 73-Year and 6-Year Complication Rates for Revision-Reconstruction Patients, N=68 PatientsYear 3%Year 6%Any Complication Excluding Rupture 1 55.5 67.7Key ComplicationsAny Reoperation 28.4 45.4Capsular Contracture Baker Grade III/IV 13.5 16.4Implant Removal with or without Replacement 21.0 34.2Implant Removal with Replacement with Study Device 4.4 10.8Implant Rupture (Based on the MRI Cohort) 2 - 0Infection 3.0 3.0Other Complications Occurring in 1% or More of Patients 3Asymmetry 4 6.1 6.1Breast Pain 4 3.3 3.3Capsular Contracture Baker Grade II with Surgical Intervention 1.5 3.7Capsular Contracture Baker Grade III 13.5 13.5Capsular Contracture Baker Grade IV 0 3.0Death 5 1.7 1.7Excess Skin/Tissue 1.6 1.6Gel Fracture 6 0 2.0Hematoma 1.5 1.5Implant Immobility 1.9 1.9Implant Rotation 1.5 1.5Irritation/Inflammation 3.0 3.0Lack of Projection 11.8 13.7Loss of Definition of Inframammary Fold 1.5 1.5Metastatic Disease 1.6 1.6Muscle Atrophy 1.5 1.5Numbness/Tingling (Paresthesia) 3.4 3.4Palpability-Implant 4 3.5 3.5Patient Dissatisfied with Aesthetic Appearance of Breast 6.3 8.4Patient Dissatisfied with Feel of Implant 1.5 3.8Position Dissatisfaction 4 4.9 4.9Ptosis (Sagging) 5.0 12.2Recurrent Breast Cancer 1.5 3.6Redness (Erythema) 1.5 1.5Scarring 1.5 6.5Seroma 4.6 4.6Silicone From Previous Rupture 1.5 1.5Size Change-Patient Request 7.8 9.9Size Change-Physician Assessment Only 0 4.8Skin Lesion 1.8 4.3Swelling (Excessive) 1.5 1.5Wrinkling 4 9.5 12.2146 revision-reconstruction patients experienced at least one complication or reoperation.2Rupture was assessed by MRI at 1, 2, 4, and 6 years (results provided in Table 10); there were no casesof rupture reported through 6 years in the non-MRI cohort of revision reconstruction patients (N=31).3No complications occurred at a rate less than 1%.4Mild occurrences not included5All causes of death were reported by the investigator to be unrelated to study procedure or device.6Gel fracture occurred in 1 revision-reconstruction patient.
Page 1 and 2: Patient Educational BrochureRECONST
Page 3 and 4: 1PATIENT EDUCATIONAL BROCHURERECONS
Page 5 and 6: 3GLOSSARYAbdomenAnaplastic Large Ce
Page 7 and 8: 5Connective TissueDisease/Disorder
Page 9 and 10: 7Latissimus Dorsi FlapLatissimus Do
Page 11 and 12: 9Primary BreastReconstructionProsth
Page 13: 11Tissue ExpanderTissue FlapReconst
Page 17 and 18: 15WARNING - The following is a list
Page 19 and 20: EventKey ComplicationsImplant Remov
Page 21 and 22: Event19Table 1 ContinuedLikelihood
Page 23 and 24: EventAny ComplicationExcluding Rupt
Page 25 and 26: Event23Likelihood of the EventOccur
Page 27 and 28: 25Mentor will continue its MemorySh
Page 29 and 30: 27Sometimes there are symptoms asso
Page 31 and 32: 29A surgeon can minimize the chance
Page 33 and 34: 31The Institute of Medicine (IOM) r
Page 35 and 36: 33• Effects on Children Born to M
Page 37 and 38: 356.2 Breast Reconstruction with Im
Page 39 and 40: 37place to create the new breast. T
Page 41 and 42: 6.5 Choosing the Right Implant for
Page 43 and 44: 41Immediate reconstruction may allo
Page 45 and 46: 437.3 Caring for Yourself in the Mo
Page 47 and 48: What to do if the Implant Rupture i
Page 49: 47Table 63-Year and 6-Year Complica
Page 53 and 54: 51Revision-ReconstructionIn the Men
Page 55 and 56: 53Revision-ReconstructionThe main r
Page 57 and 58: 55Connective Tissue Disease (CTD)In
Page 59 and 60: 5711. MENTOR’S IMPLANT TRACKING P
Page 61 and 62: 59201 Mentor Drive, Santa Barbara,
Page 63 and 64: 61201 Mentor Drive, Santa Barbara,
Page 65 and 66: 6315. INDEXAlternatives to Breast I
Page 67 and 68: 6516. REFERENCES1. Collis, N., et a
Page 69 and 70: 41. Blackburn, W. D., Jr. & Everson
Page 71 and 72: This page is intentionally left bla

Breast Reconstruction Patients Educational Brochure - Mentor

Create successful ePaper yourself

Delete template?

Save as template?