seri surgical scaffold in two-stage breast reconstruction

SERI Surgical Scaffold in Two-Stage Breast Reconstruction: Investigator

Satisfaction, Breast Stability, and Safety Profile Over Two Years in a Prospective

Clinical StudyNolan Karp, MD1; Mihye Choi, MD, FACS2; David A. Kulber, MD, FACS3; Susan

Downey, MD, FACS4; Gloria Duda, MD5; Gabriel M. Kind, MD6; Mark L. Jewell, MD7; Diane K. Murphy, MBA8; Max R. Lehfeldt, MD, FACS9; Neil Fine, MD, FACS10

1NYU School of Medicine, New York, NY, USA; 2NYU Plastic Surgery, NYU Langone Medical Center, New

York, NY, USA; 3USC Keck School of Medicine, Los Angeles, CA, USA; 4Private Practice, Los Angeles, CA, USA; 5Aesthetic Center for Plastic Surgery, McLean, VA, USA; 6Private Practice, San Francisco, CA,

USA; 7Private Practice, Eugene, OR, USA; 8Allergan, Inc., Irvine, CA, USA; 9Teleos Plastic Surgery, Pasadena, CA, USA; 10Northwestern Specialists in Plastic Surgery, Chicago, IL, USA

Presented at ORBS 2015, September 21–23, 2015, Nottingham, UK

DisclosuresThe financial arrangements of the authors with companies whose products may be related to the present report are listed below, as declared by the authors

– N Karp … – M Choi … – DA Kulber … – S Downey … – G Duda has served as a clinical investigator for Allergan, Inc., Mentor, and LifeCell. – GM Kind … – ML Jewell has served as a consultant for Allergan, Inc., Keller Medical, Solta, and New Beauty

Magazine; has received research funding through grants or contracts from Allergan, Inc., Mentor, Pfizer-Excaliard, and Solta; and holds patents or has patents pending with AorTech and Pfizer-Excaliard.

– DK Murphy is an employee of Allergan, Inc., and owns stock in the company. – MR Lehfeldt … – N Fine …

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This study was sponsored by Allergan, Inc., Irvine, CA, USA. Writing and editorial assistance was provided to the authors by Peloton Advantage, Parsippany, NJ, USA, and was funded by Allergan, Inc. All authors met the ICMJE authorship criteria. Neither honoraria nor payments were made for authorship.

Authors: Please provide your disclosure information. Thank you.

IntroductionPost-mastectomy breast reconstruction with implant placement may include the use of a device to provide soft-tissue support and stability All soft-tissue support products have been associated with complications, such as seroma, infection, and reconstruction failure1-3

SERI® Surgical Scaffold (SERI) is a silk-derived scaffold developed to provide soft-tissue support o SERI has good biocompatibility4

o SERI is bioresorbed over 12 months, accompanied by transfer of weight-bearing to the newly generated tissue5

A long-term, prospective, multicenter study evaluated the clinical safety, efficacy and surgeon/subject satisfaction of SERI following implantation during stage 1 surgery in 2-stage breast reconstruction (SURE-001) o Long-term findings over 2 years are reported here

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1. Ho G, et al. Ann Plast Surg. 2012;68:346-356. 2. Kim JYS, et al. Plast Reconstr Surg. 2012;129:28-41. 3. Mendenhall SD, et al. Plast Reconstr Surg. 2015;135:29e-42e. 4. Horan RL, et al. Hernia 2009;13:189-199. 5. Gross JE, et al. Plast Reconstr Surg. 2014;134:700e-704e.

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Prospective, Multicenter, 24-Month Study of SERI in 2-Stage Breast ReconstructionSubjects

Adult women undergoing post-mastectomy reconstruction: no radiation treatment prior to the study*

SERI implantation SERI implanted at stage 1 of breast reconstruction for lower breast soft-tissue support

Assessments Breast soft-tissue stability using 3D-imaging and dimensional analysis Safety profile, including adverse events (AEs) and reoperations/explantations Surgeon satisfaction (range: 0 [very dissatisfied] to 10 [very satisfied]): primary endpoint at month 6 Surgeon ease of use assessment (1 [very difficult] to 5 [very easy]) Subject satisfaction with breast reconstruction (1 [very dissatisfied] to 5 [very satisfied])

Analysis Descriptive analyses in the per protocol (PP; primary analysis set) and full analysis (FA) populations

*Per the protocol, subjects receiving radiation during the study were not included in efficacy or satisfaction analyses.

Baseline Subject and Stage 1 Surgery Characteristics

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Characteristic FA Population (n=139)

Age, mean (SD), years 49.8 (10.19)

White, % 77.0

BMI, mean (SD), kg/m2 24.8 (4.22)

Procedure time, mean (SD), minutes 85.8 (39.13)SERI placement, % Unilateral 46.0 SERI trimmed to <200 cm2, %* 70.6

Initial TE fill volume ≥200 cc, % 66.8

Completed with 1–3 volume fill visits, % 39.6Number of TE fills, mean (SD) 4.3 (2.06)

*Starting size of SERI was 250 cm2.

The FA population comprised 139 subjects who had SERI implanted in a total of 214 breasts Among 36 subjects with protocol deviations, 28 subjects received radiation therapy during the study (PP population, n=103)

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Breast anatomy measurements changed little from months 6 through 24 Soft-tissue stability of the lower breast was maintained through 24 months No evidence of late-term soft-tissue stretch was noted

Mean Breast Anatomy Measurements Over 24 Months*

0.0

5.0

10.0

15.0

20.0

25.0

Sternal Notch to Apex Height Apex to IMF

15.3

8.6

22.2

15.4 15.2

8.6

22.1

15.4 15

8.4

21.6

15.1 15.6

7.1

22.7

18

Baseline Month 6 Month 12 Month 24

*Based on the PP population (n=103, 160 breasts). IMF, inframammary fold.

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Representative Photos Over 24 MonthsSubject ID Diagnosis TE Final TE Fill Volume Implant

02-007 Prophylactic Mastectomy

Natrelle 133SV-12 400 cc Natrelle 20-450

Smooth/round (450 cc)

Pre-operative Stage 1 Pre-operative Stage 2

Month 12 Month 24

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08-006 Breast Cancer Natrelle 133MV-15 610 cc Natrelle 20-550



Month 12 Month 24

9


11-020 Prophylactic Mastectomy

Natrelle 133MV-13 620 cc Natrelle 20-550



Month 12 Month 24

Predefined Adverse Events of Interest Occurring at >2% Frequency (by Breast)*

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Adverse Event, n (%) FA Population (n=214 breasts)

Tissue or skin necrosis 18 (8.4)Seroma 16 (7.5)

Capsular contracture 16 (7.5)

Wrinkling/rippling 16 (7.5)Wound dehiscence 11 (5.1)Hematoma 9 (4.2)Skin rash 7 (3.3)Cellulitis 7 (3.3)

Breast redness 6 (2.8)Delayed wound healing 6 (2.8)Asymmetry 5 (2.3)

*Percentages were calculated using the total number of breasts with implants (n=214) as the denominator.

Of 139 subjects, 76 experienced 130 predefined AEs of interest; most (78.5%) were mild in severity Four device-related infections and 1 superficial wound infection occurred; no deep wound infections or suture infections occurred

Adverse Events Leading to Reoperation/ SERI Explantation (by Breast)*

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Subject No.

Device Explanted AE Time After Stage 1 Surgery, Months†

03-006 SERI; implant Breast infection; wound dehiscence 704-002 SERI; implant (bilateral) Capsular contracture 9, 10, 11‡04-038 SERI Breast reconstruction 1106-010 SERI; TE (bilateral) Scaffold/TE infection 2, 511-002 SERI; implant Breast reconstruction 1211-004 SERI; TE Periprosthetic infection 112-002 SERI; TE Radiation-induced soft-tissue

damage9

12-004 SERI; TE Breast reconstruction 312-009 SERI; TE Ruptured TE; breast reconstruction 2414-004 SERI Cellulitis 616-001 SERI Partial nonintegration 9

Of 214 breasts, 13 (6.1%) required reoperation/SERI explantation SERI was retained in 201 of 214 breasts (93.9%) at 24 months Reoperation/explantation was required in 1 subject for ptosis, in none for malposition

*Percentages were calculated using the total number of breasts with implants (N=214) as the denominator. †Calculated to the nearest month, based on 30 days per month. ‡Three successive procedures: capsulotomy and breast revision; implant exchange; free transverse rectus abdominus myocutaneous flap over 2-month period. TE, tissue expander.

The BREASTrial: Stage I. Outcomes From Time of Tissue Expander and Acellular Dermal Matrix Placement to Definitive Reconstruction

This was a single-center, randomized, 2-year study of 128 subjects (199 breasts) undergoing immediate-stage tissue expander breast reconstruction using AlloDerm® (LifeCell Corp.; Branchburg, NJ) or DermaMatrix® (Synthes, Inc.; West Chester, Pa)1

Parameter (%) All Breasts (n=116; 182 breasts)

AlloDerm (n=59; 94 breasts)

DermaMatrix (n=57; 88 breasts)

Overall complication rate (%) 36.2 33.6 38.8

Skin necrosis 19.6 17.8 21.4Infections 15.1 13.9 16.3

Seroma 4.5 6.1 3.1Hematoma 1.0 0.0 2.0Poor integration 13.9 17.4 10.4

Final TE volume (cc) Mean (range) 519 (140-870) 517 (210-860) 522 (140-870)

Number of expansions Mean (range) 3.8 (0.9-2.0) 3.7 (0.8-1.7) 4.0 (0.9-2.2)

1. Mendenhall SD, et al. Plast Reconstr Surg. 2015;135:29e-42e 12

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Surgeons reported a high degree of satisfaction with SERI at month 6; satisfaction ratings remained high through month 24 Surgeons also rated SERI as easy or very easy to use during implantation for >98% of subjects Mean subject satisfaction with breast reconstruction (5-point rating scale) was 4.4 at month 6; from months 6–24, 92.4% to 97.4% of subjects reported being satisfied or very satisfied

Excellent Surgeon and Subject Satisfaction

0123456789

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Stage 2 Month 6 Month 12 Month 18 Month 24

9.59.49.59.49.3 9.69.39.59.69.3

Per protocol (n=103) Full analysis (n=139)

Sat

isfa

ctio

n S

core

Very dissatisfied

Very satisfied

Conclusions

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SERI for soft-tissue support yielded durable breast mound stability, particularly for the lower pole of the breast Subject satisfaction with breast reconstruction was high across all time points AE rates were lower or in line with expectations o Rates of surgical complications and explantations of SERI were low

Surgeons reported consistently high satisfaction with SERI over 24 months SERI provides a safe, long-term benefit for soft-tissue support and repair in 2-stage breast reconstruction

seri surgical scaffold in two-stage breast reconstruction

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