Table 2: Relevant Papers.

 

Author, date and country

Patient group

Outcomes

Key results

1

Martin L 2013 May UK [1]

Joint Guidelines of ABS/BAPRAS

ADM does not increase the risk of post radiotherapy capsular contracture (4 folds), and might decrease this risk.

ADM is indicated in: Planned immediate IBBR

Alternative to 2 staged IBBR Mastectomy weight of  > 600 gms Adequate skin envelope

2

Sbitany H 2017 Dec USA [2]

Post mastectomy Breast Reconstruction

Use of ADM has enhanced the aesthetics and outcome

Reduced risk of capsular contracture rates Better aesthetic definition, implant coverage and soft tissue support

3

Apte A 2016 Jan UK [3]

53 One stage ADM- assisted IBBR

Patient Reported Outcome Measures (PROMs):

1.7 days mean hospital stay post-surgery.

93.3% high level of body confidence

6.7% post-surgery pain Return to light activity in 2.5 weeks and full activity 5.4 weeks

ADM-assisted IBBR shows high level of cosmetic satisfaction, shorter recovery and low incidence of post-operative pain

4

Kankam HKN, et al. [4]

2018 Jan UK

137 implant only reconstruction vs. 127 implant + ADM Reconstruction

Increase of Implant based reconstruction with ADM from 16% to decrease of DIEP and LD approach No difference of early complications rates with or without ADM

Introducing ADM has shifted the breast reconstruction approach to implant based to replace the more complicated and expensive autologous techniques

5

Tran BNN, et al. [5] 2017 Sept. USA

TE/I + ADM cost vs. DIEP cost (including complications cost)

13 304.55 TE/I +ADM

$10,237.13 DIEP

Including complications:

$13,963.46TE/I + ADM

$12,624.29DIEP

DIEP has lower cost compared to two staged TE/I + ADM approach

6

Krishnan NM

2014 April USA [6]

Comprehensive literature review was carried out for complications of two staged IBBR to determine the cost effectiveness of ADM usage vs. IBBR without using the ADM

30% complications rate with ADM 34.5% complications rate without ADM

Base cost increase of $361.96 with using the ADM.

Increased of Quality Adjusted Life Years with ADM is 1.37

Despite increased cost, ADM usage in 2 staged IBBR is cost effictive

7

Hunsicker LM

2017 Jan. USA [7]

1584 ADM-assisted direct to implant one stage operations

Complications rate comparable to 2 staged IBBR

One stage ADM- assisted IBBR is a safe, reliable and effective approach with comparable complications rate to 2 staged approach

8

Chopra K 2017 April USA [8]

Post mastectomy with 2 staged IBBR + ADM

Biopsies from ADM adjacent tissue showed less thick capsule compared to pectoral adjacent tissue

Using ADM in the first stage of 2 staged IBBR reduced the thickness and inflammatory character of the capsule

9

Headon H 2016 June UK [9]

118 post SSM with IBR + ADM (SURGIM END)

Patient Satisfaction 9/10

Capsular contracture 2.9/10

ADM(SurgiMend) in IBBR has high patient satisfaction rate and very low inflammatory reaction.

Neither prior radiotherapy nor post-operative radiotherapy are contraindications to using it.

10

Yu D, et al. 2016 May USA [10]

24 ADM capsules

Vs. 24 non-ADM capsules histologically analysed

Significantly less vascular proliferation in the ADM capsule.

Decreased inflammatory response and capsular contracture in the ADM IBBR

11

Lee KT 2016 Feb.

South Korea [11]

Meta-analysis of studies comparing submascular traditional IBBR to ADM IBBR 2011-

2014 (6199 cases)

The use of ADM increased the risks of infection, seroma and skin necrosis.

The use of ADM decreased the risk of capsular contracture and implant malposition.

ADM allowed greater expansion

Over all morbidity related to ADM use is not remarkable ADM benefits of reducing late complications and improving implant dynamics are appreciable.

12

Ibrahim AM June 2015 USA [12]

5 Independent blinded plastic surgeons objectively reviewed pre and post-operative photos of 20 TE/I IBBR vs. 18 TE/I + ADM IBBR for

cosmetic outcome

ADM improved: breast contour, lower pole projection, implant placement and inframammary fold definition

ADM-assisted IBBR is aesthetically superior to non ADM-assisted IBBR

13

Forsberg CG

2014

USA [13]

18 blinded evaluators scored the cosmetic appearance of post-operative photographs from 1 to 5 in patients had IBBR.

Total of 183, 58 ADM-assisted and 125 traditional submuscular reconstruction

ADM group showed higher infection rate, lower capsular contracture rate and better contour, symmetry and aesthetic appearance

The use of ADM in IBBR confer a significant advantage in aesthetic outcome and capsular contracture risk reduction with a higher risk of infection