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Cosmetic breast augmentation in Australia: a cost of complication study

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Abstract and Figures

Background: Treatment of complications from cosmetic breast augmentation is subsidised by government funding in Australia. Aim: We aimed to estimate the total cost to the Australian public health system of the treatment of complications following cosmetic breast augmentation. Method: Using the PRISMA 2009 statement, a systematic review was conducted to find articles reporting on complications following cosmetic breast augmentation. A quantitative analysis was performed to calculate overall complication rates. An economic cost analysis was performed on data from procedures performed in Australia between 2000-01 and 2014-15. We modelled costs to the public health system for this period and projected costs to the year 2030. Results: Thirty-nine articles were identified for inclusion in the quantitative analysis of complication rates following cosmetic breast augmentation. Economic modelling showed an estimated cost of over A10millionjustforsurgeonsandsurgicalassistantsfeestotreatcomplicationsbetween2000and2015.WeforecastoverA10 million just for surgeons’ and surgical assistants’ fees to treat complications between 2000 and 2015. We forecast over A50 million for this cost over the subsequent fifteen years. Total health spending on complications is estimated to have been almost A$200 million between 2000 and 2015. Conclusion: This study illustrates the significant economic cost to the Australian health system created by complications following cosmetic breast augmentation. We believe this study reinforces the importance of the Australian breast device registry (ABDR) to further guide regulation, economic policy and health policy.
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Australasian Journal of Plastic Surgery Volume 1 Number 2 2018
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AJOPS | ORIGINAL ARTICLE
PUBLISHED: 24-09-2018
1 Department of Plastic, Reconstructive and Hand Surgery
Peninsula Health
Frankston, Victoria, AUSTRALIA
2 Peninsula Clinical School
Central Clinical School
Monash University
The Alfred Centre
Melbourne, Victoria, AUSTRALIA
3 School of Public Health
Curtin University
Perth, Western Australia, AUSTRALIA
4 CCRE Therapeutics
School of Public Health and Preventive Medicine
Monash University
Melbourne, Victoria
AUSTRALIA
OPEN ACCESS
Correspondence
Name: George S Miller
Address: Department of Plastic and Reconstructive Surgery
Frankston Hospital
Peninsula Health
2 Hastings Road,
Frankston, Victoria, 3199
AUSTRALIA
Email: gsmiller87@gmail.com
Phone: +61 400 177 292
Citation: Miller GS, Robinson S, Reid CM, Hunter-Smith
DJ. Cosmetic breast augmentation in Australia: a cost of
complication study. Aust J Plast Surg. 2018;1(2):51–64.
https://doi.org/10.34239/ajops.v1i2.120
Accepted for publication: 9 April 2018
Copyright © 2018. Authors retain their copyright in the
article. This is an open access article distributed under
the Creative Commons Attribution Licence which permits
unrestricted use, distribution and reproduction in any
medium, provided the original work is properly cited.
Section: Breast
Cosmetic breast augmentation in Australia: a cost of
complication study
George S Miller BMedSc MBBS,1,2 Suzanne Robinson PhD,3 Christopher M Reid PhD MSc
FESC,3,4 David J Hunter-Smith MBBS MPH FRACS1,2
Abstract
Background: Treatment of complications from
cosmetic breast augmentation is subsidised by
government funding in Australia.
Aim: We aimed to estimate the total cost to the
Australian public health system of the treatment
of complications following cosmetic breast
augmentation.
Method: Using the PRISMA 2009 statement, a
systematic review was conducted to find articles
reporting on complications following cosmetic
breast augmentation. A quantitative analysis was
performed to calculate overall complication rates.
An economic cost analysis was performed on data
from procedures performed in Australia between
2000-01 and 2014-15. We modelled costs to the public
health system for this period and projected costs to
the year 2030.
Results: Thirty-nine articles were identified for
inclusion in the quantitative analysis of complication
rates following cosmetic breast augmentation.
Economic modelling showed an estimated cost
of over A$10 million just for surgeons’ and surgical
assistants’ fees to treat complications between 2000
and 2015. We forecast over A$50 million for this
cost over the subsequent fifteen years. Total health
spending on complications is estimated to have been
almost A$200 million between 2000 and 2015.
Conclusion: This study illustrates the significant
economic cost to the Australian health system
created by complications following cosmetic breast
augmentation. We believe this study reinforces the
importance of the Australian breast device registry
(ABDR) to further guide regulation, economic policy
and health policy.
Keywords: costs and cost analysis, mammaplasty, breast,
economic models, health policy
Br
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Introduction
With increased pressure on health care budgets,
we are seeing more focus on the clinical and cost
effectiveness of interventions provided by health
systems globally. The ‘Choosing Wisely’ campaign
recently adopted in a number of countries,
including Australia, focuses on encouraging
patients and clinicians to ‘discuss inappropriate
and potentially harmful tests, treatments and
procedures.’1 While the Australian campaign
is seeing the development and identication of
procedures that may be harmful to patients, there
is a paucity of robust clinical studies that clearly
dene the benet of cosmetic breast augmentation
in non-pathological female breasts. Despite this,
the number of cosmetic breast augmentations
performed in Australia each year is increasing
rapidly, with numbers of procedures more than
doubling over the past decade according to the
most recently documented Australian Institute of
Health and Welfare (AIHW) statistics.2 In addition,
there is an increasing popularity of ‘cosmetic
tourism’ by Australians for such procedures.
The process of having cosmetic breast augmentation
surgery in Australia involves a completely private
arrangement (and transactions) between a
surgeon, anaesthetist, hospital and patient, with no
funding or rebates available through the Medicare-
based public health system. The procedure is not
limited to Royal Australasian College of Surgeons
(RACS) accredited surgeons and, in many instances,
the doctor performing the surgery is a cosmetic
proceduralist. Further, the Australian Society of
Plastic Surgeons’ Breast Implant Registry does not
capture data related to non-specialist surgeons
who perform the procedures.
The most commonly documented complications
that arise from cosmetic breast augmentation
surgery are capsular contracture, implant
rupture, infection, seroma formation, haematoma,
deation, mal-positioning and/or rotation of the
implant, nipple and breast pain or sensation
changes.3-13 While the severity and implications of
complications vary widely according to individuals’
circumstances, they often require further
outpatient and inpatient surgical treatment.
Miller, Robinson, Reid, Hunter-Smith: Cosmetic breast augmentation in Australia: a cost of complication study
Government subsidies cover part or all of the
surgical and medical costs associated with the
subsequent treatment of complications, even
though this ‘burden of disease’ is created entirely
from non-essential cosmetic operations. The
management of these complications therefore
places some level of burden on the health care
system. Hanefeld et al14 suggested that the economic
burden to the United Kingdom’s National Health
Service (NHS) from complications arising from
cosmetic tourism was £8.2 million per annum.
Methods
Using the PRISMA 2009 statement we conducted
a systematic review to nd articles reporting
complication rates following cosmetic breast
augmentation using breast implants (Figure 1).
A literature review of PubMed, Ovid Medline and
the Cochrane (Central) database was performed to
identify relevant articles using the following search
terms: ‘breast augmentation’, ‘cosmetic breast
surgery’, ‘breast implants’, ‘breast prosthesis’,
‘augmentation mammoplasty’, and ‘cosmetic
breast augmentation’. Additional terms included
‘complication’, ‘revision’, ‘capsular contracture’,
‘cost’, and ‘explantation’.
The inclusion criteria were:
English language
explicit documentation of complication rates
following cosmetic breast augmentation
publication later than 1 January 2000
mean follow-up greater than one year.
Exclusion criteria were:
studies involving Poly Implant Prothese (PIP)
implants
studies published prior to 1 January 2000
mean follow-up less than one year
revision augmentations and cosmetic augmentation
performed overseas.
No restrictions were placed on the type of article,
however, special consideration was needed
for statistical analyses appearing in multiple
publications arising from the same long-term
studies. In this circumstance, duplication was
Australasian Journal of Plastic Surgery Volume 1 Number 2 2018
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AJOPS | ORIGINAL ARTICLE
avoided by including only the most recent
publication regarding the study.
Data extracted from each study included author,
year of publication, level of evidence, type of study,
number of patients, follow up, type of prosthesis
used and indication, and outcomes measured. We
extracted data regarding all reported complications,
however, analysis was performed only on more
common short-term complications involving
infection, haematoma and seroma and long-term
complications involving capsular contracture,
rupture and re-operation rates. We attempted
to report complications on a ‘per-patient’ basis
rather that ‘per-implant’. Articles that reported
complications by implant were converted to a
gure according to their overall study population
to allow analysis. Our gures may therefore show
slight discrepancies when compared with original
published data. Incidence of breast augmentation
procedures was extracted from publicly available
data from AIHW.2
Using a top-down costing approach, we calculated
the direct cost of surgical fees for complications. We
then modelled the cost over specic periods for re-
operations arising from breast augmentation. Our
analysis required specic population and surgical
assumptions to enable the calculations, including:
that all procedures performed are primary
augmentations (so as to not over-report
complication rates if we over-estimated the rate of
revision augmentations)
the ratio of saline to silicone implants in Australia
is 5 per cent saline and 95 per cent silicone (to
prevent over-estimation of higher complication rates
associated with saline implant data)
complication rates identied by current literature
worldwide apply to the Australian population.
Operations required for the treatment of
complications or for revision following breast
augmentation were matched to appropriate
Medicare procedure codes including:
exchange of implant procedures (with or without
capsulectomy)
explantation of prosthesis
mastopexy
Miller, Robinson, Reid, Hunter-Smith: Cosmetic breast augmentation in Australia: a cost of complication study
other miscellaneous operations such as drainage of
haematoma or seroma, or debridement of infected
surgical wound.
Procedure codes used in our cost analysis are
documented in Appendix 1 with the overall
Medicare benet attributable to each (including
surgeon and assistant fees). For cost analysis
we modelled the ratio of procedure codes
proportionally for each cause of re-operation. The
ratios reect the common reasons for re-operation
and an approximate rate that these occur. Our
model is designed to reect the complications
according to the proportions demonstrated in the
literature.3-12
Figure 1: PRISMA article selection process
Results
The literature search was conducted in September
2017. The search and selection process is
summarised in Figure 1. Of the 267 articles assessed
for eligibility, 73 matched inclusion criteria and
were reviewed. Of these, 39 studies suciently
reported outcome data suitable for inclusion in
a quantitative analysis of complication rates.
Appendix 2 provides details of the 39 studies used
in the quantitative analysis.
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On the reported complications arising from 39,738
breast augmentation patients, meta-analysis
revealed:
2,462 primary saline augmentations (from six
studies)
32,838 primary silicone augmentations (from 31
studies)
4,438 revision silicone augmentations (from 11
studies).
Where implant type or indication was not explicitly
reported, studies were excluded. Tables 1–3 show
the complication rates identied. No articles
reporting on complications specic to revision
augmentation with saline prostheses met the
criteria for inclusion in the analysis.
Primary augmentation with saline prostheses
Only six articles reported the outcomes of saline
prostheses following primary augmentation. Table
1 summarises rates of complications reported in
each study.
Infection, seroma and haematoma complications
were poorly reported in these studies. Only one
study reported haematoma rates in a study of 20
patients15. No studies reported seroma rates, and
two studies reported infection rates.15,16 The overall
capsular contracture rate was 15.6 per cent (10-
year rate 21.6 per cent). Rupture (or ‘deation’)
was reported in three studies at an overall rate of 6
per cent (10-year rate 7.4 per cent).15-17 Re-operation
occurred in 31.8 per cent of the 1,793 cases (10-year
rate 44.1 per cent).
Swanson et al18 reported re-operation rates of
10.7 per cent for augmentation alone and 20.5 per
cent for augmentation with mastopexy based on
average follow-up periods of 8.3 months and 8.4
months respectively. Given the follow-up periods
in this study were shorter than 12 months, it was
not included for quantitative analysis.
In ve-year reported complication rates by
Walker et al,17 other signicant complications
such as asymmetry, breast pain and malposition
were noted in 12.2 per cent, 17.0 per cent and 9.2
per cent of patients respectively. Swanson et al18
reported asymmetry in 3.8 per cent and 3.4 per cent
respectively in the two groups described above.
Miller, Robinson, Reid, Hunter-Smith: Cosmetic breast augmentation in Australia: a cost of complication study
A signicant positive correlation was detected
between the incidence of complications and patient
age but the correlation was weak (r = 0.10, p <
0.01). Swanson et al also showed that smoking was
associated with increased complication incidence,
as was revision breast surgery (p < 0.01).
Primary augmentation with silicone
prostheses
Thirty-one articles report on outcomes following
primary breast augmentation with silicone
implants and met the criteria for inclusion in
the quantitative analysis. Signicant Food and
Drug Administration (FDA) pre-approval studies
following a 1992 moratorium on silicone implants
in the USA provide most of the long-term data for
these types of prostheses. Core studies included
in this analysis6,7,9 provide prospective, long-
term analysis of silicone implants and associated
complications. Table 1 shows the categorical data
for each included study.
The 31 articles showed an overall re-operation
rate of 11.4 per cent (10-year rate 23.8 per cent)
following primary augmentation with silicone.
This is signicantly lower than reported rates from
all of the FDA studies conducted prospectively over
10 years.6,7,9 Araco et al19 report a comparatively
very low rate of re-operation in one of the largest
cohorts included in this analysis involving 3,002
patients. Caplin,9 Maxwell6 and Spear7 all report re-
operation rates greater than 25 per cent at 10 years.
Asymmetry and rippling were commonly reported
complications not analysed for overall occurrence.
Reported rates of asymmetry ranged from 0.8 per
cent to 7 per cent, while malposition was reported
in as many as 5.3 per cent of cases (range 0.8 to
5.3 per cent). Rippling was sparsely reported, but
documented rates were low (range 0.7 to 2.0 per
cent). Other complications such as nipple sensation
change, breast pain and palpable implant edges
were less commonly reported.
AJOPS | ORIGINAL ARTICLE
Miller, Robinson, Reid, Hunter-Smith: Cosmetic breast augmentation in Australia: a cost of complication st
Table 1: Results of meta-analysis
Primary saline augmentation
Author Year Patients (n) Follow up Haematoma Haematoma Seroma Seroma Infection Infection CC† CC† Rupture Rupture Re-operation Re-operation
(years) count rate count rate count rate count rate count rate count rate
Blount16 2013 402 1.2 NR NR NR NR 6 1.50% 17 4. 30% NR NR 87 21.70%
Fagrell15 2001 20 7.5 1 5% NR NR 0 0% 4 20% NR NR NR NR
Levi20 2008 325 6.04 NR NR NR NR NR NR NR NR 15 4.95% NR NR
Stevens21 2005 324 5 NR NR NR NR NR NR NR NR 17 5.30% NR NR
Walker17 2009 876 10 NR NR NR NR NR NR 182 20.80% 59 6. 80% 320 36.50%
Somogyi22 2015 515 1.5 1.5 NR NR NR NR NR NR NR NR NR 65 12.60%
Total events 1 6 203 91 407
Total patients 2462 20 422 1298 1525 1793
Overall rate 5% 1.42% 15.64% 5.97% 31.80%
Ten-year rate 5% 1.42% 21.60% 7.37% 44.10%
Primary slicone augmentation
Author Year Patients (n) Follow up Haematoma Haematoma Seroma Seroma Infection Infection CC† CC† Rupture Rupture Re-operation Re-operation
(years) count rate count rate count rate count rate count rate count rate
Araco19 2007 3002 6.1 NR NR NR NR NR NR 14 0.50% NR NR 47 1.57%
Basile23 2005 288 2 NR NR NR NR 16 5.56% NR NR NR NR NR NR
Blount16 2013 856 1.2 8 0.90% 2 0.20% 6 0.70% 11 1.30% 32 3.70% 65 7.60%
Brown24 2005 118 1.75 1 0.85% NR NR NR NR 2 1.70% NR NR NR NR
Collis25 2000 53 10 NR NR NR NR NR NR 7 14% NR NR 13 24.50%
Dancey26 2012 1400 6 NR NR NR NR NR NR 376 26.90% NR NR NR NR
Giordano27 2013 330 2 NR NR NR NR NR NR 11 6% NR NR NR NR
Haws28 2014 321 1 NR NR NR NR 4 1.40% 12 3.90% 1 0.40% NR NR
Hvilsom3 2009 5373 3.8 80 1.50% 10 0.20% 102 1.90% 226 4.20% NR NR 260 4.80%
Holmich29 2007 190 19 NR NR NR NR NR NR 117 62% NR NR 74 39%
Kjoller4 2002 754 7 17 2.30% 1 0.20% 15 2.00% 86 11.40% 3 0.50% 84 11.14%
Namnoum5 2013 4412 3 NR NR NR NR NR NR 317 7.10% NR NR 774 17.50%
Maxwell6 2015 492 10 6 1.30% 7 1.60% 8 1.70% 45 9.20% 50 10.20% 146 29.70%
Spear7 2014 455 10 NR NR 8 1.80% NR NR 86 18.90% 42 9.30% 164 36.1%
Lista8 2013 440 1.2 NR NR 15 3.40% NR NR 3 0.70% NR NR 41 10.70%
Niechajev30 2007 80 5 2 2% 2 2% NR NR NR NR 0 0 2 2.50%
Pfeiffer31 2009 436 2 NR NR 12 2.90% 58 6.70% 26 5.90% NR NR NR NR
Sevin32 2006 210 8 NR NR NR NR 0 0% 17 8% 8 4% 21 10%
Caplin9 2014 1124 9 NR NR NR NR 14 1.2% 81 7.2% NR 3.8-10.3% 317 28%
Henriksen10 2003 971 1.3 NR NR NR NR NR NR 45 4.10% NR NR 65 6%
Stevens11 2016 1116 9 NR NR 13 1.20% 10 0.90% 134 11.20% 48 4.30% 248 22.20%
Stevens33 2010 211 2.4 NR NR 2 0.95% 2 0.95% 3 1.20% NR NR 11 5.20%
Benito-Ruiz12 2016 373 5 NR NR 3 0.80% 3 0.80% 13 3.40% 4 1.10% 33 8.90%
Doren34 2015 384 5.3 1 0.26% NR NR NR NR 18 4.70% 3 0.80% 34 8.90%
Doshier35 2016 178 1.25 NR 0.84% NR NR 0 0.00% 0 0.00% 0 0.00% NR 7.97%
Drinane36 2016 55 2 .6 NR NR NR NR NR NR 4 7.28% NR NR NR NR
Flugstad37 2015 2797 1 NR NR NR NR NR NR 57 2.04% NR NR NR NR
Keramidas38 2016 180 1 0 0.00% NR NR 1 0.55% 0 0.00% NR NR NR NR
Kerfant39 2017 156 1.85 2 1.28% NR NR 2 1.28% 6 3.80% NR NR NR 9.94%
McGuire40 2017 5059 4.1 NR NR NR 0.06% NR NR 234 2.30% NR NR NR NR
Somogyi22 2015 1024 1.5 NR NR NR NR NR NR NR NR NR NR 53 5.18%
Total events 117 75 241 1951 191 2452
Total patients 31814 8393 10586 12441 31446 5219 21520
Overall rate 1.39% 0.71% 1.94% 6.20% 3.66% 11.39%
Ten-year rate 1.39% 0.71% 1.94% 14 .39% 6.30% 23.70%
Revision silicone augmentation
Author Year Patients (n) Follow up Haematoma Haematoma Seroma Seroma Infection Infection CC† CC† Rupture Rupture Re-operation Re-operation
(years) count rate count rate count rate count rate count rate count rate
Caplin9 2014 269 9 NR NR NR NR 4 1.40% 54 20.10% NR NR 101 37.50%
Henriksen10 2003 119 1.3 4 3.40% NR NR 4 3.40% 6 5.00% NR NR 65 6%
Maxwell6 2015 156 10 3 2% 5 3.20% 3 2.10% 18 11.90% 8 5.20% 74 47.30%
Spear7 2014 147 10 NR NR 9 6.00% NR NR 42 28 .70% 8 5.40% 67 46.00%
Stevens11 2016 363 9 NR NR 6 1.60% 5 1.50% 47 13.00% 12 3.30% 133 36.60%
Stevens33 2010 141 2.4 NR NR 1 0.70% 1 0.70% 2 1.70% NR NR 10 6.80%
Castello41 2011 49 2 NR NR NR NR NR NR 33 67% NR NR NR NR
Forster42 2012 230 6.1 NR NR NR NR NR NR NR NR NR NR 58 25%
Grewal43 2013 134 1 NR NR NR NR NR NR 39 29% NR NR NR NR
Doren34 2015 198 5.3 0 0 NR NR NR NR 17 8.60% 2 1.00% 38 19%
McGuire40 2017 2632 2.6 NR NR NR 0.15 NR NR 212 4.10% NR NR NR NR
Total events 7 21 17 470 30 546
Total patients 4438 473 807 1048 4208 864 1623
Overall rate 1.48% 2.60% 1.62% 11.17% 3.47% 33.64%
Ten-year rate 1.48% 2.60% 1.62% 27.60% 4.40% 47.60%
CC † = Capsular contracture (Baker III/IV) | NR = Not reported
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Table 2: Total cosmetic breast augmentations since 2000–01 by financial year
Year Bilateral augmentation Unilateral augmentation Total augmentations
2000/01 3105 269 33 74
2001/02 3496 242 3738
2002/03 3564 232 3796
2003/04 4691 247 4938
2004/05 5877 292 6169
2005/06 6370 331 6701
2006/07 7089 318 7407
2007/08 7753 367 8120
2008/09 7239 369 7608
2009/10 7643 394 8037
2010/11 7696 351 8047
2011/12 7405 421 78 26
2012/13 7607 408 8015
2013/14 7880 41 9 8299
2014/15 10383 417 10800
Total 97798 5077 102875
Prevalence 0.84%
Frequency of breast augmentation in the Australian female population 1 every 118 females
Total female population (n=11,614,645)*
* source Australian Bureau of Statistics population data June 2014
Miller, Robinson, Reid, Hunter-Smith: Cosmetic breast augmentation in Australia: a cost of complication study
Figure 2: Bilateral augmentation forecast by year until 2030.
X= number of bilateral augmentations Y= number of years
Cost analysis
Table 2 shows the gures for breast augmentation
procedures performed in Australia per year from
2000-01 to 2014-15.2 These gures do not distinguish
between primary or revision procedures, nor types
of implant used. Using these gures we estimate
the current rate of cosmetic breast augmentation
to be 0.8 per cent of the female population.44 This
equates to 1 in every 118 females in Australia.
We performed modelling to predict the complication
rates occurring at one year and 10 years from the
augmentations performed in 2014-15 alone. From
this single year’s breast augmentations, we predict
a further 2,613 re-operations would be required
over the subsequent 10 years.
Figure 2 shows projected future incidence of
cosmetic breast augmentation in Australia. Based
on the recent trend, we have projected the rate of
breast augmentation in Australian to reach over 2
Revision augmentation with silicone
prostheses
Eleven articles reporting on outcomes following
revision augmentations using silicone prostheses
were used in the quantitative analysis. Seven of
these articles prospectively studied the outcomes
of patients undergoing revision augmentation.
Indications for revision augmentation are
sporadically reported throughout the studies.
Table 1 shows the complication rates for each of
the studies.
Although fewer patients were studied following
revision augmentation, long-term complication
rates are signicantly higher than primary
augmentation. Complications such as haematoma,
seroma and infection are comparable to primary
silicone augmentation—overall rates are 1.5 per
cent, 2.6 per cent, and 1.6 per cent respectively.
Capsular contracture was higher in revision
augmentation with an overall rate of 11.2 per cent
(10-year rate 27.1 per cent). Interestingly, the overall
rate of rupture in revision silicone augmentation
was trending slightly towards a lower rate than in
primary augmentation at 3.5 per cent (10-year rate
4.1 per cent).
The most signicant measure of complications
following augmentation is the re-operation rate.
The overall rate of re-operation following revision
augmentation was calculated to be 33.6 per cent
(ten-year rate 46.7 per cent)—signicantly higher
than the corresponding rate following primary
augmentation (23.7 per cent).
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AJOPS | ORIGINAL ARTICLE
per cent of the entire Australian female population
by the year 2030, equating to 1 of every 38 females
in Australia.
Table 3 shows the estimated cumulative
complications from all augmentations performed
between 2000 and 2015 and the associated cost
for re-operations during this period. The number
of re-operations is estimated to have been 15,251
between July 2000 and June 2015.
If cosmetic breast augmentation rates were to
increase at the current rate until 2030, the cost to
the Australian health system for surgical fees alone
would be in excess of another A$50 million from
now until 2030.
Table 4 shows the total cumulative surgical
reimbursement cost directly attributable to re-
operations performed from 2000-01 to 2029-2030.
Discussion
Many articles have investigated complications
following the insertion of breast prostheses and
compared the performance of different implant
types. Most of these investigate a sole complication
such as infection or capsular contracture. In
2013, an extremely thorough report by Gurgasz
et al45 was performed on behalf of the Australian
safety and ecacy register of new interventional
procedures—surgical. The results of this review
support the statistical ndings of our analysis.
Reviews by Schaub et al,46 Wong et al47 and many
others13, 48-53 also produced results similar to ours.
Miller, Robinson, Reid, Hunter-Smith: Cosmetic breast augmentation in Australia: a cost of complication study
Table 3: Total estimated cost from complications arising f rom augmentations performed from 2000–01 – 2014–15 (A$)
Total augmentation n=10,800 Number of events from 2000–2015
Haematoma 1713.4
Seroma 684.1
Infection 2125.4
Capsular contracture 9405.3
Rupture 4319.9
Re-operation 15251.1
Complications—procedures
and healthcare interventions
(ACH 8th edition) Australia
Proportion of cases
predicted
Number of cases
predicted
Total cost predicted
30024 8% 1221 $338,107.05
31551 8% 1221 $264,651.75
45548 6% 914 $252,995.20
45551 15% 2287 $1,014,741.90
45552 15% 2287 $1,752,711.06
45553 15% 2287 $1,752,711.06
45554 15% 2287 $1,919,570.58
45555 2% 305 $233,745.90
45557 8% 1221 $1,122,416.46
45558 8% 1221 $1,683,441.54
Total 100% 15251 $10,395,092.50
Table 4: Total estimated and forecast cost of complications arising from augmentations performed f rom 2000–01
to 2029–30 (A$)
Total augmentation n=302,82 Number of events from 2000–2030
Haematoma 5039.5
Seroma 2012.2
Infection 6251.3
Capsular contracture 56153.2
Rupture 26345.4
Re-operation 93011.4
Complications—procedures
and healthcare interventions
(ACH 8th edition) Australia
Proportion of cases
predicted
Number of cases
predicted
Total cost predicted
30024 8% 7440 $2,425,812.00
31551 8% 7440 $1,612,620.00
45548 6% 5580 $1,544,544.00
45551 15% 13952 $6,190,502.40
45552 15% 13952 $10,692,533.76
45553 15% 13952 $10,692,533.76
45554 15% 13952 $11,710,471.68
45555 2% 1861 $1,426,233.18
45557 8% 7441 $6,840,213.66
45558 8% 7441 $10,259,204.34
Total 100% 93011 $63,394,668.78
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AJOPS | ORIGINAL ARTICLE
Benefits
Alderman et al54 describe the improvement
in women’s short- and long-term satisfaction
and psychosocial wellbeing following breast
augmentation using the Breast-Q outcome
measure. Their study concludes that breast
implants are effective in improving quality of life.
Their results are supported by other studies.55,56
Our study does not contradict the ndings of these
studies—we analysed the costs without factoring in
these benets. The literature is evolving regarding
the long-term outcomes and benets following
cosmetic breast augmentation.
Cost burden
From the data we have extracted from AIHW
we have demonstrated a signicant nancial
and resource burden on the Australian health
system.2 Our analysis only shows surgeons’ and
surgical assistants’ Medicare rebates. We did not
include complications arising from augmentations
performed prior to 2000, or revision augmentations
and cosmetic augmentation performed
overseas. Our results are therefore a signicant
understatement of the real cost to the public
health system and wider economy. If nothing else,
this economic analysis provides a perspective
regarding the use of resources and the future
challenges to the Australian health sector from a
growing population.
The overall re-operation rate calculated in our
analysis includes 3,002 patients from a series by
Araco et al19 which reported disproportionately
lower re-operation rates than other studies. If we
removed this single article our results show even
higher costs.
Livingston57 reported the cost of cosmetic tourism
on a single health service over 12 months. For
each patient presenting with complications from
cosmetic tourism the associated cost of treatment
averaged A$12,600. This study is reinforced by
the ndings of Miyagi58 who reported similar
costs for treatment of cosmetic tourists in the
United Kingdom. Adabi59 showed costs for treating
complications from cosmetic tourism in the USA
Miller, Robinson, Reid, Hunter-Smith: Cosmetic breast augmentation in Australia: a cost of complication study
averaged US$18,211 per complication, equating to
a cost of over US$1.3 billion on the US economy and
health system.
If we attempted to calculate the total economic
cost of these complications to Australia’s health
system, we could apply the rates determined by
Livingston and Adabi to our calculated incidence
of re-operations from 2000–2015, as follows:
15,251 re-operations at A$12,600 (Livingston) implies
a total cost of A$192 million
15,251 re-operations at US$18,200 (Adabi) implies
a total cost of US$278 million (or A$358 million at
recent exchange rates).
These gures are clearly signicant. While the
applicability of the results of Livingston and Adabi to
Australia must be considered, these large monetary
gures do illustrate the potentially greater cost of
these complications than the gures we estimated.
The cost of the wide range of resources involved in
surgical management of complications could easily
escalate the real cost to something similar to the
hypothetical gures above.
For the future it is important to capture more
detailed data on the cost and medical impact of
cosmetic tourism, including the cost of managing
complications in the public health system. This
needs to be part of a wider discussion relating
to the ‘movement of patients, quality assurance
and standards of care, and procedures for legal
responsibility’.14
We acknowledge that our study has several
limitations. The rst is the lack of high-quality
evidence in the literature. There are no randomised
trials in the meta-analysis. This paper relies
heavily on retrospective and case series data.
We also note that our calculations are estimates
and do not represent gures from a registry or
prospective dataset. Future data collected by the
Australian breast device registry (ABDR) will
enable more accurate modelling and calculation of
the burden of disease created by cosmetic breast
augmentation. The ABDR also allows tracking of
device performance and complication proles. This
is of particular importance regarding conditions
such as anaplastic large cell lymphoma (ALCL).
Australasian Journal of Plastic Surgery Volume 1 Number 2 2018
59
AJOPS | ORIGINAL ARTICLE
Social and psychological burden
The burden of disease created by cosmetic
breast augmentation extends beyond monetary
considerations; medical, social, lifestyle and
psychological risks are associated with cosmetic
surgery. Boulton et al60 illustrated hidden risks—
including medical, social and lifestyle factors—
associated with cosmetic surgery, particularly in
a medical system becoming increasingly market-
based. A recent review by Brunton61 highlighted
the negative psychological impacts of cosmetic
surgery on some patients and described the various
motivating factors linked to poor psychological
outcomes.
Alderman62 reported a signicant improvement in
satisfaction with breasts, psychosocial wellbeing
and sexual wellbeing in a study of 611 patients
following breast augmentation. However, physical
wellbeing was signicantly below baseline
scores both at six weeks and six months. From a
prospective, multi-centre study Murphy55 reported
a 95 per cent rate of satisfaction six years after
augmentation and signicant improvement in body
image, however, he did not nd any improvement
in overall physical health following breast
augmentation. Despite many articles describing the
positive psychological impact following cosmetic
breast augmentation, both Figueroa-Haas63 and
Lipworth64 documented increased suicide risk and
a trebled risk of death from alcoholism and the
abuse of prescription and recreational drugs in
women with breast augmentation.
Medical burden of breast augmentation
Complications following cosmetic breast
augmentation are common. In the short-term,
complications such as infection, seroma, and
haematoma are expected in a low percentage of
patients but become more prevalent over a longer
period. Our results show that women undergoing
cosmetic breast augmentation should be prepared
for at least a 20 per cent rate of re-operation
within ten years, with an increased risk with each
year they have the implant in-situ. These results
are comparable to other systematic reviews and
meta-analyses.13,45-53,65,66 For patients undergoing
revision augmentation, the risk of needing further
surgery is even greater and expected sooner. We
have found that about half of patients will require
a further operation within ten years of revision
augmentation.
Rarer types of complications following cosmetic
breast augmentation were not taken into
account such as brachial plexus impingement,67
silicone lymphadenopathy,68 chronic/late onset
haematoma,69 pneumothorax and cardiac
tamponade70 and recently an increased rate of
ALCL detection.71, 72 Many of these rare events have
signicant negative health effects for the patients
involved and treatment commonly requires
considerable time and resources.
Conclusion
This review presents complication rates following
cosmetic breast augmentation with saline and
silicone prostheses. While we recognise the
potential benet some women gain from cosmetic
breast augmentation, we believe the medical,
social, lifestyle and psychological risks are not fully
appreciated in this minimally regulated market.
Our analysis demonstrates that the economic
costs of complications following cosmetic breast
augmentation are signicant, reinforcing the
important role of the Australian Breast Device
Registry and suggesting a need for increased
regulation.73
Further investigation and more detailed economic
modelling that captures the entire health care cost
of complications following breast augmentation
is needed. A wider discussion around the rights
of patients and the responsibilities of public
health systems is also required focusing on how
we can modify current practices and regulations
to improve patients’ awareness of the potentially
signicant complications as well as who should bear
the nancial burden. The increasing popularity of
cosmetic tourism adds another signicant hurdle
in steps towards fuller regulation.
Miller, Robinson, Reid, Hunter-Smith: Cosmetic breast augmentation in Australia: a cost of complication study
Australasian Journal of Plastic Surgery Volume 1 Number 2 2018
60
AJOPS | ORIGINAL ARTICLE
Acknowledgements
Vicky Tobin PhD, Monash University Plastic and
Reconstructive Surgery Group (Peninsula Clinical
School), Peninsula Health, Frankston, Victoria,
Australia, for contribution to the study design and
critical analysis.
Disclosure
The authors have no nancial or commercial
conicts of interest to disclose.
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Miller, Robinson, Reid, Hunter-Smith: Cosmetic breast augmentation in Australia: a cost of complication study
Australasian Journal of Plastic Surgery Volume 1 Number 2 2018
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AJOPS | ORIGINAL ARTICLE
Appendix 1
Code Description of procedure
Surgeon
Medicare
rebate ($AUD)
Surgical
assistant
rebate ($AUD)
30024 Wound of soft tissue, debridement of extensively infected post-surgical
incision
$326.05 $0.00
31551 Breast, haematoma, seroma or inflammatory condition including abscess,
granulomatous mastitis or similar, exploration and drainage of when
undertaken in the operating theatre of a hospital
$216.75 $0.00
45548 Breast prosthesis, removal of, as an independent procedure $276.80 $0.00
45551 Breast prosthesis, removal of, with excision of fibrous capsule $443.70 $0.00
45552 Breast prosthesis, removal of, with excision of fibrous capsule and
replacement of prosthesis
$638.65 $127.73
45553 Breast prosthesis, removal and replacement with another prosthesis
following medical complications (such as rupture, migration of the
prosthetic material, or capsule formation)
$638.65 $127.73
45554 Breast prosthesis, removal and replacement with another prosthesis,
following medical complications (such as rupture, migration of prosthetic
material, or capsule formation) where new pocket is formed including
excision of fibrous capsule
$699.45 $139.89
45555 Silicone breast prosthesis, removal of and replacement with prosthesis
other than silicone gel prosthesis
$638.65 $127.73
45557 Breast ptosis, correction of by mastopexy by any means (unilateral) $766.05 $153.21
45558 Breast ptosis, correction of by mastopexy by any means (bilateral) $1,148.95 $229.79
Author Year Patients (n) Calculated patient
years
Follow-up
years
Primary saline implants
Blount16 2013 402 482.4 1.2
Fagrell15 2001 20 150 7.5
Levi20 2008 325 1963 6.04
Stevens21 2005 324 1620 5
Walker17 2009 876 8760 10
Somogyi22 2015 515 772.5 1.5
Primary silicone implants
Araco19 2007 3002 18312.2 6.1
Basile23 2005 288 576 2
Blount16 2013 856 102 7.2 1.2
Brown24 2005 118 206.5 1.75
Caplin92014 1124 10116 9
Collis25 2000 53 530 10
Dancey26 2012 1400 8400 6
Giordano27 2013 330 660 2
Haws28 2014 321 321 1
Henriksen10 2003 971 1262.3 1.3
Holmich29 2007 190 3610 19
Hvilsom32009 5373 20417.4 3.8
Kjoller42002 754 5278 7
Appendix 2
Australasian Journal of Plastic Surgery Volume 1 Number 2 2018
64
AJOPS | ORIGINAL ARTICLE
Lista82013 440 528 1.2
Maxwell62015 492 4920 10
Namnoum52013 4412 14528 3
Niechajev30 2007 80 400 5
Pfeiffer31 2009 436 872 2
Sevin32 2006 210 1680 8
Spear72014 455 4550 10
Stevens11 2015 1116 8928 8
Stevens33 2010 211 506.4 2.4
Benito-Ruiz12 2016 373 1865 5
Doren34 2015 384 2035.2 5.3
Doshier35 2016 178 222.5 1.25
Drinane36 2016 55 143 2.6
Flugstad37 2015 2797 2797 1
Keramidas38 2016 180 180 1
Kerfant39 2017 156 288.6 1.85
McGuire40 2016 5059 20741.9 4.1
Somogyi22 2015 1024 1536 1.5
Revision silicone implants
Caplin92014 269 2421 9
Castello41 2011 49 98 2
Forster42 2012 230 1403 6.1
Grewal43 2013 134 134 1
Henriksen10 2003 119 154.7 1.3
Maxwell62015 156 1560 10
Spear72014 147 1470 10
Stevens11 2015 363 2904 8
Stevens33 2010 141 338.4 2.4
Doren34 2015 198 1049.4 5.3
McGuire40 2016 2632 6843.2 2.6
Author Year Patients (n) Calculated patient
years
Follow-up
years
... Complications after cosmetic breast augmentation (BA) are relatively common compared to other cosmetic plastic surgical procedures [1][2][3]. There is a growing consensus amongst plastic surgeons that during the consent phases of patient/doctor consultation, there exists a potential issue surrounding whether patients are being fully informed about the short-term and long-term risks, be it medical or financial [3][4][5]. ...
... Complications after cosmetic breast augmentation (BA) are relatively common compared to other cosmetic plastic surgical procedures [1][2][3]. There is a growing consensus amongst plastic surgeons that during the consent phases of patient/doctor consultation, there exists a potential issue surrounding whether patients are being fully informed about the short-term and long-term risks, be it medical or financial [3][4][5]. While there are strict legal documents that explicitly point out all potential risks associated with BA surgery, these documents can be vague or insufficient in explicitly illustrating the likelihood of such events actually occurring for potential patients [6]. ...
... For dependability of the experimental process, two currently practising Sydney-based certified plastic surgeons were engaged to present the information in the video recordings, Dr Jeremy Hunt 2 and Dr Catherine Boorer. 3 Both plastic surgeons were RACS accredited and experienced in performing the BA procedure and communicating the relevant supporting informed consent information to potential patients. Their role in the video was to explain to the participants the potential risks in the hypothetical scenario of the first cosmetic augmentation consultation. ...
Article
Full-text available
Background: For women who undergo cosmetic breast augmentation, their post-operative risk assessment may not match their pre-operative understanding of the involved risks and likelihood of revision surgeries. This may be due to the potential issues surrounding whether patients are being fully informed about all possible risks and related financial implications during the consent phases of patient/doctor consultation. Methods: To explore comprehension, risk preference, and perceptions of breast augmentation procedure, we conducted a recorded online experiment with 178 women (18-40 years) who received varying amounts of risk-related information from two experienced breast surgeons in a hypothetical first consultation scenario. Results: We find patient's age, self-rated health, income, education level, and openness to experience to be significant factors impacting initial breast augmentation risk preferences (before receiving any risk information). Further, more emotionally stable patients perceived greater breast augmentation risks, were less likely to recommend breast augmentation, and were more likely to acknowledge the likelihood for future revision surgery. After providing women with risk-related information we find increases in risk assessment in all treatment conditions, and that increased amounts of risk information do decrease women's willingness to recommend breast augmentation. But that increased risk information does not appear to increase women's assessment of the likelihood of future revision surgery. Finally, we find some participant individual differences (such as education level, having children, conscientiousness and emotional stability) appear to impact risk assessment post receiving risk information. Conclusion: Continuous improvement of the informed consent consultation process is vital to optimising patient outcomes efficiently and cost-effectively. Greater acknowledgement and emphasis on disclosure of related risks and financial burden when complications arise is also important. As such, future behavioural research is warranted into the factors impacting women's understanding both prior to and across the BA informed consent process.
... The complication profile of surgical tourism has been well recorded, 11,32 and for breast augmentation, delayed complications can represent a significant cost burden on the public health system of the patient's country of origin, 33 further aggravating the cost of complications from private sector breast augmentation leading to reparative surgery in public hospitals. 34 Given that breast implants may remain in situ for 10-15 years and complications can arise at any time, it behooves surgeons to provide fully informed financial consent that outlines several "what if" scenarios to emphasize the potential longer-term risks to patients and to reduce the ever attendant legal challenge to the surgeon for a "failure to disclose" in their informed consent process. 35 Equally important, however, is a treating surgeon's awareness of the possibility of a patient's decisional regret postoperatively if their cosmetic result falls short of their expectations. ...
Article
Full-text available
Background Informed consent is a fundamental pillar of patient rights and is an essential part of good clinical practice. In 2019, the International Confederation of Plastic Surgery Societies launched a survey to collect feedback on informed consent practices, with an aim to develop an international guideline for cosmetic surgery Methods A 15-question survey was sent to delegates of the International Confederation of Plastic Surgery Societies for dissemination to their national society members. The survey comprised a range of quantitative and qualitative questions. Descriptive and thematic analysis was performed. Results There were 364 respondents. Over half of the respondents reported no local informed consent policy, whereas others noted national society, specialist college, or government policies. The majority of respondents believed that the performing surgeon should be responsible for obtaining informed consent with at least two face-to-face consultations. Most respondents agreed with a cooling-off period (duration based on procedure type and use of high-risk devices). Regarding cosmetic breast augmentation, the majority of respondents felt that the performing surgeon should be responsible for postoperative management, including cases that occur as part of surgical tourism. Some respondents incorporate financial consent as part of their informed consent practice. Most supported the development of an international informed consent guideline. Conclusions Informed consent should result from face-to-face consultations with the performing surgeon. There should be a minimum cooling-off period. Postoperative surveillance should be available in all settings. The findings of this survey will help inform an international standardized informed consent guideline for cosmetic surgery.
Article
Full-text available
Background: Natrelle® 410 silicone breast implants are approved in the US for breast augmentation, reconstruction, and revision. Methods: In two ongoing, prospective, multicenter 10-year studies, 17,656 subjects received Natrelle 410 implants for augmentation (n=5059), revision-augmentation (n=2632), reconstruction (n=7502), or revision-reconstruction (n=2463). Capsular contracture, implant malposition, and late seroma were documented. Cox proportional hazards regression analyses evaluated potential associations between subject-, implant-, and surgery-related factors and these complications. Results: Median follow-up was 4.1, 2.6, 2.1, and 2.3 years in the augmentation, revision-augmentation, reconstruction, and revision-reconstruction cohorts, respectively. Incidence of capsular contracture across cohorts ranged from 2.3 to 4.1 percent, malposition, 1.5 to 2.7 percent, and late seroma, 0.1 to 0.2 percent. Significant risk factors for capsular contracture were subglandular implant placement, periareolar incision site, and older device age in the augmentation cohort (p < 0.0001), older subject age in the revision-augmentation cohort (p < 0.0001), and higher body mass index (p = 0.0026) and no povidone-iodine pocket irrigation (p = 0.0006) in the reconstruction cohort. Significant risk factors for malposition were longer incision size in the augmentation cohort (p = 0.0003), capsulectomy at the time of implantation in the reconstruction cohort (p = 0.0028), and implantations performed in physicians' offices versus hospitals or standalone surgical facilities in both revision cohorts (p < 0.0001). The incidence of late seroma was too low to perform risk factor analysis. Conclusions: These data reaffirm the safety of Natrelle 410 implants. Knowledge of risk factors for capsular contracture and implant malposition offers guidance for reducing complications and optimizing outcomes.
Article
Full-text available
Background: Since approval in March 2012, data on Sientra's (Santa Barbara, CA) silicone gel implants have been updated and published regularly to provide immediate visibility to the continued safety and performance of these devices. The 9 year follow-up data support the previously published data confirming the ongoing safety and efficacy of Sientra silicone gel breast implants. Objectives: The authors provide updated 9 year study data for Sientra's round and shaped silicone gel breast implants. Methods: The Core Study is an ongoing 10 year study that enrolled 1788 patients with 3506 Sientra implants across four indications (primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction). For the safety analysis, Kaplan-Meier risk rates were calculated to evaluate postoperative complications, including all breast implant-related adverse effects. For the effectiveness analyses, results were presented through 8 years as patient satisfaction scores were assessed at even years. Results: Through 9 years, the overall risk of capsular contracture was 12.6%. Smooth devices (16.6%, 95% CI, 14.2%, 19.5%) had a statistically significantly higher rate of capsular contracture compared to textured devices (8.0%, 95% CI, 6.2%, 10.4%). Out of the 610 reoperations in 477 patients, over half of all reoperations were due to cosmetic reasons (n = 315; 51.6%). Patient satisfaction remains high through 8 years, with 90% of primary augmentation patients indicating their breast implants look natural and feel soft. Conclusions: The 9-year follow-up data from the ongoing Core Study of the Sientra portfolio of HSC and HSC+ silicone gel breast implants reaffirm the very strong safety profile as well as continued patient satisfaction. Level of evidence: 2 Therapeutic.
Article
Full-text available
Background: Capsular contracture remains a common and dreaded complication of breast augmentation. The etiology of capsular contracture is believed to be multi-factorial, and its causes may include biofilm formation due to implant/pocket contamination with skin flora. It has been shown that insertion funnel use reduces skin contact and potential contamination by 27-fold in a cadaver model. After incorporating the funnel into our surgical protocols, we anecdotally believed we were experiencing fewer capsular contractures in our augmentation practices. Objectives: The purpose of this study was to test the hypothesis that capsular contracture related reoperation rates decreased after insertion funnel adoption using data from multiple practices. Methods: At seven participating centers, we retrospectively reviewed the surgical records from March 2006 to December 2012 for female patients who had undergone primary breast augmentation with silicone gel implants. Group 1 consisted of consecutive augmentations done without the insertion funnel, and Group 2 consisted of consecutive augmentations done with the insertion funnel. The primary outcome variable was development of grade III or IV capsular contracture that led to reoperation within 12 months. Results: A total of 1177 breast augmentations met inclusion criteria for Group 1 and 1620 breast augmentations for Group 2. The rate of reoperation due to capsular contracture was higher without use of the insertion funnel (1.49%), compared to Group 2 with funnel use (0.68%), a 54% reduction (P = 0.004). Conclusions: The insertion funnel group experienced a statistically significant reduction in the incidence of reoperations performed due to capsular contracture within 12 months of primary breast augmentation. Level of evidence: 3 Therapeutic.
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"Cosmetic Tourism," the process of traveling overseas for cosmetic procedures, is an expanding global phenomenon. The model of care by which these services are delivered can limit perioperative assessment and postoperative follow-up. Our aim was to establish the number and type of complications being treated by a secondary referral hospital resulting from "cosmetic tourism" and the cost that has been incurred by the hospital in a 1-year period. Retrospective cost analysis and chart review of patients admitted to the hospital between the financial year of 2012 and 2013 were performed. Twelve "cosmetic tourism" patients presented to the hospital, requiring admission during the study period. Breast augmentation was the most common procedure and infected prosthesis was the most common complication (n = 4). Complications ranged from infection, pulmonary embolism to penile necrosis. The average cost of treating these patients was AUD12597.71.TheoverallfinancialburdenofthecomplicationtothehospitalwasAUDAUD 12 597.71. The overall financial burden of the complication to the hospital was AUD151 172.52. The "cosmetic tourism" model of care appears to be, in some cases, suboptimal for patients and their regional hospitals. In the cases presented in this study, it appears that care falls on the patient local hospital and home country to deal with the complications from their surgery abroad. This incurs a financial cost to that hospital in addition to redirecting medical resources that would otherwise be utilized for treating noncosmetic complications, without any remuneration to the local provider.
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'Medical Tourism' - the phenomenon of people travelling abroad to access medical treatment - has received increasing attention in academic and popular media. This paper reports findings from a study examining effect of inbound and outbound medical tourism on the UK NHS, by estimating volume of medical tourism and associated costs and benefits. A mixed methods study it includes analysis of the UK International Passenger Survey (IPS); interviews with 77 returning UK medical tourists, 63 policymakers, NHS managers and medical tourism industry actors policymakers, and a review of published literature. These informed costing of three types of treatments for which patients commonly travel abroad: fertility treatment, cosmetic and bariatric surgery. Costing of inbound tourism relied on data obtained through 28 Freedom-of-Information requests to NHS Foundation Trusts. Findings demonstrate that contrary to some popular media reports, far from being a net importer of patients, the UK is now a clear net exporter of medical travellers. In 2010, an estimated 63,000 UK residents travelled for treatment, while around 52,000 patients sought treatment in the UK. Inbound medical tourists treated as private patients within NHS facilities may be especially profitable when compared to UK private patients, yielding close to a quarter of revenue from only 7% of volume in the data examined. Costs arise where patients travel abroad and return with complications. Analysis also indicates possible savings especially in future health care and social costs averted. These are likely to be specific to procedures and conditions treated. UK medical tourism is a growing phenomenon that presents risks and opportunities to the NHS. To fully understand its implications and guide policy on issues such as NHS global activities and patient safety will require investment in further research and monitoring. Results point to likely impact of medical tourism in other universal public health systems.
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Background: Antibacterial lavage with topical antibiotics may reduce the occurrence of capsular contracture (CC) in breast augmentation. Objectives: The authors investigate the efficacy of povidone-iodine combined with antibiotic irrigation in reducing the CC rate. Methods: The charts of 330 consecutive women who underwent cosmetic breast augmentation during 2 different periods (group A: 2004–2009, n = 165; group B: 2009–2010, n = 165) were retrospectively reviewed. All patients in the series underwent augmentation with the same surgeon (A.S.) via the inframammary approach and dual-plane pocket. In group A, patients received a single perioperative dose of 1.5 g of intravenous cephalothin and 750 mg of oral cephalexin twice a day for 7 days after discharge. In group B, patients perioperatively received 750 mg of intravenous cefuroxime, and each implant and pocket were irrigated with 25 mL of a 10% povidone-iodine solution mixed with 750 mg of cefuroxime and 80 mg of gentamicin diluted in 15 mL of 0.9% sodium chloride solution. After discharge, patients received 500 mg of oral levofloxacin once a day for 5 days. Postoperative complications included occurrence of infection, hematoma, seroma, and CC. Results: Mean (SD) postoperative follow-up in groups A and B was 24 (+/− 13) months and 22 (+/− 3) months, respectively. The postoperative superficial wound infection rate was 1.8% and 1.2%, the seroma rate was 1.8% and 1.2%, and the hematoma rate was 0.6% and 1.2% in groups A and B, respectively. Ten CC cases (Baker grade 3 or 4) in group A and 1 in group B were reported (6% vs 0.6%; P = .006). Conclusions: Povidone-iodine and antibiotic irrigation in cosmetic breast augmentation yielded a lower CC rate than standard perioperative antibiotics in this series of patients. Level of Evidence: 3
Article
Background: The role of prophylactic antibiotics in breast augmentation remains controversial. However, the majority of surgeons are administering antibiotics. Objective: To investigate the effect of antibiotic(s) use in the incidence of infection and capsular contracture following breast augmentation. Methods: From September 2004 to November 2010, 180 patients underwent primary bilateral breast augmentation. They were prospectively divided into two equal groups: in group A (n=90), no antibiotics were given and, in group B (n=90), only one intravenous dose of cephalosporin was administered during the induction of general anesthesia. Preoperative data included age, body mass index, smoking status, medical history and implant volume. All operations were performed by the same surgeon using the same surgical technique and implant type. No drains were used. Operative data included operative time and estimated blood loss. Patients were evaluated for complications such as infection, hematoma and capsular contracture. The study concluded when all of the patients underwent the one-year follow-up. The Student's t test was used to analyze the results. Results: All patients completed the study and both groups had similar demographic data. No differences in operative data were observed. The mean operative time was 35 min and the mean blood loss was found to be minimal. In group A, no implant infections were reported, while a wound infection that occurred was treated successfully with oral antibiotics. In group B, no implant or wound infection was noticed. No capsular contractures or hematomas were observed. Conclusions: The number of patients who underwent primary breast augmentation without antibiotics (n=90) was insufficient to draw any definitive conclusions. However, the present prospective study demonstrated that prophylactic use of antibiotics in breast augmentation had no significant effect on infection and capsular contracture rates. Further randomized clinical trials, in combination with guidelines from aesthetic plastic surgery societies, appear to be warranted.
Article
Background Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a rare, Non-Hodgkin lymphoma arising in the capsule of breast implants. BIA-ALCL presents as a recurrent effusion and/or mass. Tumours exhibit CD30 expression and are negative for anaplastic lymphoma kinase (ALK). We report the multi-disciplinary management of the UK series and how the stage of disease may be used to stratify treatment. Methodsmaterials-methods Between 2012 and 2016, 23 cases of BIA-ALCL were diagnosed in 15 regional centres throughout the UK. Data on breast implant surgeries, clinical features, treatment and follow-up were available for 18 patients. Results The mean lead-time from initial implant insertion to diagnosis was 10 years (range: 3-16). All cases were observed in patients with textured breast implants or expanders. Fifteen patients with breast implants presented with stage I disease (capsule confined), and were treated with implant removal and capsulectomy. One patient received adjuvant chest-wall radiotherapy. Three patients presented with extra-capsular masses (stage IIA). In addition to explantation, capsulectomy and excision of the mass, all patients received neo-/adjuvant chemotherapy with CHOP as first line. One patient progressed on CHOP but achieved pathological complete response (pCR) with Brentuximab Vedotin. After a mean follow-up of 23 months (range: 1-56) all patients reported here remain disease-free. Discussion BIA-ALCL is a rare neoplasm with a good prognosis. Our data support the recommendation that stage I disease be managed with surgery alone. Adjuvant chemotherapy may be required for more invasive disease and our experience has shown the efficacy of Brentuximab as a second line treatment.
Article
The aim of this study was to prospectively evaluate patient satisfaction and quality of life with elective breast augmentation. Patients with bilateral submuscular breast augmentations prospectively completed the BREAST-Q preoperatively and 6 weeks and 6 months postoperatively; t tests compared preoperative and postoperative scores at 6 weeks and 6 months, and standard indicators of effect sizes were calculated. Logistic regression was used to evaluate the association between patient and surgical factors on satisfaction outcomes. The study sample included 611 female patients with the following characteristics: (1) mean age of 33.5 years; (2) mean body mass index of 21.7; (3) and mean implant volume of 360; with (4) 73 percent having received a silicone implant. Significant improvements were found in patient satisfaction with breasts (p < 0.001), psychosocial well-being (p < 0.001), and sexual well-being (p < 0.001) at 6 weeks and 6 months postoperatively, and all were associated with a very large Kazis effect size of 3.66, 2.39, and 2.56 at 6 months, respectively. However, at both 6 weeks and 6 months postoperatively, physical well-being remained significantly below preoperative baseline scores. In addition, satisfaction with breasts and with the overall surgical experience was significantly lower among older patients (p = 0.01 and 0.02, respectively). Breast augmentation is associated with high patient satisfaction and significant improvements in quality of life. However, physicians should inform patients that submuscular augmentations are associated with a delay in recovery of physical functioning and be aware that older patients may experience diminished satisfaction and should counsel accordingly. Therapeutic, IV.
Article
Background: The safety of augmentation mammaplasty has increased dramatically in the past 20 years. Capsular contracture (CC) is the most commonly reported complication of augmentation mammaplasty. Objectives: The authors report the incidence of CC in a low-risk patient population after primary augmentation. Methods: The authors retrospectively reviewed the charts of 856 consecutive patients who underwent primary augmentation mammaplasty between 1999 and 2009. This series did not include patients who underwent breast augmentation–mastopexy, secondary augmentation, revision, and/or reconstruction. Data points included demographics, functional and aesthetic outcomes, complications, and revision rate/type. Results: The overall incidence of CC in 856 patients was 2.8%. Average follow-up time was 14.9 months. Antibiotic irrigation decreased CC rates from 3.9% to 0.4% (P = .004). Tobacco users had higher rates of contracture than nonsmokers (5.5% vs 1.9%; P = .036). Saline implants had a higher CC rate than silicone gel (4.3% vs 1.3%; P = .032). Using multivariate logistic regression, CC was 7.89 times more likely in saline implants than in silicone gel (P = .027, 95% confidence interval, 1.26–49.00). Conclusions: Based on our findings, it is apparent that the early CC rate in primary augmentation can be less than 1%. To avoid CC, we advocate an inframmamary approach, submuscular implant placement, and antibiotic irrigation of the breast pocket. Level of Evidence: 3