Keywords
breast neoplasm - breast reconstruction - exposed implant - infection
Palavras-chave
neoplasia de mama - reconstrução da mama - exposição de implante - infecção
Introduction
The rate of postmastectomy breast reconstruction (PMBR) has increased worldwide.[1]
[2]
[3]
[4]
[5] In the United States, there was an increase of 35% between 2000 and 2017, with more
than 100 thousand procedures performed in 2017.[6] In Brazil's public health system, the rate of PMBRs increased from 15% in 2008 to
29% in 2014.[3] Breast reconstruction is associated with cosmetic and psychosocial benefits, and
improvements in quality of life.[7]
[8]
[9]
[10] Among the different types of breast reconstruction, implant-based surgery is the
most common option.[1]
[2]
[11] Several studies[12]
[13]
[14]
[15] have already demonstrated that this type of reconstruction is not associated with
a negative impact on the oncologic results of breast cancer treatment, or with an
increased risk of developing postoperative complications when compared with mastectomy
alone.
Of all possible complications, implant infection and exposure remain major concerns,
as they can lead to implant loss and bad cosmetic results.[7]
[16]
[17]
[18] The rate of implant infection varies between 1% and 35.4%, and exposure occurs in
0.25% to 8.3% of all implant-based breast reconstructions.[19]
[20]
[21]
[22]
[23] Several factors are associated with implant infection and exposure: chemotherapy,
radiotherapy, tumor size, obesity, older age, axillary dissection, smoking, and the
comorbidities of the patient.[16]
[19]
[24]
[25]
Traditionally, implant infection is treated with antibiotic therapy, removal of the
implant, and delayed reconstruction.[23]
[26]
[27]
[28]
[29]
[30] More recently, cases of implant salvage have been reported.[11]
[23]
[26]
[29]
[30]
[31]
[32] However, there is no consensus on the definition of implant salvage and on the clinical
management of this situation. Device salvage might be defined as maintaining the implant
itself, or the implant pocket, or even as salvage of the reconstructive result.[11] The attempt of saving the implant may include only systemic antibiotics, or antibiotics
associated with a surgical procedure (wound drainage, pocket lavage, capsulotomy,
and implant exchange).[11]
[26]
[29]
[31]
[32] To salvage exposed implants, authors report capsular flap coverage,[33]
[34] device exchange with primary suture,[26]
[31] or device exchange with muscular flap.[26]
[31]
In face of the lack of structured and clear information concerning the management
of patients with implant exposure with or without infection after breast reconstruction,
in the present manuscript, we review our cases and provide a clinical roadmap for
the management of these patients.
Methods
We conducted a retrospective review of consecutive patients submitted to implant-based
breast reconstruction between January 1st, 2014, and June 30st, 2016. Mastectomies
were performed by one of seven surgeons of Breast Unit of Hospital Nossa Senhora das
Graças, in the city of Curitiba, Southern Brazil. The same surgeon performed all breast
reconstructions and managed the complications. Preoperative antibiotic prophylaxis
with 2 g of Cefazolin was administrated in every case. Clindamycin was used for patients
allergic to β-lactams. We used implants from two manufacturers: Allergan plc (Dublin,
Ireland), and Mentor Worldwide LLC (Irvine, CA, United States). The study was approved
by the local Ethics Committee (under protocol no. 178.554).
The following demographic data were analyzed for each patient: age, presence of comorbidities,
body mass index (BMI), smoking, previous breast surgeries, chemotherapy, radiotherapy,
and axillary dissection. Regarding the surgical technique, the following data were
evaluated: type of mastectomy (nipple-sparing or skin-sparing mastectomy), use of
autologous tissue, timing of reconstruction (immediate or delayed), type of protheses
(definitive or temporary), and breast weight. The type of reconstruction was defined
individually for each patient by the surgical team, considering oncological staging,
the patients' desire, biophysical characteristics, type of surgery, risk factors,
and adjuvant treatment. Patients submitted to breast reconstruction with a different
team of surgeons, those submitted to cosmetic surgeries, those with follow-up shorter
than 3 months, and patients initially submitted to reconstruction with a myocutaneous
flap were excluded.
The patients were treated according the same management protocol ([Fig. 1]). Briefly, after identifying implant exposure, three factors are evaluated: previous
irradiation, presence of infection, and presence of necrosis. For patients previously
submitted to radiotherapy, implant removal and myocutaneous reconstruction is indicated.
Primary suture or local flap advancement are indicated for those that have not received
irradiation, have no signs of severe infection, and have minor necrosis. Patients
presenting severe infection and/or extensive necrosis are submitted to implant removal
and delayed reconstruction with a tissue expander after at least 3 months. If there
is another failure in this second procedure, reconstruction with a myocutaneous flap
is indicated.
Fig. 1 Management protocol for exposed implants after immediate breast reconstruction.
Severe implant infection was defined as local inflammatory signs (erythema, edema,
cellulitis, local warmth), with or without purulent discharge, associated with systemic
inflammatory response (fever, leukocytosis, or hypotension). Necrosis of the flap
was defined as absence of vitality of the overlying tissue, causing loss of function.
Extensive necrosis is defined when there is no possibility of approaching the viable
tissues surrounding the lesion.
Statistical Analysis
Descriptive data was presented as frequencies and percentages. The Pearson Chi-squared
test was used to compare the rates of complications of each risk factor, and Fisher
exact test was used when necessary. The Student t-test was used for the continuous variables, and the Mann-Whitney U test, for the
ordinal variables. Values of p < 0.05 were considered statistically significant. The software used was the Epi Info
(Centers for Disease Control and Prevention, Atlanta, GA, United States), version
7.
Results
A total of 277 mastectomies with implant-based reconstruction were performed in 232
patients in the period analyzed. Of the 45 contralateral mastectomies performed, 32
(71.1%) were prophylactic (11 with proven breast cancer related-mutations, and the
others with family history of breast cancer or presence of atypical lesions), and
13 (28.9%) were oncologic (synchronic tumors). The mean follow-up was of 19.2 months.
[Table 1] shows the clinical and epidemiological characteristics of the study cohort. The
mean age was of 50.2 years (range: 23 to 84 years), and 83% of the patients were younger
than 65 years of age at the day of the surgery. Most patients did not have any comorbidities
(79.4%), and had BMIs of up to 25 kg/m2 (64.3%). Of all patients, 12.3% had history of smoking, and 27.4% received neoadjuvant
chemotherapy. In total, 56 patients had 1 or more complications (20.2%); of these,
36 needed hospitalization. The most common complication was implant exposure (n = 33; 11.9%), followed by small tissue necrosis (n = 27; 9.4%), severe infection (n = 18; 6.5%) and extensive necrosis (n = 7; 2.5%). The mean time between surgery and prosthesis exposure was of 7 weeks.
Table 1
Clinical and epidemiological characteristics of the study cohort
|
Characteristic
|
Number of patients (%)
|
|
Age in years (standard deviation)
|
50.2 (10.56)
|
|
Menopausal status
|
|
|
Premenopausal
|
167 (60.3%)
|
|
Postmenopausal
|
110 (39.7%)
|
|
Comorbidities
|
|
|
None
|
220 (79.4%)
|
|
Cardiovascular disease
|
45 (16.2%)
|
|
Diabetes
|
16 (5.8%)
|
|
History of smoking
|
|
|
Yes
|
34 (12.3%)
|
|
No
|
243 (87.7%)
|
|
Body mass index
|
|
|
≤ 25 kg/m2
|
178 (64.3%)
|
|
25–30 kg/m2
|
66 (23.8%)
|
|
≥ 30 kg/m2
|
33 (11.9%)
|
|
Type of mastectomy
|
|
|
Skin-sparing mastectomy
|
80 (28.9%)
|
|
Nipple-sparing mastectomy
|
197 (71.1%)
|
|
Previous breast surgery
|
|
Yes
|
55 (19.9%)
|
|
No
|
222 (80.1%)
|
|
Radiotherapy
|
|
|
Prior to surgery
|
12 (4.3%)
|
|
After surgery
|
42 (15.2%)
|
|
No
|
224 (80.9%)
|
|
Neoadjuvant chemotherapy
|
|
Yes
|
76 (27.4%)
|
|
No
|
201 (72.6%)
|
|
Mean weight of the breast (grams)
|
408.06
|
|
Complications
|
|
|
No
|
221 (79.8%)
|
|
Yes
|
56 (20.2%)
|
|
Prothesis exposure
|
33 (11.9%)
|
|
Small-tissue necrosis
|
27 (9.4%)
|
|
Severe infection
|
18 (6.5%)
|
|
Extensive necrosis
|
7 (2.5%)
|
[Table 2] shows the comparison between patients with and without implant exposure. No associations
were found regarding age, menopausal status, comorbidities, history of smoking, previous
breast surgery, radiotherapy, type of surgery, type of prothesis, mean weight of the
breast, and manufacturer of the prothesis. A higher proportion of BMIs between 25 kg/m2 and 30 kg/m2 was found among patients with exposure than among those without it (30.3% (n = 10 out of 33) versus 22.9% (n = 56 out of 244) respectively), as well as a higher proportion of BMIs above 30 kg/m2 (21.2% versus 10.7% respectively), but these findings were not statistically significant
(odds ratio [OR] = 1.68; 95% confidence interval [95%CI]: 0.72–3.90; p = 0.17; and OR = 2.35; 95%CI: 0.90–6.18; p = 0.06 respectively). Among patients with implant exposure there was also a higher
proportion of axillary dissection (27.3% (n = 9 out of 33) versus 18.9% (n = 46 out of 244) among patients without exposure), although this difference was not
statistically significant.
Table 2
Univariate analysis between the two groups
|
Characteristic
|
Prothesis exposure (n = 33) (%)
|
No exposure (n = 244) (%)
|
Odds ratio (95% confidence interval)
|
Fisher exact
|
|
Menopausal status
|
|
|
|
|
|
Premenopausal
|
20 (12.0%)
|
147 (88%)
|
1.01 (0.48–2.12)
|
NS*
|
|
Postmenopausal
|
13 (11.8%)
|
97 (88.2%)
|
|
|
|
Comorbidities**
|
|
|
|
|
|
None
|
24 (11.0%)
|
196 (89.0%)
|
|
|
|
Diabetes
|
2 (12.5%)
|
14 (87.5%)
|
1.16 (0.25–5.45)
|
NS
|
|
Cardiovascular disease
|
8 (18.0%)
|
37 (82.0%)
|
1.76 (0.74–4.23)
|
NS
|
|
History of smoking
|
|
|
|
|
|
Yes
|
5 (14.7%)
|
29 (85.3%)
|
1.32 (0.47–3.70)
|
NS
|
|
No
|
28 (11.5%)
|
215 (88.5%)
|
|
|
|
Body mass index
|
|
|
|
|
|
≤ 25 kg/m2
|
16 (9.0%)
|
162 (91.0%)
|
|
|
|
25–30 kg/m2
|
10 (15.1%)
|
56 (84.9%)
|
1.80 (0.77–4.21)
|
NS
|
|
≥ 30 kg/m2
|
7 (21.2%)
|
26 (78.8%)
|
2.72 (1.02–7.26)
|
NS
|
|
Previous breast surgery
|
|
|
|
|
|
No
|
29 (13.1%)
|
193 (86.9%)
|
0.52 (0.17–1.55)
|
NS
|
|
Yes
|
4 (7.3%)
|
51 (92.7%)
|
|
|
|
Radiotherapy
|
|
|
|
|
|
No
|
28 (12.6%)
|
195 (87.4%)
|
|
|
|
Prior to surgery
|
1 (8.3%)
|
11 (91.7%)
|
0.63 (0.07–5.09)
|
NS
|
|
After surgery
|
4 (9.5%)
|
38 (90.5%)
|
0.73 (0.24–2.21)
|
NS
|
|
Neoadjuvant chemotherapy
|
|
|
|
|
Yes
|
10 (13.1%)
|
66 (86.9%)
|
1.17 (0.53–2.59)
|
NS
|
|
No
|
23 (11.4%)
|
178 (88.6%)
|
|
|
|
Mean weight of the breast (grams)
|
453.7
|
397.4
|
p = 0.197***
|
|
|
Type of mastectomy
|
|
|
|
|
|
Skin-sparing mastectomy
|
11 (13.8%)
|
69 (86.2%)
|
1.26 (0.58–2.75)
|
NS
|
|
Nipple-sparing mastectomy
|
22 (11.1%)
|
175 (88.9%)
|
|
|
|
Type of prothesis
|
|
|
|
|
|
Silicone
|
20 (13.4%)
|
129 (86.6%)
|
|
|
|
Temporary expander
|
2 (11.8%)
|
15 (88.2%)
|
1.16 (0.24–5.47)
|
NS
|
|
Definitive expander
|
11 (10.1%)
|
98 (89.9%)
|
1.38 (0.63–3.01)
|
NS
|
|
Prothesis Manufacturer
|
|
|
|
|
|
Allergan plc
|
19 (12.3%)
|
135 (87.7%)
|
1.05 (0.50–2.20)
|
NS
|
|
Mentor Worldwide LLC
|
14 (11.8%)
|
105 (88.2%)
|
|
|
|
Axillary dissection
|
|
|
|
|
|
Yes
|
9 (16.4%)
|
46 (83.6%)
|
1.68 (0.73–3.88)
|
NS
|
|
No
|
23 (10.4%)
|
198 (89.6%)
|
|
|
Abbreviation: NS, not significant.
Notes: *The Fisher exact test was considered not significant when p > 0.05. **The percentage is over 100% because some patients had 2 or more comorbidities.
***The Student t-test was used for the comparative analysis of the means.
[Figure 2] illustrates the protocol for the management of all patients with implant exposure.
The first question is if the patient had been previously submitted to radiotherapy.
Of the 33 cases of exposed prosthesis, 2 (6.1%) patients had history of radiotherapy
and had their devices removed ([Fig. 3]); delayed reconstruction with a myocutaneous flap was performed in both cases. The
remaining 31 patients had not received radiotherapy, and were evaluated for signs
of severe infection. The answer was affirmative in 12 cases, and they were submitted
to implant removal. At the end of the follow-up, 4 of these patients had undergone
reconstruction with a tissue expander, and 1 (8.3%), with a myocutaneous flap. The
remaining 7 patients (58.3%) either chose not to proceed with the delayed reconstruction
(n = 6), or did not have success with the second attempt (n = 1).
Fig. 2 Clinical management of the study cohort according to the protocol.
Fig. 3 Temporal evolution of extrusion in an irradiated patient.
In total, 19 patients had no signs of severe infection or previous irradiation; of
these, 5 (26.3%) presented with extensive tissue necrosis ([Fig. 4]). All of them were initially submitted to removal of the device. After the removal,
4 (66.7%) patients underwent reconstruction with a tissue expander, and 1 (16.7%),
with a myocutaneous flap. One of these patients died due to the oncologic disease.
The remaining 14 (42.4%) patients had no signs of severe infection, previous irradiation,
or extensive tissue necrosis, and were submitted to primary suture as an attempt to
salvage the implant ([Fig. 4]). Of these, the original implant was kept in 8 cases (57.1%). Of the remaining 6
patients, 3 (50%) changed the implant for a tissue expander; 2 (33.3%) choose not
to reconstruct the breast; and 1 (16.7%) was submitted to reconstructiona with myocutenoues
flap due to the bad quality of the skin.
Fig. 4 Postoperative photographs after immediate reconstruction. (A) Good result after immediate reconstruction. (B) Local severe infection. (C) Minor exposure of the prothesis. (D) Extensive necrosis.
At the end of the follow-up, reconstruction was successful in 24 (72.7%) out of 33
patients with prosthesis exposure. Considering all 277 patients, our success rate
was of 96.7% (n = 268).
Discussion
Immediate breast reconstruction after mastectomy has become a widely-accepted surgical
option, and it can yield good cosmetic results, improving the quality of life of the
patients.[9] Surgical complications, such as implant exposure and/or infection, may result in
the removal of the device, additional surgical procedures, bad cosmetic results, and
psychological suffering for the patients.[7]
[16]
[17]
[18]
[29] Therefore, precise management of these complications is imperative. In this manuscript,
we presented a clinical protocol for exposed implants with and without associated
infection. We also reviewed all cases of immediate implant-based reconstruction to
evaluate the application of this protocol.
Our complication rate of 20.2% is similar to that reported in the literature.[16]
[18]
[25]
[35] Of all complications, prosthesis exposure was the most common, and was present in
11.9% of our patients (33 out of 277 implant-based reconstructions). This percentage
is slightly higher than that described by other authors, which ranges from 0.25% to
8.3%.[19]
[20]
[23] Our high percentage of immediate reconstructions with definitive implants may be
an explanation for this discrepancy. We have not found any statistically significant
factors associated with prothesis exposure; this might be due to the small number
of cases, as other authors have already demonstrated that smoking, radiotherapy, tumor
size, obesity, older age, axillary dissection, chemotherapy, and patient comorbidities
are associated with complications of reconstructions.[16]
[19]
[24]
[25] Our rate of implant loss of 9.0% (25 of 277 implant-based reconstructions) is comparable
to those published in the literature, which vary from 0.9% to 13%.[16]
[17]
[18]
Our clinical protocol to manage the complications of implant-based reconstruction
is based on clinical parameters and on the experience of a single surgeon. The first
parameter is the history of radiotherapy. If the patient has been irradiated before,
the exposed prosthesis must be removed. Bennett et al.[31] evaluated 68 patients (with a total of 71 implant-based breast reconstructions)
who developed infection or skin necrosis/exposure over a 20-year period. The patients
were treated in one of three ways: explantation with or without delayed reconstruction;
explantation with or without immediate autologous reconstruction; or implant salvage.
Of the 20 patients submitted to the attempt to salvage the implant, 65% underwent
radiotherapy prior to their complication. The implant was successfully kept in 4 (30.8%)
out of 13 patients with a history of radiotherapy, and in 5 (71.4%) out of 7 with
no history of radiotherapy. The authors[31] concluded that patients previously submitted to radiotherapy have a higher rate
of success when the size of the implant is reduced, or when new tissue, such as a
flap, is introduced.
The second parameter to be analyzed is if the patient with the prosthesis exposed
presents signs of severe infection. In that case, the implant is removed, and the
patient receives systemic antibiotics. A delayed reconstruction is proposed after
at least three months. Most authors who investigated the possibility of salvaging
infected implants excluded patients with severe infection.[11]
[31]
[32] Spear and Seruya[26] reported their 15-year experience with the management of infected or exposed breast
protheses after reconstructive or cosmestic surgery. A total of 69 patients with 87
events of breast device infection/exposure were included in the analysis. Out of 26
cases of severe infection without prosthesis exposure, the implant was successfully
salvaged in 8 (30.8%). On the other hand, none of the patients with severe infection
and prosthesis exposure (n = 7) had their device salvaged. Therefore, the literature supports the decision contained
in our protocol to remove the implant of the patients with severe infection and prosthesis
exposure.
The last parameter is if there is extensive tissue necrosis. In this situation, there
is no possibility of approximating the viable tissues surrounding the lesion, and
the implant needs to be removed. If there is no sign of severe infection, no history
of radiotherapy, and no extensive tissue necrosis, a primary suture is indicated.
This approach was successful in 8 out of 14 patients (57.1%) in the present study.
Two studies[33]
[34] reported the use of a capsular flap to cover exposed implants after breast reconstruction.
Brandstetter et al.[33] reported the case of a patient presenting with a small exposure of breast implant
after a skin-sparing mastectomy. The patient was submitted to capsulotomy, removal
of the implant, lavage of the pocket, and insertion of a new implant, which was covered
with a capsular flap.[33] Varga et al.[34] reported 19 cases of patients submitted to capsuloplasty after implant exposure;
they did not specified the extent of the exposure and, in most of cases, new implants
were used. Our data demonstrates that performing a primary suture can prevent the
patients from undergoing an invasive surgical procedure, and it is successful in most
cases.
There are limitations to the present study. First, the small number of patients with
implant exposure was insufficient to demonstrate which risk factors are associated
with this complication. However, it is important to emphasize that this was not the
aim of the present study, as other authors have already investigated this subject.
Second, the protocol presented needs to be validated by other groups of surgeons,
as well as the patients' acceptance of its proposals.
Conclusion
Our clinical protocol combines the evidence from the literature, clinical and individualized
data of the patient, and the experience of a surgeon specialized in breast reconstruction.
This protocol, based on three key points (history of radiotherapy, severe infection,
and extensive tissue necrosis), is a practical and potentially-reproducible method
of managing one of the most common complications of implant-based breast reconstruction.
