Keywords breast - mammaplasty - breast implants - postoperative complications - hematoma
Introduction
Postoperative hematoma is a frequent surgical complication, with an incidence ranging
from 1% to 7% in breast implant surgeries.[1 ]
[2 ] Hematomas usually require surgical drainage to not cause problems such as areola
necrosis in mammoplasty or capsular contracture in breast implant insertion. Severe
cases may require blood transfusions, incurring additional risks such as infection
and blood products-related hemolytic and immunological reactions.[3 ]
In addition to good hemostasis, surgeons have studied other ways to reduce the incidence
of hematoma. Surgical drains do not prevent arterial hematoma but reduce the incidence
of seroma and can solve small-volume venous hematoma.[4 ]
Several medications have been used to reduce the incidence of hematoma. Tranexamic
acid has been increasingly used to decrease the incidence of hematoma and seroma,
blood loss, and the need for blood transfusions without elevating the risk of thromboembolic
events.[5 ]
[6 ]
[7 ]
[8 ]
Hemostasis is a balance between fibrinolysis and the coagulation cascade. In tissue
injury, the coagulation cascade produces thrombin, which converts fibrinogen into
fibrin and stabilizes platelets. The fibrinolysis cascade causes lysine to bind to
plasminogen receptors, activating them into plasmin, leading to fibrin degradation
and platelet activation. This system prevents one cascade from overriding the other.
However, in the postoperative period, temporary fibrinolysis suspension reduces bleeding.[9 ]
[10 ]
[11 ]
Patented in 1957, tranexamic acid is a synthetic lysine analog that competitively
blocks plasminogen receptors and inhibits their tissular activation. Plasminogen receptor
blockade prevents their activation into plasmin and, as a result, the lysis of fibrin
polymers. Additionally, tranexamic acid reduces platelet consumption and acts as an
anti-inflammatory since plasmin has several inflammatory effects.[3 ]
[9 ]
Randomized studies using tranexamic acid have observed decreased intraoperative bleeding
in surgeries such as rhinoplasty, rhytidoplasty, liposuction, and reduction mammoplasty.
Topical use of tranexamic acid reduced drain output in reduction mammoplasty.[3 ]
In recent years, there has been an increase in breast implant removal surgeries, popularly
known as explantation but better described as total intact capsulectomy. These surgeries
involve a large detachment of the breast to remove the entire capsule surrounding
the implant. Such detachment can favor the appearance of hematomas, especially if
the implant is under the muscle.[12 ]
[13 ]
[14 ]
Although there are studies on tranexamic acid in several plastic surgery procedures,
the literature has no articles regarding this medication in total intact capsulectomy
surgeries.
Objective
This study aimed to determine the influence of tranexamic acid on hematoma prevention
in breast explantation surgery with intact total capsulectomy.
Methods
This retrospective study collected medical records data to determine the incidence
of hematoma requiring surgical drainage in 280 patients sequentially operated on by
the author from January 2022 to December 2023. The Research Ethics Committee of Plataforma
Brasil evaluated this study under number 76656623.0.0000.5470.
All patients in the study underwent total intact capsulectomy with or without mastopexy;
no subject had a new breast implant inserted. The only difference between the groups
was the use of tranexamic acid or not. All patients had received breast implants for
aesthetic reasons.
There is no reliable populational data regarding the annual explantation rate in Brazil.
Sample calculation employed a population of 10,000 patients undergoing explantation
annually with a margin of error of 5% and a confidence level of 90%, reaching a value
of 264. Therefore, the sample consisted of 280 patients divided into two groups of
140 subjects.
From January to September 2022, 140 patients underwent total intact capsulectomy and
several reconstruction types without tranexamic acid.
From October 2022 to December 2023, another 140 patients underwent total intact capsulectomy
and several reconstruction types with the administration of 1 gram of tranexamic acid
during anesthetic induction ([Fig. 1 ]). In addition, each dissected breast received irrigation with 10 mL of a 10 mL solution
containing 500 mg of tranexamic acid and 10 mL of saline, with a total volume of 20 mL.
Fig. 1 Hematoma in the left breast.
All patients received a Blake 15 drain, kept until the 24-hour output was lower than
30 ml. Office follow-ups occur at 7, 30, and 90 days.
The study analyzed the quantitative and qualitative characteristics of the samples
from both groups ([Tables 1 ] and [2 ]).
Table 1
Receiving TA
Not receiving TA
Total
p value
N
%
N
%
N
%
Allergy
No
125
89.3%
129
92.1%
254
90.7%
0.410
Yes
15
10.7%
11
7.9%
26
9.3%
Previous surgeries
No
60
42.9%
64
45.7%
124
44.3%
0.630
Yes
80
57.1%
76
54.3%
156
55.7%
Comorbidities
No
81
57.9%
82
58.6%
163
58.2%
0.904
Yes
59
42.1%
58
41.4%
117
41.8%
Hematoma
No
140
100%
132
94.3%
272
97.1%
0.004
Yes
0
0%
8
5.7%
8
2.9%
Implant position
Subglandular
98
70.0%
100
71.4%
198
70.7%
0.793
Submuscular
42
30.0%
40
28.6%
82
29.3%
Rupture
No
131
93.6%
129
92.1%
260
92.9%
0.643
Yes
9
6.4%
11
7.9%
20
7.1%
Smoking
No
133
95.0%
131
93.6%
264
94.3%
0.607
Yes
7
5.0%
9
6.4%
16
5.7%
Reconstruction type
Explantation with mastopexy
84
60.0%
83
59.3%
167
59.6%
0.903
Explantation alone
56
40.0%
57
40.7%
113
40.4%
Medication use
No
98
70.0%
101
72.1%
199
71.1%
0.693
Yes
42
30.0%
39
27.9%
81
28.9%
Capsular contracture
Grade I
82
58.6%
93
66.4%
175
62.5%
0.583
Grade II
27
19.3%
21
15.0%
48
17.1%
Grade III
18
12.9%
16
11.4%
34
12.1%
Grade IV
13
9.3%
10
7.1%
23
8.2%
Table 2
Mean
Median
SD
CV
Min
Max
N
CI
p value
Implant type
Receiving TA
10.24
10.0
4.68
46%
1.0
21.0
140
0.78
0.817
Not receiving TA
10.37
10.0
4.61
44%
2.0
23.0
140
0.76
Age
Receiving TA
40.79
40
9.27
23%
20
71
140
1.53
0.990
Not receiving TA
40.77
40
8.95
22%
23
67
140
1.48
BMI
Receiving TA
23.77
23.4
3.63
15%
16.9
36.4
140
0.60
0.686
Not receiving TA
23.58
22.6
3.86
16%
16.9
38.6
140
0.64
Implant size
Receiving TA
291
295
63
22%
120
500
140
11
0.648
Not receiving TA
295
290
70
24%
150
500
140
12
Moreover, this study recorded the incidence of hematoma requiring surgical drainage
and performed statistical analysis to verify that the difference between the groups
was not random. A new surgical treatment occurred in all hematoma cases ([Fig. 2 ]).
Fig. 2 Comparison of quantitative variables between groups receiving tranexamic acid (TA)
or not.
Inclusion criteria:
Patients undergoing total intact capsulectomy
Patients over 18 years old
Patients with bilateral breast implants
Exclusion criteria:
Patients with previous coagulopathy
Patients with breast implants for breast reconstruction
Patients who underwent combined surgeries, such as total intact capsulectomy and liposuction
Results
This study used parametric statistical tests after verifying the normality of the
main outcome quantitative variables with the Shapiro-Wilks test (N ≥ 100). Parametric
tests have more power to detect significance.
Excluding the incidence of hematoma, the groups with or without tranexamic acid were
homogeneous since there was no statistically significant mean difference in quantitative
([Fig. 3 ]) or qualitative variables ([Figs. 4 ] and [5 ]).
Fig. 3 Comparison of qualitative variables between groups receiving tranexamic acid (TA)
or not.
Fig. 4 Characterization of the implant position, reconstruction type, and capsular contracture
between groups receiving tranexamic acid (TA) or not.
Fig. 5 Incidence of qualitative variables in patients with hematoma.
Pearson's chi-square test assessed whether there was an association between two qualitative
variables, i.e., tranexamic acid and hematoma, and the p value was calculated ([Table 1 ]).
The Student's t-test assessed the association between two quantitative variables ([Table 2 ]).
Hematomas occurred only in the group without tranexamic acid; as such, this group
underwent an analysis of other factors ([Tables 3 ] and [4 ] and [Fig. 6 ]) using the Student's t-test. The chi-square test evaluated qualitative factors.
Table 3
Hematoma
Mean
Median
SD
CV
Min
Max
N
CI
p value
Implant type
With hematoma
10.38
11.0
3.42
33%
5.0
15.0
8
2.37
0.998
Without hematoma
10.37
10.0
4.68
45%
2.0
23.0
132
0.80
Age
With hematoma
41.00
41
6.37
16%
30
51
8
4.41
0.941
Without hematoma
40.76
39
9.10
22%
23
67
132
1.55
BMI
With hematoma
25.01
24.2
3.41
14%
21.6
32.0
8
2.37
0.285
Without hematoma
23.50
22.6
3.88
17%
16.9
38.6
132
0.66
Implant size
With hematoma
350
345
63
18%
250
450
8
43
0.020
Without hematoma
291
283
69
24%
150
500
132
12
Table 4
With hematoma
Without hematoma
Total
p value
N
%
N
%
N
%
Allergy
No
7
87.5%
122
92.4%
129
92.1%
0.615
Yes
1
12.5%
10
7.6%
11
7.9%
Previous surgeries
No
3
37.5%
61
46.2%
64
45.7%
0.631
Yes
5
62.5%
71
53.8%
76
54.3%
Comorbidities
No
5
62.5%
77
58.3%
82
58.6%
0.816
Yes
3
37.5%
55
41.7%
58
41.4%
Implant position
Subglandular
7
87.5%
93
70.5%
100
71.4%
0.300
Submuscular
1
12.5%
39
29.5%
40
28.6%
Rupture
No
6
75.0%
123
93.2%
129
92.1%
0.063
Yes
2
25.0%
9
6.8%
11
7.9%
Smoking
No
7
87.5%
124
93.9%
131
93.6%
0.471
Yes
1
12.5%
8
6.1%
9
6.4%
Reconstruction type
Explantation with mastopexy
7
87.5%
76
57.6%
83
59.3%
0.094
Explantation alone
1
12.5%
56
42.4%
57
40.7%
Medication use
No
5
62.5%
96
72.7%
101
72.1%
0.531
Yes
3
37.5%
36
27.3%
39
27.9%
Capsular contracture
Grade I
6
75.0%
87
65.9%
93
66.4%
0.342
Grade II
0
0.0%
21
15.9%
21
15.0%
Grade III
2
25.0%
14
10.6%
16
11.4%
Grade IV
0
0.0%
10
7.6%
10
7.1%
Fig. 6 Incidence of qualitative variables in patients with hematoma.
Side distribution of hematomas, which only occurred in the group without tranexamic
acid used the two-proportion Z test ([Table 5 ]).
Table 5
Hematoma
N
%
p value
Left
3
37.5%
0.317
Right
5
62.5%
It was not possible to statistically verify the relationship between the side of breast
implant rupture and the side of the hematoma. Among the 20 cases with breast implant
rupture, only two had hematoma, and the rupture and the hematoma occurred on the left
side.
Discussion
The search for reducing postoperative hematomas has been constant throughout the history
of surgery. The advent of the electric scalpel, drains, and medications proved the
efforts for hematoma reduction.
Tranexamic acid is the best candidate for the antifibrinolytic drug of choice, as
it has as low cost, high hospital availability, safety in not increasing thromboembolic
events, and few contraindications.
Studies indicate that 10 μg/mL of tranexamic acid is required for 80% inhibition of
plasminogen activation. This concentration translates into an intravenous dose of
10 mg/kg with adequate serum and tissue levels for 8 and 17 hours, respectively.[10 ]
[15 ]
[16 ]
The most common administration form includes a 10 mg/kg or 1 g bolus in anesthetic
induction followed by a constant infusion of 1 mg/kg/hour or 1 g every 8 hours.[10 ]
[16 ]
In 1994, Oerli demonstrated that 1 g of tranexamic acid three times a day in patients
undergoing mastectomy decreased drain output and hospital stay.[17 ] In 2019, Knight showed that tranexamic acid in a single intravenous dose during
surgery reduced the incidence of hematoma.[18 ] Ausen et al., in 2015, reported that the topical use of tranexamic acid decreased
drain output.[19 ]
The greatest contraindications to the intravenous administration of tranexamic acid
include intracranial bleeding, a history of thromboembolic diseases, and allergy to
the medication. High intravenous doses can cause complications such as seizures, especially
in patients with a history of neurological diseases and renal dysfunction.[16 ]
[20 ] Several studies have reported no increased risk of thromboembolic events with tranexamic
acid.[11 ]
[21 ]
Topical tranexamic acid has reduced risks and is an alternative to intravenous use
with a comparable effect in reducing hematomas, drain output, and the need for blood
transfusion.[22 ]
[23 ]
[24 ] Combined intravenous and topical use provides a hemostatic effect and reduces the
risk of adverse effects.[15 ] Although studies revealed that the plasma concentration with topical use is less
than 10% of the intravenous level, the lowest effective topical concentration is unknown.
In addition, it remains unclear whether the dose, the exposure time, or both influence
its efficacy.[11 ]
In comparative studies, the efficacy of topical use is equal to or greater than intravenous
use, with a 29% reduction in blood loss and a 45% reduction in the need for blood
transfusion.[10 ]
The present study demonstrated that the groups receiving tranexamic acid or not were
comparable in qualitative (comorbidities, allergies) and quantitative variables (implant
size, body mass index). Since there was no statistically significant mean difference
between the groups, they can be deemed homogeneous ([Figs. 3 ]
[4 ]
[5 ]).
Group homogeneity is critical because biases cannot influence outcomes after introducing
a new variable.
Group homogeneity is critical because biases cannot influence outcomes after introducing
a new variable.
Our data showed that, in both groups, patients seeking explantation have an average
age of 40 years old, are in good health, are not overweight, do not smoke or have
allergies, and maintained a 300 mL subglandular breast implant for 10 years.
Regarding the surgical procedure, approximately 60% of the patients underwent explantation
with mastopexy, while 40% underwent explantation only. Reasons for explantation included
ruptured breast implants (7.1% of subjects) and grade III or IV capsular contracture
(20.3% of patients). These data suggest that a significant portion of the patients
opted for the explantation with no surgical indication.
There was a statistical significance between tranexamic acid and hematoma incidence
(p value = 0.004). The group receiving tranexamic acid had no hematomas, while the group
who did not receive it had an incidence of hematomas of 5.7%. The p value of 0.004 indicates a 0.4% probability that these findings were random; therefore,
a strong association between these data shows that tranexamic acid prevents hematomas
in breast explantation surgeries.
The hematoma rate in the group not receiving tranexamic acid ranged from 1 to 7% of
breast surgeries.[1 ]
In addition, there was a statistical significance for the implant size. The average
size was 350 mL for cases with hematoma versus 291 mL in the group without hematoma
(p value = 0.020). This relationship between implant size and hematoma may be due to
the larger dissection area in larger implants. It could be expected that major surgeries
such as explantation with mastopexy or explantation of submuscular implants would
have a higher incidence of hematoma. This argument would be justified due to the larger
dissection area in major surgeries and the manipulation of the highly irrigated pectoral
muscle. However, this study did not show statistically significant differences in
the incidence of hematoma between the groups with submuscular or subglandular implants
or between the groups undergoing explantation alone or explantation with mastopexy.
The difference in the incidence of hematoma between the breasts, with 62.5% occurring
on the right side and 37.5% on the left side, had no significance, with a p value of 0.317.
A breast implant rupture results in loss of the original shape, increasing the dissection
area for capsulectomy. However, there was no relationship between the breast side
with the ruptured implant and the incidence of hematoma.
It is worth highlighting the limitations of a retrospective study, including the lack
of randomization in patient allocation into groups and the absence of procedural standardization
since some patients underwent explantation alone and others underwent explantation
with mastopexy.
Conclusion
Topical and intravenous use of tranexamic acid reduces the incidence of hematoma after
surgery involving intact total capsulectomy in patients with breast implants.
Bibliographical Record
