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Histological evaluation of capsules formed by texturized silicone implants with and without polyester mesh coverage (Parietex®). A study on female rats

ABSTRACT

Purpose

To evaluate capsules formed by microtextured silicone implants with and without Parietex® mesh coverage histologically.

Methods

Sixty Wistar rats were divided in two groups (meshed and unmeshed). Each group was, then, divided into two subgroups for evaluation at 30 and 90 days. Capsules were analyzed based on hematoxylin and eosin (HE) and picrosirius staining.

Results

The number of fibroblasts, neutrophils and macrophages was similar among all subgroups. There was a higher lymphocyte reaction in the 30-day meshed group (p = 0.003). Giant cell reaction, granulation tissue and neoangiogenesis were similar among the subgroups. Synovial metaplasia was milder at 90-day in the unmeshed (p = 0.002) and meshed group (p < 0.001). Capsular thickness was significantly greater in the meshed samples (30-day p < 0.001 and 90-day p < 0.001). There was a similar amount of collagen types I and III in both groups.

Conclusions

The mesh-covered implants produced capsules similar to the microtextured ones when analyzing inflammatory variables. Synovial metaplasia was milder at 90 than at 30 days, and the capsular thickness was significantly greater in the meshed group. A similar amount of collagen types I and III was observed. Due to these characteristics, the mesh coverage did not seem to significantly affect the local inflammatory activity.

Key words
Breast Implants; Prostheses and Implants; Mammaplasty; Rats

Introduction

Breast reconstruction can be performed with autologous techniques, using the patient’s own tissues, which is generally cited as the standard procedure11 Recht, A, Edge SB, Solin LJ, Robinson DS, Estabrook A, Fine RE, Fleming GF, Formenti S, Hudis C, Kirshner JJ, Krause DA, Kuske RR, Langer AS, Sledge GW, Jr Whelan TJ, Pfister DG, American Society of Clinical Oncology. Postmastectomy radiotherapy: clinical practice guidelines of the American Society of Clinical Oncology. J Am Soc Clin Oncol. 2001;19(5):1539–1569. https://doi.org/10.12/JCO.21.19.5.1539
https://doi.org/10.12/JCO.21.19.5.1539...
. Autologous reconstruction, however, may not be possible in some patients. For example, thin women may not have enough abdominal tissue to enable the reconstruction with rectus abdominis muscle flap22 Wang HY, Ali RS, Chen SC, Chao TC, Cheng MH. One-stage immediate breast reconstruction with implant following skin-sparing mastectomy in Asian patients. Ann Plast Surg. 2008;60(4):362–366. https://doi.org/10.1097/SAP.0b013e318063ef70
https://doi.org/10.1097/SAP.0b013e318063...
. In addition, some women might not be willing to accept the donor site morbidity, extended operative and recovery time, inherent to autologous reconstruction. The presence of comorbidities can also limit the options for reconstruction33 Malata CM, McIntosh SA, Purushotham AD. Immediate breast reconstruction after mastectomy for cancer. Br J Surg. 2000;87(11):1455-1472. https://doi.org/10.1046/j.1365-2168.2000.01593.x
https://doi.org/10.1046/j.1365-2168.2000...
.

The alternative to autologous reconstruction is the implant-based surgery, in which an important restriction is the inadequate soft tissue coverage, which can lead to skin damage, implant exposure, poor aesthetic results and asymmetry44 Agha-Mohammadi S, De La Cruz C, Hurwitz DJ. Breast reconstruction with alloplastic implants. J Surg Oncol. 2006;94(6):471-478. https://doi.org/10.1002/jso.20484
https://doi.org/10.1002/jso.20484...
.

An alternative to provide tissue coverage is the acellular dermal matrix, which provides an extra layer and support for the lower pole of the reconstructed breast. The acellular dermal matrix has also reduced complications such as visibility of implant ripples, unstable position55 Breuing KH, Warren SM. Immediate bilateral breast reconstruction with implants and inferolateral AlloDerm slings. Ann Plast Surg. 2005;55(3):232–239. https://doi.org/10.1097/01.sap.0000168527.52472.3c
https://doi.org/10.1097/01.sap.000016852...
and capsular contracture66 Liu J, Hou J, Li Z, Wang B, Sun J. Efficacy of acellular dermal matrix in capsular contracture of implant-based breast reconstruction: a single-arm meta-analysis. Aesthetic Plast Surg. 2020;44 (3):735–742. https://doi.org/10.1007/s00266-019-01603-2
https://doi.org/10.1007/s00266-019-01603...
.

Although well established in the literature, the use of acellular dermal matrix is expensive, often prohibitive in Brazil. Therefore, the use of synthetic meshes may be a low-cost option.

The use of meshes made by different materials has been increasingly applied during immediate breast reconstruction with silicone implants. The complication rates when using polypropylene and titanium meshes on silicone implants seem to be similar to those observed in pure silicone implants. However, the use of synthetic meshes entails new scenarios and the demand for surgeons to recognize new complications and their histological behavior77 De Riggi MA, Rocco N, Gherardini G, Esposito E, D’Aiuto M. Management of implant exposure in one-stage breast reconstruction using titanium-coated polypropylene mesh: sub-mammary intercostal perforator flap. Aesthetic Plast Surg. 2016;40(6):896–900. https://doi.org/10.1007/s00266-016-0720-z
https://doi.org/10.1007/s00266-016-0720-...
, since there is lack of knowledge regarding inflammatory alterations on meshes associated with silicone implants.

According to some authors, a capsular contracture with clinical symptoms is related to local inflammatory activity88 Prantl, L, Pöppl, N, Horvat, N, Heine, N, Eisenmann-Klein, M. Serologic and histologic findings in patients with capsular contracture after breast augmentation with smooth silicone gel implants: is serum hyaluronan a potential predictor?. Aesthetic Plast Surg. 2005;29(6):510–518. https://doi.org/10.1007/s00266-005-5049-y
https://doi.org/10.1007/s00266-005-5049-...

9 Prantl L, Schreml S, Fichtner-Feigl S, Pöppl N, Eisenmann-Klein M, Schwarze H, Fuchtmeier B. Clinical and morphological conditions in capsular contracture formed around silicone breast implants. Plast Reconstr Surg. 2007;120(1):275–284. https://doi.org/10.1097/01.prs.0000264398.85652.9a
https://doi.org/10.1097/01.prs.000026439...
-1010 Poeppl N, Schreml S, Lichtenegger F, Lenich A, Eisenmann-Klein M, Prantl L. Does the surface structure of implants have an impact on the formation of a capsular contracture? Aesthetic Plast Surg. 2007;31(2):133-139. https://doi.org/10.1007/s00266-006-0091-y
https://doi.org/10.1007/s00266-006-0091-...
. Several studies have successfully evaluated the use of meshes during breast reconstruction with implants1111 Haynes DF, Kreithen JC. Vicryl mesh in expander/implant breast reconstruction: long-term follow-up in 38 patients. Plast Reconstr Surg. 2014;134(5):892-899. https://doi.org/10.1097/PRS.0000000000000610
https://doi.org/10.1097/PRS.000000000000...

12 Dieterich M, Angres J, Stubert J, Stachs A, Reimer T, Gerber B. Patient-reported outcomes in implant-based breast reconstruction alone or in combination with a titanium-coated polypropylene mesh - A detailed analysis of the BREAST-Q and overview of the literature. Geburtshilfe Frauenheilkd. 2015;75(7):692-701. https://doi.org/10.1055/s-0035-1546218
https://doi.org/10.1055/s-0035-1546218...

13 Baldelli I, Cardoni G, Franchelli S, Fregatti P, Friedman D, Pesce M, Ponte E, Santori G, Santi P. Implant-based breast reconstruction using a polyester mesh (Surgimesh-PET): a retrospective single-center study. Plast Reconstr Surg. 2016;137(6):931e-939. https://doi.org/10.1097/PRS.0000000000002180
https://doi.org/10.1097/PRS.000000000000...

14 Caputo GG, Marchetti A, Dalla Pozza E, Vigato E, Domenici L, Cigna E, Governa M. Skin-reduction breast reconstructions with prepectoral implant. Plast Reconstr Surg. 2016;137(6):1702-1705. https://doi.org/10.1097/PRS.0000000000002227
https://doi.org/10.1097/PRS.000000000000...

15 Gschwantler-Kaulich D, Schrenk P, Bjelic-Radisic V, Unterrieder K, Leser C, Fink-Retter A, Salama M, Singer C. Mesh versus acellular dermal matrix in immediate implant-based breast reconstruction - A prospective randomized trial. Eur J Surg Oncol. 2016;42(5):665-671. https://doi.org/10.1016/j.ejso.2016.02.007
https://doi.org/10.1016/j.ejso.2016.02.0...

16 Pukancsik D, Kelemen P, Gulyás G, Újhelyi M, Kovács E, Éles K, Mészáros N, Kenessey I, Pálházi P, Kovács T, Kásler M, Mátrai Z. Clinical experiences with the use of ULTRAPRO® mesh in single-stage direct-to-implant immediate postmastectomy breast reconstruction in 102 patients: a retrospective cohort study. Eur J Surg Oncol. 2017;43(7):1244-1251. https://doi.org/10.1016/j.ejso.2017.01.236
https://doi.org/10.1016/j.ejso.2017.01.2...

17 Zenn M, Venturi M, Pittman T, Spear S, Gurtner G, Robb G, Mesbahi A, Dayan J. Optimizing outcomes of postmastectomy breast reconstruction with acellular dermal matrix: a review of recent clinical data. Eplasty. 2017;17:e18.

18 Momeni A, Kanchwala SK. Improved pocket control in immediate microsurgical breast reconstruction with simultaneous implant placement through the use of mesh. Microsurgery. 2018;38(5):450-457. https://doi.org/10.1002/micr.30123
https://doi.org/10.1002/micr.30123...

19 Pompei S, Evangelidou D, Arelli F, Ferrante G. The use of TIGR matrix in breast aesthetic and reconstructive surgery: is a resorbable synthetic mesh a viable alternative to acellular dermal matrices? Clin Plast Surg. 2018;45(1):65-73. https://doi.org/10.1016/j.cps.2017.08.005
https://doi.org/10.1016/j.cps.2017.08.00...

20 Gfrerer L, Liao EC. Technique refinement in prepectoral implant breast reconstruction with vicryl mesh pocket and acellular dermal matrix support. Plast Reconstr Surg Glob Open. 2018;6(4):e1749. https://doi.org/10.1097/GOX.0000000000001749
https://doi.org/10.1097/GOX.000000000000...

21 Potter S, MacKenzie M, Blazeby JM. Does the addition of mesh improve outcomes in implant based breast reconstruction after mastectomy for breast cancer? BMJ. 2018;362:k2607. https://doi.org/10.1136/bmj.k2607
https://doi.org/10.1136/bmj.k2607...

22 Bonomi S, Sala L, Gennaro M, Ricci C, Cortinovis U. Skin-reducing mastectomy and direct-to-implant breast reconstruction with submuscular-dermal-mesh pocket. Ann Plast Surg. 2019;82(1):19-27. https://doi.org/10.1097/SAP.0000000000001614
https://doi.org/10.1097/SAP.000000000000...

23 Casella D, Di Taranto G, Marcasciano M, Sordi S, Kothari A, Kovacs T, Lo Torto F, Cigna E, Calabrese C, Ribuffo D. Evaluation of prepectoral implant placement and complete coverage with TiLoop Bra mesh for breast reconstruction: a prospective study on long-term and patient-reported BREAST-Q outcomes. Plast Reconstr Surg. 2019;143(1):1e-9e. https://doi.org/10.1097/PRS.0000000000005078
https://doi.org/10.1097/PRS.000000000000...
-2424 Hansson E, Burian P, Hallberg H. Comparison of inflammatory response and synovial metaplasia in immediate breast reconstruction with a synthetic and a biological mesh: a randomized controlled clinical trial. J Plast Surg Hand Surg. 2020;54(3):131–136. https://doi.org/10.1080/2000656X.2019.1704766.
https://doi.org/10.1080/2000656X.2019.17...
. However, the histological behavior of Parietex Composite® (Covidien, Boulder, United States) associated with silicone implants is not known.

The aim of this study was to evaluate the capsules formed around silicone implants with and without a Parietex Composite® coverage histologically, assessing the mesh effect on inflammatory variables, synovial metaplasia, capsular thickness and collagen types I and III.

Methods

This study was carried out in the vivarium and in the Laboratory of Operative Technique and Experimental Surgery at Universidade Estadual de Ponta Grossa (protocol numbers 13,252/2018 and 3,973/2018), after being approved by the Ethics Committee on the Use of Animals (CEUA), process number 032/2018.

This is a primary interventional prospective non-randomized study. No calculations were performed for the sample size, obtaining a smaller sample based on already published studies similar to this one, facilitating the process of acceptance by the CEUA.

Sixty albino rats (Rattus norvegicus) weighing between 200 and 300 grams, 100 days old, of Wistar strain, were used. The 60 animals were distributed in two groups of 30 rats each (implants with and without mesh coverage), and each group was divided into two subgroups, to be evaluated at 30 and 90 days. Four rats were allocated per 450-cm3 acrylic box, lined with wood shavings. They had free access to water and a specific diet for the species, ad libitum, in addition to alternating light in 12-hour cycles at room temperature.

By the date of the first euthanasia, with 30 days, eight animals in the unmeshed group and five in the meshed group died. One animal from each group was excluded due to the lack of quality of the piece, and two animals from the meshed group by rotation of the mesh-implant set. After that, the following distribution was made (Table 1):

Table 1
Final distribution of animals in groups and subgroups.

Implanted materials

LifeSil® (Curitiba, PR, Brazil) implants were used, which have the same characteristics as micro-texture implants, except that they are not filled with silicone, constituted only by the 20-mm-diameter microtextured implant cover.

The Parietex Composite® mesh, used to cover the outer surface of the implants in one of the groups, consisted of three-dimensional multifilament polyester with an absorbable, continuous and hydrophilic film on one side. The film consists of porcine collagen, polyethylene glycol and glycerol.

Surgical procedure

The animals were anesthetized with intraperitoneal injection of ketamine 10%, 80 mg/kg, and xylazine 2%, 10 mg/kg. No fasting was performed, and they were placed in prone position after trichotomy.

A 1,5 -cm-long incision was made in the posteroinferior costal margin, in the midline. The implant pocket was round, with a 5-mm margin from the implants.

The implants were positioned 5 mm from the incision. On the meshed implants, the matrix was positioned on the dorsal side. The suture was performed with four stitches, Prolene® 5.0 (Ethicon, Somerville, New Jersey, United States), and there were no dressings.

Postoperative analgesia was performed with two subcutaneous doses of ketoprofen 5 mg/kg, with an administration interval of 24 hours.

Euthanasia was performed with triple the therapeutic dose of Cetamin®/240–270 mg/kg and Xilazin®/30–40 mg/kg intraperitoneally, followed by cervical dislocation.

Histological evaluation

Hematoxylin and eosin staining

The procedure was used for the evaluation of inflammatory variables, synovial metaplasia, and capsular thickness.

Picrosirius coloring

This technique was used to assess the amount of collagen types I and III. The software AxioVision® 4.9.1.0 (Zeiss, Oberkochen, Germany) was used to obtain the images. The percentage of collagen types I and III was measured using semi-automatic segmentation, in the Image Proplus® 4.5 morphometry program (Media Cybernetics, Rockville, MD, United States).

Table 2
Percentage of cases with moderate/intense classification according to the group (meshed or unmeshed) and subgroup (30 days or 90 days).

Statistical analysis

For each of the variables, the groups with and without mesh coverage were compared, in the 30 and 90-day subgroups. Then, the subgroups were compared with one another.

The results were described by averages, standard deviations, medians, minimum and maximum values (quantitative variables) or by frequencies and percentages (categorical variables). Fisher’s exact test was used for inflammatory variables, the Mann-Whitney non-parametric test for capsular thickness and Student’s t test for comparison in relation to the percentage of collagen. The significance level of 0.05 was adjusted by applying the Bonferroni correction (p < 0.012). The data were analyzed with the Stata/SE® v. 14.1 (Stata Corporation LLC, College Station, TX, United States) software.

Results

Hematoxylin and eosin staining

Only the variables with statistical significance were highlighted in the pictures. Table 2 shows the percentage of rats that had each characteristic evaluated as moderate or accentuated.

Giant cell reaction was analyzed only as present or absent. All animals of all groups had the presence of this variable.

Fibroblasts

In the unmeshed group, in both subgroups (30 and 90 days), most animals had a mild presence. In the meshed group, the majority had a moderate presence at 30 days and a mild presence at 90 days. Although the 30 and 90-day unmeshed subgroups and the 90-day meshed subgroup showed a mild presence, no statistical significance was obtained.

Neutrophils

The majority of the animals, in both groups, had a mild presence. No significant differences were found between the two groups in the different subgroups.

Macrophages

This variable had a mild presence in both groups, in all analyzed animals. Thus, there was no statistical comparison.

Lymphocytes

In the unmeshed group, the presence was mild in the 30-day subgroup, whereas in the meshed group the majority of the animals exhibited a moderate or intense presence of this variable in both subgroups.

When comparing the 30-day meshed and unmeshed groups, statistical significance was obtained (p = 0.003) (Fig. 1).

Figure 1
Photomicrography of microtextured implant (a) and meshed implant (b), showing lymphocytes.

Giant cell reaction

This reaction was only analyzed as absent or present, and all animals in the four subgroups had this characteristic. Thus, there was no statistical comparison.

Granulation tissue

The vast majority of animals had a mild presence of this variable. When the groups and subgroups were compared, there was no statistical significance.

Neoangiogenesis

In all subgroups, the majority of the rats had a mild presence of the variable. When the groups and subgroups were compared with one another, there was no statistical significance.

Synovial metaplasia

In the 30-day subgroups, a moderate or intense presence of this variable was found in most animals, while in the 90-day subgroups most of them had a mild presence. In both groups, when comparing 30 and 90-day subgroups, there was statistically significant difference (unmeshed p = 0.002/meshed p<0.001) (Fig. 2).

Figure 2
Photomicrography of microtextured implant(a) and meshed implant (b), showing synovial metaplasia.

Capsule thickness

This finding was lower in the unmeshed compared to the meshed group, with statistical significance (30 days p < 0.001 / 90 days p < 0.001) (Fig. 3).

Figure 3
Photomicrography of microtextured implant (a) and meshed implant (b), showing capsular thickness (magnification x20).

Table 3 contains the median with the minimum and maximum values of capsular thickness. Table 4 contains p-values.

Table 3
Median, minimum and maximum values of the capsule thickness (μm) according to the group (meshed or unmeshed) and the subgroup (30 and 90 days).
Table 4
Compared groups and subgroups in relation to capsular thickness with p-value.

Picrosirius staining

Collagen types I and III

The Fig. 4 shows type I collagen in reddish color and type III collagen in greenish color. In the meshed group, the matrix is exhibited by the bluish color.

Figure 4
Photomicrography evidencing collagen fibers. (a) 30-day unmeshed group, (b) 90-day unmeshedgroup, (c) 30-day meshed group, (d) 90-day meshed group.

In the unmeshed group, in both subgroups, the averages were slightly higher for collagen type I. However, when the groups and subgroups were compared with one another, no statistical significance was found (Tables 5 and 6).

Table 5
Descriptive statistics of collagen type I according to the subgroups.
Table 6
Compared groups and subgroups in relation to collagen type I with p-value.

The following graphic shows that collagen type I was similar between groups (Fig. 5).

Figure 5
Average, standard errors and standard deviations of area percentages with collagen type I in each subgroup.

The amount of collagen type III was similar between groups and subgroups. When the groups and subgroups were compared, there was no statistical significance (Tables 7 and 8).

Table 7
Descriptive statistics of collagen type III according to the subgroups.
Table 8
Compared groups and subgroups in relation to collagen type III with p-value.

The Fig. 6 shows that type III collagen was similar between the groups.

Figure 6
Average, standard errors and standard deviations of area percentages with type III collagen in each subgroup.

Discussion

The rat (Rattus norvegicus albinus) chosen by the authors is the most used animal in capsular contracture studies, for presenting easy reproducibility of results and resistance to surgical procedures2525 Bergmann PA, Tamouridis G, Lohmeyer JA, Mauss KL, Becker B, Knobloch J, Mailänder P, Siemers F. The effect of a bacterial contamination on the formation of capsular contracture with polyurethane breast implants in comparison with textured silicone implants: an animal study. J Plast Reconstr Aesthetic Surg. 2014;67(10):1364–1370. http://doi.org/10.1016/j.bjps.2014.05.04.
https://doi.org/10.1016/j.bjps.2014.05.0...

26 Mendes PRDS, Bins-Ely J, Lima EADS, De Vasconcellos ZAA, D’Acampora AJ, Neves RDE. Histological study on acute inflammatory reaction to polyurethane-coated silicone implants in rats. Acta Cir Bras. 2008;23(1):93–101. http://doi.org/10.1590/S0102-86502008000100015
https://doi.org/10.1590/S0102-8650200800...
-2727 Wagenführ-Júnior J, Ribas Filho JM, Nascimento MM do, Ribas FM, Wanka MV, Godoi A by L. Histopathological reaction over prosthesis surface covered with silicone and polyurethane foam implanted in rats. Acta Cir Bras. 2012;27(12):866–873. http://dx.doi.org/10.1590/S0102-86502012001200007
https://doi.org/10.1590/S0102-8650201200...
.

Due to the difficulty in obtaining large animal samples for research in our institution, we have based our sample size on already published studies similar to this, which also used animals for experimentation. Thus, no calculations were performed for the sample size, obtaining a smaller sample, facilitating the process of acceptance by the CEUA. Since it’s a small sample, there may have been a loss of statistical power in the analysis of some variables. Despite differing percentages in their values, we need to rely on the stipulated significance range (p<0.012 with Bonferroni correction) to complete the analysis, even though there are increased chances of false negative results.

Following Mendes et al.2626 Mendes PRDS, Bins-Ely J, Lima EADS, De Vasconcellos ZAA, D’Acampora AJ, Neves RDE. Histological study on acute inflammatory reaction to polyurethane-coated silicone implants in rats. Acta Cir Bras. 2008;23(1):93–101. http://doi.org/10.1590/S0102-86502008000100015
https://doi.org/10.1590/S0102-8650200800...
, subcutaneous dissection was carried out, superficial to the panniculus carnosus, on the rats’ back, unlike Silva et al.2828 Silva EN, Ribas-Filho JM, Czeczko NG, Pachnicki JPA, Netto MRM, Lipinski LC, Noronha L, Colman J, Zeni JO, Carvalho CA. Histological evaluation of capsules formed by silicone implants coated with polyurethane foam and with a textured surface in rats. Acta Cir Bras. 2016;31(12):774–782. https://doi.org/10.1590/s0102-865020160120000001
https://doi.org/10.1590/s0102-8650201601...
and Silva et al.2929 Silva EN, Ribas-Filho JM, Tabushi FI, Silva MAP, Siqueira EBD, de Noronha L, da Silva ABD, Lipinski LC, Guth I, Vosgerau LM. Smooth muscle alpha actin immunoexpression (α-Sma) and CD-117 antibody (C-Kit) in capsules formed by polyurethane foam-coated silicone implants and with textured surface: a study on rats. Aesthetic Plast Surg. 2019;43(1):233-242. https://doi.org/10.1007/s00266-018-1238-3
https://doi.org/10.1007/s00266-018-1238-...
, who performed deeper dissection at this plane.

The coverage of silicone implants in breast reconstruction is usually carried out with acellular dermal matrix66 Liu J, Hou J, Li Z, Wang B, Sun J. Efficacy of acellular dermal matrix in capsular contracture of implant-based breast reconstruction: a single-arm meta-analysis. Aesthetic Plast Surg. 2020;44 (3):735–742. https://doi.org/10.1007/s00266-019-01603-2
https://doi.org/10.1007/s00266-019-01603...
,1818 Momeni A, Kanchwala SK. Improved pocket control in immediate microsurgical breast reconstruction with simultaneous implant placement through the use of mesh. Microsurgery. 2018;38(5):450-457. https://doi.org/10.1002/micr.30123
https://doi.org/10.1002/micr.30123...
. However, the use of meshes might be as safe as and presents lower cost.

The reason why the authors chose to use a synthetic mesh in this study is that several papers already reported successful use of this material when associated to silicone implants in human beings1111 Haynes DF, Kreithen JC. Vicryl mesh in expander/implant breast reconstruction: long-term follow-up in 38 patients. Plast Reconstr Surg. 2014;134(5):892-899. https://doi.org/10.1097/PRS.0000000000000610
https://doi.org/10.1097/PRS.000000000000...

12 Dieterich M, Angres J, Stubert J, Stachs A, Reimer T, Gerber B. Patient-reported outcomes in implant-based breast reconstruction alone or in combination with a titanium-coated polypropylene mesh - A detailed analysis of the BREAST-Q and overview of the literature. Geburtshilfe Frauenheilkd. 2015;75(7):692-701. https://doi.org/10.1055/s-0035-1546218
https://doi.org/10.1055/s-0035-1546218...

13 Baldelli I, Cardoni G, Franchelli S, Fregatti P, Friedman D, Pesce M, Ponte E, Santori G, Santi P. Implant-based breast reconstruction using a polyester mesh (Surgimesh-PET): a retrospective single-center study. Plast Reconstr Surg. 2016;137(6):931e-939. https://doi.org/10.1097/PRS.0000000000002180
https://doi.org/10.1097/PRS.000000000000...

14 Caputo GG, Marchetti A, Dalla Pozza E, Vigato E, Domenici L, Cigna E, Governa M. Skin-reduction breast reconstructions with prepectoral implant. Plast Reconstr Surg. 2016;137(6):1702-1705. https://doi.org/10.1097/PRS.0000000000002227
https://doi.org/10.1097/PRS.000000000000...

15 Gschwantler-Kaulich D, Schrenk P, Bjelic-Radisic V, Unterrieder K, Leser C, Fink-Retter A, Salama M, Singer C. Mesh versus acellular dermal matrix in immediate implant-based breast reconstruction - A prospective randomized trial. Eur J Surg Oncol. 2016;42(5):665-671. https://doi.org/10.1016/j.ejso.2016.02.007
https://doi.org/10.1016/j.ejso.2016.02.0...

16 Pukancsik D, Kelemen P, Gulyás G, Újhelyi M, Kovács E, Éles K, Mészáros N, Kenessey I, Pálházi P, Kovács T, Kásler M, Mátrai Z. Clinical experiences with the use of ULTRAPRO® mesh in single-stage direct-to-implant immediate postmastectomy breast reconstruction in 102 patients: a retrospective cohort study. Eur J Surg Oncol. 2017;43(7):1244-1251. https://doi.org/10.1016/j.ejso.2017.01.236
https://doi.org/10.1016/j.ejso.2017.01.2...

17 Zenn M, Venturi M, Pittman T, Spear S, Gurtner G, Robb G, Mesbahi A, Dayan J. Optimizing outcomes of postmastectomy breast reconstruction with acellular dermal matrix: a review of recent clinical data. Eplasty. 2017;17:e18.

18 Momeni A, Kanchwala SK. Improved pocket control in immediate microsurgical breast reconstruction with simultaneous implant placement through the use of mesh. Microsurgery. 2018;38(5):450-457. https://doi.org/10.1002/micr.30123
https://doi.org/10.1002/micr.30123...

19 Pompei S, Evangelidou D, Arelli F, Ferrante G. The use of TIGR matrix in breast aesthetic and reconstructive surgery: is a resorbable synthetic mesh a viable alternative to acellular dermal matrices? Clin Plast Surg. 2018;45(1):65-73. https://doi.org/10.1016/j.cps.2017.08.005
https://doi.org/10.1016/j.cps.2017.08.00...

20 Gfrerer L, Liao EC. Technique refinement in prepectoral implant breast reconstruction with vicryl mesh pocket and acellular dermal matrix support. Plast Reconstr Surg Glob Open. 2018;6(4):e1749. https://doi.org/10.1097/GOX.0000000000001749
https://doi.org/10.1097/GOX.000000000000...

21 Potter S, MacKenzie M, Blazeby JM. Does the addition of mesh improve outcomes in implant based breast reconstruction after mastectomy for breast cancer? BMJ. 2018;362:k2607. https://doi.org/10.1136/bmj.k2607
https://doi.org/10.1136/bmj.k2607...

22 Bonomi S, Sala L, Gennaro M, Ricci C, Cortinovis U. Skin-reducing mastectomy and direct-to-implant breast reconstruction with submuscular-dermal-mesh pocket. Ann Plast Surg. 2019;82(1):19-27. https://doi.org/10.1097/SAP.0000000000001614
https://doi.org/10.1097/SAP.000000000000...

23 Casella D, Di Taranto G, Marcasciano M, Sordi S, Kothari A, Kovacs T, Lo Torto F, Cigna E, Calabrese C, Ribuffo D. Evaluation of prepectoral implant placement and complete coverage with TiLoop Bra mesh for breast reconstruction: a prospective study on long-term and patient-reported BREAST-Q outcomes. Plast Reconstr Surg. 2019;143(1):1e-9e. https://doi.org/10.1097/PRS.0000000000005078
https://doi.org/10.1097/PRS.000000000000...
-2424 Hansson E, Burian P, Hallberg H. Comparison of inflammatory response and synovial metaplasia in immediate breast reconstruction with a synthetic and a biological mesh: a randomized controlled clinical trial. J Plast Surg Hand Surg. 2020;54(3):131–136. https://doi.org/10.1080/2000656X.2019.1704766.
https://doi.org/10.1080/2000656X.2019.17...
.

In a recent study with Parietex® mesh, the same chosen for this study, Parietex® mesh was compared to other types of synthetic meshes and presented less intense fibrosis than the ones of polypropylene mesh3030 Biondo-Simões MLP, Sichciopi AA, Ioshii SO, Robes RR, Biondo-Simões R. Comparative study of fibrosis induced by Marlex®, Parietex Composite®, Vicryl® and Ultrapro® meshes. Acta Cir Bras. 2018;33(9):792-798. https://doi.org/10.1590/s0102-865020180090000007
https://doi.org/10.1590/s0102-8650201800...
.

Capsular thickness and the progression to a contracture with clinical symptoms in breast implants are proportional to the inflammatory activity8-0,31. Bui et al.3232 Bui JM, Perry TA, Ren CD, Nofrey B, Teitelbaum S, van Epps DE. Histological characterization of human breast implant capsules. Aesthetic Plast Surg. 2015;39(3):306–315. http://doi.org/10.1007/s00266-014-0439-7
https://doi.org/10.1007/s00266-014-0439-...
investigated the relation between the capsule histology and the contracture clinical symptoms and concluded that the contracture development is related to an increase in the capsular thickness, the alignment of collagenous fibers, the presence of contractile microfibroblasts, and greater alpha-SMA expression.

Due to this association between inflammation, capsular thickness and contracture, we opted for analyzing the inflammatory variables when studying the Parietex® mesh.

In this study, the capsular thickness was smaller in the unmeshed group. Other authors also found smaller capsular thickness in textured implants when compared to implants that used other types of coverage, namely: Balderrama et al.3333 Balderrama CMSR, Ii JMR, Ii OM, Gregori N, Ii C. Healing reaction to mammary prostheses covered by textured silicone and silicone. Acta Cir Bras. 2009;24(5):367–376. http://doi.org/10.1590/S0102-86502009000500006
https://doi.org/10.1590/S0102-8650200900...
, investigating polyurethane foam; and Vieira et al.3434 Vieira VJ, d’Acampora AJ, Marcos ABW, Di Giunta G, de Vasconcellos ZAA, Bins-Ely J, d’Eça Neves R, Figueiredo CP. Vascular endothelial growth factor overexpression positively modulates the characteristics of periprosthetic tissue of polyurethane-coated silicone breast implant in rats. Plast Reconstr Surg. 2010;126(6):1899–1910. https://doi.org/10.1097/PRS.0b013e3181f446d5
https://doi.org/10.1097/PRS.0b013e3181f4...
and Silva et al.2828 Silva EN, Ribas-Filho JM, Czeczko NG, Pachnicki JPA, Netto MRM, Lipinski LC, Noronha L, Colman J, Zeni JO, Carvalho CA. Histological evaluation of capsules formed by silicone implants coated with polyurethane foam and with a textured surface in rats. Acta Cir Bras. 2016;31(12):774–782. https://doi.org/10.1590/s0102-865020160120000001
https://doi.org/10.1590/s0102-8650201601...
, evaluating polyurethane coating.

This research is in disagreement with Bergmann et al.2525 Bergmann PA, Tamouridis G, Lohmeyer JA, Mauss KL, Becker B, Knobloch J, Mailänder P, Siemers F. The effect of a bacterial contamination on the formation of capsular contracture with polyurethane breast implants in comparison with textured silicone implants: an animal study. J Plast Reconstr Aesthetic Surg. 2014;67(10):1364–1370. http://doi.org/10.1016/j.bjps.2014.05.04.
https://doi.org/10.1016/j.bjps.2014.05.0...
, who found smaller capsular thickness in implants covered with titanium mesh, TiLOOP® (PFM Medical, Köln, Germany), when comparing them with textured implants.

The presence of fibroblasts in the capsules ranged from discrete to moderate, which is in agreement with Haddad Filho et al.3535 Haddad Filho D, Zveibel DK, Alonso N, Gemperli R. Comparison between textured silicone implants and those bonded with expanded polytetrafluoroethylene in rats. Acta Cir Bras. 2007;22(3):187–194. https://doi.org/10.1590/S0102-86502007000300006
https://doi.org/10.1590/S0102-8650200700...
, who compared textured implants with PTFE-E-covered implants. This study disagrees with Bergmann et al.2525 Bergmann PA, Tamouridis G, Lohmeyer JA, Mauss KL, Becker B, Knobloch J, Mailänder P, Siemers F. The effect of a bacterial contamination on the formation of capsular contracture with polyurethane breast implants in comparison with textured silicone implants: an animal study. J Plast Reconstr Aesthetic Surg. 2014;67(10):1364–1370. http://doi.org/10.1016/j.bjps.2014.05.04.
https://doi.org/10.1016/j.bjps.2014.05.0...
, who reported greater number of myofibroblasts in capsules of TiLOOP®-covered implants when comparing them with textured implants in 60-day subgroups.

Haddad Filho et al.3535 Haddad Filho D, Zveibel DK, Alonso N, Gemperli R. Comparison between textured silicone implants and those bonded with expanded polytetrafluoroethylene in rats. Acta Cir Bras. 2007;22(3):187–194. https://doi.org/10.1590/S0102-86502007000300006
https://doi.org/10.1590/S0102-8650200700...
found a higher number of neutrophils in the mesh-covered group at 30 days, unlike this study, that did not find differences in the neutrophil count.

All capsules under analysis presented similar number of macrophages, which is in agreement with other studies3333 Balderrama CMSR, Ii JMR, Ii OM, Gregori N, Ii C. Healing reaction to mammary prostheses covered by textured silicone and silicone. Acta Cir Bras. 2009;24(5):367–376. http://doi.org/10.1590/S0102-86502009000500006
https://doi.org/10.1590/S0102-8650200900...
,3535 Haddad Filho D, Zveibel DK, Alonso N, Gemperli R. Comparison between textured silicone implants and those bonded with expanded polytetrafluoroethylene in rats. Acta Cir Bras. 2007;22(3):187–194. https://doi.org/10.1590/S0102-86502007000300006
https://doi.org/10.1590/S0102-8650200700...
.

In the meshed group, the number of lymphocytes was higher at 30 days, contradicting Haddad Filho et al.3535 Haddad Filho D, Zveibel DK, Alonso N, Gemperli R. Comparison between textured silicone implants and those bonded with expanded polytetrafluoroethylene in rats. Acta Cir Bras. 2007;22(3):187–194. https://doi.org/10.1590/S0102-86502007000300006
https://doi.org/10.1590/S0102-8650200700...
, who found similar numbers between the textures and PTFE-E covered groups.

Giant cell reaction was observed in all samples, which is in agreement with other studies that compared textured implants to implants using different types of coverage2626 Mendes PRDS, Bins-Ely J, Lima EADS, De Vasconcellos ZAA, D’Acampora AJ, Neves RDE. Histological study on acute inflammatory reaction to polyurethane-coated silicone implants in rats. Acta Cir Bras. 2008;23(1):93–101. http://doi.org/10.1590/S0102-86502008000100015
https://doi.org/10.1590/S0102-8650200800...
,2727 Wagenführ-Júnior J, Ribas Filho JM, Nascimento MM do, Ribas FM, Wanka MV, Godoi A by L. Histopathological reaction over prosthesis surface covered with silicone and polyurethane foam implanted in rats. Acta Cir Bras. 2012;27(12):866–873. http://dx.doi.org/10.1590/S0102-86502012001200007
https://doi.org/10.1590/S0102-8650201200...
,3333 Balderrama CMSR, Ii JMR, Ii OM, Gregori N, Ii C. Healing reaction to mammary prostheses covered by textured silicone and silicone. Acta Cir Bras. 2009;24(5):367–376. http://doi.org/10.1590/S0102-86502009000500006
https://doi.org/10.1590/S0102-8650200900...
,3535 Haddad Filho D, Zveibel DK, Alonso N, Gemperli R. Comparison between textured silicone implants and those bonded with expanded polytetrafluoroethylene in rats. Acta Cir Bras. 2007;22(3):187–194. https://doi.org/10.1590/S0102-86502007000300006
https://doi.org/10.1590/S0102-8650200700...
. Unlike Silva et al.2828 Silva EN, Ribas-Filho JM, Czeczko NG, Pachnicki JPA, Netto MRM, Lipinski LC, Noronha L, Colman J, Zeni JO, Carvalho CA. Histological evaluation of capsules formed by silicone implants coated with polyurethane foam and with a textured surface in rats. Acta Cir Bras. 2016;31(12):774–782. https://doi.org/10.1590/s0102-865020160120000001
https://doi.org/10.1590/s0102-8650201601...
, who found a moderate to intense presence of giant cell reaction in polyurethane-covered samples, it seems relevant to emphasize that in this study this variable was only classified as present or absent.

The granulation tissue was present in a discrete way, without differences between groups, in accordance with other studies99 Prantl L, Schreml S, Fichtner-Feigl S, Pöppl N, Eisenmann-Klein M, Schwarze H, Fuchtmeier B. Clinical and morphological conditions in capsular contracture formed around silicone breast implants. Plast Reconstr Surg. 2007;120(1):275–284. https://doi.org/10.1097/01.prs.0000264398.85652.9a
https://doi.org/10.1097/01.prs.000026439...
,3333 Balderrama CMSR, Ii JMR, Ii OM, Gregori N, Ii C. Healing reaction to mammary prostheses covered by textured silicone and silicone. Acta Cir Bras. 2009;24(5):367–376. http://doi.org/10.1590/S0102-86502009000500006
https://doi.org/10.1590/S0102-8650200900...
,3535 Haddad Filho D, Zveibel DK, Alonso N, Gemperli R. Comparison between textured silicone implants and those bonded with expanded polytetrafluoroethylene in rats. Acta Cir Bras. 2007;22(3):187–194. https://doi.org/10.1590/S0102-86502007000300006
https://doi.org/10.1590/S0102-8650200700...
. This result is in disagreement with Silva et al.2828 Silva EN, Ribas-Filho JM, Czeczko NG, Pachnicki JPA, Netto MRM, Lipinski LC, Noronha L, Colman J, Zeni JO, Carvalho CA. Histological evaluation of capsules formed by silicone implants coated with polyurethane foam and with a textured surface in rats. Acta Cir Bras. 2016;31(12):774–782. https://doi.org/10.1590/s0102-865020160120000001
https://doi.org/10.1590/s0102-8650201601...
, who found intense formation of granulation tissue in polyurethane implants.

Neovascular formation was essentially mild in all subgroups, corroborating findings by Silva et al.2828 Silva EN, Ribas-Filho JM, Czeczko NG, Pachnicki JPA, Netto MRM, Lipinski LC, Noronha L, Colman J, Zeni JO, Carvalho CA. Histological evaluation of capsules formed by silicone implants coated with polyurethane foam and with a textured surface in rats. Acta Cir Bras. 2016;31(12):774–782. https://doi.org/10.1590/s0102-865020160120000001
https://doi.org/10.1590/s0102-8650201601...
in subgroups from the same evaluation period. This result opposes to the one by Haddad Filho et al.3535 Haddad Filho D, Zveibel DK, Alonso N, Gemperli R. Comparison between textured silicone implants and those bonded with expanded polytetrafluoroethylene in rats. Acta Cir Bras. 2007;22(3):187–194. https://doi.org/10.1590/S0102-86502007000300006
https://doi.org/10.1590/S0102-8650200700...
, who found, in the unmeshed subgroup, greater intensity of vascular formation in the 90-day subgroups when compared to the 30-day subgroups. Those authors also reported higher neoangiogenesis in the PTFE-E group at 30 days. Other authors also found more intense neovascularization in the presence of another coverage in addition to the textured one2727 Wagenführ-Júnior J, Ribas Filho JM, Nascimento MM do, Ribas FM, Wanka MV, Godoi A by L. Histopathological reaction over prosthesis surface covered with silicone and polyurethane foam implanted in rats. Acta Cir Bras. 2012;27(12):866–873. http://dx.doi.org/10.1590/S0102-86502012001200007
https://doi.org/10.1590/S0102-8650201200...
,3434 Vieira VJ, d’Acampora AJ, Marcos ABW, Di Giunta G, de Vasconcellos ZAA, Bins-Ely J, d’Eça Neves R, Figueiredo CP. Vascular endothelial growth factor overexpression positively modulates the characteristics of periprosthetic tissue of polyurethane-coated silicone breast implant in rats. Plast Reconstr Surg. 2010;126(6):1899–1910. https://doi.org/10.1097/PRS.0b013e3181f446d5
https://doi.org/10.1097/PRS.0b013e3181f4...
.

Bergmann et al.2525 Bergmann PA, Tamouridis G, Lohmeyer JA, Mauss KL, Becker B, Knobloch J, Mailänder P, Siemers F. The effect of a bacterial contamination on the formation of capsular contracture with polyurethane breast implants in comparison with textured silicone implants: an animal study. J Plast Reconstr Aesthetic Surg. 2014;67(10):1364–1370. http://doi.org/10.1016/j.bjps.2014.05.04.
https://doi.org/10.1016/j.bjps.2014.05.0...
, however, reported intense neovascular formation in the textured group when compared to the titanium-covered mesh group.

This study partially agrees with Prantl et al.99 Prantl L, Schreml S, Fichtner-Feigl S, Pöppl N, Eisenmann-Klein M, Schwarze H, Fuchtmeier B. Clinical and morphological conditions in capsular contracture formed around silicone breast implants. Plast Reconstr Surg. 2007;120(1):275–284. https://doi.org/10.1097/01.prs.0000264398.85652.9a
https://doi.org/10.1097/01.prs.000026439...
, who evaluated implant capsules in humans and found the presence of synovial metaplasia in most of them, whereas in this study this variable was present in all animals of both groups.

Unlike Basseto et al.3636 Bassetto F, Scarpa C, Caccialanza E, Montesco MC, Magnani P. Histological features of periprosthetic mammary capsules: silicone vs. polyurethane. Aesthetic Plast Surg. 2010;34(4):481–485. https://doi.org/10.1007/s00266-010-9483-0
https://doi.org/10.1007/s00266-010-9483-...
, who found similar synovial metaplasia between the subgroups, this study showed a more pronounced presence of this characteristic in the 30-day subgroups.

The moderate and accentuated presence of synovial metaplasia at 30 days and mild at 90 days differs from the findings by Silva et al.2828 Silva EN, Ribas-Filho JM, Czeczko NG, Pachnicki JPA, Netto MRM, Lipinski LC, Noronha L, Colman J, Zeni JO, Carvalho CA. Histological evaluation of capsules formed by silicone implants coated with polyurethane foam and with a textured surface in rats. Acta Cir Bras. 2016;31(12):774–782. https://doi.org/10.1590/s0102-865020160120000001
https://doi.org/10.1590/s0102-8650201601...
, who detected an absent or mild presence throughout the evaluation period, despite the fact that those researchers compared textured implants with polyurethane implants.

The findings of this study are close to those found by Hansson et al.2424 Hansson E, Burian P, Hallberg H. Comparison of inflammatory response and synovial metaplasia in immediate breast reconstruction with a synthetic and a biological mesh: a randomized controlled clinical trial. J Plast Surg Hand Surg. 2020;54(3):131–136. https://doi.org/10.1080/2000656X.2019.1704766.
https://doi.org/10.1080/2000656X.2019.17...
, who compared the use of biological and synthetic meshes and reported the presence of synovial metaplasia in most cases, since in this research this variable was observed in all cases.

Alterations in collagenous fibers might be present in capsular contracture cases3131 Minami E, Koh IHJ, Ferreira JCR, Waitzberg AFL, Chifferi V, Rosewick TF, Pereira MD, Saldiva PHN, de Figueiredo LFP. The composition and behavior of capsules around smooth and textured breast implants in pigs. Plast Reconstr Surg. 2006;118(4):874–884. https://doi.org/10.1097/01.prs.0000240878.24213.b7
https://doi.org/10.1097/01.prs.000024087...
,3232 Bui JM, Perry TA, Ren CD, Nofrey B, Teitelbaum S, van Epps DE. Histological characterization of human breast implant capsules. Aesthetic Plast Surg. 2015;39(3):306–315. http://doi.org/10.1007/s00266-014-0439-7
https://doi.org/10.1007/s00266-014-0439-...
,3737 Moyer KE, Ehrlich HP. Capsular contracture after breast reconstruction: Collagen fiber orientation and organization. Plast Reconstr Surg. 2013;131(4):680–685. https://doi.org/10.1097/PRS.0b013e31828189d0
https://doi.org/10.1097/PRS.0b013e318281...
. Therefore, they were analyzed in this study. Brazin et al.3838 Brazin J, Malliaris S, Groh B, Mehrara B, Hidalgo D, Otterburn D, Silver RB, Spector JA. Mast cells in the periprosthetic breast capsule. Aesthetic Plast Surg. 2014;38(3):592–601. https://doi.org/10.1007/s00266-014-0318-2
https://doi.org/10.1007/s00266-014-0318-...
studied patients with grade IV Baker contracture and concluded that the capsule collagenous production by fibroblasts is mediated by mastocytes.

In agreement with Minami et al., who observed a slight increase in collagen type III in the textured implant group, in this study the results in the unmeshed group (microtextured implant) in the 30 and 90-day subgroups were similar. Those authors also found a slight decrease in collagen type III in the textured group from 30 to 90 days. Similar results were found in this study in the 30 and 90-day subgroups.

This study disagrees with Balderrama et al.3333 Balderrama CMSR, Ii JMR, Ii OM, Gregori N, Ii C. Healing reaction to mammary prostheses covered by textured silicone and silicone. Acta Cir Bras. 2009;24(5):367–376. http://doi.org/10.1590/S0102-86502009000500006
https://doi.org/10.1590/S0102-8650200900...
, who found a significant decrease in the amount of type III collagen in the textured group in the 30 to 60-day subgroups, because in this study type III collagen remained similar in the unmeshed sample. Those authors also found a significant increase in the amount of type I collagen in the subgroup from 30 to 60 days, whereas in this study, in the unmeshed group, a similar amount of type I collagen was found in the subgroups analyzed.

Differing from Silva et al.2828 Silva EN, Ribas-Filho JM, Czeczko NG, Pachnicki JPA, Netto MRM, Lipinski LC, Noronha L, Colman J, Zeni JO, Carvalho CA. Histological evaluation of capsules formed by silicone implants coated with polyurethane foam and with a textured surface in rats. Acta Cir Bras. 2016;31(12):774–782. https://doi.org/10.1590/s0102-865020160120000001
https://doi.org/10.1590/s0102-8650201601...
, the percentage of collagen types I and III was similar between textured implants and those with additional coating in all subgroups analyzed, despite the fact that those researchers used polyurethane implants for comparison. Due to these characteristics, themesh coverage did not seem to significantly affectthe local inflammatory activity.

Conclusions

The implants covered by Parietex Composite® mesh produced capsules similar to those ones found in textured implants when analyzing inflammatory variables. Synovial metaplasia was milder at 90 than at 30 days, and the capsular thickness was significantly greater with the mesh coating. A similar amount of collagen types I and III was formed in the meshed and unmeshed implant capsules. Due to these characteristics, the mesh coating did not seem to significantly affect the local inflammatory activity.

Acknowledgments

Not applicable.

  • Research performed at Postgraduate Program in Principles of Surgery, Mackenzie Evangelical School of Medicine, Curitiba (PR), Brazil. Part of Master Degree, Postgraduate Program in Principles of Surgery. Tutor: Prof. Dr. Jurandir Marcondes Ribas Filho.
  • Data availability statement

    Data will be available upon request.
  • Funding

    Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
    Grant 001

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Publication Dates

  • Publication in this collection
    14 June 2021
  • Date of issue
    2021

History

  • Received
    09 Jan 2021
  • Reviewed
    11 Mar 2021
  • Accepted
    13 Apr 2021
Sociedade Brasileira para o Desenvolvimento da Pesquisa em Cirurgia https://actacirbras.com.br/ - São Paulo - SP - Brazil
E-mail: actacirbras@gmail.com