gms | German Medical Science

GMS German Plastic, Reconstructive and Aesthetic Surgery – Burn and Hand Surgery

Deutsche Gesellschaft der Plastischen, Rekonstruktiven und Ästhetischen Chirurgen (DGPRÄC)
Deutsche Gesellschaft für Verbrennungsmedizin (DGV)

ISSN 2193-7052

Capsular contracture at a high speciality center in Mexico: a case series

Kapselfibrosen in einem hochspezialisierten Zentrum in Mexiko: Eine Fallserie

Short Report

  • Gabriel Barrera-Garcia - Division of Plastic and Reconstructive Surgery, Hospital Central Sur de Alta Especialidad de Petróleos Mexicanos, Mexico City, Mexico
  • corresponding author Jaime Aron Garcia Espinoza - Division of Plastic and Reconstructive Surgery, Hospital Central Sur de Alta Especialidad de Petróleos Mexicanos, Mexico City, Mexico
  • Carlos Gonzalez-Alvarado - Division of Plastic and Reconstructive Surgery, Hospital Central Sur de Alta Especialidad de Petróleos Mexicanos, Mexico City, Mexico
  • Olin Carrasco-Ortiz - Division of Plastic and Reconstructive Surgery, Hospital Central Sur de Alta Especialidad de Petróleos Mexicanos, Mexico City, Mexico
  • Cuahutemoc Marquez-Espriella - Division of Plastic and Reconstructive Surgery, Hospital Central Sur de Alta Especialidad de Petróleos Mexicanos, Mexico City, Mexico
  • Jorge Eduardo Gutierrez-Salgado - Division of Plastic and Reconstructive Surgery, Hospital Central Sur de Alta Especialidad de Petróleos Mexicanos, Mexico City, Mexico
  • Rodrigo Dávila-Diaz - Division of Plastic and Reconstructive Surgery, Hospital Central Sur de Alta Especialidad de Petróleos Mexicanos, Mexico City, Mexico
  • Ma Irene Salgado-Rivera - Department of Pathological Anatomy, Hospital Central Sur de Alta Especialidad de Petróleos Mexicanos, Mexico City, Mexico

GMS Ger Plast Reconstr Aesthet Surg 2020;10:Doc04

doi: 10.3205/gpras000055, urn:nbn:de:0183-gpras0000559

Veröffentlicht: 18. August 2021

© 2021 Barrera-Garcia et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.


Abstract

Introduction: Breast augmentation surgery is among the most frequent plastic surgery procedures worldwide. The most frequent complication related in the medium-long term is capsular contracture, however ethiology and risk factors are not fully settled down.

Objective: To describe epidemiology and risk factors associated whit capsular contracture at a high speciality center in Mexico City.

Material and methods: A descriptive and observational study was performed, describing epidemiological variables, associated risk factors, and histopathological analysis of patients diagnosed with capsular contracture.

Results: 36 patients with a mean age of 53.7 years were included. 18 patients did not present comorbidities, 4 were hypertense, 4 had history of cancer, 8 patients presented multiple comorbidities (gastric cancer, ischemic heart disease and venous insuffiency), and 2 hypothyroidisms. Although smoking was not the most prevalent risk factor, these patients were related to severe capsular contracture. The subglandular plane was the most used while periareolar and submammary surgical approach were chosen almost equally. 21 capsules were analyzed. It was observed that in grade I and II capsules, the collagen fibers were disorganized, abundant type III collagen and abundant cellularity were found, while in grades III and IV collagen fibers were well arranged horizontally and abundant type I collagen with low cellularity and calcification was present.

Conclusions: Grade III and IV capsular contracture were the most prevalent, subglandular plane and tobacco use were related to severe capsular contracture presentation. We did not find any difference between type and implant texture used among patients.

Keywords: capsular contracture, breast augmentation surgery, breast reconstruction

Zusammenfassung

Einleitung: Brustvergrößerungen gehören weltweit zu den häufigsten Eingriffen der plastischen Chirurgie. Die häufigste mittelfristige Komplikation ist die Kapselfibrose, wobei Ätiologie und Risikofaktoren noch nicht vollständig geklärt sind.

Zielsetzung: Beschreibung der Epidemiologie und der Risikofaktoren der Kapselfibrose in einem hochspezialisierten Zentrum in Mexiko-Stadt

Material und Methoden: Es wurde eine deskriptive Beobachtungsstudie von Patienten, bei denen eine Kapselfibrose diagnostiziert wurde, durchgeführt, in der epidemiologische Variablen, assoziierte Risikofaktoren und die histopathologische Analyse beschrieben werden.

Ergebnisse: 36 Patienten mit einem Durchschnittsalter von 53,7 Jahren wurden eingeschlossen. 18 Patienten wiesen keine Begleiterkrankungen auf, 4 waren hypertensiv, 4 hatten eine Krebsvorgeschichte, 8 Patienten wiesen mehrere Begleiterkrankungen auf (Magenkrebs, ischämische Herzkrankheit und venöse Insuffizienz), und 2 Hypothyreose. Obwohl Rauchen nicht der häufigste Risikofaktor war, waren diese Patienten von einer schweren Kapselkontraktur betroffen. Die subglanduläre Lage wurde am häufigsten verwendet, während periareolärer und submammärer chirurgischer Zugang fast gleich häufig waren. Es wurden 21 Kapseln analysiert. Dabei wurde festgestellt, dass in Kapseln der Grade I und II die Kollagenfasern desorganisiert waren und reichlich Kollagen des Typs III und reichlich Zellularität vorhanden waren, während in den Graden III und IV die Kollagenfasern horizontal angeordnet waren und reichlich Kollagen des Typs I mit geringer Zellularität und Verkalkung vorhanden war.

Schlussfolgerungen: Kapselfibrosen der Grade III und IV waren am häufigsten, subglanduläre Lage und Tabakkonsum standen im Zusammenhang mit der schweren Form der Kapselfibrose. Wir fanden keinen Unterschied zwischen dem Typ und der Textur des verwendeten Implantats bei den Patienten.

Schlüsselwörter: Kapselfibrose, Brustvergrößerung, Brustrekonstruktion


Introduction

Augmentation mammoplasty is one of the most frequent procedures in plastic surgery, either for aesthetics or reconstruction secondary to breast cancer. According to the International Society of Aesthetic Plastic Surgery (ISAPS), more than 1.8 million augmentation mammoplasties were performed during 2018 worldwide, increasing 6.1% over the previous year [1]. Capsular contracture is the most frequent cause of reoperation, occurring in up to 30% of patients, being diagnosed an average of 45,000 cases annually [2].

Patients who undergo implant replacement due to capsular contracture require complex reoperation surgery, have a high rate of dissatisfaction and recurrence of 18% to 30% [3]. Although its pathogenesis has not been clarified, some theories propose that the combination of acute and chronic inflammatory factors trigger the disease [4]. Other lines of research suggest as a cause subclinical infection by normal bacterial flora of the skin (Coagulase-negative staphylococci, Cutibacterium acnes and Corinebacterium sp that accesses the implants during their placement [4] and some others suggest that bacterial biofilm stimulates the development of periprosthetic fibrosis that produces the contracture, likewise the HACEK group and various species of Ralstonia sp have been implicated as causal [5]. The first to demonstrate this association was Dobke in 1992 [6]. In his study he removed 55 capsule implants, all with clinical evidence of contracture, 56% of the implants carried biofilm. Subsequently, Del Pozo found in his research that there is a close relationship between the development of contracture and the presence of bacteria in the implants [7]. Until now, the role of textured implants in their development has not been clarified, since no study is conclusive due to the various biases.

The clinical presentation is heterogeneous, since it can be detected microscopically between 4 to 8 months after surgery, but the risk of clinical manifestation extends several years later. The most frequent symptoms are breast pain, stiffness and deformity, depending on the degree of severity according to Baker: I (normal breasts), II (minimal contracture), III (moderate contracture) and IV (severe contracture) [8]. The first-line treatment is capsulectomy with or without implant exchange, and some useful measures under study include different plane placement, prosthetic irrigation with antibiotics, use of vitamin E, external ultrasound, NSAIDs, chemotherapeutics, and leukotriene inhibitors [9].


Material and methods

We present an epidemiological and histopathological data analysis of a capsular contracture case series in a high speciality center in Mexico.

A descriptive, retrospective, observational and cross-sectional study was carried out in patients from Hospital Central Sur de Alta Especialidad de Petroleos Mexicanos in Mexico City. All patients diagnosed with capsular contracture who underwent capsulectomy or capsulotomy with implant exchange in a period of 10 years were included. The epidemiological variables obtained through the clinical records were: age, time from implant placement to exchange, type of implant (smooth or textured), histopathological capsule description, Baker’s capsular contracture stage, associated comorbidities, use of drains and implant brand. Statistical analysis was performed through central tendency and dispersion measures (percentages, median, mode, standard deviation, and interquartile ranges).

Patients with mechanical complications of breast prostheses (rupture, exposure, hematoma) or with implant exchange due to postoperative complications were excluded.


Results

A total of 36 patients with capsular contracture clinical diagnosis were included. The age range between patients was 44–57 years with an average of 53.7 years. The average from placement to exchange was 11.61 years. Baker’s IV stage capsular contracture patients had a higher average with 15.8 years, showing a direct relationship between implant carrying time and capsular contracture severity.

The most common indications for implant placement were aesthetic breast augmentation (83.6%) and breast cancer reconstruction (16.4%). Periareolar and submammary surgical approaches were used (50% of patients in each group) without any capsular contracture difference between groups.

Subglandular plane was used in 69.5% of cases, while in 30.5% a submuscular plane was used based on the surgeon’s criteria. Dual plane was not used in this case series. Subglandular plane had a more severe contracture (grade III, IV) percentage when comparing with the submuscular group (Table 1 [Tab. 1]). Among the removed implants, 83.3% were textured and 16.6% smooth, this trend was also a surgeon related preference. A higher incidence of severe capsular contracture (grade III, IV) was detected in the textured implant group although these results are not conclusive. Eighteen patients did not present comorbidities when the implant were placed, 4 were hypertense, 4 had history of cancer, 8 patients presented multiple comorbidities (gastric cancer, ischemic heart disease and venous insuffiency) and 2 hypothyroidisms. However, all of these patients were homogeneously distributed between groups. Five of the eight patients in the multiple comorbidity group had grade IV capsular contracture (Figure 1 [Fig. 1]).

Smoking was not a predominant risk factor in the studied population since only 3 patients presented it (smoking index of 10). However, these three patients presented the most severe degree of contracture (Figure 2 [Fig. 2]).

Only 21 capsules had histopathological analysis, observing an important variation in morphology, cellularity, number of fibroblasts and lymphocytes, organization of collagen fibers, capsular structure, thickness of the capsule and the inflammatory pattern (acute or chronic). Capsules in general tend to have little cellularity. However, evidence was found of a greater number of cells, calcifications, foamy macrophages and histiocytes in regions located at the capsule-implant interface, becoming more noticeable in capsules with more severe contractures. Grade I represented 9.52% of the series, grade II 19.04%, grade III 33.3%, and grade IV 38% of the total analyzed capsules under microscope (Table 2 [Tab. 2]).

Microscopic analysis revealed that in mild contractures (I and II), the collagen fibers were arranged in an irregular and disorganized disposition and thin and with abundant immature collagen (collagen III predominance) (Figure 3 [Fig. 3]). In severe contractures (grade III and IV), the fibers were well organized and arranged horizontally, with narrow spaces between them, greater capsular thickness and higher percentage of mature collagen (type I) (Figure 4 [Fig. 4]). The cellularity degree was variable. Grade I and II showed greater cellularity than observed in grade III and IV. In grades I and II, there was a predominance of fibroblasts and polymorphonuclear lymphocytes showing an acute inflammation pattern without calcifications. In grade III and IV, a chronic pattern was observed, with the presence of calcifications in 57% of capsules grade III and 50% in grade IV. Furthermore, low cellularity was observed with the presence of less than 20 fibroblasts per field and less than 50 lymphocytes per field, also a pronounced synovial metaplasia was found in this group.


Discussion

The highest incidence of capsular contracture among patients in this study was Baker’s III and IV. However, these degrees are related to more symptomatic clinical presentation, such as greater pain and deformity that motivate the patient to seek for medical attention. The role of biofilms with the development of capsular contracture has recently been elucidated. These microorganisms trigger a sustained inflammatory reaction that develops synovial metaplasia and subsequent formation of periprosthetic capsule [10]. The investigation of this phenomenon is too difficult since conventional cultures are not efficient in detecting biofilms and techniques such as PCR have been developed at present to detect them in breast implants [11]. But its etiological role is increasingly accepted and efforts are made in order to avoid prosthetic contamination. Currently, the Keller Funnel is a tool that has been associated with decreased contamination of breast prostheses and a decrease in capsular contracture rate [12].

However, the biofilm is not the only associated factor in its physiopathology since various studies have analyzed inherent factors to the host, such as surgical technique and implant properties. Montemurro et al. showed that smoking increases surgical site infection rate, seroma and therefore the incidence of capsular contracture. Our study found that smokers had greater severity of capsular contracture, results may be similar to those of Montemurro et al. In the same study, it was concluded that age and BMI are not an inherent risk factor for the development of the disease [13].

Li et al. studied the associated factors related to surgical technique. They analyzed the surgical approaches for implant placement and concluded that the periareolar approach was related to a higher incidence of capsular contracture compared to the submammary approach [14]. This correlates with our study where the periareolar approaches presented more severe degrees of contracture. Another factor involved is the implant plane placement. Calobrace et al. found that the use of the subglandular plane is associated with a higher incidence of contracture [15] which is in accordance with our findings where the subglandular plane was associated with more severe contractures (grade III and IV). Calobrace et al. also found that prosthetic sizes greater than 355 cm³ and antibiotic irrigation of the pocket were associated with a higher contracture rate. An uncertainty zone is the use of postoperative drainage since in primary mammoplasties, some authors do not recommend their routine use while others systematize their usage. However, studies with solid evidence are necessary to conclude on this matter.

Regarding the time implants were carried, several authors classify capsular contracture as immediate when it occurs within the first two years after its placement, mediate if it appears after 2 to 5 years and late after five years [15]. The relationship between severity and years since its placement has not been determined. In our series, it was found that grade IV contractures had the highest mean years of carriage, but more studies are needed in this regard.

Several studies have concluded that the use of smooth implants is associated with a higher incidence of capsular contracture because they are associated with greater incidence of seroma and movement within the pocket, whereas textured implants have shown lower risk [16], [17]. In our case series, the vast majority of the implants used were textured. However, a higher contracture rate compared to the one reported worldwide was observed, so a study that includes groups with the same number of textured and smooth implant usage is required.

In the histopathological analysis, the severe grade capsules presented greater thickness and a regular-parallel alignment, supporting the theory that alignment of the fibers is a key point in the development of contracture. In this order, disruption in the alignment of these fibers has a direct impact on the severity of the disease and could even be a future therapeutic target [18]. Wolfram et al. analyzed the cellular and molecular composition of fibrous capsules through immunohistochemistry, observing the presence of macrophages, dendritic cells, fibroblasts and CD4 T lymphocytes [19]. In flow cytometry, the presence of T cells (TH17) was demonstrated, which directly correlated with an increase in the severity of capsular fibrosis, and therefore greater severity of the disease. In this study, the observed lymphocyte population was not typified. However, it was observed that in mild degrees of the disease an acute inflammatory pattern developed with an abundant population of lymphocytes and in severe degrees a chronic pattern with granulomatosis, similar to that observed in diseases like tuberculosis. Bui et al. found that the development and thickness of the capsule relates to the alignment of the collagen fibers, the distance between them, the persistence of lymphocytes in the prosthetic periphery, and the presence of smooth muscle α-actin chains [20].

Because of the importance of this clinical entity due to the high rate of patients who undergo breast augmentation surgery or reconstruction, solid evidence is needed to define etiological, adjuvant risk and predisposing factors of the disease. So, in this way, plastic surgeons could count with therapeutic or prophylactic actions in order to reduce the incidence and the costs related to it.


Conclusions

The highest incidence of capsular contracture (Baker’s grade III and IV) occurred in the subglandular prosthetic placement group, in patients with more than 15 years implant carriage and among smokers. In our study, we even found an increased tendency between textured implants and capsular contracture. But we could not conclude a solid evidence related to implant form and texture due to their selection bias (surgeon preference).

Histological analysis revealed acute inflammation patterns in grade I and II capsules, while a chronic inflammation pattern with synovial metaplasia was observed in grade III and IV capsules.


Notes

Competing interests

The authors declare that they have no competing interests.


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