Health care Research in Europe


Nowadays, around 300,000 women from United States of America (USA) are going for Breast Augmentation Surgery (BAS) every year, being this the second most common aesthetic intervention in women, only after liposuction (1). Moreover, about 110,000 women get Breast Reconstructive Surgery (BRS) after mastectomy, of whom more than 81% obtain breast prostheses (1). It is important to say that the most common age for this surgery is around 30 to 40 years and doing a comparison with data from 2000, the quantity of BAS has raised by 41%, and its demand pursues to increase every year (2).

Regarding breast enhancement, it is necessary to mention that the first silicone gel implants, was delivered in the early 1960s, and had high adverse effects rates, being the most common complication the capsular contracture, with an incidence around of 70%. The basis for this phenomenon comprises the fact that this is a foreign body reaction in which pathologic scar tissue encircles the implant, causing it to deform, appear misshapen, harden, and others adverse reactions (1). In order to reduce all these adverse effects, new generations of implants have been developed. At the moment, it is possible to find two primary breast implants: saline and silicone gelfilled implants, and it can be differentiated in their chemical conformation and texture and be available in diverse and varied sizes and shapes. Furthermore, the form of breast implants can be round or anatomical. Clearly, the selection of prosthesis depends on personal inclination, anatomy, tissues elasticity and surgeon’s surgical experience (2).

On the other hand, it is essential to cite the possible negative consequences of this surgery. One of the main complications that can occur in this intervention is infection, which generates physical, psychological, professional, and profitable issues for patients (3). Infection is the principal cause of morbidity reported after breast enhancement and complicates 0,27% – 2,5% of surgeries, according studies (3). Consequently, Mesa, Cataño and Tuberquia have conducted a retrospective cohort study (3), published in 2021, including 9691 female patients, aimed to evaluate women with breast augmentation during 5 years. As result, they found that incidence of infection was 0,38% in patients infected either in one or both implants, during this period of time. Consistent with past reports, the most frequent microorganisms found in breast prostheses infections were Staphylococcus Aureus followed by Pseudomonas Aeruginosa (3).

Continuing with the complications, it is important to underline that capsular contracture is other of the most commonly identified adverse effects of BAS, which is a tightening of the scar tissue that forms throughout the breast implant. Some studies publishing rates of roughly 20% (4). Moreover, Breast Implant Illness (BII) has been described in the literature, being defined as a group of symptoms, which begins after this surgical intervention. These manifestations may include: fatigue, arthralgia, myalgia, cognitive impairment, alopecia, skin lesions, Raynaud Syndrome and others (4). A possible etiology of BII is an autoimmune or inflammatory reaction in response to a triggering agent (silicone), and presents as a wide range of symptoms similar to connective tissue disease (4).

In this context, Wee et al. (4) have conducted a retrospective study, published in 2020, with 752 participants, with the objective of to get knowledge of symptoms associated with BII, and to evaluate how these symptoms change after removal of breast implants. The results demonstrated a rapid and steady improvement across 11 common clinical manifestations domains following removal of breast implants in patients presenting for implant removal for presumed BII. In addition, findings suggest that determined patients (higher BMI) and implant (presence of contracture) characteristics may be linked with greater symptom improvement after implant removal (4). Another important consequence of breast implants is Breast Animation Deformity (BAD), a situation in which the appearance of the augmented or reconstructed breast changes or is distorted due to contraction of the major pectoralis muscle. With this in mind, Dyrberg et al. (5) performed a systematic review in order to identify papers that define and classify BAD and describe how the degree of animation was evaluated. After screening 866 publications, four studies were included and findings reported that the median percentage of patients with some degree of BAD was 58% and the highest percentages (73% – 78%) were informed in patients operated on using the Regnault technique or the dual-plane technique (5). In line, it is essential to mention that one of the biggest concerns regarding breast implants is the possible correlation with the development of tumors. Therefore, it is necessary to mention Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), which is a variant of Anaplastic Large Cell Lymphoma (ALCL) that manifests with seroma effusion linked with breast implants and its incidence rates fluctuate across the world (6). The etiology of BIA-ALCL is still incompletely understood, however; the main hypothesis for BIAALCL, embraces genetic predisposition, bacterial biofilm, chronic inflammation, and textured breast implant (6).

In order to evaluate Breast Implant-Associated Lymphoma, Kricheldorff et al. (7) conducted a selective search review, published in 2018, and concluded that the risk that a woman with breast implants will develop a primary anaplastic large-cell lymphoma is approximated at 0,35 to 1 case per million persons per year. The incidence of implant-associated ALCL is thus very low, but markedly higher than that of other primary lymphomas of the breast (7); hence, it is mandatory to suggest medical controls and early diagnosis of the clinical entity. On the other hand, it is also necessary to take into account the benefits obtained from breast implant surgery. In relation to this perspective, Diaz JF. (8) conducted a retrospective review of 494 consecutive patients who underwent breast augmentation mammaplasty, with the goal of to outline steps to decrease complications and improve satisfaction and patient outcomes. Findings indicated that the median BREAST Q score for the patient’s overall satisfaction with outcome was 86%. The median score for psychological well-being, physical well-being, and sexual well-being was 100%, 90%, and 88%, respectively (8). In the same way, Noorizadeh and Bari (9) performed a prospective study, published in 2020, which included 60 married women who undergone breast enhancement surgery. The goal was to assess the effect of this surgical intervention on quality of life, satisfaction, and marital life; and the results reported that breast augmentation surgery significantly improved the variables of satisfaction with breasts, psychosocial well-being, and sexual well-being (9).

It is also imperative to consider the role of breast implant surgery in transgender patients. In the United States of America, 0,6% of adults presently identify as transgender; worldwide estimations of the transgender population range from 0,4% to 1,3% (10). Gender-affirming surgery (GAS) is often an essential step for transgender patients, therefore; surgical breast augmentation is frequently cited as the most important surgical intervention requested by transfeminine patients. With this background, Bekeny et al. (10) conducted a narrative review, published in 2021, aimed to outline the current state of breast augmentation for transfeminine patients. They included 59 articles and concluded that breast augmentation is an important step in a transfeminine patient’s surgical experience. Complication rates are low and similar to those reported in cisgender patients (10). With the same alignment, it is feasible to say that gender-affirmation surgery is fundamental in the management of gender dysphoria. For transgender women (transwomen), feminization of the chest is a basic element in this process. Consequently, Miller et al. (11) have developed a retrospective review, published in 2019, aimed to evaluate technical implications and results in relation to BAS and gender dysphoria. They included 34 patients and concluded that breast augmentation in transwomen is safe and typically leads to high patient satisfaction with improvement of gender dysphoria (11).

Another variable to consider in breast implant surgery is the reconstruction mammoplasty in women diagnosed and treated for breast cancer. In this context, Ranieri et al. (12) conducted a cross-sectional study, published in 2021, with the objective of to examine the long-termrepercussions of mammoplasty on the mental well-being of women. They included 44 women and their findings emphasize the need to provide psychological support to those who have underwent breast augmentation and reconstruction surgery. Additionally, this study infers the necessity for personalized psychological interventions to increase the emotional adaptation process and mental well-being (12).

Regarding patient related outcome measures (PROM), Williams et al. (13) performed a systematic review, published in 2019, aimed to assess the available literature for validated PROM in breast augmentation mammoplasty. They concluded that bilateral augmentation mammoplasty has been demonstrated to give an increment in patient reported outcomes in domains of satisfaction with breasts and psychological well-being. Nevertheless, there is some decrease in physical well-being following this surgical intervention (13). Finally, it is necessary to highlight breastfeeding concerns in women with breast augmentation surgery. In this scenario, Jewell et al. (14) conducted an observational study in order to compare lactation outcomes and concluded that women who gave birth after breast augmentation with silicone or saline implants, most were able to breast-feed their infants without complications. Lactation complications were comparable between the silicone and saline groups, and the incidence was similar to reports in the general population of women who breast-feed (14).