RESUMEN
Background: Capsular contracture is common in breast augmentation and reconstruction surgery. The present systematic review discusses the safety of textured and smooth implants in the submuscular position. Methods: A literature search was conducted on PubMed and EMBASE from inception until June 2020. The primary outcome was reduction of capsular contracture (Baker grade); others included time of capsular contracture onset, implant position/rupture rate/surface, hematoma/seroma risk, surgeon assessment and patient satisfaction. A total of 7731 patients were included from six publications. Results: The overall risk rate for capsular contracture increased from 7.6 to 25% in 10 years. The capsular contracture rates in textured and smooth implants were 3-14% and 6-20%, respectively, and no significant difference between implants was observed when the implants were placed submuscularly. Submuscular placement and textured implants also reduced the incidence of other complications. Conclusion: This systematic review suggests that appropriate placement reduces capsular contracture rate, irrespective of implant surface.
Lay abstract Breast reconstruction using breast implants is accompanied by complications that occur following surgery and which can lead to repeated surgeries and, ultimately, patient dissatisfaction. A search of published research was conducted on two major databases, and research published before June 2020 was included in our analysis. The primary outcome was the reduction of capsular contracture, a particular postoperative complication. Six articles (including one randomized controlled trial) were identified, with a total of 7731 patients. The overall risk for developing capsular contracture in breast reconstruction and augmentation patients increased from 7.6 to 25% over a period of 10 years. This systematic review suggests that with appropriate placement of the implant, the rate of capsular contracture and other complications can be reduced in women undergoing surgery, irrespective of implant surface type.
Asunto(s)
Implantes de Mama , Contractura Capsular en Implantes/prevención & control , Mamoplastia/métodos , Implantación de Mama/efectos adversos , Implantación de Mama/métodos , Implantes de Mama/efectos adversos , Implantes de Mama/clasificación , Femenino , Humanos , Contractura Capsular en Implantes/epidemiología , Contractura Capsular en Implantes/etiología , Incidencia , Mamoplastia/efectos adversos , Satisfacción del Paciente , CirujanosRESUMEN
Breast implants are used for a wide range of cosmetic and reconstructive purposes. In addition to breast augmentation, implants can be used for postmastectomy breast reconstruction, correction of congenital breast anomalies, breast or chest wall deformities, and male-to-female top surgery. Breast implants may confer significant benefits to patients, but several factors are important to consider preoperatively, including the impact on mammography, future lactation, and potential long-term implant complications (e.g., infection, capsular contracture, rupture, and the need for revision, replacement, or removal). A fundamental understanding of implant monitoring is also paramount to implant use. Patients with silicone breast implants should undergo routine screening for implant rupture with magnetic resonance imaging or ultrasonography completed five to six years postoperatively and then every two to three years thereafter. With the exception of complications, there are no formal recommendations regarding the timing of breast implant removal or exchange. Women with unilateral breast swelling should be evaluated with ultrasonography for an effusion that might indicate breast implant-associated anaplastic large cell lymphoma. There are no specific breast cancer screening recommendations for patients with breast implants, but special mammographic views are indicated to enhance accuracy. Although these discussions are a routine component of consultation and postoperative follow-up for plastic surgeons performing these procedures, family physicians should have a working knowledge of implant indications, characteristics, and complications to better counsel their patients, to ensure appropriate screening, and to coordinate care after surgery.
Asunto(s)
Implantación de Mama , Implantes de Mama , Mama , Efectos Adversos a Largo Plazo , Mastectomía/efectos adversos , Complicaciones Posoperatorias/diagnóstico , Cuidados Posteriores/métodos , Mama/diagnóstico por imagen , Mama/cirugía , Implantación de Mama/efectos adversos , Implantación de Mama/instrumentación , Implantación de Mama/métodos , Implantes de Mama/efectos adversos , Implantes de Mama/clasificación , Femenino , Humanos , Efectos Adversos a Largo Plazo/diagnóstico , Efectos Adversos a Largo Plazo/etiología , Efectos Adversos a Largo Plazo/prevención & control , Masculino , Mamografía/métodos , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Procedimientos de Cirugía Plástica/métodos , Cirugía de Reasignación de Sexo/métodos , Cirugía Plástica/métodosRESUMEN
BACKGROUND: Breast implant illness (BII) is a rising concern among many patients. Although not fully understood, a connection between silicone breast implants and systemic diseases may be present. This connection may influence the types of breast surgeries performed. OBJECTIVES: To evaluate changing trends in breast surgeries in Israel over time, with regard to implantation, explantation, and implant exchange surgeries. METHODS: In this ecological study, we presented data from four private medical centers in Israel regarding the number of breast implant surgeries performed in the years 2018-2019. Data were collected bi-yearly. The types of surgeries included breast implantation, explantation, and breast implant exchange. RESULTS: When we summed and compared the yearly data, we saw that the number of implantations in 2018 was 2267 (80.1% of breast implant procedures that year), and 1929 (68.9%) in 2019. The number of implant exchanges in 2018 and 2019 was 482 (17.0%) and 608 (21.7%), respectively. In 2018, 80 (2.8%) explantations were performed and 262 (9.4%) in 2019. CONCLUSIONS: There appears to be a trend in the rise of implant removal surgeries in addition to a decrease in breast implantations. One possible reason may be patient concerns of BII. Another reason may be the increased public interest and discussion about systemic effects of breast implants. More research is needed in this field to achieve better understanding of the phenomenon, the reasons behind it, and the possible solutions and ways of treatment.
Asunto(s)
Enfermedades Autoinmunes , Implantación de Mama , Implantes de Mama , Remoción de Dispositivos , Complicaciones Posoperatorias , Reoperación , Geles de Silicona/efectos adversos , Enfermedades Autoinmunes/diagnóstico , Enfermedades Autoinmunes/etiología , Implantación de Mama/efectos adversos , Implantación de Mama/instrumentación , Implantación de Mama/métodos , Implantación de Mama/estadística & datos numéricos , Implantes de Mama/efectos adversos , Implantes de Mama/clasificación , Implantes de Mama/tendencias , Remoción de Dispositivos/métodos , Remoción de Dispositivos/estadística & datos numéricos , Análisis de Falla de Equipo , Femenino , Humanos , Inflamación/diagnóstico , Inflamación/etiología , Israel/epidemiología , Persona de Mediana Edad , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Falla de Prótesis , Reoperación/métodos , Reoperación/estadística & datos numéricosRESUMEN
BACKGROUND: Breast cancer is the most common cancer in women worldwide, and is a leading cause of cancer death among women. Prophylactic or curative mastectomy is often followed by breast reconstruction for which there are several surgical approaches that use breast implants with which surgeons can restore the natural feel, size and shape of the breast. OBJECTIVES: To assess the effects of different types of breast implants on capsular contracture, surgical short- and long-term complications, postoperative satisfaction level and quality of life in women who have undergone reconstructive breast surgery after mastectomy. SEARCH METHODS: We searched the Cochrane Breast Cancer Group's Specialised Register on 20 July 2015, MEDLINE (1985 to 20 July 2015), EMBASE (1985 to 20 July 2015) and the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 8, 2015). We also searched the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov on 16 July 2015. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs that compared different types of breast implants for reconstructive surgery. We considered the following types of intervention: implant envelope surfaces - texturised versus smooth; implant filler material - silicone versus saline, PVP-Hydrogel versus saline; implant shape - anatomical versus round; implant volume - variable versus fixed; brands - different implant manufacturing companies and implant generation (fifth versus previous generations). DATA COLLECTION AND ANALYSIS: Two review authors independently assessed methodological quality and extracted data. We used standard Cochrane methodological procedures. The quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. MAIN RESULTS: Five RCTs with 202 participants met the inclusion criteria. The women participants were typically in their 50s, and the majority of them (about 82%) received reconstructive surgery following breast cancer, while the others had reconstructive surgery after prophylactic mastectomy. The studies were heterogenous in terms of implant comparisons, which prevented us from pooling the data.The studies were judged as being at an unclear risk of bias for most risk of bias items owing to poor quality of reporting in the trial publications. Three of the five RCTs were judged to be at high risk of attrition bias, and one at high risk of detection bias.Textured silicone versus smooth silicone implants: textured implants were associated with worse outcomes when compared to smooth implants (capsular contracture: risk ratio (RR) 0.82, 95% CI 0.14 to 4.71; 1 study, 20 participants; very low quality evidence; reintervention: RR 0.82, 95% CI 0.14 to 4.71; 1 study, 20 participants; very low quality evidence). No results in this comparison were statistically significant.Silicone versus saline implants: saline-filled implants performed better than silicone-filled implants for some outcomes; specifically, they produced less severe capsular contracture (RR 3.25, 95% CI 1.24 to 8.51; 1 study, 60 participants; very low quality evidence) and increased patient satisfaction (RR 0.60, 95% CI 0.41 to 0.88; 1 study, 58 participants; very low quality evidence). However reintervention was significantly more frequent in the saline-filled implant group than in the silicone-filled group (OR 0.08, 95% CI 0.01 to 0.43; 1 study, 60 participants; very low quality evidence).Poly(N-vinyl-2-pyrrolidone) hydrogel-filled (PVP-hydrogel) versus saline-filled implants: PVP-hydrogel-filled implants were associated with worse outcomes when compared to saline-filled implants (capsular contracture: RR 3.50, 95% CI 0.83 to 14.83; 1 study, 40 participants; very low quality evidence; short-term complications: RR 2.10, 95% CI 0.21 to 21.39; 1 study, 41 participants; very low quality evidence).Anatomical versus round implants: anatomical implants were associated with worse outcomes than round implants (capsular contracture: RR 2.00, 95% CI 0.20 to 20.15; 1 study, 36 participants; very low quality evidence; short-term complications: RR 2.00, 95% CI 0.42 to 9.58; 1 study, 36 participants; very low quality evidence; reintervention: RR 1.50, 95% CI 0.51 to 4.43; 1 study, 36 participants; very low quality evidence). No results in this comparison were statistically significant.Variable-volume versus fixed-volume implants: data about one-stage reconstruction using variable-volume implants were compared with data about fixed-volume implants positioned during the second surgical procedure of two-stage reconstructions. Fixed-volume implant reconstructions were possibly associated with a greater number of women reporting that their reconstruction corresponded with expected results (RR 0.25, 95% CI 0.10 to 0.62; 1 study, 40 participants; very low quality evidence) and fewer reinterventions (RR 7.00, 95% CI 1.82 to 26.89; 1 study, 40 participants; very low quality evidence) when compared to variable-volume implants. A higher patient satisfaction level (rated from 1 to 6, with 1 being very bad and 6 being very good) was found with the fixed-volume implants for overall aesthetic result (mean difference (MD) -1.10, 95% CI -1.59 to -0.61; 1 study, 40 participants; very low quality evidence).There were no studies that examined the effects of recent (fifth) generation silicone implants versus previous generations or different implant manufacturing companies. AUTHORS' CONCLUSIONS: Despite the central role of breast reconstruction in women with breast cancer, the best implants to use in reconstructive surgery have been studied rarely in the context of RCTs. Furthermore the quality of these studies and the overall evidence they provide is largely unsatisfactory. Some of our results can be interpreted as early evidence of potentially large differences between different surgical approaches, which should be confirmed in new high-quality RCTs that include a larger number of women. These days - even after a few million women have had breasts reconstructed - surgeons cannot inform women about the risks and complications of different implant-based breast reconstructive options on the basis of results derived from RCTs.
Asunto(s)
Implantes de Mama/clasificación , Neoplasias de la Mama/cirugía , Mamoplastia , Femenino , Humanos , Hidrogeles , Mastectomía , Persona de Mediana Edad , Satisfacción del Paciente , Procedimientos Quirúrgicos Profilácticos , Falla de Prótesis , Ensayos Clínicos Controlados Aleatorios como Asunto , Geles de Silicona , Cloruro de SodioAsunto(s)
Implantes de Mama , Mama , Procedimientos de Cirugía Plástica , Complicaciones Posoperatorias/diagnóstico , Mama/diagnóstico por imagen , Mama/cirugía , Implantes de Mama/efectos adversos , Implantes de Mama/clasificación , Femenino , Humanos , Efectos Adversos a Largo Plazo/diagnóstico , Efectos Adversos a Largo Plazo/etiología , Complicaciones Posoperatorias/etiología , Procedimientos de Cirugía Plástica/efectos adversos , Procedimientos de Cirugía Plástica/instrumentación , Procedimientos de Cirugía Plástica/métodosRESUMEN
Three sisters who carried the BRCA-1 gene mutation had a preventive mastectomy and were reconstructed with silicone breast implants. After the reconstruction all three patients developed fatigue, arthralgia, myalgia and sleep disturbances within a period of four years. Because the complaints were thought to be related to the silicone breast implants, they were advised to have the implants replaced by non-silicone gel containing Monobloc Hydrogel breast implants. After this replacement operation, all complaints improved as evaluated 2.5 years later. Since the complaints developed during the presence of silicone implants and since the reversal was observed after replacement by hydrogel implants we postulate that our patients suffered from ASIA due to silicone implants, i.e. Silicone Implant Incompatibility Syndrome (SIIS). The generation of this syndrome in three sisters suggests that the susceptibility to the development of SIIS may be genetically determined.
Asunto(s)
Enfermedades Autoinmunes , Implantación de Mama/efectos adversos , Implantes de Mama/efectos adversos , Mastectomía/rehabilitación , Complicaciones Posoperatorias , Geles de Silicona/efectos adversos , Adulto , Enfermedades Autoinmunes/etiología , Enfermedades Autoinmunes/inmunología , Enfermedades Autoinmunes/fisiopatología , Enfermedades Autoinmunes/cirugía , Autoinmunidad/efectos de los fármacos , Implantación de Mama/métodos , Implantes de Mama/clasificación , Susceptibilidad a Enfermedades/etiología , Femenino , Genes BRCA1 , Humanos , Mastectomía/métodos , Mutación , Cuidados Posoperatorios/efectos adversos , Cuidados Posoperatorios/métodos , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/inmunología , Complicaciones Posoperatorias/fisiopatología , Complicaciones Posoperatorias/cirugía , Medicina Preventiva/métodos , Falla de Prótesis , Reoperación/métodos , Hermanos , Geles de Silicona/uso terapéutico , Resultado del TratamientoRESUMEN
This study aimed to assess the effectiveness and safety of BellaGel implants after implantation in Asian women and inform surgeons of another option for use in breast augmentation and reconstruction. This study was conducted in eight hospitals from November 27, 2015 to April 30, 2018. All patients underwent augmentation mammoplasty or implant-based breast reconstruction with BellaGel implants. Complication rates were compared between groups, and the cumulative hazard function was compared using the Kaplan-Meier survival analysis. Implants were grouped by surface type, and the cumulative hazard functions of total complication cases were compared. The biomechanical properties of the BellaGel implant and other company representative implants were tested using a mechanical testing machine, and surface topography was analyzed using a 3D laser scanning confocal microscope. There was a significant difference in the incidence of complications between the reconstruction (17.1%) and augmentation (4.7%) groups, but no significant difference in the complication rates of each group. There was no difference in the reoperation or revision rates between the groups. The log rank test showed a statistically significant difference in cumulative hazard function between the groups. Among the three types of implants (smooth, textured, and microtextured), the microtextured type had the lowest complication rate. The BellaGel microtexture implant had the highest maximal tensile load and displacement value. The BellaGel and Silksurface implants had the highest stored energy, although there was no significant difference. BellaGel implants can serve as a criterion for the selection of safe and effective implants among currently available implants.
Asunto(s)
Implantación de Mama , Implantes de Mama , Mamoplastia , Ensayo de Materiales , Complicaciones Posoperatorias , Geles de Silicona , Adulto , Fenómenos Biomecánicos , Implantación de Mama/efectos adversos , Implantación de Mama/instrumentación , Implantación de Mama/métodos , Implantes de Mama/efectos adversos , Implantes de Mama/clasificación , Implantes de Mama/estadística & datos numéricos , Estudios de Cohortes , Femenino , Humanos , Incidencia , Mamoplastia/efectos adversos , Mamoplastia/instrumentación , Mamoplastia/métodos , Ensayo de Materiales/métodos , Ensayo de Materiales/estadística & datos numéricos , Microscopía Confocal/métodos , Persona de Mediana Edad , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , República de Corea/epidemiología , Estudios Retrospectivos , Geles de Silicona/efectos adversos , Geles de Silicona/química , Geles de Silicona/farmacología , Geles de Silicona/normas , Propiedades de SuperficieAsunto(s)
Implantación de Mama/psicología , Implantes de Mama/efectos adversos , Implantes de Mama/psicología , Cultura , Actitud , Implantación de Mama/efectos adversos , Implantación de Mama/economía , Implantación de Mama/educación , Implantes de Mama/clasificación , Implantes de Mama/economía , Comercio , Falla de Equipo , Femenino , Fraude/prevención & control , Humanos , Reembolso de Seguro de Salud , Mastectomía/educación , Mastectomía/métodos , Mastectomía/psicología , Mastectomía/rehabilitación , Educación del Paciente como Asunto , Diseño de Prótesis , Falla de Prótesis/efectos adversos , Geles de Silicona/efectos adversos , Geles de Silicona/economíaRESUMEN
OBJECTIVE: Even if the safety of the polyurethane prosthesis has been the subject of many studies and professional and public controversies. Nowadays, polyurethane covered implants are very popular in plastic surgery for the treatment of capsular contracture. MATERIALS AND METHODS: We have identified 41 papers (1 is a communication of the FDA) by using search browsers such as Pubmed, Medline, and eMedicine. Eleven manuscripts have been used for an introduction, and the remaining thirty have been subdivided into three tables whose results have been summarized in three main chapters: (1) capsular formation and contracture, (2) complications, (3) biodegradation and cancer risk. RESULTS: (1) The polyurethanic capsule is a well defined foreign body reaction characterized by synovial metaplasia, a thin layer of disarranged collagen fibers and a high vascularization. These features make possible a "young" capsule and a low occurrence of capsular contracture even over a long period (10 years); (2) the polyurethane implants may be difficult to remove but there is no evidence that they cause an increase in the other complications; (3) there is no evidence of polyurethane related cancer in long-term studies (after 5 years). CONCLUSIONS: Polyurethane foam covered breast implants remain a valid choice for the treatment of capsular contracture even if it would be very useful to verify the ease of removal of the prosthesis and to continue investigations on biodegradation products.
Asunto(s)
Implantación de Mama/efectos adversos , Implantes de Mama/clasificación , Poliuretanos , Animales , Implantes de Mama/efectos adversos , Contractura/epidemiología , Femenino , Reacción a Cuerpo Extraño/epidemiología , Humanos , Poliuretanos/efectos adversos , Complicaciones Posoperatorias/epidemiologíaRESUMEN
In this study 26 previously implanted silicone breast implants from the same manufacturer (Dow Corning) were investigated with two different analytical methods to characterize potential aging processes such as migration of monomer material from the gel and shell to local and distant sites, chemical alterations of the polymer, and infiltration of body compounds such as lipids. (1)H and (29)Si NMR relaxation measurements (spin-lattice, T1, and spin-spin, T2, relaxation times) were used to study the molecular dynamics of polysiloxane chains, both in gels and in shells. In addition, changes in physical properties were monitored by differential scanning calorimetry (DSC). The results of these measurements indicate that NMR relaxation times are influenced by implant generation, implantation time, shell texture and implant status. (1)H T2 values of shells and gels show a tendency to increase with increasing implantation time, indicating higher mobility and possible disintegration of the polymer network of older implants. Furthermore, the data suggest that aging also involves the migration of low cyclic molecular weight (LMW) silicone and linear chain polymer material from the gels into the shells. The high "bleeding" rate of second-generation (G2) implants (implantation period around 1973-1985), exhibiting thin shells is reflected in reduced relaxation times of these devices, most likely due to a loss of low molecular weight fractions from the gels. Moreover, "gel bleeding" also influences the melting behavior observed in DSC studies. Increased shell rigidity (high Tm and Tg) tends to be correlated with longer (29)Si relaxation times of the corresponding gels, suggesting a reduced transfer of LMW silicones and linear chain polymer from the gel to the shell and to the outside. Remarkably, textured implants seem to be less susceptible to degradation processes than implants with thin shells.
Asunto(s)
Materiales Biocompatibles/química , Implantes de Mama/clasificación , Rastreo Diferencial de Calorimetría/métodos , Análisis de Falla de Equipo/métodos , Espectroscopía de Resonancia Magnética/métodos , Siliconas/análisis , Siliconas/química , Estabilidad de Medicamentos , Isótopos , Ensayo de Materiales/métodos , Conformación Molecular , Protones , Silicio , TemperaturaRESUMEN
Concern about breast prostheses impairing breast cancer detection has become a priority issue. This article provides a review of the literature on the influence of implants on early detection methods of breast cancer, specifically breast self-examination (BSE), clinical breast examination (CBE), and mammography. Background information on implants is presented, including indications for surgery, types of prostheses, location of placement, and associated complications. Conclusions from the literature suggest that the presence of implants may facilitate BSE and CBE, yet challenge interpretation of mammography. However, there is no evidence that these women will have a later stage diagnosis or a poorer prognosis if diagnosed with breast cancer.
Asunto(s)
Implantes de Mama , Neoplasias de la Mama/prevención & control , Mamografía/métodos , Tamizaje Masivo/métodos , Adulto , Anciano , Implantes de Mama/clasificación , Neoplasias de la Mama/epidemiología , Autoexamen de Mamas/métodos , Contraindicaciones , Femenino , Humanos , Persona de Mediana Edad , Sensibilidad y Especificidad , Estados Unidos/epidemiologíaRESUMEN
This article summarizes the updates and revisions to the second edition of the BI-RADS MRI lexicon. A new feature in the lexicon is background parenchymal enhancement and its descriptors. Another major focus is on revised terminology for masses and non-mass enhancement. A section on breast implants and associated lexicon terms has also been added. Because diagnostic breast imaging increasingly includes multimodality evaluation, the new edition of the lexicon also contains revised recommendations for combined reporting with mammography and ultrasound if these modalities are included as comparison, and clarification on the use of final assessment categories in MR imaging.
Asunto(s)
Implantes de Mama/clasificación , Neoplasias de la Mama/clasificación , Neoplasias de la Mama/diagnóstico , Imagen por Resonancia Magnética/métodos , Terminología como Asunto , Vocabulario Controlado , Femenino , HumanosAsunto(s)
Implantación de Mama/efectos adversos , Implantes de Mama , Enfermedades Pulmonares Intersticiales/diagnóstico , Pulmón/patología , Falla de Prótesis/efectos adversos , Embolia Pulmonar , Implantación de Mama/métodos , Implantes de Mama/efectos adversos , Implantes de Mama/clasificación , Lavado Broncoalveolar/métodos , Enfermedad Crónica , Remoción de Dispositivos , Diagnóstico Diferencial , Femenino , Humanos , Efectos Adversos a Largo Plazo/diagnóstico , Persona de Mediana Edad , Embolia Pulmonar/diagnóstico , Embolia Pulmonar/etiología , Embolia Pulmonar/fisiopatología , Embolia Pulmonar/terapia , Elastómeros de Silicona/farmacología , Cloruro de Sodio/farmacología , Tomografía Computarizada por Rayos X/métodosAsunto(s)
Implantación de Mama , Implantes de Mama , Implantación de Mama/efectos adversos , Implantación de Mama/métodos , Implantes de Mama/efectos adversos , Implantes de Mama/clasificación , Diseño de Equipo , Falla de Equipo , Estética , Femenino , Humanos , Mamoplastia/efectos adversos , Mamoplastia/métodos , Siliconas , Cloruro de Sodio , Propiedades de SuperficieAsunto(s)
Implantes de Mama , Mamografía , Mama/patología , Implantes de Mama/efectos adversos , Implantes de Mama/clasificación , Femenino , Humanos , Imagen por Resonancia Magnética , Mamografía/métodos , Falla de Prótesis , Siliconas , Tecnología Radiológica , Tomografía Computarizada por Rayos X , Ultrasonografía MamariaRESUMEN
Despite popularity, breast augmentation has not advanced significantly in 20 years. The re-operation data for breast augmentation has been excessive at 15% to 20% in every Federal Drug Administration pre-market approval study for the past 15 years. Recently, a more scientific approach to breast augmentation has described a true process approach to this procedure. One element, tissue-based pre-operative planning, has been shown to reduce re-operation rate to less than 3% in published peer-reviewed studies. The High Five process was published in 2005 and codifies the 5 most important pre-operative decisions made during a breast augmentation procedure. Application into clinical practice of this planning system is discussed.
Asunto(s)
Antropometría , Tamaño Corporal , Implantación de Mama , Implantes de Mama , Toma de Decisiones Asistida por Computador , Cuidados Preoperatorios , Adulto , Antropometría/métodos , Imagen Corporal , Implantación de Mama/educación , Implantación de Mama/instrumentación , Implantación de Mama/psicología , Implantes de Mama/clasificación , Implantes de Mama/provisión & distribución , Conducta de Elección , Femenino , Humanos , Planificación de Atención al Paciente/organización & administración , Educación del Paciente como Asunto , Participación del Paciente/métodos , Participación del Paciente/psicología , Selección de Paciente , Cuidados Preoperatorios/métodos , Cuidados Preoperatorios/psicología , Reoperación , Cirugía Asistida por ComputadorRESUMEN
OBJECTIVE: The study was carried out through summarizing and comparing the percentages of long-term complications of four types breast implants, and analyzing the cause of complications. METHODS: The study reviewed 573 patients with breast implants including textured or smooth silicone gel-filled or saline filled implants which were placed between 1993 and 2002. 427 cases were selected to followed-up in which the surgical technique, the plane of placement and the operator were all the same. Basing on outcomes of following-up, we summarized all kinds of long-term complications and the incidence of every type of implant. RESULTS: There were 803 of 832 prostheses (94.24%) with good results in 427 cases, while 49 prostheses (5.76%) with varied complications in 42 cases. Baker level III or IV contracture occurred in 26 prostheses, reduction of the breast in 24 prostheses, malposition or pain in 10 prostheses. Rupture or leakage were detected in repeated surgery in 24 prostheses. The more severe capsular contracture happened in cases with silicone gel-filled implant than in cases with saline-filled implant. The reduction of the breast due to the rupture or leakage of implants almost occurred in cases with saline-filled implants. The study also implied the complication incidence had the positive correlation with the length of time after implantation. CONCLUSIONS: The data provided by the statistic analysis demonstrated that the distinctly difference of the complication incidence exist only between smooth saline-filled implants and smooth silicone gel-filled implants. But there were no difference among the others. In 30 of 49 prostheses with varied complication of rupture or leakage were detected which could cause the other severe complication. So the quality of implants is the key to decrease the complication incidence, then the degeneration of prostheses after being implanted becomes the urgent and troublesome problem to solve for all of us.