REVIEW DEMETRIUS M. COOMBS, MD RITWIK GROVER, MD ALEXANDRE PRASSINOS, MD RAFFI GURUNLUOGLU, MD, PhD Department of Plastic Surgery, Department of Plastic Surgery, Division of Plastic and Reconstructive Department of Plastic Surgery, Dermatology and Dermatology and Plastic Surgery Institute, Dermatology and Plastic Surgery Surgery, Department of Surgey, Plastic Surgery Institute, Cleveland Clinic; Profes- Cleveland Clinic Institute, Cleveland Clinic Yale School of Medicine, New Haven, CT sor, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, OH Breast augmentation surgery: Clinical considerations ABSTRACT t present, 300,000 US women undergo Abreast augmentation surgery each year,1 Women receive breast implants for both aesthetic and making this the second most common aes- reconstructive reasons. This brief review discusses the thetic procedure in women (after liposuc- evolution of and complications related to breast implants, tion),2–4 and making it extremely likely that as well as key considerations with regard to aesthetic clinicians will encounter women who have and reconstructive surgery of the breast. breast implants. In addition, approximately 110,000 women undergo breast reconstruc- KEY POINTS tive surgery after mastectomy, of whom more Nearly 300,000 breast augmentation surgeries are per- than 88,000 (81%) receive implants (2016 5 formed annually, making this the second most common data). aesthetic procedure in US women (after liposuction). This review discusses the evolution of breast implants, their complications, and key considerations with regard to aesthetic and Today, silicone gel implants dominate the world market, reconstructive breast surgery, as the principles and in the United States, approximately 60% of implants are similar. contain silicone gel fi ller. ■ EVOLUTION OF IMPLANTS Capsular contracture is the most common complication of Reports of breast augmentation surgery, also breast augmentation, typically presenting within the fi rst known as augmentation mammoplasty, date postoperative year and with increasing risk over time. It back to 1895, when a fatty tumor (lipoma) was occurs with both silicone and saline breast implants. successfully transplanted from a patient’s back to a breast defect in a mastectomy patient.2,3,6,7 Numerous studies have demonstrated the safety of In the 1930s, implantation of a glass ball into silicone breast implants with regard to autoimmune a patient’s breast marked the fi rst implant- based breast augmentation.6 By 1954, attempts disease incidence. However, the risk of associated ana- at breast augmentation using local dermal-fat plastic large-cell lymphoma must be discussed at every fl aps, adipose tissue, and even omentum were consultation, and confi rmed cases should be reported to described. a national registry. Alloplastic materials gained popular- ity throughout the 1950s and 1960s and in- cluded polyurethane, polytetrafl uoroethylene (Tefl on), and other synthetics. Adverse re- actions associated with alloplastic materials were plentiful: local tissue reactions, distor- tion of the breast mound, increased fi rmness, and discomfort all contributed to the eventual discontinuation of their use. The history of doi:10.3949/ccjm.86a.18017 alloplastic breast augmentation also included CLEVELAND CLINIC JOURNAL OF MEDICINE VOLUME 86 • NUMBER 2 FEBRUARY 2019 111 BREAST AUGMENTATION SURGERY TABLE 1 From silicone to saline, and back again The fi rst silicone gel implants, introduced in Silicone breast implants by generation the early 1960s,8–19 had high complication rates—some centers reported an incidence of First generation (1960s) capsular contracture of up to 70%.8,11 This is Shell Thick, smooth, silicone elastomer in 2 pieces with a foreign body reaction in which pathologic Dacron patches posteriorly to facilitate positioning scar tissue encases the implant, causing it to along the chest wall distort, appear misshapen, harden, and even 11 Filler Silicone gel, moderate viscosity become painful. Attempts to minimize this reaction led to later generations of silicone Shape Anatomic or “teardrop” implants with polyurethane shells.12 Complications High capsular contracture rate (approached 100% Infl atable implants fi lled with sterile saline at 10 years after implantation) solution were originally developed in France in 1965. Unlike silicone implants, saline im- Second generation (1970s)a plants have undergone minimal changes since Shell Thinner, smooth, seamless, no Dacron patches their inception, and grew in popularity during the 1970s in view of the high rates of capsular Filler Silicone gel, thinner and less viscous contracture with silicone implants.8 However, saline implants have their own problems, and Shape Round as they became increasingly popular, defl ation Complications Rupture (nearly 60%), diffusion or ”bleeding” of and the unnatural feel of saline sparked a re- silicone molecules into periprosthetic space and newed interest in silicone gel. onto breast implant capsule By the late 1980s, the thinner-shelled gen- Third generation (1980s)b eration of silicone implants displayed its own frustrating complications including implant Shell Thicker, multilayer silicone elastomer, no Dacron rupture, capsular contracture, infection, and patches possible systemic and disseminated granulo- Filler Silicone gel with larger particles, increased cross- matous disease. From 1992 to 2006, the US linking, more viscous and thick Food and Drug Administration (FDA) placed a moratorium on silicone implants due to con- Fourth and fi fth generation (1990s to present)c cerns about a possible link with autoimmune Shell and fi ller Shell thickness and gel viscosity redesigned accord- and connective tissue diseases and the pos- ing to strict criteria by American Society for Testing sible carcinogenic nature of silicone. Methodology and US Food and Drug Administration While silicone implants were prohibited in the United States, development continued Shape Anatomic (teardrop) abroad, and eventually the moratorium was lift- a During this period subpectoral implant placement gained popularity, decreasing ed after several meta-analyses failed to reveal any capsular contracture rates. link regarding the aforementioned concerns.13 b Restricted from US market temporarily in 1992; textured surfaces were introduced Today, silicone gel implants dominate the during this period in an effort to decrease capsular contracture. 14 c Greater quality control during manufacturing; wider variety of implant shapes and world market. In the United States, approxi- surface texturing available. mately 60% of implants contain silicone gel fi ller, and trends are similar in Europe.7 Table 1 summarizes the evolution of silicone 2,6,11,12 epoxy resin, shellac, beeswax, paraffi n, rub- breast implants over the last 50 years. Ta- ber, petroleum jelly, and liquefi ed silicone. ble 2 lists the advantages and disadvantages of 2,6,8,15 Outcomes were not good, and many patients silicone and saline breast implants. ultimately needed mastectomy.7 ■ The fi rst modern breast prosthesis was CURRENT IMPLANT OPTIONS developed in 1961, and since then, implant Currently, 3 companies (Allergan, Mentor, composition and design have evolved signifi - Sientra) manufacture and distribute breast cantly.8 implants and implant-associated products 112 CLEVELAND CLINIC JOURNAL OF MEDICINE VOLUME 86 • NUMBER 2 FEBRUARY 2019 COOMBS AND COLLEAGUES TABLE 2 Advantages and disadvantages of silicone and saline breast implants Advantages Disadvantages Silicone Consistency with palpation mimics dense, Exposure to silicone in the event of rupture, natural breast tissue and rupture not immediately evident Quicker adjustment to alterations Higher initial cost (nearly double that of saline in the external environment implants), including cost of recommended monitoring (imaging) to ensure implant integrity Saline Only a small incision is required for implant Overfi lling leads to increased fi rmness, insertion (implant fi lled with saline to desired palpability of the implant edge volume through a port) Underfi lling results in rippling and a higher risk Saline is safely absorbed by the body in the of rupture from the shell folding upon itself event of rupture, and rupture is immediately evident (breast defl ation) Consistency with palpation mimics water (as opposed to natural breast tissue) No concern for silicone exposure in the event of rupture Slow to adjust to alterations in the external environment (eg, feels cold after swimming) Slightly higher rate of rupture such as tissue expanders and sizers in the US malrotation.20,21 market.6 The fi rst textured implants were covered Another company, Motiva, makes an im- with polyurethane foam, but they were ulti- An early report plant that is available in Europe, Asia, and mately withdrawn from the US market be- of breast Australia, and the device is currently under- cause of concern for in vivo degradation to going a 10-year clinical trial in the United carcinogenic compounds. The focus subse- augmentation States that began recruiting patients in 16 quently turned to texturing implant shells by surgery centers in April 2018.16 Pending fi nal ap- mechanically creating pores of different sizes. proval, the Cleveland Clinic Department of Smooth implants, by contrast, are manufac- was in 1895 Plastic Surgery may be among the centers in- tured by repeatedly dipping the implant shell volved in the clinical trial of the Motiva im- into liquid silicone.2 plant. Innovations in the Motiva