At present, 300,000 US women undergo breast augmentation surgery each year,1 making this the second most common aesthetic procedure in women (after liposuction),2–4 and making it extremely likely that clinicians will encounter women who have breast implants. In addition, approximately 110,000 women undergo breast reconstructive surgery after mastectomy, of whom more than 88,000 (81%) receive implants (2016 data).5
This review discusses the evolution of breast implants, their complications, and key considerations with regard to aesthetic and reconstructive breast surgery, as the principles are similar.
EVOLUTION OF IMPLANTS
Reports of breast augmentation surgery, also known as augmentation mammoplasty, date back to 1895, when a fatty tumor (lipoma) was successfully transplanted from a patient’s back to a breast defect in a mastectomy patient.2,3,6,7 In the 1930s, implantation of a glass ball into a patient’s breast marked the first implant-based breast augmentation.6 By 1954, attempts at breast augmentation using local dermal-fat flaps, adipose tissue, and even omentum were described.
Alloplastic materials gained popularity throughout the 1950s and 1960s and included polyurethane, polytetrafluoroethylene (Teflon), and other synthetics. Adverse reactions associated with alloplastic materials were plentiful: local tissue reactions, distortion of the breast mound, increased firmness, and discomfort all contributed to the eventual discontinuation of their use. The history of alloplastic breast augmentation also included epoxy resin, shellac, beeswax, paraffin, rubber, petroleum jelly, and liquefied silicone. Outcomes were not good, and many patients ultimately needed mastectomy.7
The first modern breast prosthesis was developed in 1961, and since then, implant composition and design have evolved significantly.8
From silicone to saline, and back again
The first silicone gel implants, introduced in the early 1960s,8–19 had high complication rates—some centers reported an incidence of capsular contracture of up to 70%.8,11 This is a foreign body reaction in which pathologic scar tissue encases the implant, causing it to distort, appear misshapen, harden, and even become painful.11 Attempts to minimize this reaction led to later generations of silicone implants with polyurethane shells.12
Inflatable implants filled with sterile saline solution were originally developed in France in 1965. Unlike silicone implants, saline implants have undergone minimal changes since their inception, and grew in popularity during the 1970s in view of the high rates of capsular contracture with silicone implants.8 However, saline implants have their own problems, and as they became increasingly popular, deflation and the unnatural feel of saline sparked a renewed interest in silicone gel.
By the late 1980s, the thinner-shelled generation of silicone implants displayed its own frustrating complications including implant rupture, capsular contracture, infection, and possible systemic and disseminated granulomatous disease. From 1992 to 2006, the US Food and Drug Administration (FDA) placed a moratorium on silicone implants due to concerns about a possible link with autoimmune and connective tissue diseases and the possible carcinogenic nature of silicone.
While silicone implants were prohibited in the United States, development continued abroad, and eventually the moratorium was lifted after several meta-analyses failed to reveal any link regarding the aforementioned concerns.13
Today, silicone gel implants dominate the world market.14 In the United States, approximately 60% of implants contain silicone gel filler, and trends are similar in Europe.7
Table 1 summarizes the evolution of silicone breast implants over the last 50 years.2,6,11,12Table 2 lists the advantages and disadvantages of silicone and saline breast implants.2,6,8,15
CURRENT IMPLANT OPTIONS
Currently, 3 companies (Allergan, Mentor, Sientra) manufacture and distribute breast implants and implant-associated products such as tissue expanders and sizers in the US market.6
Another company, Motiva, makes an implant that is available in Europe, Asia, and Australia, and the device is currently undergoing a 10-year clinical trial in the United States that began recruiting patients in 16 centers in April 2018.16 Pending final approval, the Cleveland Clinic Department of Plastic Surgery may be among the centers involved in the clinical trial of the Motiva implant. Innovations in the Motiva implant include a high-performance shell that maintains consistent strength and includes a proprietary barrier layer, improved silicone gel filler, 3-D imprinted surface texturing, and an implant shape that adapts with vertical and horizontal movement. It also contains radio-frequency identification transponders that can transmit data about the implant wirelessly.17–19