![]() ![]() This moratorium fostered the creation of fourth- and fifth- generation silicone gel implants under FDA and subsequently American Society for Testing Methodology guidelines. In 1992, the FDA issued a moratorium on all third- generation silicone gel implants and required manufacturers to provide additional safety and effectiveness data. 7 These nonpolyurethane textured surfaces gained popularity, both on silicone implants around the world and on silicone and saline implants in the United States. The textured surface was created on the actual silicone polymer shell to mimic the effects of polyurethane on reducing capsular contracture rates. This led to abandoning polyurethane in favor of a new type of textured surface which was developed for third-generation devices. Questions surrounding the safety of polyurethane surface, including concerns about the carcinogenic nature of the breakdown product of polyurethane, 2,4- touluenediamine (2,4-TDA), seen in bench studies and the delamination of the polyurethane shell seen clinically. 6 The polyurethane-textured surface was designed to reduce the risk of capsular contracture and create a “one breast feel” based on the adherence of this surface type to the surrounding breast tissue. ![]() By 1972, second-generation gel implants became available, which offered a silicone shell, silicone gel, and a polyurethane textured surface (Surgitek, a subsidiary of Bristol-Myers Squibb ), designed to achieve an improved aesthetic outcome. Silicone breast implants were grandfathered in by the Food and Drug Administration (FDA) based on the overall safety profile of silicone devices used widely in medicine. The first silicone gel breast implant was manufactured by Dow Corning Corporation (Midland, MI) in 1962. Evolution of Breast Implant Surface Textures In this review, the authors will describe the evolution of breast implant surface textures compare available implant surfaces present long-term safety data from the 10-Year US-based Core clinical studies list the key benefits and risks associated with smooth and textured implants and provide perspectives on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The purpose of this article is to describe implant options and stress the importance of maintaining these options to allow surgeons to weigh the risks and benefits of the choices to provide the best individualized outcome for each patient. 3–5 In contrast, device preferences differ substantially outside the United States, with 90% usage of textured implants in Europe and Australia. 2 The current breakdown of breast implant usage in the United States is approximately 87% smooth and 13% textured. ![]() Silicone implants currently available in the United States include fourth- and fifth-generation devices from three manufacturers, Sientra (Santa Barbara, CA), Allergan (Irvine, CA), and Mentor (Irvine, CA). 1 During this time, the characteristics and usage of smooth and textured breast implants have changed due to the advances in gel and texture technology, the approval of shaped implants, and the evolution of surgical techniques. Since 1997, the number of augmentation procedures in the United States has increased by 207%, according to The American Society for Aesthetic Plastic Surgery. Breast augmentation is one of the most common aesthetic operations performed in the United States. ![]()
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