Objective Comparison of FDA-Approved Breast Implant Products in the USA: 5-Year Update

Abstract

There are currently four companies offering FDA-approved breast implants: Allergan, Sientra, Mentor, and Ideal Implant. In 2015, our paper "Objective Comparison of Commercially Available Breast Implant Devices" sought to provide a unique conceptual framework to better understand the similarities and differences between FDA-approved breast implant products and tissue expanders. This paper uses the same variables, such as fill material, shape, relative dimensions, and surface coating, to aid understanding of both the surgical trainee and the operating surgeon of what devices each company offers, with a focus on how the market has evolved over the ensuing 5years. The product catalogs of each FDA-approved company were carefully explored to determine the current available breast implants and tissue expanders. Subsequently, flow charts were created to provide a clear and objective survey of each companies' offerings, highlighting where there are overlap and deficiencies, and where there has been contraction or growth. Disruptions to the industry, including both technological innovation and the recognition of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), have caused a significant shift in the details of the available permanent breast implants, breast tissue expanders, sizers, and warranty programs. As it has been in 2015, company jargon and brand names continue to make it challenging to discern the similarities and differences between company devices and programs. This project remained independent of any company's funding, support, or input, making it a uniquely objective and informative survey of the current breast implant market that should assist surgeons in decision-making regarding the breast implant procedures. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .