Decision and management algorithms to address patient and food and drug administration concerns regarding breast...

During the U.S. Food and Drug Administration's advisory panel hearings to evaluate the premarket approval for conventional silicone gel implants on October 14 and 15, 2003, panel members and patient advocate representatives focused on four specific areas of concern: reoperation rates in primary breast augmentation; levels, depth, and methods of patient education and informed consent; modes, frequency, and management of silicone gel implant device failures, including management of "silent" ruptures; and methods of monitoring and managing symptoms or symptom complexes that may or may not be associated with connective tissue disease or other undefined symptom complexes. These concerns, with a reported 20 percent reoperation rate for primary augmentation within just 3 years, and a lack of concise, definitive management protocols addressing these areas of concern may have contributed to the Food and Drug Administration's rejection of the premarket approval, despite the panel's recommendation for approval. This article presents decision and management algorithms that have been used successfully for 7 years in a busy breast augmentation practice (Tebbetts and Tebbetts). The algorithms have been further expanded and refined by a group of surgeons with diverse experiences and expertise to address the following clinical situations that coincide with concerns expressed by patients and the Food and Drug Administration: implant size exchange, grade III to IV capsular contracture, infection, stretch deformities (implant bottoming or displacement), silent rupture of gel implants, and undefined symptom complexes (connective tissue disease or other). In one practice (Tebbetts and Tebbetts) that uses the TEPID system (tissue characteristics of the envelope, parenchyma, and implant and the dimensions and fill distribution dynamics of the implant), implant selection is based on quantified patient tissue characteristics, pocket selection is based on quantified soft-tissue coverage, and anatomic saline implants have fill volumes that are designed to minimize shell collapse and fold fatigue; in this practice, the algorithms contributed to a 3 percent overall reoperation rate in 1662 reported cases with up to 7 years of follow-up, compared with a 20 percent reoperation rate at 3 years in the 2003 premarket approval study.