Out points criteria for breast implant removal without replacement and criteria to minimize reoperations following breast augmentation

Breast augmentation is a totally elective, medically unnecessary procedure, and surgeons and patients must prioritize minimizing tradeoffs, costs, and risks at the primary operation and at reoperations. At the U.S. Food and Drug Administration's advisory panel hearings in October of 2003 to consider approval of conventional silicone gel implants, data documented an overall reoperation rate of 20 percent at just 3 years after primary breast augmentation. Subsequently, the premarket approval was not granted. Similarly high reoperation rates have been reported in previous saline and silicone gel premarket approval studies over the past two decades, demonstrating that high reoperation rates are not device dependent and suggesting a need to reexamine surgical management criteria. Bilateral implant removal without replacement limits additional reoperations in a wide range of clinical situations. Surgeons and patients often prefer other options to avoid removal without replacement, but other options carry a higher tradeoffs, costs, and risks to the patient. If minimizing tradeoffs, costs, and risks of reoperations is a priority, surgeons must define and patients must understand and accept "out points," that is, specific criteria for bilateral implant removal without replacement. Defining out points is challenging. Enforcing them when difficult clinical situations occur is even more challenging. This article presents out points that have been incorporated into staged, repetitive informed consent documents and used in the author's practice for more than 10 years. In peer-reviewed and published reports of more than 1600 patients, these out points criteria, in conjunction with the TEPID system (tissue characteristics of the envelope, parenchyma, and implant and the dimensions and fill distribution dynamics of the implant) of implant and pocket selection based on individual patient quantifiable tissue criteria and surgical techniques that minimize tissue trauma and bleeding, resulted in an overall reoperation rate of 3 percent in 1662 reported cases with up to 7 years of follow-up, compared with the 20 percent reoperation rate at 3 years in the most recent Food and Drug Administration study.