Elective Replacement of Shaped Textured Implants with Round Smooth Implants: Is it Worth it? An Evaluation of Patient- and Outcomes in 530 Consecutive Cases

Abstract

BACKGROUND: The number of patients undergoing exchange of shaped, textured implants for round, smooth devices has greatly increased in the setting of BIA-ALCL. To date, there are no published studies evaluating long-term outcomes following these replacements. The objective of this study is thus to examine long-term patient- and surgeon-reported outcomes in terms of aesthetics, comfort, and complications. METHODS: A prospectively-collected database of all patients who underwent postmastectomy, implant-based reconstruction by a single surgeon (PGC) was analyzed. All patients who underwent initial reconstruction with shaped, textured implants which were then replaced with round, smooth implants between 1994-2022 with a minimum follow-up of 1 year were included. Demographics and peri-operative complications (hematoma, cellulitis, seroma) were recorded. Patient-reported outcomes (PROs) were collected using the BREAST-Q Reconstruction Module as well as a 5-point Likert scale surveying aesthetic outcome and comfort level. The BREAST-Q is a PRO measure administered to all patients undergoing breast reconstruction at our institution at the pre-operative visit followed by 3 months, 6 months, 1 year, 2 years, and 5 years post-operatively. Patients who had scores at least one year post-operatively were included. The following domains were evaluated in this study: Satisfaction with Breasts, Psychosocial Well-being, Physical Well-Being (Chest), and Sexual Well-Being. Values were converted to summary scores ranging from 0-100, and a difference of 4 points was considered clinically significant. Surgeon-reported outcomes included evaluation of aesthetics using a 5-point Likert scale and Baker classification of capsular contracture. RESULTS: In total, 530 patients were reviewed and 307 met inclusion criteria with a mean age of 46 and mean BMI of 23.25. Mean follow-up was 3.8 years. 74% of cases were bilateral and 22.8% had a history of radiation. Pairwise comparison of BREAST-Q data demonstrated statistically significant, long-lasting improvement in all domains. At one-year follow-up after exchange of shaped, textured implants to round, smooth implants, psychosocial well-being (72.68 to 76.45; p=0.0075) and physical well-being (78.79 to 81.88; p=0.0078) significantly increased. Overall breast satisfaction (61.94 to 67.27; p=0.0082) and sexual well-being (53.89 to 57.98; p=0.0002) were also significantly higher in parallel with a clinically significant increase in BREAST-Q score of 5.33 and 4.09 points, respectively. Most patients felt they looked better (56.4%) or the same (27.3%) and were more comfortable (54.4%) or the same (39.4%) after the exchange procedure. The senior surgeon rated 40.1% of patients as a better aesthetic grade after replacement and 50.3% as the same aesthetic grade. 36.8% of patients were rated as having a decrease in Baker capsular contracture grade and only 4.3% with increased contracture. 2.9% of patients experienced a peri-operative complication and there were no reconstructive failures. CONCLUSION: Exchange of textured to smooth implants is safe, does not appear to sacrifice aesthetic outcome, and provides a more comfortable and satisfactory outcome for patients with a low rate of complications. These results should be given consideration when counseling patients with textured implants and can aid in making an informed decision regarding exchange.