Single centre, long-term experience with Mentor Contour Profile Gel Implants. What can we learn after 21 years of follow up?

Background: The difficulty in obtaining long-term data with the use of breast implants is well known. The majority of available data are from multicenter studies with different surgical techniques, and different implants. Methods: The authors provide retrospective 10-year study data (2001 to 2011) with Mentor Contour Profile Gel implants after a mean of 13 years of follow-up, in the first single-center study of such size and length. This study included 835 patients with 1674 Mentor implants across 6 surgery types, all of them performed with a consistent surgical technique developed by the senior author (J.L.M.Y.). Long-term complication rates were analyzed. For the safety analysis, Kaplan-Meier risk rates were calculated. Results: A total of 85% of the patients had long-term follow-up data (at least 7 years). The overall complication rate was 13.2%. The reoperation rate was 12.3%, being just 6.2% caused by complications. The 21-year Kaplan Meier cumulative incidence rate was 1.7% for capsular contracture and 5.1% for implant rupture. The periareolar approach and having a previous capsular contracture were found to be risk factors to develop a new capsular contracture. Low-height, high-projected implants had a significant higher risk of implant rotation. No breast implant-associated anaplastic large cell lymphoma or breast implant illness cases were found; 89.2% of the patients reported being satisfied or very satisfied with the surgery and the implant. Conclusion: With a consistent surgical technique, these 21-year follow-up data of the Mentor Contour Profile Gel implants reaffirm the very strong safety profile of these implants, and continued patient satisfaction with them. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.