BACKGROUND: Natrelle saline-filled breast implants (Allergan, Santa Barbara, CA) are in widespread use in the United States for both breast augmentation and reconstruction. The primary safety concerns are local complications and secondary surgeries. OBJECTIVE: This study provides long-term data on complications and effectiveness. METHODS: The study began as a prospective, multicenter study of 901 augmentation subjects and 237 reconstruction subjects implanted with Natrelle saline breast implants. After completing 5 years of annual visits with physician examinations, subjects were asked to enroll in a survey-based study for follow-up through 10 years. Survey questions encompassed the major safety outcomes of implant deflation, capsular contracture, breast pain, reoperation, and implant removal/replacement as well as subject satisfaction. Safety results were analyzed with Kaplan-Meier cumulative risk rates, and subject satisfaction was measured on a 6-point scale from definitely satisfied to definitely dissatisfied. RESULTS: Of the 876 augmentation subjects and 194 reconstruction subjects who completed the 5-year study, 781 augmentation subjects (89.2%) and 170 reconstruction subjects (87.6%) consented to participate in the survey study. The survey response rate at 10 years was 91.4% for augmentation subjects and 85.9% for reconstruction subjects. Reoperation was the most frequent safety issue for both subject groups, and 90% of the implants remained intact at 10 years. Subject satisfaction was 87.5% for augmentation subjects and 86.3% for reconstruction subjects at 10 years. CONCLUSIONS: This study demonstrates the long-term safety and effectiveness of Natrelle saline breast implants. The 10 years of data amassed in the clinical study provide a solid foundation to facilitate the informed decision process.
BACKGROUND:Natrelle saline-filled breast implants (Allergan, Santa Barbara, CA) are in widespread use in the United States for both breast augmentation and reconstruction. The primary safety concerns are local complications and secondary surgeries. OBJECTIVE: This study provides long-term data on complications and effectiveness. METHODS: The study began as a prospective, multicenter study of 901 augmentation subjects and 237 reconstruction subjects implanted with Natrelle saline breast implants. After completing 5 years of annual visits with physician examinations, subjects were asked to enroll in a survey-based study for follow-up through 10 years. Survey questions encompassed the major safety outcomes of implant deflation, capsular contracture, breast pain, reoperation, and implant removal/replacement as well as subject satisfaction. Safety results were analyzed with Kaplan-Meier cumulative risk rates, and subject satisfaction was measured on a 6-point scale from definitely satisfied to definitely dissatisfied. RESULTS: Of the 876 augmentation subjects and 194 reconstruction subjects who completed the 5-year study, 781 augmentation subjects (89.2%) and 170 reconstruction subjects (87.6%) consented to participate in the survey study. The survey response rate at 10 years was 91.4% for augmentation subjects and 85.9% for reconstruction subjects. Reoperation was the most frequent safety issue for both subject groups, and 90% of the implants remained intact at 10 years. Subject satisfaction was 87.5% for augmentation subjects and 86.3% for reconstruction subjects at 10 years. CONCLUSIONS: This study demonstrates the long-term safety and effectiveness of Natrelle saline breast implants. The 10 years of data amassed in the clinical study provide a solid foundation to facilitate the informed decision process.