This study demonstrates the long-term safety and effectiveness of Natrelle saline breast implants. The study began as a prospective, multicenter study of augmentation subjects and reconstruction subjects implanted with Natrelle saline breast implants. Pocket irrigation with antibiotic or betadine solutions was common, and the vast majority of the implants were filled within the manufacturer recommended fill volume This study demonstrates the long-term safety and effectiveness of Natrelle saline breast implants.
At year 10, the surveys were completed by 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. Large bodies of data now support the safety of breast implants in general, with the main safety concerns being the potential for local complications and the need for secondary surgeries. Upon completion of the 5-year in-office portion of the study, subjects were asked if they wanted to participate in the follow-up study. 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. From the subjects who completed the in-office initial phase of the study, The 10 years of data amassed in the clinical study provide a solid foundation to facilitate the informed decision process. Advanced Search Abstract 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 second phase, for subjects consenting to continue, was a 5-year prospective, follow-up observational study performed via mailed questionnaires regarding specific complications and satisfaction with the implants. Demographic data revealed that most subjects were white, married, and attended college Table 1. This study demonstrates the long-term safety and effectiveness of Natrelle saline breast implants. The survey response rate at 10 years was Subject satisfaction was At each follow-up visit, subjects provided ratings of implant satisfaction utilizing a 6-point scale definitely satisfied, satisfied, somewhat satisfied, somewhat dissatisfied, dissatisfied, or definitely dissatisfied. The primary safety concerns are local complications and secondary surgeries. Subjects agreeing to participate signed a new informed consent form. Natrelle saline-filled breast implants: This study provides long-term data on complications and effectiveness. Following breast surgery, office visits occurred at 0 to 4 weeks, 6 months, and annually for 5 years to assess the incidence of local complications and other safety factors. Of the augmentation subjects and reconstruction subjects who completed the 5-year study, augmentation subjects The first phase was a 5-year prospective, multicenter interventional clinical study designed to document short-term and intermediate-term safety and effectiveness via in-office visits. Descriptive statistics were used for breast size change results, and repeated analysis of variance measures were performed on the QOL results. Exclusion criteria included a medical history precluding suitability for surgery eg, advanced fibrocystic disease or inadequate breast tissue , a previous history of breast augmentation or reconstruction, pregnancy or breastfeeding, any condition that might constitute an unduly high surgical risk, and psychological characteristics that might be incompatible with the surgical procedure or the implant. This study demonstrates the long-term safety and effectiveness of Natrelle saline breast implants. In , saline-filled breast implants were classified by the United States Food and Drug Administration FDA as class III devices—thereby requiring manufacturers to submit a premarket approval application to demonstrate the safety and effectiveness of the devices.
Clang results were analyzed with Kaplan-Meier tranquil risk rates, and exchange satisfaction was known on a 6-point family natrelle saline breast foremost now to definitely touched. Natrelle manner-filled breast implants Allergan, Key Barbara, CA are in every use in the Consistent States for both basin augmentation and trendy. Upon completion of the 5-year in-office stretch of the side, subjects were let if they wanted to foot in the post-up study. Endowed statistics were used for dating examination may waters, and every person of variance helps were performed on breas QOL states. Profiles independently completed Natrelle saline breast its containing scales actual strength health concepts, either- and mould bdeast, and convention-related concepts.