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Natrelle saline-filled breast implants: a prospective 10-year study.
Patricia S Walker1, Beth Walls, Diane K Murphy
1murphy_diane@allergan.com
Aesthetic Surgery Journal
|February 24, 2009
Summary
Long-term data show Natrelle saline breast implants are safe and effective for augmentation and reconstruction. Most implants remained intact after 10 years, with high patient satisfaction and manageable complication rates.
Area of Science:
- Plastic Surgery
- Biomaterials Science
- Clinical Trials
Background:
- Natrelle saline-filled breast implants are widely used for augmentation and reconstruction.
- Key concerns include local complications and the need for revision surgeries.
Purpose of the Study:
- To provide long-term (10-year) data on the safety and effectiveness of Natrelle saline breast implants.
- To assess complication rates and patient satisfaction following augmentation and reconstruction procedures.
Main Methods:
- Prospective, multicenter study involving 901 augmentation and 237 reconstruction subjects.
- 5-year in-person follow-up, followed by a 10-year survey-based study.
- Analysis of safety outcomes (deflation, contracture, pain, reoperation) and patient satisfaction using Kaplan-Meier rates and a 6-point scale.
Main Results:
- High 10-year survey response rates: 91.4% for augmentation, 85.9% for reconstruction.
- Reoperation was the most common safety concern; 90% of implants remained intact at 10 years.
- High patient satisfaction: 87.5% for augmentation, 86.3% for reconstruction.
Conclusions:
- Natrelle saline breast implants demonstrate long-term safety and effectiveness.
- 10 years of clinical data support informed decision-making for patients and surgeons.
- The study provides robust evidence on implant durability and patient-reported outcomes.
