Natrelle round silicone breast implants: Core Study results at 10 years

Area of Science:

• Plastic Surgery
• Biomaterials Science

Background:

• Allergan's Natrelle round silicone-filled breast implants received FDA approval in 2006.
• Approval was based on interim results from the Core Study.

Purpose of the Study:

• To present the final 10-year study results for Natrelle round silicone-filled breast implants.
• To evaluate the safety and patient satisfaction of these implants over a decade.

Main Methods:

• Seven hundred fifteen subjects received smooth and Biocell textured Natrelle round silicone implants.
• Subjects attended annual clinic visits for 10 years, with MRI assessments for rupture at specified intervals.

Main Results:

• Complication rates showed modest increases over 6-year data; Kaplan-Meier capsular contracture rates varied by procedure type.
• Submuscular placement had significantly lower capsular contracture rates compared to subglandular placement in augmentation subjects.
• Overall rupture rates were 13.0% for subjects and 7.7% for implants; 81.8% of augmentation subjects retained their original implant at 10 years.
• High patient satisfaction was reported across all procedure types, with significant improvements in overall breast aesthetics.

Conclusions:

• The 10-year Natrelle Core Study data demonstrate the safety and high patient satisfaction associated with these breast implants.
• Findings provide valuable guidance for surgeons and patients considering breast implant procedures.