NCT00443274

Safety Follow-up Study in Subjects With Silicone Gel-filled Breast Implants as Compared Both to Saline-filled Breast Implants and to National Norms

Breast Implant Follow-up Study: A Long-term Observational Study of the Safety of Allergan Silicone Gel-filled Breast Implants as Compared Both to Saline-filled Breast Implants and to National Norms (410-arm)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 56,460 (actual)
• Sponsor: Allergan · Industry
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Ten year safety study examining rates of rare adverse events, child bearing issues, effects of mammography, MRI compliance and results, and long-term benefit of silicone-filled breast implants.

Conditions

• Breast Implant

Interventions

Type	Name	Description
OTHER	NBIR - US National Breast Implant Registry	NBIR is intended to be a surveillance tool to track patient safety and real-world outcomes associated with breast implants used for aesthetic or reconstructive purposes..
DEVICE	410 Arm	Anatomically shaped silicone gel-filled breast implants.
DEVICE	BIFs - Breast Implant Follow-Up Study	Round silicone gel-filled breast implants and saline-filled breast implants

Timeline

• Start date: 2006-11-01
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2007-03-05
• Last updated: 2025-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study