NCT01785069

Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants

A Prospective Multicenter Study of the Safety and Effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-filled X-style and L-style Breast Implants

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 355 (actual)
• Sponsor: Allergan · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, multicenter study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Style and L-Style Breast Implants.

Conditions

• Breast Augmentation
• Breast Reconstruction
• Breast Implant Revision

Interventions

Type	Name	Description
DEVICE	Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection	Surgical implant

Timeline

• Start date: 2012-12-10
• Primary completion: 2015-11-30
• Completion: 2015-11-30
• First posted: 2013-02-06
• Last updated: 2020-06-25
• Results posted: 2020-06-25

Locations

29 sites across 1 country: United States

Regulatory

• FDA-regulated device study