Prevalence of Asymptomatic Rupture in SILIMED Breast Implants

Completed

• Conditions: Breast Implant Rupture

• Registration Number: NCT02206282
• Lead Sponsor: Silimed Industria de Implantes Ltda

Brief Summary

A prospective clinical research is to assess the prevalence of implant rupture and presence of extracapsular gel in an un-referred population of women who have been implanted with the Silimed gel-filled mammary implants with or without any local or systemic systemic symptoms.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2010-11
• Study Completion: 2011-02
• Status Verified: 2014-07
• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-30
• Last Update Submitted: 2014-07-30
• Study First Posted: 2014-08-01
• Last Update Posted: 2014-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 390

Inclusion Criteria

• Female
• Subject implanted with the original Silimed gel-filled implant.

Exclusion Criteria

• MR imaging is not possible because of the following:
• Metal implant
• Battery activated stimulator
• Pregnancy
• Tattoos
• Body weight >300 pounds
• History of metal fragments in the eye
• Any other contraindication to MR exam.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Magnetic Resonance Image	1 year	390 Magnetic Resonance Images.