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Inamed 410 Silicon-Filled Breast Implant European MRI-Study

Phase 4
Completed
Conditions
breastimplants
10006295
Registration Number
NL-OMON30753
Lead Sponsor
Allergan Medical
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
30
Inclusion Criteria

women who were implanted in 1995-1999 with McGan Medical Silicone-Filled breast omplants Styles 410 and still have at least one of those original implants
patients must be willing to undergo a MRI-scan. Patients must be eligible for MRI
Patients must hcommit to following study requirements and must have signed and dated the Informed Consent prior to any study procedures being performed

Exclusion Criteria

patient is pregnant or nursing
patient has any type of implanted material or metal devices that may make her ineligible for MRI
patient has a history of severe claustrophobia that may make her ineligible for MRI
patient only had other implants that McGhan Style 410

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>n.a.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>n.a.</p><br>
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