Prevalence of Asymptomatic Rupture in SILIMED Breast Implants

NCT ID: NCT02206282

Last Updated: 2014-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

390 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Study Completion Date

2011-02-28

Brief Summary

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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

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Conditions

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Breast Implant Rupture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Silimed Industria de Implantes Ltda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wanda Elizabeth Massiere Correa, MD

Role: PRINCIPAL_INVESTIGATOR

Insituto Ivo Pitanguy

Other Identifiers

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IMR-LT-001

Identifier Type: -

Identifier Source: org_study_id

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