Prevalence of Asymptomatic Rupture in SILIMED Breast Implants

July 30, 2014 updated by: Silimed Industria de Implantes Ltda
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

390 women (780 implants) from Rio de Janeiro and other Brazilian cities will be randomly selected to undergo MRI detection of asymptomatic rupture using a stratified sampling design, stratifying on implant age (time since implantation). Sixty-five (65) women will be selected from each of six implant age groups between 6-18 years.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnetic Resonance Image
Time Frame: 1 year
390 Magnetic Resonance Images.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Silimed Industria de Implantes Ltda

Investigators

  • Principal Investigator: Wanda Elizabeth Massiere Correa, MD, Insituto Ivo Pitanguy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

July 28, 2014

First Submitted That Met QC Criteria

July 30, 2014

First Posted (Estimate)

August 1, 2014

Study Record Updates

Last Update Posted (Estimate)

August 1, 2014

Last Update Submitted That Met QC Criteria

July 30, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMR-LT-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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