Status:

COMPLETED

Prevalence of Asymptomatic Rupture in SILIMED Breast Implants

Lead Sponsor:

Silimed Industria de Implantes Ltda

Conditions:

Breast Implant Rupture

Eligibility:

FEMALE

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-fill...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

August 1 2006

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 1 2011

Estimated Enrollment :

390 Patients enrolled

Trial Details

Trial ID

NCT02206282

Start Date

August 1 2006

End Date

February 1 2011

Last Update

August 1 2014

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