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OpenTrials
Completed

NCT Number: NCT02206282

Prevalence of Asymptomatic Rupture in SILIMED Breast Implants

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.

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Key information

Conditions

Breast Implant Rupture

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Magnetic Resonance Image

    Time frame: 1 year

    390 Magnetic Resonance Images.

Sponsors and collaborators

Lead sponsor

Silimed Industria de Implantes Ltda

Industry

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Aug 1, 2014
Registry last updated
Aug 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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