Prevalence of Asymptomatic Rupture in SILIMED Breast Implants

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02206282

Enrollment

390

Registered

2014-08-01

Start date

2006-08-31

Completion date

2011-02-28

Last updated

2014-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Implant Rupture

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-filled mammary implants with or without any local or systemic systemic symptoms.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Magnetic Resonance Image	1 year	390 Magnetic Resonance Images.

Outcome results