Prevalence of Asymptomatic Rupture in SILIMED Breast Implants

N/ACompletedNCT02206282

Silimed Industria de Implantes Ltda390 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

390

Conditions

Breast Implant Rupture

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Magnetic Resonance Image

390 Magnetic Resonance Images.

Time frame: 1 year

Data from ClinicalTrials.gov

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