Prevalence of Asymptomatic Rupture in SILIMED Breast Implants

Silimed Industria de Implantes

Status: Completed

Conditions: Breast Implant Rupture

Study type: Observational

Funder types: Industry

Identifiers

NCT02206282

IMR-LT-001

Details and patient eligibility

About

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.

Enrollment: 390 patients

Sex: Female

Volunteers: No 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.