Prevalence of Asymptomatic Rupture in SILIMED Breast Implants

Breast Implant Rupture Clinical Trial

Official title:

Prevalence of Asymptomatic Rupture in SILIMED Breast Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206282
• Other study ID #: IMR-LT-001
• Status: Completed
• Phase: N/A
• First received: July 28, 2014
• Last updated: July 30, 2014
• Start date: August 2006
• Est. completion date: February 2011

Study information

• Verified date: July 2014
• Source: Silimed Industria de Implantes Ltda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: February 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Implant Rupture
• Rupture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Silimed Industria de Implantes Ltda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnetic Resonance Image	390 Magnetic Resonance Images.	1 year	Yes