Macrolane Retrospective Study

Galderma R&D93 enrolled

Overview

This is a retrospective, multicenter chart review of medical records on the use of Macrolane for female breast enhancement. The primary objective is to evaluate the safety profile of Macrolane Volume Restoration Factor 20 and Macrolane Volume Restoration Factor 30 when used for female breast enhancement in clinical practice.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Women Who Have Had Breast Enhancement With Macrolane VRF

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Females treated with Macrolane Volume Restoration Factor 20 and/or Volume Restoration Factor 30 for breast enhancement. * Signed Informed Consent Exclusion Criteria: * Subjects that have actively asked not to be contacted by the clinic * Subjects that have participated or participates in clinical studies with Macrolane for breast enhancement

Locations (4)

Stureplanskliniken

Gothenburg, Sweden

Akademikliniken

Malmo, Sweden

Stureplanskliniken

Stockholm, Sweden

Akademikliniken

Stockholm, Sweden

Outcomes

Primary Outcomes

Number of Adverse Events

Number of Adverse events reported during the study period

Time frame: 01may2008 - 31dec2009

Data from ClinicalTrials.gov

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