Women Who Have Had Breast Enhancement With Macrolane VRF
Conditions
Keywords
Macrolane, Retrospective
Brief summary
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.
Interventions
None listed
Sponsors
Galderma R&D
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | 01may2008 - 31dec2009 | Number of Adverse events reported during the study period |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Reported Being at Least Somewhat Satisfied at Any Tine Post-procedure | up to 12 months post-procedure | The alternative outcomes were: still satisfied, never satisfied, 3-5 months, 6-8 months, 9-11 months, 12 months or more, still satisfied when retreated. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Macrolane Women that have had breast enhancement with Macrolane Volume Restoration Factor. | 93 |
| Total | 93 |
Baseline characteristics
| Characteristic | Macrolane |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 93 Participants |
| Region of Enrollment Sweden | 93 participants |
| Sex: Female, Male Female | 93 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 93 |
| serious Total, serious adverse events | 0 / 93 |
Outcome results
Primary
Number of Adverse Events
Number of Adverse events reported during the study period
Time frame: 01may2008 - 31dec2009
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Macrolane | Number of Adverse Events | 46 number of AE |
Other Pre-specified
Number of Participants Who Reported Being at Least Somewhat Satisfied at Any Tine Post-procedure
The alternative outcomes were: still satisfied, never satisfied, 3-5 months, 6-8 months, 9-11 months, 12 months or more, still satisfied when retreated.
Time frame: up to 12 months post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Macrolane | Number of Participants Who Reported Being at Least Somewhat Satisfied at Any Tine Post-procedure | 89 participants |