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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macrolane | Women that have had breast enhancement with Macrolane Volume Restoration Factor. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Number of Adverse events reported during the study period | 01may2008 - 31dec2009 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 12 months post-procedure |
Inclusion Criteria:
Exclusion Criteria:
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Women that have had breast enhancement in clinics in Sweden (and UK).
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| Name | Affiliation | Role |
|---|---|---|
| Per Hedén, Md PhD | Akademikliniken | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stureplanskliniken | Gothenburg | 411 05 | Sweden | |||
| Akademikliniken |
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| ID | Title | Description |
|---|---|---|
| FG000 | Macrolane | Women that have had breast enhancement with Macrolane Volume Restoration Factor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Macrolane | Women that have had breast enhancement with Macrolane Volume Restoration Factor. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Adverse Events | Number of Adverse events reported during the study period | Posted | Number | number of AE | 01may2008 - 31dec2009 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Macrolane | Women that have had breast enhancement with Macrolane Volume Restoration Factor. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Capsular contracture associated with breast implant | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Q-Med AB | +46 18 4749000 | reception.seupp@galderma.com |
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| Malmö |
| 217 53 |
| Sweden |
| Stureplanskliniken | Stockholm | 111 44 | Sweden |
| Akademikliniken | Stockholm | 115 42 | Sweden |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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. | Posted | Number | participants | up to 12 months post-procedure |
|
|
|
| 0 |
| 93 |
| 21 |
| 93 |
| Implant site nodule | General disorders |
|
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