Breast Augmentation
Conditions
Keywords
Patients who participated in pilot study (31GB0601) and performed breast augmentation with previous formulation of Macrolane
Brief summary
Several subjects included in a Pilot study (CTN 31GB0106) during 2002-2003 still had Macrolane deposits in the breast when the last study visit was performed. An additional follow up visit is planned to follow duration and safety of the former formulation of Macrolane that was used in the Pilot study (CTN 31GB0106).
Detailed description
All subjects included in a Pilot study between 2002-2003 (CTN 31GB0106) are offered to take part in a seven year safety follow up after the initial injection of the former formulation of Macrolane into the breasts. The study will not involve any additional treatments. The follow up will include relevant medical history, weight, breast examination, ultrasound and mammography to determine if there are/have been any safety issues since the final study visit in the Pilot study (CTN 31GB0106), as well as a comprehensive MRI investigation to assess the breast structure and determine if there are still deposits of Macrolane in the breast.
Interventions
RADIATIONRadiologial breast examination
MRI of breast, mammography and ultrasound of breast
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Participant in 31GB0601
Exclusion criteria
* There are no exclusion citeria in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation | 7 years +/- 6months post treatment | The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment. |
| To Evaluate the Long Term Safety of Macrolane in Breast Enhancement | 7 years +/- 6 months post treatment | To evaluate the long term safety of Macrolane in breast enhancement, using relevant medical history, breast examination, mammography and ultrasound as well as a comprehensive MRI investigation. Participants with AE/SAE since participation in study 31GB0106 or any findings at the breast examination, mammography, ultrasound or comprehensive MRI investigation |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants in the Pilot Study 31GB0601 This is an additional safety follow up 7-years post treatment, for subjects enroled in a pilot study using a previous formulation of Macrolane for breast augmentation.
Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Participants in the Pilot Study 31GB0601 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 31 years STANDARD_DEVIATION 4.3 |
| Region of Enrollment Sweden | 6 participants |
| Sex: Female, Male Female | 6 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 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation
The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment.
Time frame: 7 years +/- 6months post treatment
Population: MRI were performed by 4 women out of 6. One woman was pregnant and therefore not included and one did not want to perform MRI.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants in the Pilot Study 31GB0601 | To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation | 4 participants with remaining product |
Primary
To Evaluate the Long Term Safety of Macrolane in Breast Enhancement
To evaluate the long term safety of Macrolane in breast enhancement, using relevant medical history, breast examination, mammography and ultrasound as well as a comprehensive MRI investigation. Participants with AE/SAE since participation in study 31GB0106 or any findings at the breast examination, mammography, ultrasound or comprehensive MRI investigation
Time frame: 7 years +/- 6 months post treatment
Population: Subjects that participated in study 31GB0106 was asked to partícipate in the study 31GB0904. 6 subjects signed Informed consent for this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants in the Pilot Study 31GB0601 | To Evaluate the Long Term Safety of Macrolane in Breast Enhancement | 0 participants |