Breast AugmentationSOFTONENCT07904091
Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years
An observational study of Breast Augmentation and Breast Reconstruction, run by Laboratoires ARION at 5 sites in France.
Trial summary
The aim of this observational, Post-market, Retro-prospective, open, non-randomized, non-comparative, multicentric, European study is to evaluate the safety and performance of the Monobloc® - Silicone SoftOne® breast implants at 10 years. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Augmentation, Breast Reconstruction
- What is being tested?
- Breast augmentation and Breast reconstruction
- Type of treatment
- Medical device
- How many people
- 630 participants
- Where
- 5 sitesFrance
- Study dates
- 7 Sep 2023to 7 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who are at least 18 years old, unless otherwise medically advised, who fit the indications and who do not meet contraindications. * Breast augmentation for aesthetic purpose: volume augmentation through insertion of implant * Breast reconstruction: Breast reconstruction following the removal of all or part of the damaged mammary gland. * Breast reconstruction after anti-cancer treatments other than mastectomy. * New intervention because of complications or other undesirable results following a previous surgical procedure related to a mastectomy or following cancer treatments. * Post-traumatic, defined as a total or partial ablation of one or both breasts through an act of surgery (for any reason), or as a result of the injury itself.
Who may be able to join
- Woman implanted with at least one Monobloc® - Silicone SoftOne® breast implants between 2011 to 2013
- Woman having received information and signed informed consent
- Woman aged 18 years and older at the implantation
- Woman affiliated to the health social security system
Who cannot join
- Pregnant or breastfeeding woman at the time of intervention
- Woman under guardianship or curatorship
- Woman under legal protection
- Woman who refuses to participate
- Woman unable to understand questionnaires
- Woman with an active infection in the body at the time of intervention
Show all 19Show fewer
- Woman with a recent history of breast abscess at the time of intervention
- Woman with an history of abnormal wound healing and scarring process
- Woman with an immune system deficiency
- Woman with a persistent or recurrent breast cancer
- Woman with a lupus (e.g. acute disseminated lupus erythematosus) at the time of intervention
- Woman with an uncontrolled diabetes or other disorder affecting wound healing at the time of intervention
- Woman with tissue changes due to chest wall irradiation, skin grafts under tensile stress, or radical excision of the pectoralis major muscle.
- Woman with lymphorea at the time of intervention
- Woman with a psychological instability characterized by inappropriate attitude or motivation at the time of intervention
- Woman with lack of perception of the risks associated with the surgical procedure and the breast implant at the time of intervention
- Woman with a benign or malignant breast tumor at the time of intervention
- Woman with inadequate tissue coverage or tissue injury at the time of intervention
- Woman with contraindication of non-emergent surgical procedures (biological, immunological, cardio-vascular
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Academia Aesthetica
Bordeaux, 33200
Cabinet de chirurgie esthétique de Marseille
Marseille, 13008
Cabinet de chirurgie esthétique de Paris
Paris, 75001
Cabinet Médical Esthétique Paris 7
Paris, 75007
CHU de Toulouse
Toulouse, 31400
About this study
Official title: Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years: Post-marketing Clinical Follow-up Study
The aim of this observational, Post-market, Retro-prospective, open, non-randomized, non-comparative, multicentric, European study is to evaluate the safety and performance of the Monobloc® - Silicone SoftOne® breast implants at 10 years.
The primary objective is to evaluate the rate of women who had at least one re-intervention within the 10 years of follow-up. the secondary objectives are To evaluate the safety and performance outcomes of women who underwent breast augmentation and/or breast reconstruction using the Monobloc® - Silicone SoftOne® breast implants at 10 years
Participants will have one follow-up visit during which data will be retrospectively documented at the following time points: preoperative visit, operative visit, follow-up 10 years
Read the detailed description
The aim of the study is to allow Laboratoires ARION to communicate to competent authorities and to the scientific community data relative to the safety and performance outcomes of the Monobloc® - Silicone SoftOne® breast implants at 10 years for women who underwent breast augmentation and/or breast reconstruction.
2 groups based on indication will be analyzed during this clinical investigation:
- Breast augmentation (aesthetic): primo-implantation or revision for breast augmentation
- Breast reconstruction: primo-implantation or revision for breast reconstruction 3 families of implantswill be analyzed during this clinical investigation :
- Smooth
- Micro-textured
- Textured
- Conditions
- Breast Augmentation, Breast Reconstruction
- Being tested
- Breast augmentation, Breast reconstruction
- Keywords
- Breast reconstruction, Breast augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast augmentationDevice
Breast augmentation with implants
Breast reconstructionDevice
Breast reconstruction with implants
| Study group | Role | What they receive |
|---|---|---|
| aesthetic | implantation or revision for breast augmentation Receives: Device: Breast augmentation | |
| reconstruction | primo-implantation or revision for breast reconstruction Receives: Device: Breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of women who had at least one re-intervention within the 10 years of follow-up.
rate of subjects who had at least one re-intervention within the 10 years of follow-up
Measured: 10 years of follow-up
Secondary outcomes (9)
Evaluation of the reintervention rate by subgroups
Rate of patients who had at least one re-intervention within the 10 years of follow-up by subgroups
Measured: 10 years of follow-up
Evaluation of reintervention rate related to complications
Rate of patients who had at least one re-intervention related to complications within the 10 years of follow-up
Measured: 10 years of follow-up
Evaluation of high clinical interest adverse events
Rate of patients with at least one adverse event of high clinical interest within the 10 years of follow up: carcinoma, BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma), neurological diseases, connective tissue diseases
Measured: 10 years of follow-up
Evaluation of common complications of breast surgery
Complications rate of Common complications of breast surgery by subgroups (textures and indications) within 10 years: Rupture/fissure/transudation (A0410) ; Capsular contraction (A010102) ; Extrusion (A0411) ; Esthetic issues (asymmetry, rotation, malposition, migration, ptosis, folds) (A0104)
Measured: 10 years of follow-up
Evaluation of systemic complications
Rate of patients who had at least one systemic complication within the 10 years follow-up:
- Cardiovascular: damage to blood vessels, thrombosis, pulmonary embolism, Ischemic Heart Disease
- Nervous: Nervous System Injury, neurological reactions
- Metaplasic: LAGC-AIM, breast cancer
- Infectious: Toxic Shock Syndrome
- Conjonctive: Connective Tissue Disease
- Autoimmune disorder (ASIA syndrome, siliconoma)
Measured: 10 years of follow-up
Evaluation of local complication
Rate of implants with at least one local complication within 10 years of follow-up:
- Vascular: hematoma, bleedings
- Cutaneous: abnormal healing, erythema, Hyperesthesia
- Peri-prosthetic: capsular contracture , calcifications, atrophy in pectoralis muscle
- Inflammatory: hypertrophy, oedema, granuloma, seroma, lymphorrhea
- Local infection
- Necrosis
- Pain
Measured: 10 years of follow-up
Evaluation of Quality of life
Evaluation of the Quality of life by a 3-point scale (Likert scale)
Measured: 10 years of follow-up
Evaluation of Self-esteem
Evaluation of the Self-esteem by Rosenberg' scale
Measured: 10 years of follow-up
Evaluation of patient satisfaction
Rate of satisfied patient at 10 years post-implantation according to a 5-point scale (Likert scale)
Measured: 10 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start7 Sep 2023
- Primary completion7 Jun 2026
- Study completion7 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires ARION
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
- Investigators
- Kelly LAVERGNE, Study chair, EVAMED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904091
- Sponsor's protocol ID
- 2022-A02757-36
- Acronym
- SOFTONE
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study data will be the property of the Sponsor. It is agreed that the results of this research (partially or in full) may not be communicated at scientific meetings or published in scientific journals or in any other medium except with the prior written consent of the sponsor of their content. This also applies to any modification that could subsequently be requested by an editor, a reading committee or an editorial committee. The authors will agree, by mutual agreement, on the choice of the publisher and the journal of first publication to which they will grant the publication rights. The sponsor of this study reserves the right to use the results of this trial in its medical information. Third parties may not use these rights without the prior written consent of the promoter or his representative.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years: Post-marketing Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT07904091
- Acronym / sponsor ID
- SOFTONE / 2022-A02757-36
- Conditions
- Breast Augmentation, Breast Reconstruction
- Keywords
- Breast reconstruction, Breast augmentation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- Laboratoires ARIONIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 7 Jun 2026 (actual)
- Study completion
- 7 Jan 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this observational, Post-market, Retro-prospective, open, non-randomized, non-comparative, multicentric, European study is to evaluate the safety and performance of the Monobloc® - Silicone SoftOne® breast implants at 10 years.
The primary objective is to evaluate the rate of women who had at least one re-intervention within the 10 years of follow-up. the secondary objectives are To evaluate the safety and performance outcomes of women who underwent breast augmentation and/or breast reconstruction using the Monobloc® - Silicone SoftOne® breast implants at 10 years
Participants will have one follow-up visit during which data will be retrospectively documented at the following time points: preoperative visit, operative visit, follow-up 10 years
Detailed description
The aim of the study is to allow Laboratoires ARION to communicate to competent authorities and to the scientific community data relative to the safety and performance outcomes of the Monobloc® - Silicone SoftOne® breast implants at 10 years for women who underwent breast augmentation and/or breast reconstruction.
2 groups based on indication will be analyzed during this clinical investigation:
- Breast augmentation (aesthetic): primo-implantation or revision for breast augmentation
- Breast reconstruction: primo-implantation or revision for breast reconstruction 3 families of implantswill be analyzed during this clinical investigation :
- Smooth
- Micro-textured
- Textured
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aesthetic | – | Device: Breast augmentationimplantation or revision for breast augmentation |
| reconstruction | – | Device: Breast reconstructionprimo-implantation or revision for breast reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who are at least 18 years old, unless otherwise medically advised, who fit the indications and who do not meet contraindications. * Breast augmentation for aesthetic purpose: volume augmentation through insertion of implant * Breast reconstruction: Breast reconstruction following the removal of all or part of the damaged mammary gland. * Breast reconstruction after anti-cancer treatments other than mastectomy. * New intervention because of complications or other undesirable results following a previous surgical procedure related to a mastectomy or following cancer treatments. * Post-traumatic, defined as a total or partial ablation of one or both breasts through an act of surgery (for any reason), or as a result of the injury itself.
Key inclusion criteria (4 listed)
- Woman implanted with at least one Monobloc® - Silicone SoftOne® breast implants between 2011 to 2013
- Woman having received information and signed informed consent
- Woman aged 18 years and older at the implantation
- Woman affiliated to the health social security system
Key exclusion criteria (19 listed)
- Pregnant or breastfeeding woman at the time of intervention
- Woman under guardianship or curatorship
- Woman under legal protection
- Woman who refuses to participate
- Woman unable to understand questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast augmentationBreast augmentation with implants | Device | aesthetic |
| Breast reconstructionBreast reconstruction with implants | Device | reconstruction |
Primary outcome
rate of women who had at least one re-intervention within the 10 years of follow-up.
Time frame: 10 years of follow-up
rate of subjects who had at least one re-intervention within the 10 years of follow-up
9 secondary outcomes
Evaluation of the reintervention rate by subgroups
Time frame: 10 years of follow-up
Evaluation of reintervention rate related to complications
Time frame: 10 years of follow-up
Evaluation of high clinical interest adverse events
Time frame: 10 years of follow-up
Evaluation of common complications of breast surgery
Time frame: 10 years of follow-up
Evaluation of systemic complications
Time frame: 10 years of follow-up
Evaluation of local complication
Time frame: 10 years of follow-up
Evaluation of Quality of life
Time frame: 10 years of follow-up
Evaluation of Self-esteem
Time frame: 10 years of follow-up
Evaluation of patient satisfaction
Time frame: 10 years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No. The study data will be the property of the Sponsor. It is agreed that the results of this research (partially or in full) may not be communicated at scientific meetings or published in scientific journals or in any other medium except with the prior written consent of the sponsor of their content. This also applies to any modification that could subsequently be requested by an editor, a reading committee or an editorial committee. The authors will agree, by mutual agreement, on the choice of the publisher and the journal of first publication to which they will grant the publication rights. The sponsor of this study reserves the right to use the results of this trial in its medical information. Third parties may not use these rights without the prior written consent of the promoter or his representative.
Related trials for Breast Augmentation
RecruitingObservational study
The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
Breast Augmentation, Mammaplasty
Active, not recruiting
Memory Gel and Shape Combined Cohort
Primary Breast Augmentation, Primary Breast Reconstruction
Not yet recruiting
Effect of Adding Ultrasound-Guided PECS II Block to Standard Multimodal Analgesia in Breast Augmentation Surgery
Postoperative Pain After Breast Augmentation Surgery, Postoperative Analgesia
Recruiting
Improved Breast Enlargement Using the Subject's Own Fat Tissue
Breast Augmentation
Recruiting
Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation
Capsular Contracture Associated With Breast Implant, Capsular Contracture Grade III
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly LAVERGNE study chair
EVAMED
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Augmentation and Breast Reconstruction, run by Laboratoires ARION at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of women who had at least one re-intervention within the 10 years of follow-up. (time frame: 10 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.