Breast Implant LeakageNCT06257251
Silicone Particles in Breast Implant Capsules
An observational study of Breast Implant Leakage, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
Breast implantation is one of the most common surgical procedures in plastic surgery. It is used to reconstruct a breast after mastectomy following cancer or to increase breast volume for aesthetic purposes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Implant Leakage
- What is being tested?
- Histological slides digitization
- Type of treatment
- Pill or oral medicine
- How many people
- 65 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Nov 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted and operated at CHU-Brugmann (Horta \& Brien) between January 2013 and October 2023 for surgical revision of their breast implants, requiring partial or complete sampling of the peri-prosthetic capsule.
Who may be able to join
- Patients admitted and operated at CHU-Brugmann Hospital (Horta \& Brien)
- Surgery between January 2013 and October 2023
- Type of surgery: surgical revision of their breast implants requiring partial or complete sampling of the peri-prosthetic capsule.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU Brugmann
Brussels, 1020
Christophe Al Sammour, Christophe.ALSAMMOUR@chu-brugmann.be
About this study
Official title: Silicone Particles in Breast Implant Capsules: a Retrospective Monocentric Study Evaluation of Silicone Bleeding
Breast implantation is one of the most common surgical procedures in plastic surgery. It is used to reconstruct a breast after mastectomy following cancer or to increase breast volume for aesthetic purposes. Since their introduction in the 1960s, silicone breast implants have been the subject of multiple controversies, and their safety has long been questioned. One of the initial concerns was silicone bleeding, which refers to the sweating of silicone gel through the implant's shell. Once outside the implant, silicone particles accumulate in the peri-prosthetic capsule, but they can also migrate to distant sites through the lymphatic system. These particles are not entirely biologically inert, as they initiate a foreign body inflammatory reaction characterized by the presence of macrophages and giant cells that cluster around the particles. The resulting chronic inflammation can be the source of local complications, such as granuloma formation or the onset of breast pain.
Silicone bleeding was first described in the 1970s and was particularly common with second-generation implants (1970-1982), which had thin shells and low-viscosity gel. Despite the technical improvements made to current breast implants, silicone can still be detected in the peri-prosthetic capsules of silicone breast implants. Most patients are asymptomatic, but they may occasionally experience local pain.
Read more
An increasing number of patients with breast implants are suffering for breast implant illness (BII) : a disease with nonspecific systemic signs and symptoms such as fatigue, skin rash, or headaches…etc, the precise etiology of which remains unexplained. Although the causative link has never been proven, some authors hypothesize that silicone could be responsible for these systemic complaints. While there is ongoing debate and research on the topic, some people believe that silicone bleeding from breast implants may contribute to the development of BII symptoms. However, it's important to note that the connection between silicone bleeding and BII has not been definitively proven.
It is a single center retrospective study that will include a total of 65 patients who have undergone breast implant capsulectomy. Capsulectomy is a surgical procedure involving the partial or complete removal of the peri-prosthetic capsule that forms around a breast implant. The peri-prosthetic capsule is a naturally occurring fibrous tissue that forms in response to the presence of the implant in the body. Sometimes, this capsule can become thickened, contracted, or cause complications such as capsular contracture, asymmetry, or pain. Capsulectomy can be performed as part of a surgical revision of breast implants to address these complications or for other reasons.
The main objective of this study is to quantify silicone particles in the periprosthetic capsules of breast implants using an innovative method of quantification based on histological examination of capsule specimens. The secondary objective is to compare the amount of silicone in capsules from different types of breast implants (saline or silicone) to assess whether texture, shell, silicone gel and time of implantation could influence silicone bleeding and breast implant illness.
- Conditions
- Breast Implant Leakage
- Being tested
- Histological slides digitization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histological slides digitizationOther
Histological slides of the capsule samples taken during surgery will be collected for analysis and digitized. Using the NDPview2 software, the investigators will manually count the silicone particles present in the peri-prosthetic capsule and measure the surface area of the capsule to estimate the silicone particle density.
| Study group | Role | What they receive |
|---|---|---|
| Breast implant capsulectomy | Patients admitted and operated at CHU-Brugmann hospital for surgical revision of their breast implants. Receives: Other: Histological slides digitization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Silicone particles quantity
Manual count of the silicone particles present in the peri-prosthetic capsule
Measured: 1 day
Peri-prosthetic capsule thickness
Peri-prosthetic capsule thickness
Measured: 1 day
Silicone particle's' size
Size of the silicone particles present in the peri-prosthetic capsule
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start14 Nov 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Implant LeakageStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Socorro ORTIZ, Brugmann University Hospital
- Investigators
- Socorro Ortiz, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257251
- Sponsor's protocol ID
- CHUB-silicone
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silicone Particles in Breast Implant Capsules: a Retrospective Monocentric Study Evaluation of Silicone Bleeding
- ClinicalTrials.gov ID
- NCT06257251
- Acronym / sponsor ID
- CHUB-silicone
- Conditions
- Breast Implant Leakage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Feb 2024 (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.
Breast implantation is one of the most common surgical procedures in plastic surgery. It is used to reconstruct a breast after mastectomy following cancer or to increase breast volume for aesthetic purposes. Since their introduction in the 1960s, silicone breast implants have been the subject of multiple controversies, and their safety has long been questioned. One of the initial concerns was silicone bleeding, which refers to the sweating of silicone gel through the implant's shell. Once outside the implant, silicone particles accumulate in the peri-prosthetic capsule, but they can also migrate to distant sites through the lymphatic system. These particles are not entirely biologically inert, as they initiate a foreign body inflammatory reaction characterized by the presence of macrophages and giant cells that cluster around the particles. The resulting chronic inflammation can be the source of local complications, such as granuloma formation or the onset of breast pain.
Silicone bleeding was first described in the 1970s and was particularly common with second-generation implants (1970-1982), which had thin shells and low-viscosity gel. Despite the technical improvements made to current breast implants, silicone can still be detected in the peri-prosthetic capsules of silicone breast implants. Most patients are asymptomatic, but they may occasionally experience local pain.
An increasing number of patients with breast implants are suffering for breast implant illness (BII) : a disease with nonspecific systemic signs and symptoms such as fatigue, skin rash, or headaches…etc, the precise etiology of which remains unexplained. Although the causative link has never been proven, some authors hypothesize that silicone could be responsible for these systemic complaints. While there is ongoing debate and research on the topic, some people believe that silicone bleeding from breast implants may contribute to the development of BII symptoms. However, it's important to note that the connection between silicone bleeding and BII has not been definitively proven.
It is a single center retrospective study that will include a total of 65 patients who have undergone breast implant capsulectomy. Capsulectomy is a surgical procedure involving the partial or complete removal of the peri-prosthetic capsule that forms around a breast implant. The peri-prosthetic capsule is a naturally occurring fibrous tissue that forms in response to the presence of the implant in the body. Sometimes, this capsule can become thickened, contracted, or cause complications such as capsular contracture, asymmetry, or pain. Capsulectomy can be performed as part of a surgical revision of breast implants to address these complications or for other reasons.
The main objective of this study is to quantify silicone particles in the periprosthetic capsules of breast implants using an innovative method of quantification based on histological examination of capsule specimens. The secondary objective is to compare the amount of silicone in capsules from different types of breast implants (saline or silicone) to assess whether texture, shell, silicone gel and time of implantation could influence silicone bleeding and breast implant illness.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast implant capsulectomy | – | Other: Histological slides digitizationPatients admitted and operated at CHU-Brugmann hospital for surgical revision of their breast implants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted and operated at CHU-Brugmann (Horta \& Brien) between January 2013 and October 2023 for surgical revision of their breast implants, requiring partial or complete sampling of the peri-prosthetic capsule.
Key inclusion criteria (3 listed)
- Patients admitted and operated at CHU-Brugmann Hospital (Horta \& Brien)
- Surgery between January 2013 and October 2023
- Type of surgery: surgical revision of their breast implants requiring partial or complete sampling of the peri-prosthetic capsule.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Histological slides digitizationHistological slides of the capsule samples taken during surgery will be collected for analysis and digitized. Using the NDPview2 software, the investigators will manually count the silicone particles present in the peri-prosthetic capsule and measure the surface area of the capsule to estimate the silicone particle density. | Other | Breast implant capsulectomy |
Primary outcome
Silicone particles quantity
Time frame: 1 day
Manual count of the silicone particles present in the peri-prosthetic capsule
Peri-prosthetic capsule thickness
Time frame: 1 day
Peri-prosthetic capsule thickness
Silicone particle's' size
Time frame: 1 day
Size of the silicone particles present in the peri-prosthetic capsule
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No
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.
Socorro Ortiz, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Implant Leakage, run by Brugmann University Hospital at 1 site in Belgium.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe Al Sammour (32204773997, Christophe.ALSAMMOUR@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Silicone particles quantity (time frame: 1 day). The study lists 3 primary outcomes in all. 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 16 Feb 2024.