Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257251
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2024-02-05
Brief Title:
Silicone Particles in Breast Implant Capsules
Sponsor:
Brugmann University Hospital
Organization:
Brugmann University Hospital
Study Overview
Official Title:
Silicone Particles in Breast Implant Capsules a Retrospective Monocentric Study Evaluation of Silicone Bleeding
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 implants 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 headachesetc 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 its 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
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 headachesetc 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 its 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None