Prospective Controlled Cohort Study of the Incidence, Trajectory, and Clinical Correlates of Persistent Systemic Symptoms in Women With and Without Silicone Breast Implants

NCT07810803 | Recruiting

• 1 other identifier: 024
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective controlled cohort will enroll women before primary aesthetic breast surgery. Women receiving silicone implants will be compared with women undergoing nonimplant mastopexy or reduction. Standardized systemic symptom, psychosocial, quality-of-life, and local breast assessments will be collected before surgery and through five years. The primary outcome is the incidence of a prespecified, adjudicated persistent new-onset multisystem symptom phenotype. Revision, explantation, local implant complications, and symptom changes after implant removal will also be evaluated.

Conditions

Systemic Symptoms; Breast Implant Illness; Breast Implant Complications

Keywords

Breast Implant Illness; Silicone Breast Implants; Persistent Systemic Symptoms; Explantation

Outcome Measures

Primary Outcomes (1)

• Incidence of an Adjudicated Persistent New-Onset Multisystem Symptom Phenotype

  Proportion of participants who develop new or clinically meaningful worsening in at least two prespecified systemic symptom domains, persisting for at least 6 months, beginning after the initial 3-month postoperative recovery window, and not better explained by an alternative diagnosis after blinded adjudication. The final domain list and thresholds will be locked before enrollment.

  10 years

Secondary Outcomes (2)

• Incidence of Revision or Explantation Attributed to Systemic Symptoms

  10 years

• Change in Systemic Symptom Burden After Explantation or Exchange

  10 years

Study Arms (1)

Silicone Breast Implant Cohort

Women who independently choose primary aesthetic augmentation with silicone implants after standard counseling.

Device: Silicone Breast Implant Exposure; Other: Standardized Systemic Symptom and Psychosocial Assessment

Interventions

Silicone Breast Implant Exposure DEVICE

Implant characteristics include manufacturer/lot when available, texture, shape, volume, pocket plane, incision route, and laterality. Exposure is chosen as clinical care before enrollment and is not assigned by the study. Linked arm/group(s): Silicone Breast Implant Cohort.

Silicone Breast Implant Cohort

Standardized Systemic Symptom and Psychosocial Assessment OTHER

A locked battery will include validated measures of fatigue, pain interference, cognitive function, physical function, anxiety, depression, global health, and breast/body satisfaction. Proposed instruments include PROMIS short forms and BREAST-Q scales, subject to final licensing and language validation. Linked arm/group(s): Silicone Breast Implant Cohort, Nonimplant Breast Surgery Control Cohort.

Silicone Breast Implant Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult women planning primary aesthetic breast surgery, enrolled before receiving silicone implants or before a nonimplant breast procedure such as mastopexy or reduction.

You may qualify if:

• Female sex and age 18 years or older.
• Planning primary aesthetic breast augmentation with silicone implants or planning nonimplant aesthetic breast surgery such as mastopexy or reduction.
• No prior permanent breast implant.
• Completion of the full baseline systemic-symptom and psychosocial assessment before surgery.
• Ability to participate in annual follow-up for five years.
• Written informed consent.

You may not qualify if:

• Breast reconstruction after cancer, prophylactic mastectomy, congenital deformity, or major trauma.
• Known active autoimmune, inflammatory, neurologic, endocrine, infectious, or malignant condition expected to cause major systemic symptom change, unless the final protocol intentionally includes and stratifies these conditions.
• Current pregnancy or breastfeeding.
• Prior permanent breast implant or tissue expander.
• Inability to complete validated questionnaires in the authorized language.
• Planned simultaneous major surgery expected to dominate systemic recovery beyond the prespecified postoperative window.

Sponsors & Collaborators

• Research Inc: lead

Study Sites (1)

IQ interquirofanos

Medellín, Colombia

RECRUITING

Related Publications (5)

• Ribeiro PDC, Sato EI. Autoimmune/autoinflammatory syndrome induced by adjuvants: a focus on silicone. Clin Rheumatol. 2022 Nov;41(11):3275-3283. doi: 10.1007/s10067-022-06274-0. Epub 2022 Jul 7.

  PMID: 35798923 BACKGROUND

• Ferreira S, Barros AS, Marques M. Breast Implant Illness: Symptoms, Outcomes with Explantation and Potential Etiologies-A Systematic Review and Meta-analysis. Aesthetic Plast Surg. 2025 Dec;49(23):6600-6620. doi: 10.1007/s00266-025-05142-x. Epub 2025 Aug 11.

  PMID: 40788544 BACKGROUND

• Spit KA, Scharff M, de Blok CJ, Niessen FB, Bachour Y, Nanayakkara PW. Patient-reported systemic symptoms in women with silicone breast implants: a descriptive cohort study. BMJ Open. 2022 Jun 9;12(6):e057159. doi: 10.1136/bmjopen-2021-057159.

  PMID: 35680258 BACKGROUND

• Tervaert JWC, Shoenfeld Y, Cruciani C, Scarpa C, Bassetto F. Breast implant illness: Is it causally related to breast implants? Autoimmun Rev. 2024 Jan;23(1):103448. doi: 10.1016/j.autrev.2023.103448. Epub 2023 Sep 13.

  PMID: 37714420 BACKGROUND

• Shivarov V, Yordanov A, Ivanova M, Tsoneva E. Breast Implant Illness and Autoimmune/Inflammatory Syndrome Induced by Adjuvants: Mechanistic Rationale and a Practical Multidisciplinary Diagnostic Algorithm. J Clin Med. 2026 Jul 21;15(14):5721. doi: 10.3390/jcm15145721.

  PMID: 42513634 BACKGROUND

MeSH Terms

Interventions

Psychiatric Rehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• juan velez, MD, plastic surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Velez, MD, Plastic surgeon

CONTACT

+57 301 6918526; info@velezlara.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: January 12, 2014
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)