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

Recruitingn/aAges 18 Years - anyAllResearch Inc
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • Silicone Breast Implant Exposure
  • Standardized Systemic Symptom and Psychosocial Assessment
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Where

1 site
IQ interquirofanos
Medellรญn, Colombia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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