Prospective look at systemic symptoms in women with vs without silicone breast implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective controlled cohort follows women undergoing primary aesthetic breast procedures, comparing those receiving silicone implants to those having nonimplant mastopexy or reduction. Researchers collect standardized symptom, psychosocial, quality-of-life, and local breast data before surgery and annually for five years. The primary outcome is a prespecified, adjudicated cluster of new multisystem symptoms; the study also tracks revisions, explantations, implant-related complications, and symptom changes after any implant removal. A nested subcohort will examine symptom trajectories before and after explantation or exchange, with multidisciplinary adjudication for persistent cases and evaluation for alternative diagnoses. The design addresses prior limitations by including a contemporaneous nonimplant control group and a predefined symptom phenotype rather than relying solely on individual reports.

Why it matters

Who can join: the full rules

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.

Where it's running

• IQ interquirofanos
  Medellín, Colombia Recruiting

Study contacts

• Principal investigator: juan velez, MD, plastic surgery
• Study coordinator: Juan Velez, MD, Plastic surgeon
• Email: info@velezlara.com
• Phone: +57 301 6918526

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing ways to clean infected dental implants

  This will test three different cleaning methods to remove bacterial biofilm from bone-level dental implants in healthy, non-smoking adults with peri-implantitis and no vertical bone loss.

  Recruiting University of Zagreb · Zagreb · NCT07529444

• Implant-based breast reconstruction after bariatric (weight-loss) surgery

  This registry-based project will use national data to see how common breast implants are and whether women who've had bariatric weight-loss surgery have different complication rates after implant-based breast augmentation or reconstruction.

  Recruiting Vastra Gotaland Region · Gothenburg · NCT07059104

• Long-term follow-up of Motiva silicone breast implants

  This project sees if Motiva silicone breast implants are safe and work well over up to 10 years for adult women having primary or revision breast augmentation.

  Recruiting at 33 sites Motiva USA LLC · Beverly Hills, California and 32 other locations · NCT06938399

• Follow-up on Euromi silicone gel breast implants

  This study is tracking patients with Euromi silicone gel breast implants for 10 years to see how safe and effective they are and to check for any problems like implant rupture.

  Recruiting Euromi Biosciences · Nancy · NCT05987475

• Identifying risk factors for seroma formation after breast surgery

  This study is trying to find out which patients are more likely to develop fluid buildup after breast surgery so that doctors can give better advice and care to prevent it.

  Recruiting University Hospital Augsburg · Augsburg, Bavaria · NCT05899387

• Investigating bacterial biofilms in breast implant complications

  This study is trying to see if bacteria that form biofilms are linked to problems some people have with breast implants, especially those experiencing Breast Implant Illness.

  Recruiting at 3 sites Indiana University · Carmel, Indiana and 2 other locations · NCT05736354

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.