Molecular Mechanisms Associated With Breast Implant Complications

Conditions

• Breast Implant; Complications
• Infection or Inflammation

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

Bacterial biofilms cause implant failures, chronic inflammation, and immune polarization. The study investigates the possible role of bacterial biofilm as a factor in the etiology of Breast Implant Illness. Three patient cohorts will be studied (A) Subjects with breast implant with BII manifestations (B) Subjects with breast implants without BII manifestations (C) Subjects without breast implants who underwent breast surgery procedure. Blood, surgically discarded tissue, implants, and associated capsules will be collected through this protocol.

Key Dates

Start date

Jan 3, 2021

Status verified

May 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

1,000 participants (estimated)

Arms

• Arm: BII Subjects
  Subjects with breast implants having BII manifestations.
• Arm: Non-BII Subjects
  Subjects with breast implants with no reported BII symptoms.
• Arm: Subjects without Breast Implants
  Subjects without breast implants.

Primary Outcome Measure

Presence of Biofilm in Breast Tissue [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

• Mithun Sinha, PhD.
  3172782713
  [email protected]
• Bryce Hockman
  3172782715
  [email protected]

Locations (3)

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