Immunogenetic profiling to assess susceptibility to immune-inflammatory manifestations associated with breast implants

SILICONE BREAST IMPLANTS

Silicone breast implants (SBIs) are medical devices widely used in clinical practice for aesthetic breast augmentation or contouring and for reconstructive purposes, particularly following oncological surgery or corrective procedures.

Advances in materials, device design and surgical techniques have progressively consolidated their role in plastic and reconstructive surgery.

Although breast implants are generally considered to have a favourable safety profile, some patients may experience local complications or, less frequently, systemic manifestations, even when surgery has been performed correctly and in accordance with appropriate technical standards.

THE GENETIC TEST FOR ASSESSING SUSCEPTIBILITY TO BREAST IMPLANT-ASSOCIATED ADVERSE REACTIONS

BREASTIMPLANT ASIA-BIAI is a targeted genetic test designed to assess the presence of specific immunogenetic profiles that may be associated with increased individual susceptibility to symptoms or manifestations compatible with an immune-inflammatory response in people with silicone breast implants.

The test is intended to support the specialist in integrating immunogenetic information into pre-operative assessment, individual risk profiling and subsequent clinical follow-up.

WHEN TESTING MAY BE CONSIDERED

Testing may be considered within specialist assessment for:

• Individuals with a history of allergic conditions, immune disorders or suspected increased sensitivity.
• Individuals who have experienced adverse events associated with breast implants or other prosthetic devices.
• Individuals considering breast implant surgery for the first time who wish to assess their biological susceptibility.

The decision to perform the test should always be considered in the context of the individual’s personal medical history, overall clinical condition, reason for surgery and any concurrent conditions of immunological or inflammatory relevance.

INTERPRETATION OF THE RESULT

POSITIVE

Detection of the risk-associated HLA profile is consistent with increased susceptibility to medium- or long-term immune-mediated adverse reactions following breast implant surgery.

The result is an indicator of individual predisposition that may be relevant to pre-operative counselling and subsequent clinical follow-up. It is not a contraindication to treatment and does not predict with certainty that a complication will occur.

NEGATIVE

The risk-associated HLA profile was not detected. The test therefore provides no evidence of marker-associated increased susceptibility.

A negative result does not demonstrate a reduction in overall risk and does not exclude adverse events. Other contributing factors may include device characteristics, individual inflammatory responses, concurrent clinical conditions, immunological features not covered by the test, unanalysed genetic determinants and surgical or procedural variables.

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