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Background <p>Silicone breast implants (BI) lead to a physiological response to the foreign body, resulting in a formation of fibrous tissue that encapsulates the foreign material, which further leads to the capsule contracture (CC). The aim was to compare the prophylactic effects of cromolyn sodium (CS) on capsule formation in an experimental subcutaneous implantation rat model using two routes of drug administration, local and systemic.</p> Methods <p>Silicone BI shells were subcutaneously implanted into female Wistar rats. After implantation, animals were randomly divided into three groups: <i>per os</i> administration of CS in a daily dose 10 mg/kg of body weight via drinking water (CR), CS injected locally in implantation area (single dose 10 mg/0.25 mL) on the 10th day after implantation (CL) and control group without CS treatment (C). Histopathological analysis of tissue samples and capsule thickness measurement was performed 10, 30 and 90 days after implantation.</p> Results <p>Ten days after implantation, greater inflammatory zone around BI was observed in CR compared to C group, while the capsule was not yet formed. Fibrous capsule was significantly thinner in both CS groups, compared to the control, 30 and 90 days after implantation.</p> Conclusion <p>Locally applied single dose in implantation site proved to be as effective as three months <i>per os</i> administration of CS in reducing the fibrous capsule thickness and prevention of CC. Local application of CS would have a great application in clinical practice as a much more compliant administration route for the patients, as it can replace long-term daily oral CS administration while giving the same results.</p>

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Comparative Analysis of the Effect of Systemic and Local Administration of Cromolyn on Capsular Formation Around Silicone Implants: An Experimental Study

  • 期刊论文

  • 发表日期：

    2025年6月10日

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  • Stefan Mladenović,
  • Predrag Kovacević,
  • Sanja Stojanović,
  • Nikola Zivković,
  • Dragan Mihailović,
  • Milena Radenković Stošić,
  • Goran Šijan,
  • Stevo Najman

摘要

Background

Silicone breast implants (BI) lead to a physiological response to the foreign body, resulting in a formation of fibrous tissue that encapsulates the foreign material, which further leads to the capsule contracture (CC). The aim was to compare the prophylactic effects of cromolyn sodium (CS) on capsule formation in an experimental subcutaneous implantation rat model using two routes of drug administration, local and systemic.

Methods

Silicone BI shells were subcutaneously implanted into female Wistar rats. After implantation, animals were randomly divided into three groups: per os administration of CS in a daily dose 10 mg/kg of body weight via drinking water (CR), CS injected locally in implantation area (single dose 10 mg/0.25 mL) on the 10th day after implantation (CL) and control group without CS treatment (C). Histopathological analysis of tissue samples and capsule thickness measurement was performed 10, 30 and 90 days after implantation.

Results

Ten days after implantation, greater inflammatory zone around BI was observed in CR compared to C group, while the capsule was not yet formed. Fibrous capsule was significantly thinner in both CS groups, compared to the control, 30 and 90 days after implantation.

Conclusion

Locally applied single dose in implantation site proved to be as effective as three months per os administration of CS in reducing the fibrous capsule thickness and prevention of CC. Local application of CS would have a great application in clinical practice as a much more compliant administration route for the patients, as it can replace long-term daily oral CS administration while giving the same results.