Intragastric balloons are minimally invasive medical devices used in weight management therapies. Designed for temporary placement within the stomach, these devices aid in reducing food intake and promoting satiety, making them a valuable tool in the treatment of overweight and obesity. This article outlines the structural components, clinical applications, and regulatory classification of intragastric balloons within the Mexican healthcare framework.
Structure and Function of Intragastric Balloons
An intragastric balloon system typically consists of a soft, expandable silicone balloon connected to an inflation catheter. The balloon is inserted endoscopically and inflated with sterile saline or air to occupy space in the stomach. This induces a feeling of fullness and helps reduce caloric intake.
Some advanced models feature an adjustable inflation mechanism, allowing volume modifications post-placement without device removal. This adjustability supports personalized treatment plans and enhances patient tolerance throughout the therapy duration.
Key components may include:
- Silicone Balloon: Biocompatible and flexible, with a typical diameter around 90 mm.
- Inflation Catheter: Non-collapsible and permanently attached, enabling initial deployment and subsequent volume adjustments.
- Extension Tubing: polymer-based, with luer-lock connectors for secure inflation control.
- Insertion Accessories
- Inflation Syringe: Standard luer-lock syringe for balloon inflation and deflation.
Types of Intragastric Balloons
Intragastric balloons differ based on:
- Inflation Method: Saline-filled vs. air-filled.
Saline-filled systems are used in approximately 80% of procedures due to their added safety benefits. If a leak occurs, the patient’s urine may change color, serving as an early warning sign. In contrast, air-filled systems do not provide any visible indication if the balloon deflates.
- Adjustability: Fixed-volume vs. adjustable-volume.
Adjustable-volume systems offer greater flexibility and allow for patient-specific customization, which can lead to better clinical outcomes and fewer adverse events.
How Are Intragastric Balloons Classified and Grouped in Mexico?
Under the Mexican regulatory framework, intragastric balloons are classified as Class III medical devices. This classification indicates a higher level of regulatory oversight due to their invasiveness, prolonged use and potential risks associated with the complexity of their design.
Grouping Strategy for Registration:
According to COFEPRIS guidelines, devices with the same intended use, manufacturer, and distinctive denomination may be grouped under a single sanitary registration.
For intragastric balloons, grouping is permitted when the models:
- Are packaged by the manufacturer together with implantation or filling accessories in the same package or sterilization tray.
- Include components that are not considered standalone medical devices.
- If any accessory (e.g., a syringe) is packaged separately and selected by the surgeon, it must be registered independently.
Conclusion
Intragastric balloons represent a structured, non-surgical approach to weight management. Their design supports safe deployment and potential volume adjustment, enhancing patient adherence and therapeutic outcomes. Understanding their classification and regulatory requirements is essential for proper clinical use and market authorization in Mexico.
Need help evaluating your medical device for Mexican sanitary registration? Contact Veraque for expert regulatory guidance.
