MySimba is a prescription-only medical device designed to support sustainable weight management in adults with obesity or overweight with weight-related comorbidities. It combines innovative technology with established behavioral principles to help users develop healthier eating habits, reduce caloric intake, and achieve long-term weight control. Unlike conventional appetite suppressants, MySimba employs a non-pharmacological approach that focuses on retraining eating behaviors through gentle gastric stimulation. It is intended for use as part of a comprehensive weight management program, including dietary changes and increased physical activity, under medical supervision.

Features

• CE-marked class IIa medical device
• Comprises an ingestible gastric balloon and a wearable activity tracker
• Connects via Bluetooth to a dedicated mobile application
• Provides real-time feedback on eating pace and meal duration
• Tracks physical activity and sleep patterns
• Includes personalized coaching content and progress monitoring
• Designed for 4-month treatment cycles
• Made from biocompatible materials that pass naturally

Benefits

• Supports gradual, sustainable weight loss through behavior modification
• Helps retrain eating habits by promoting slower, more mindful consumption
• Provides objective data to help clinicians tailor weight management strategies
• Encourages consistency through daily tracking and feedback
• Redensifies satiety signals without systemic pharmacological effects
• Integrates seamlessly with existing lifestyle modification programs

Common use

MySimba is indicated for weight management in adult patients with a body mass index (BMI) of 27–40 kg/m², particularly those with comorbidities such as prediabetes, hypertension, or dyslipidemia. It is used as an adjunct to a reduced-calorie diet and increased physical activity. Typical users include individuals who have struggled with traditional weight loss methods, those seeking a non-pharmacological alternative, or patients ineligible for or wishing to avoid bariatric surgery. The device is often incorporated into multidisciplinary weight management programs involving dietitians, endocrinologists, or obesity medicine specialists.

Dosage and direction

MySimba is not a pharmaceutical product and does not have a dosage in the conventional sense. Treatment involves a structured 16-week program:

• The gastric balloon is ingested under medical supervision with water
• The balloon inflates in the stomach and remains for approximately 16 weeks
• Patients wear the activity tracker daily and sync data to the mobile app
• Meals should be consumed slowly, aiming for at least 20 minutes per meal
• The app provides real-time feedback during eating and activity
• After 16 weeks, the balloon deflates and passes naturally through the digestive system
• Patients should maintain regular follow-up with their healthcare provider throughout treatment

Precautions

• Use only under supervision of a healthcare professional trained in weight management
• Not recommended for patients with previous gastrointestinal surgery (except uncomplicated appendectomy)
• Caution advised in patients with inflammatory bowel disease or motility disorders
• Monitor for signs of intolerance during the first 3–7 days after placement
• Ensure adequate hydration throughout treatment period
• Regular medical follow-up required to monitor progress and adjust lifestyle interventions
• Not intended for use during pregnancy or breastfeeding
• Use with caution in patients with eating disorders

Contraindications

• History of bariatric surgery or gastric banding
• Structural abnormalities of the gastrointestinal tract
• Large hiatal hernia (>5 cm)
• Severe hepatic impairment or cirrhosis
• Active peptic ulcer disease
• Pregnancy, breastfeeding, or planning pregnancy
• History of bowel obstruction or strictures
• Allergy to silicone or device components
• Unable or unwilling to participate in comprehensive weight management program
• Psychiatric conditions that may impair compliance with treatment

Possible side effects

Most side effects are mild to moderate and typically occur during the first week of treatment:

• Nausea (45% of patients)
• Abdominal cramping or discomfort (40%)
• Vomiting (30%)
• Reflux symptoms (25%)
• Constipation or diarrhea (20%)
• Headache (15%)
• Feeling of fullness or early satiety (expected effect)
• These symptoms generally resolve within 3–7 days as the body adapts
• Rare complications (<1%) include esophageal impaction, intestinal obstruction, or balloon deflation requiring endoscopic removal

Drug interaction

As a non-pharmacological device, MySimba does not have pharmacokinetic drug interactions. However, considerations include:

• May affect absorption of medications that require specific timing with food
• Consult physician regarding timing of medications that require empty stomach administration
• Weight loss may necessitate adjustment of medications for diabetes, hypertension, or other conditions
• No known interactions with weight loss medications, though concomitant use should be medically supervised

Missed dose

Not applicable as MySimba is a continuous-use medical device. However, patients should:

• Wear the activity tracker consistently for accurate data collection
• Sync data with the mobile app at least once daily
• Resume normal use if tracker was temporarily removed
• Contact healthcare provider if the gastric balloon is expelled prematurely

Overdose

Not applicable. The device contains no active pharmaceutical ingredients. In case of suspected device malfunction:

• Contact healthcare provider immediately if severe abdominal pain, fever, or vomiting occurs
• Seek emergency care if symptoms suggest bowel obstruction
• Healthcare providers should have a protocol for device retrieval if necessary

Storage

• Store unused device in original packaging at room temperature (15–30°C)
• Protect from moisture and direct sunlight
• Activity tracker should be charged regularly using provided accessories
• Mobile app data should be backed up according to manufacturer instructions
• Do not attempt to sterilize or reuse any components

Disclaimer

MySimba is a prescription medical device that should be used only under appropriate medical supervision. Individual results may vary, and weight loss requires commitment to lifestyle changes. This information is for educational purposes only and does not replace professional medical advice. Always consult with a qualified healthcare provider before starting any weight management program. The manufacturer is not responsible for improper use or outcomes resulting from failure to follow instructions.

Reviews

Clinical studies demonstrate that MySimba users achieve an average of 10–15% total body weight loss when combined with lifestyle modification. In a 12-month multicenter trial, 83% of patients maintained significant weight loss at 6 months post-treatment. Patients report improved eating behaviors, reduced portion sizes, and better awareness of hunger cues. Healthcare providers note the value of objective data in personalizing treatment plans and improving patient engagement. The most common feedback highlights the initial adjustment period as challenging but worthwhile for long-term benefits.