Fresh hope for Kenyans battling obesity after the national drug regulator approved the use of a pill-sized gastric balloon that reduces a patient’s food intake.
The Pharmacy and Poisons Board (PPB) has given a clinic in Nairobi the greenlight to administer Allurion – a soft polyutherane balloon packed into a swallowable capsule connected to a thin tube.
“The granted approvals herein are in accordance to the laws of Kenya, Health Amendment Law 2019 and the applicant is required to adhere to the stipulated conditions,” PPB says in the device registration certificate it granted the clinic.
The attached conditions include submission of annual reports to the Medical Devices Department, Directorate of Product Evaluation.
“The annual report must include all complaints and adverse events received by the manufacturer relating to problems with the use of the device,” PPB says.
Dr Pranav Pancholi, a cosmetic surgeon, explains that the balloon is inflated once it is in the stomach.
“After the pill-sized capsule has been swallowed and is confirmed to be in place using X-ray, the balloon is inflated with about half a litre of water,” he says of the device developed in 2009 by two students at the Harvard School of Medicine.
“We then take another X-ray to make sure the balloon is fully inflated and resting in the correct position in the stomach. Our team will monitor the patient for one hour before allowing them to return home. The procedure is painless and is done without anaesthesia,” Dr Pancholi said.
“The balloon stays in place for approximately four months and, in that period, the patient has regular check-ups at our clinic for us to monitor the progress,” he says.
“It (the balloon) is made up of a biodegradable material that deflates automatically after that duration, and is then passed out naturally.”
The procedure, now used in 40 countries, includes remote patient monitoring through the Allurion Virtual Care Suite – which includes the Allurion Connected Scale, Allurion Health Tracker, and Allurion Insights – a provider portal that enables end-to-end patient management.
“We administer it to adults above 18 years of age and a body mass index (BMI) of 27,” said Dr Pancholi.
According to the World Health Organization (WHO), healthy BMI ranges from 19 to 25, with people below 19 being classified as being underweight.
For adults, WHO defines being overweight and obese as having a BMI greater than or equal to 25, and greater than or equal to 30, respectively.
The balloon aids weight loss by reducing food intake by taking up space in the stomach, inducing early satiety (feeling of fullness), delaying gastric emptying and reducing stomach capacity.
“The placement process lasts around 15 minutes and is done by a physician under supervision. The patient may need to swallow the balloon with a glass of water and the doctor is always at hand to ensure painless and successful installation of the balloon at a cost of Sh450,000,” Dr Pancholi said.
According to multiple globally peer-reviewed clinical studies, most people lose 10 to 15 per cent of their total body weight through the Allurion Balloon Programme in 16 weeks.
Up to 95 per cent of the weight loss can be sustained for 12 months after the balloon has passed, with the patient taking control over what they eat.
“Dieting can make you feel hungry but Allurion gives you control because patients feel less hungry, feel fuller more quickly after eating, and have help avoiding hunger attacks typically experienced when dieting,” added Dr Pancholi who has been at Harvard University attending a training programme on the balloon.
Once a patient loses weight, the next step is to tuck in and align their skin.
“We then do a radiofrequency assisted skin tightening procedure. It is a relatively new and minimally invasive procedure that uses thermal energy to promote skin tightening and remove unwanted fat.”
According to the Centers for Disease and Control Prevention (CDC), as of 2018, obesity prevalence in Kenya stood at 60.3 per cent among urban residents and 19.5 per cent among rural residents, with the higher risk of obesity being among women in urban areas associated with increased consumption of high-calorie and high-fat diets.
CDC further established that 43.4 per cent of women and 34 per cent of men were overweight or obese in the country.
To control the rising burden of obesity and non-communicable diseases, WHO recommends a tax on sugar-sweetened beverages. Whereas the approach has been widely adopted in countries such as South Africa, Kenya is yet to implement a standalone sugar tax policy.