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Gastric balloon pill launched in UK

Most of the UK media has got rather overexcited about the UK launch of Obalon, a gastric balloon in pill form that can be swallowed to help overweight people achieve rapid weight loss without invasive surgery.

The Obalon pills are designed to be inflated into balloons in the stomach, reducing the free volume of the stomach and therefore how much a person can eat before they feel full.

Intra-gastric balloons are not new, and are sometimes provided to extremely obese people through the NHS, although these often have to be surgically implanted.

Obalon has been approved in Europe for overweight and obese adults, but in the UK is currently only available privately. It is designed to be used for a maximum period of three months.

But as a course of three balloons can cost up to £4,000, is this new treatment a good option?

What is the Obalon balloon device and how does it work?

The device is made by a company also called Obalon. It comprises three lightweight balloons that are placed in the stomach over a 12-week period. The number of balloons used can be tailored to the person’s weight loss progress, with a single balloon placed in the stomach initially and additional balloons added if needed.

Each balloon is contained in a capsule or pill, attached to a tiny tube that is used to inflate the balloon once in the stomach.

Who is the Obalon balloon suitable for?

The balloon is designed to be used by people with a body mass index (BMI) of 27 or above, who have previously failed to lose weight through diet and exercise.

A BMI of 25 or above is considered as being overweight (30 or above is considered as being obese).

How does the Obalon balloon get into the stomach?

If you opted for this treatment, you would have to swallow the capsule (reportedly the size of a large vitamin pill), with a very small tube attached. Once the capsule reaches the stomach, it opens up and releases the balloon. The doctor looks at where the balloon is placed with an X-ray and then inflates the balloon with gas through the tube (it is not clear what type of gas is used). After the balloon is inflated, the tube is removed, leaving the balloon in the stomach.

According to the manufacturer, the procedure takes about 15 minutes and no sedation or anaesthetic is needed. A special diet is followed for three days afterwards, consisting of clear liquids only on day one and soft foods only on day two with most people able to eat solid foods on day three.

A second balloon can be introduced 30 days after the first and a third, 30 days after that, depending on a person’s progress. Twelve weeks after the first balloon is swallowed, all balloons are removed using an endoscope. Light sedation may be required for this procedure, which takes about 15-30 minutes.

How is the Obalon balloon designed to be used?

The balloon is designed to be used at the same time as developing healthier eating habits. To achieve lasting weight loss, the person would need to stick to these healthier habits after any balloons are removed.

What evidence is there that the Obalon balloon works to help weight loss?

Obalon has conducted a study of the balloon in 119 obese patients, mainly women, who initially received a single balloon. Just under half received a second balloon and a further six a third balloon, during the treatment period. 110 patients completed at least eight weeks of treatment (a 7.6% drop-out rate).

According to the company, the women achieved an average weight loss of 8kg which they say represents an average “excess” weight loss of about 50%.

This is broadly similar to the reported effectiveness of gastric banding and gastric bypass surgery, which normally result in around an excess weight loss of around 50% to 70%.

Techniques such as gastric banding or gastric bypass have a longer, more proven pedigree when it comes to sustaining long-term weight loss.

It is currently uncertain whether the Obalon balloon would achieve similar results over the long term due to a lack of evidence.

Are there any risks or side effects from Obalon balloon treatment?

In the same study, about one in 10 patients reported nausea, 6.7% reported vomiting and 7.6% requested early removal of the balloons. No serious complications were reported.

However, doctors are advised to closely monitor patients undergoing the procedure during the entire 12 weeks, to detect possible complications. These could include:

  • deflation of the balloon (which could result in bowel obstruction – which can be potentially fatal)
  • reflux
  • indigestion
  • stomach pain and cramps
  • constipation
  • diarrhoea
  • bloating
  • gastric ulcer
  • injury to the stomach or oesophagus (tube that carries food from the mouth to the stomach)

Because the Obalon balloon is so new, it is currently difficult to assess how safe it is compared with other similar types of weight loss treatment.

Complications associated with endoscopy (the procedure used to remove the balloon) include:

  • abdominal discomfort
  • sore throat
  • digestive tract injury
  • bronchial aspiration (liquid or fluid lodging in the airway of the lung if present in the stomach)

The product is not suitable for people with certain conditions such as disorders of the gastro-oesophageal tract and type 1 diabetes or for women who are, or plan to become, pregnant, or are breastfeeding.

An urgent safety notice, issued by the UK medical devices regulator the MHRA last September, advised that Obalon inflation systems such as the balloon should not be used at elevations higher than 660 metres above sea level. Lower air pressure at such altitudes will result in overinflation of the balloon. This height equates to just over twice the height of the famous Shard tower in London, but is less than the height of many of the larger hills and mountains across the UK including Ben Nevis, Snowdon and Scafell Pike.

Is the Obalon balloon available on the NHS?

No. It is only available privately, from a company called Spire Healthcare. Treatment through Spire costs £1,995 for one balloon, £2,995 for two and £3,995 for three.

However, an intra-gastric balloon procedure without invasive surgery is available on the NHS.

The balloon can be passed through your mouth and down into your stomach using an endoscope (a thin, flexible tube that has a light and a camera on one end).

This is normally offered free on the NHS to people who are very obese (a BMI of 40 or above), who have failed to respond to other treatments, and who agree to commit to long-term follow-up treatment after surgery at a specialised obesity service.

You can find more on gastric balloon treatment from the British Obesity Surgery Patients Association.

How can I be sure it will work for me?

As yet little research into the effectiveness of this recent product has been undertaken. It may help weight loss but is unlikely to be a magic cure for obesity. As the company advises, people who have it will need to stick to a healthy diet and lifestyle during the 12 weeks and afterwards.

Before taking the radical step of spending thousands of pounds to swallow balloons, it is always recommended that you try to lose weight through a balanced, calorie-controlled diet and increased exercise. 

 

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