Gastric perforation by intragastric balloon in a patient with Nissen fundoplication. Response of the Spanish Bariatric Endoscopy Group

Dear Editor,

We read with great interest the scientific letter published in your journal by Dr Ríos et al. entitled “Gastric perforation by intragastric balloon in a patient with Nissen fundoplication”.¹ We at the Grupo Español de Trabajo para el Tratamiento Endoscópico del Metabolismo y la Obesidad (GETTEMO) [Spanish Working Group for the Endoscopic Treatment of Metabolism and Obesity], support and appreciate the documenting of incidents detected with each of the procedures. There is no doubt that this multicentre cohort contributes towards advances in bariatric endoscopy, helping to provide us with increasingly effective and safer treatments to recommend to our patients.

However, we feel that we should take this opportunity to make a number of points:

• 1.

  For a number of years now there has been a large amount of literature and evidence to support the intragastric balloon as a well-tolerated and safe procedure, with low overall rates of incidents (2.5%) and major complications (0.84%), a virtually non-existent need for repeat surgery (0.07%) and mortality rates close to 0%.^2,3 As these rates vary according to the type of balloon, we believe that the authors should qualify this aspect (it is not correct to say “Apollo or MedSil Orbera-type balloon”).

• 2.

  Currently, the most effective treatment in the long term in morbid obesity is surgery. However, in patients with morbid obesity, the intragastric balloon is also indicated as a bridge to surgery (particularly when BMI > 50 kg/m²), or when the patient refuses surgery or it is contraindicated. As has been documented for years and we recently highlighted in the article published in 2017 by the Grupo Español de Endoscopia Bariátrica [Spanish Bariatric Endoscopy Group], “Multicenter study on the safety of bariatric endoscopy”,² previous gastric surgery, such as the Nissen procedure in this case, is one of the absolute contraindications for intragastric balloons.^3,4 We therefore agree with the authors that the balloon should not have been implanted given the previous Nissen procedure, but not that the patient's degree of obesity was a contraindication.

• 3.

  Nissen-type surgery reduces elasticity and gastric accommodation and increases rigidity and fundic fibrosis. When the fundoplication is competent, the ability to vomit and belch decreases, which can lead to a greater incidence of gastric dilation. All this can increase the risk of ischaemia and necrosis of the wall, and perforation.

• 4.

  We do not believe that there can be any justification for the statement, “in our case the patient was not warned of the risk”. The current recommendation in bariatric endoscopy is that the endoscopist should always warn and inform about this type of risk, with that information also being provided in writing in a specific Informed Consent form.^3,4

• 5.

  It is surprising that in the resolving of the complication there is no mention of any assessment by the endoscopist responsible, and that a gynaecological surgeon appears as the first signatory. We think perhaps this was because the problem was resolved surgically in a different centre from where the balloon was implanted. We would stress here that any centre performing bariatric endoscopy should have an emergency department with a specialist endoscopist and surgeon capable of quickly and efficiently resolving any complications.^4,5

• 6.

  Last of all, it would be interesting to find out if this atypical case went beyond being purely a medical issue and whether or not there is any legal claim or lawsuit involving any of the parties involved.

Conflicts of interest

Dr Espinet-Coll works with Apollo Endosurgery and Dr López-Nava works with Apollo Endosurgery and ReShape Medical, but there are no conflicts of interest for this letter.

Acknowledgements

Grupo Español de Trabajo para el Tratamiento Endoscópico del Metabolismo y la Obesidad (GETTEMO) [Spanish Working Group for the Endoscopic Treatment of Metabolism and Obesity].