Risks of The Gastric Balloon

Alert for Fluid-Filled Intragastric Balloons by the FDA

 

The FDA has issued an alert to healthcare providers about potential adverse events linked to fluid-filled intragastric balloons for the treatment of obesity.

 

Intragastric balloon

 

The FDA has recently received multiple reports of two different types of adverse events associated with fluid-filled intragastric balloons:

  • The first type of adverse event involves over inflating with fluid (spontaneous hyperinflation) in patients’ stomachs, resulting in the need of premature device removal.
  • The second type of adverse event is the development of acute pancreatitis, which has also resulted in premature removal.

The FDA recommends that providers closely monitor patients with these devices for the above adverse events.

Symptoms to look for in balloon over-inflation include:

  • Intense abdominal pain
  • Swelling of the abdomen (with or without discomfort)
  • Difficulty breathing
  • Vomiting

 

Balloon 3

The reports indicate that balloon over-inflation can occur as soon as nine days after implantation and as yet there isn’t enough information to determine what is causing the balloon to over-inflate.

 

Acute pancreatitis develop in patients’ due to the compression of gastrointestinal structures created by the inflated balloon.

Symptoms to look for with acute pancreatitis are:Balloon 4

  • Severe abdominal pain
  • Back pain

 

The reports indicate that acute pancreatitis can occur as soon as three days after implantation.

It is important that healthcare providers are aware of these adverse events to be able to identify the symptoms and treat the patient as soon as possible by removing the device.

 

The FDA is working closely with the manufacturers of the intragastric balloon to better understand these issues of acute pancreatitis and over-inflation in patients with fluid-filled intragastric balloons.

 

Gastric Band Surgery Can Be Safe and Effective for Obese Adolescents

A newly published study has found that gastric band surgery has significant benefits for severely obese teenagers and, despite its controversial nature, should still be considered as a first option to manage obesity during adolescence.

Led by University of Adelaide researchers, in collaboration with Flinders Medical Centre, and published in the journal Obesity Surgery, the study is the first to show medium to long-term follow-up (3-5 years) of gastric band surgery in Australian adolescents.

The research followed 21 severely obese teenagers between 14 and 18 years who had Laparoscopic Adjustable Gastric Banding in the South Australian Health Service.

Severe obesity is associated with serious physical and psychological conditions affecting quality of life. Australian revised National Health and Medical Research Council guidelines for obesity management say that gastric band surgery should be considered in adolescents with severe obesity – that is with a body mass index (BMI) over 40 kg/m2 or over 35 kg/m2 (weight/height2) with the presence of obesity-related diseases and who don’t respond to medical treatment. However, there is no data available in Australian adolescents beyond 24 months’ post-surgery.

 

teenagers

“We are talking about a group of adolescents with severe obesity and significant health and psychological problems related to their increased weight – this is not for everyone,” says corresponding author and Paediatric Endocrinologist Dr Alexia Peña, who is a Senior Lecturer with the University of Adelaide’s Robinson Research Institute.

The study found that weight and BMI improved significantly at all follow-up times following surgery from three months through to 45 months and, in some cases, as long as five years. BMI loss was between 7.1 and 14.7 kg/m2.

“The median BMI reduction of 10 kg/m2 with the lap band is a good result when compared to BMI reduction using the few medications available or lifestyle measures, which is around 1-3 kg/m2,” says Dr Peña. “Lap band surgery is reversible and allows time for adolescents to mature to make a more informed decision on a permanent surgical procedure if required later in life. This is not the case for other surgeries currently offered for obesity management.

“It is also important that teenagers undergoing this surgery have access to an experienced surgeon as part of a multidisciplinary paediatric team of doctors and Health professionals to ensure there is long-term regular follow-up.”

Paediatric surgeon Mr Sanjeev Khurana, who did all the lap band surgeries between 2009 and 2013, says lap band surgery is a reversible surgical procedure that can be safely used in teens with severe obesity.

“Although gastric banding has been controversial and is currently less used in adults with severe obesity, lap band surgery is one of the most studied surgeries for obesity management, has a high safety record and can be a temporary option to manage severe obesity during adolescence,” says Mr Khurana, who is also a Senior Lecturer in the University of Adelaide’s Discipline of Paediatrics.

“Our findings support lap band surgery as a safe and effective option for management of adolescents with severe obesity – provided it is performed by an experienced surgeon and managed afterwards in a paediatric multidisciplinary environment with regular follow-up until adulthood.”

Source:

University of Adelaide

 

Journal Reference:

Authors: Alexia Sophie Peña, Tarik Delko, Richard Couper, Kerri Sutton, Stamatiki Kritas, Taher Omari, Jacob Chisholm, Lilian Kow, Sanjeev Khurana.

 

Title: Laparoscopic Adjustable Gastric Banding in Australian Adolescents: Should It Be Done?

 

Clinical Paper Reference: Obesity Surgery, 2017; DOI:10.1007/s11695-017-2544-6

 

 

 

Fear of Cancer After The Sleeve Gastrectomy

The Truth About Reflux After The Sleeve Gastrectomy

 

In my humble opinion and observance of patients over a period of working in the field of bariatrics for 13 years; in the rush to seek a quick fix operation to experience rapid weight loss many people overlook the negative side effects of the procedures.

gastric sleeve

It is recognised that some of the main complications of the sleeve gastrectomy and the gastric bypass are leaks and internal hernias but since the rise of the sleeve gastrectomy procedure some studies are showing a post sleeve acid reflux rate of between 20-30%. The question and concern is, that this form of acid reflux can be the cause of oesophageal cancer. So could this mean that in the weight loss surgery world we are creating a whole generation of sleeve patients with a lifetime risk of cancer?

 

GERD

In a recent edition of the Bariatric News Dr Robert Rutledge who has pioneered the mini gastric bypass procedure explains that a primary cause of gastric cancer is commonly caused by the bacteria H. Pylori and that patients who were likely infected were at a higher long term risk of developing gastric cancer. He advised that if surgeons are worried about gastric cancer they should look for Heliobacter Pylori and treat it appropriately. In his opinion the sleeve is creating moderate to severe acid reflux with oesophagitis in a moderate to large percentage of patients. General surgeons know that this is a pre-cancerous and potential cause of oesophageal cancer.

 

 

 

At the moment the data is limited for the gastric sleeve but in 20 years’ time we could see acid reflux rates as high as 50% so the question is patients considering the gastric sleeve procedure should be concerned about long term oesophagitis which is an unequivocal precursor to cancer.

 

Body Shape Impacts On Mortality

According to the findings of a large study published in the BMJ people who are lean for life have the lowest mortality, while those with a heavy body shape from childhood up to middle age have the highest mortality.

 

fat-people

The paper entitled: Trajectory of body shape in early and middle life and all cause specific mortality: results from two prospective US cohort studies was led by a team of US researchers who tracked the evolution of body shape and associated mortality among two large cohort studies.

In total, 80,266 women and 36,622 men enrolled in the study recalling their weight at ages 5, 10,20, 30 and 40 years. They also provided body mass index at age 50, and were followed from age 60 over a median of 15-16 years for death. They answered detailed questionnaires on lifestyle and medical information every two years, and on diet every four years. Among the cohort fine distinct body shapes were identified from age 5-50: lean-stable, lean-moderate increase, lean-marked increased, medium-stable/increase, and heavy-stable/increase.

 

suitable-for-all-body-shapes-sizes

The results showed that people who remained stably lean throughout life had the lowest mortality, with a 15-year risk of death being 11.8% in women, and 20.3% in men. Those who reported being heavy as children and who remained heavy, or gained further weight, especially during middle age, had the highest mortality, with a 15-year risk of death being 19.7% in women and 24.1% in men.

“Our findings provide further scientific rationale for recommendations of weight management, especially avoidance of weight gain in midlife, for long term health benefit,” the author concluded.

In a second study, an international team of researchers found that increasing levels of BMI are associated with higher risk of premature death. It was expected that a higher BMI is associated with a reduced life expectancy, but the previous largest study showed that when compared to normal weight, overweight was associated with reduced mortality and only high levels obesity were associated with increased mortality.

The various limitations in the study such as smoking and prevalent or pre-diagnostic illness were not taken into account, both of which could lead to lower body weight, and increased mortality.

So, researchers in the current study sought to clarify this association by carrying out a large meta-analysis of 230 prospective studies with more than 3.74 million deaths among more than 30.3 million participants.

They analysed people who never smoked to rule out the effects of smoking, and the lowest mortality was observed in the BMI range 23-24 among this group. Lowest mortality was found in the BMI range 22-23 among healthy never smokers, excluding people with prevalent diseases. Among people who never smoked and studied over a longer duration of follow up of more than 20 and 25 years, where the influence of pre-diagnostic weight loss would be less, the lowest mortality was observed in the BMI range 20-22.

The findings of the study demonstrate the importance of smoking and health conditions in the association between BMI and mortality and reinforces concerns about the adverse effects of excess weight. There is an emphasis on the need to maintain a healthy weight although also a recognition that there are major challenges in finding effective ways to prevent weight gain, support weight loss and prevent further weight regain in both individuals and populations.

 

 

Weight Loss Surgery Improves Pain and Physical Function

According to a study titled, “Change in Pain and Physical Function Following Bariatric Surgery for Severe Obesity” published in JAMA, it found that a large percentage of patients with severe obesity that underwent bariatric surgery experienced improvement in pain, physical function and walking capacity over three years.

The study was designed to record and report changes in pain and physical function in the first three years following bariatric surgery and to identify factors associated with improvement. Up to date the authors had noted that variability and durability of improvements in pain and physical function following a gastric bypass or gastric band had not been well documented.

Stairs

The study was conducted at ten hospitals between February 2005 and February 2009 and led by Dr Wendy C King from the University of Pittsburgh, along with her colleagues they examined changes in pain and physical function in three years after bariatric surgery.

 

There were 2,458 patients included in the study, 70% underwent the gastric bypass and 25% had the gastric band procedure. Among the primary findings through three years of follow up approximately 50-70 percent of adults experienced clinically significant improvements in perceived bodily pain and physical function and in objectively measured walking capacity. Approximately three-fourths of participants with severe knee and hip pain experienced improvements in osteoarthritis symptoms.

Hips and knees

The study found that between year one and year three, rates of improvement significantly decreased for bodily pain and physical function but improvement rates for walk time, knee and hip pain, knee and hip function did not!

 

Indications that were associated with pre surgery to post surgery improvements at years one, two and three were:

  • Younger age
  • Male sex
  • Higher income
  • Lower BMI
  • Less depressive symptoms pre surgery
  • No diabetes
  • No swelling or ulcerations of the legs

This study’s large geographically diverse sample, inclusion of multiple validated measures of pain and physical function, longitudinal design and three year follow up make it one of the most informative studies following gastric bypass and gastric banding.

Reference: JAMA 2016;315(13):1362-1371.doi10.1001/jama2016.3010

Title: Change in Pain and Physical Function Following Bariatric Surgery for Severe Obesity

Authors: Wendy C King, Jia-Yuh Chen, Steven h Belle, Anita p Courcoulas, Gregory F Dakin, Katherine A Elder,David R Flum, Marcelo W Hinojosa, James E Mitchell, Walter J Pories, Bruce M Wolfe and Susan Z Yanovski

 

Post Op Assessments Aid Weight Loss

Researchers from the Neuropsychiatric Research Institute, Fargo, ND have published a paper on their study which assessed how certain weight control practices and eating behaviours can significantly influence the amount of weight loss after surgery.

 

The paper titled, “Postoperative Behavioural Variables and Weight Changes 3 Years After Bariatric Surgery”, was published in the well-respected JAMA Surgery and suggested that the utility of programmes to modify problematic eating behaviours and eating patterns should be addressed in research.

“The results of this study suggest that certain behaviours, many of which are modifiable, are associated with weight loss differences of significant impact in patients undergoing the gastric bypass or the adjustable gastric band”, the authors write. “The magnitude of this difference is large and clinically meaningful. In particular, the data suggest that developing positive changes in behaviour, including ceasing negative behaviours, can affect the amount of weight loss”.

Thinking of Food 2

Weight loss surgery has been proven to induce weight loss but the amount of weight loss that patients achieves varies. In the past, research has been focussed on pre-operative factors and post-operative predictors of weight loss have not been thoroughly researched. The aim of this study was to examine post-operative eating behaviours and weight control, and their effects on change in weight among adults undergoing their first time weight loss procedure.

 

Behaviours studied were divided into those that were never present, those who were always present and those that underwent a healthy change after surgery (development of a positive behaviour or omission of a negative behaviour).

 

The study included a total of 2,022 participants, 1,513 underwent the gastric bypass and 509 had the gastric band procedure. The researchers found that the three behaviours that predicted a patient to lose an average of 39% of their baseline weight, which is about 14% greater weight loss compared with patients who made no positive changes in these behaviours, and 6% greater weight loss compared with patients who always reported positively and attended follow up were:

stop-eating

 

No 1 – Weekly self-weighing

No 2- Stopping eating when feeling satisfied

No 3 – Stopping eating continuously during the day (grazing)

 

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Weekly self weighing

The outcomes suggest that structured programmes to modify problematic eating behaviours and eating patterns following surgery should be evaluated to improve weight loss outcomes which means that the post-operative period requires more targeting from the healthcare professionals to ensure success.

 

 

 

Title: Postoperative Behavioural Variables and Weight Change 3 Years After Bariatric Surgery

Authors: James E. Mitchell, MD; Nicholas J. Christian, PhD; David R. Flum, MD, MPH; Alfons Pomp, MD; Walter J. Pories, MD; Bruce M. Wolfe, MD; Anita P. Courcoulas, MD, MPH; Steven H. Belle, PhD, MScHyg

Reference: JAMA Surg. Published online April 20, 2016. doi:10.1001/jamasurg.2016.0395

 

 

Gastric Bypass & Alcohol Abuse

Researchers from the University at Buffalo Research Institute on Addictions in collaboration with the Penn State College of Medicine are investigating why a significant percentage of people who opt for a gastric bypass procedure for weight loss develop alcohol abuse problems.

The researchers plan to focus their study on the possible neurological causes for the increased vunerability for alcohol use disorders in this group of people.Senior research scientist; Dr Panayotis K Thanos stated: “Recent findings have shown the risk of developing an alcohol use disorder following gastric bypass surgery was nearly double the risk in the general population. Although other studies have shown the risk to be not quite that high, the numbers all point to the need for greater research in this area.”

Dr Thanos added; “Most alcohol use disorders manifest during a person’s teens or 20’s. However, people who have a gastric bypass tend to be older, so the alcohol abuse arises at a much later onset date than in the general population.” So this likelihood of developing alcohol problems is unusual because of the older age of the patients.

Alcohol

Results of the study could prove valuable to clinicians when they formulate personalised post operative treatment plans for patients who may already have an increased risk of alcohol use disorders, in order to help prevent develoment of the addiction.

Dr Thanos concluded; “We will explore whether this outcome is due to changes in the brain’s dopamine system that are a unique result of the gastric bypass surgery, and independent of weight loss or post surgical change of diet.  Such a change in the dopamine system may increase preference for an intake of alcohol based on its increased rewarding effects in the brain. This, in turn, poses an increased risk for development of addiction.”

Reference: Bariatric News Issue 28