The US Food and Drug Administration have permitted a surgically implanted device for the use of one of the most major health problem around the world… Obesity.
Obesity: The National Institute of Health and Care Excellence (NICE) recommend the use of Body Mass Index (BMI) to evaluate overweight and obese persons. Obese individuals have a larger absolute lean body mass (LBM) and fat masses than non-obese people of the same age, gender, and height.
According to NICE classification of obesity, the person having BMI of 30-34.9 is considered Grade 1 obese, whereas the person with 35-39.9 BMI falls under the category of Grade 2 obese and the individual who has >40 BMI is Grade 3 obese (i.e. weight being a threat to the health).
Device: The VBLOC Vagal Blocking Therapy in the form of Maestro Rechargeable System by Enteromedics.inc resembles a pace maker like equipment which constitutes of a pulse generator, wire leads and electrodes and is fitted in the abdomen. Its implantation does not require hospitalization but can be executed in the outpatient departments. This therapy does not affect the normal functioning of the GI system and allows proper/adequate absorption of the nutrients and their utilization.
Candidates for this therapy: The first of its kind device is directed to be used for treating adults having BMI of 40-45 kg/m2 or of 35kg/m2 or greater along with other health problems ranging from high cholesterol concentrations to the high blood pressure levels and for individuals who have been unable to adhere and achieve the desired results from their weight management plans for last 5 years.
Patients intolerable to the weight reduction medications can highly benefit from this device. The trials conducted also showed the therapy to be able to control the blood sugar levels in addition to the weight control and reduction.
Mechanism of action: This very concept was initiated by observing the patients who had temporary weight loss after their surgical vagotomy for treating the troublesome GI ulcers. The device brings about its action by blocking the signals of the nerve connecting the stomach and brain in a daily scheduled manner which in turn decreases the patients’ appetite and craving for food and makes him/her feel full, therefore helping in less consumption of calories and weight loss in a safe way.
Study trials conducted on VBLOC: The data and outcomes from the double blinded, randomized trial helped in analyzing and finalizing the results of the use of this rechargeable system for weight loss and control and hence it was concluded that the benefits of the therapeutic technique outweighs the side effects.
Another major positive aspect of VBLOC is the reversibility of this process which enables the device to be switched off without any further surgical procedures e.g. in cases like pregnancy.
Contraindications: Following patients cannot use the VBLOC system;
- Suffering from esophageal varices
- Liver cirrhosis
- Portal hypertension
- Clinically significant hernia
- Have to undergo magnetic resonance imaging
- Have surgical complications
- Already have an electrically operated medical device implanted e.g. implanted defibrillator, pace maker etc.
Side effects: Readily occurring side effects that were noticed include;
- Nausea and vomiting
- Belching and constipation
- Difficulty in swallowing
- Dyspepsia/heart burn
- Pain at the neuro regulation site.