A weight loss device cleared by the FDA
In this video, I am going to discuss a novel device called Plenity® which was cleared by the FDA for weight loss.
Although Plenity comes as an oral capsule, it is technically recognized and cleared by the FDA as a device. Plenity is indicated as an adjunct to diet and exercise in weight management in adults with a Body Mass Index or BMI of 25–40 kg/m². To calculate your BMI, please click on the link I listed below.
Plenity Is made of naturally derived cellulose and citric acid which form a three dimensional matrix. The matrix is formulated as hydrogel particles which are assembled inside a capsule.
Once inside the stomach, Plenity capsule releases the hydrogel particles which expand after absorbing water and occupy a quarter of the space inside the stomach. The hydrated gel particles then mix with ingested foods creating a larger volume inside the stomach and small intestine leading to satiety and fullness. Most people feel less hungry after taking Plenity capsules.
When the hydrated gel particles reach the colon, their three dimensional structures break down and the water is released and absorbed by the colon. The degraded Plenity particles are subsequently eliminated through bowel movement.
Plenity capsules are taken twice a day. Three capsules of Plenity should be taken with 16oz of water 20-30 min before lunch and dinner.
Studies have shown that 6 out of 10 adults lost about 10% of their body weight or an average of about 22 lbs after taking Plenity for 6 months.
1 in 4 adults achieved an even greater weight loss, about 14% of body weight or an average of about 30 lbs after 6 months.
Plenity is contraindicated in people with the following conditions:
Being pregnant
Having allergic reactions to ingredients of Plenity such as cellulose, citric acid etc
esophageal webs, diverticuli, and rings
suspected gastrointestinal strictures (for example, patients with Crohn’s disease)
complications from prior gastrointestinal surgery that could affect GI transit and motility
People who have active gastro-esophageal reflux disease or ulcers and people who are taking oral medications should use Plenity with caution
Plenity requires a prescription from a healthcare provider. It is not covered by health insurance. It costs $98 for a 4-week supply or $3.5 a day.
Link for BMI calculation:
https://www.nhlbi.nih.gov/health/educ...