Tag Archives: FDA

‘Stomach Pump’ Weight Loss Device Approved by FDA

Obese people who are struggling to lose weight may have a new option, but it may seem very unusual for some.

Asire Assist Bariatrics

FDA approves new ‘stomach pump’ weight loss device to cut a third of your calories. Photo by CBS News

The FDA approved a new device known as the AspireAssist. You do not have to undergo major surgery and it works by removing some of what is inside your stomach through a tube after you eat, cutting about a third of your calories.

The device is made up of a surgically placed tube in the stomach that removes food in the stomach after you eat just before the food is digested. Patients drain about a third of what is in their stomach,” says Katherine Crothall, PhD, president and CEO of Aspire Bariatrics, Inc., the developer of the device. I think that is a good percentage of contents removed that could lead to more weight loss that regular digestion.

The trial included 111 patients who had counseling about nutrition and exercise with 60 people who got the counseling alone. After twelve months, those who used AspireAssist lost an average of 12 percent body weight, while the counseling-only group lost over 3 percent.

The good thing is that both groups showed a little improvement in obesity related health issues such as diabetes and high blood pressure.

The device is intended for adults who are obese with a BMI of 35 to 55, who have not lost weight or kept the pounds off through non-surgical treatments. It is recommended for individuals to receive counseling on exercise and healthy eating so they will make long term lifestyle changes.

The thing I like most about this device is that it is less invasive than weight loss surgery and possibly a lot less risky. Surgery does lead to more weight loss though, says Stacy Brethauer, MD, a staff bariatric surgeon at Cleveland Clinic. He is familiar with the device but has to relation to the company.

Side effects of the AspireAssist include nausea, indigestion, diarrhea, constipation and vomiting, according to the FDA.

If you calculate the treatment, including the device placement, monitoring, lifestyle counseling and follow-up, you could be expected to pay anywhere from $8,000 to $13,000 in the first year. This is not so bad compared to the cost of weight-loss surgery, which could range from $30,000 to $35,000, says John Morton, MD, immediate past president of the American Society for Metabolic and Bariatric Surgery. Insurance may cover the cost for patients who qualify which is a great idea in my opinion.

It is hard to tell how big of a role this device can play in weight loss, but if patients use the device properly and stay dedicated, then there is no doubt they will lose weight.

Source: www.fda.gov “FDA approves AspireAssist obesity device” June 14, 2016

 

Leeman Taylor
Bachelor Degree in Criminal Justice
Real Estate Investor & Internet Marketer

FDA Approves Weight Loss Balloon

Obese people seeking to lose weight now have a new option: a weight loss balloon that has been recently approved by the Food and Drug Administration (FDA). With more than a third of the U.S. population overweight or obese, this new device will be a very powerful tool for fat loss in my opinion.

ReShape Weight Loss Balloon

FDA approves new weight loss balloon to help patients lose weight by making them feel full. WebMD photo

The ReShape Dual Balloon is inserted through the mouth, into the stomach, and inflated with a sterile solution. The procedure only takes about 30 thirty minutes while the patient is mildly sedated.  It fills the space in the stomach to give you a feeling of fullness and it can be left there for up to six months (FDA). I believe this will be a better solution for patients who want to lose weight in a non-surgical manner instead of going through LAP band or gastric bypass surgery.

The approval of this weight loss device was based on a study of 326 obese individuals, with ages between 22 and 60, who had at least one obesity-related health issue. There were 187 people who lost an average of 14.3 pounds by the time the device was removed. Members who did not receive the weight loss balloon only lost 7.3 pounds on average. Six months later, patients who lost the initial 14.3 pounds kept about 10 pounds of that weight off (FDA). This is good news for those individuals who struggle with weight management after one year of reaching their fat loss goals.

“For those with obesity, significant weight loss and maintenance of that weight loss often requires a combination of solutions including efforts to improve diet and exercise habits,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This new balloon device provides doctors and patients with a new non-surgical option that can be quickly implanted, is non-permanent, and can be easily removed.”

I personally love natural weight loss which is physical activity and healthy eating. This was also recommended for patients who wish to keep the lost weight off after the balloon was removed according to the FDA press release. With this new weight loss balloon, patients have another option to fight obesity but like any other procedure, it comes with its side effects.

Some of the complications included discomfort during the procedure, rare cases of allergic reaction, infection and breathing difficulties, heart attack and esophageal tear, says the FDA. Also, patients may experience vomiting, abdominal pain, nausea, feelings of indigestion and gastric ulcers, adds the FDA.

I believe this new fat loss balloon by ReShape Medical Inc. is what obese or overweight people really need to help them lose weight and keep it off for good.

Leeman Taylor
Bachelor Degree in Criminal Justice
Real Estate Investor & Internet Marketer

Source: www.fda.gov “FDA approves non-surgical temporary balloon device to treat obesity” 28 July 2015 U.S. Food and Drug Administration

FDA Approves New Weight Loss Device for Obesity

Obese individuals struggling to lose weight now have a new FDA-approved weight loss treatment device, the Maestro Rechargeable System, which pinpoints the nerve passage between the stomach and the brain that controls your appetite (FDA 2015).

Maestro Recharchargeable System Weight Loss Device

The Maestro Rechargeable Device is a new FDA-approved device for weight loss. Photo by HNGN

Just like the recently FDA-approved weight loss drug Saxenda, this obesity device is for individuals 18 and over who have struggled to lose weight with a weight loss program, and who have at least one other obesity-related health condition such as type 2 diabetes. Diet and exercise are the most important factors for fat loss and this new device can make an effective combination in my opinion.

“Obesity and its related medical conditions are major public health problems,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “Medical devices can help physicians and patients to develop comprehensive obesity treatment plans.”

According to the FDA, the Maestro Rechargeable System consists of a rechargeable electrical pulse generator, wire leads and electrodes surgically implanted into the abdomen. This device is effective by sending intermittent electrical pulses to the trunks in the abdominal vagus nerve, which regulates the stomach in signaling the brain that the stomach feels full or empty. Patients can charge the device with external controllers and I believe it’s very convenient how health care professionals can adjust the settings.

How safe is the Maestro Rechargeable System?

In the clinical study, 233 patients with a body mass index (BMI) of 35 or above received the device but the 157 patients who received the active devices lost 8.5 percent more excess weight after 1 year, compared to the 76 patients who received a non-activated Maestro electrical pulse generator (FDA 2015).

As a part of the approval, the manufacturer must conduct a 5 year post approval study to collect additional safety and effectiveness data. Serious adverse side effects reported were nausea, vomiting and complications from surgery. Other adverse effects included pain, problems swallowing, heartburn, chest pain and mild nausea.

Maestro Weight-Loss Device

EntroMedics, Inc, new weight loss device, the Maestro Rechargeable System, sends signals to the trunks in the abdominal vagus nerve to control appetite. Photo by CBS News

With this new weight-loss device approved by the FDA, obese individuals now have a new option to combine with traditional diet and exercise.

The Maestro Rechargeable System is manufactured by EnteroMedics of St. Paul, Minnesota.

Leeman Taylor
Senior Criminal Justice Major at Florida A&M University
Real Estate Investor & Internet Marketer

Source: FDA.gov “FDA approves first-of-kind device to treat obesity” 14 January 2015 U.S. Food and Drug Administration

Weight Loss Diet Pills Rarely Work

New weight loss supplements and diet pills are advertised everyday by drug companies claiming to help you lose weight fast. According to a new Consumer Report, diet pills rarely work and they aren’t even FDA approved (Olsen 2014).

Weight Loss Diet Pills

Weight loss supplements and diet pills rarely work, according to Consumer Reports. Clipart Photo

A national survey of about 3,000 Americans, were given supplements they believed to be safe and effective. One-fourth of the participants believed that the products had lesser side effects than over the counter or prescription medications, and about 20 percent thought the supplements were safer than prescription drugs because they’re “natural.” When we are searching for weight loss supplements, we don’t usually think about whether the product is actually FDA approved or even consult our primary care doctors for advice.

Peter Cohen, M.D., a physician at Harvard Medical School and the Cambridge Health Alliance who studies supplements says, “The barrage of advertising leads us to think there’s a magic way to melt away 10 pounds –even when we have no evidence that the supplements work.” Unlike over the counter and prescription drugs, supplements don’t have to be proven safe and effective before they hit stores (Olsen 2014). “Of all dietary supplements, the one for weight loss seems to cause the most harm –sometimes liver failure or even death,” Cohen says.

In the survey, a third of the participants who took the supplements didn’t lose weight. Another third lost a few pounds but only 9 percent lost all the weight they wanted and kept it off. The shocking part is that the supplements had little to do with it because 85 percent of the people followed a diet or exercise program (Olsen 2014).

This Consumer Reports survey basically shows us that there is no way around diet and exercise. Research proves that the key to fat loss is finding a diet that works for you. A recent review of 48 studies published in the Journal of the American Medical Association found that popular programs like Atkins, Jenny Craig, and Weight Watchers, all worked as well as the other. The dieters lost nearly 18 pounds after 6 months on average (Olsen 2014). Find a weight loss program like the Venus Factor for Women, that works for you and live a healthier, happier lifestyle.

Leeman Taylor
Senior Criminal Justice Major at Florida A&M University
Real Estate Investor & Internet Marketer

Source: Olsen, D. “Taking diet pills? Don’t waste your money.” 30 December 2014 ConsumerReports.org

New Weight Loss Drug Saxenda FDA Approved

The new weight loss drug Saxenda (liraglutide) has been approved by the FDA for weight-management in addition to exercise and a low-calorie diet. This drug is approved for adults who suffer from obesity or who are overweight and have at least one weight-related issue such as type 2 diabetes, hypertension, or high cholesterol (FDA 2014). With more than one-third of adults in America overweight (CDC), this new drug can help millions lose weight and focus on a healthy lifestyle.

Saxenda Weight Loss Drug

New weight loss drug Saxenda is approved by FDA. Photo by PR Newswire

According to James Smith, M.D., M.S., acting director of the Division Evaluation of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research, “Obesity is a public health concern and threatens the overall well-being of patients.” He then goes on to say that Saxenda provides an additional treatment option for chronic weight management when combined with physical activity and a low-calorie diet (FDA 2014).

What is Saxenda?

Saxenda is a glucagon-like peptide-1 receptor agonist and should not be combined with any other drug in its class, including Victoza, a treatment for type-2 diabetes. On the other hand, the safety and effectiveness for treating type-2 diabetes has not been established for Saxenda.

In the clinical trials, 4,800 obese and overweight individuals with and without weight-related issues were evaluated. Approximately 50 percent of patients with type-2 diabetes, who were treated with Saxenda, lost at least 5 percent of their body weight compared with 16 percent of individuals treated with placebo (FDA 2014). Patients should be evaluated for 16 weeks to determine if the treatment is working or not.

What are the side effects of Saxenda?

Saxenda should not be used in individuals with a personal or family history of MTC or individuals with multiple endocrine neoplasia syndrome type-2. The most commonly observed side effects were nausea, vomiting, diarrhea, low-blood sugar, constipation, and reduced appetite. As any weight loss drug, there will be side effects but I still believe the benefits of Saxenda outweigh the bad and still should be considered as a weight management alternative.

Novo Nordisk manufactures and distributes the drug in Denmark and it is expected to be released in 2015.

Leeman Taylor
Senior Criminal Justice Major at Florida A&M University
Real Estate Investor & Internet Marketer

Source: FDA.gov “FDA approves weight-management drug Saxenda” 23 December 2014 U.S. Food and Drug Administration

“Natural” on Food Labels Doesn’t Mean Anything

“Natural” doesn’t mean anything when looking on the labels of packaged goods according to Consumer Report.

Natural Food - All Natural Chicken

Natural Food – All Natural Chicken

Over 66% of consumers who shop for natural foods think that the word “natural” means something. I even find myself doing this from time to time thinking that the product I am buying is really all-natural! I thought just because the label said “natural” that the food didn’t contain any artificial ingredients, pesticides and genetically-engineered organisms. When I see the word on poultry or meat I never thought about growth hormones, antibiotics or other drugs in the animals’ feed. This whole entire time of being a consumer, I was absolutely WRONG!

 

In fact, the word “natural” doesn’t mean anything when it comes to federal labeling rules. This means that companies can misguide you in a way that is perfectly legal.

Natual - Fat Free - No Preservatives

Natual – Fat Free – No Preservatives

Consumers were asked what the word natural should mean on a label and a shocking 85 percent said that it should mean no pesticides were used when growing it and that it contained no genetically modified or artificial ingredients of any sort. I can honestly say that I thought the same thing when I read the labels. I didn’t really think about how the food was grown and what chemicals were used during the process. I definitely didn’t think about the various hormones that could have possibly been used during the animals feeding process either. This is very different from the current federal rules however.

 

 

 

Natural - Cage Free Eggs

Natural – Cage Free Eggs

Urvashi Rangin, executive director of the Consumer Reports Food Safety and Sustainability Center in Yonkers, said “Our findings show consumers expect much more from ‘natural’ food labels and that there is a strong consumer mandate for better food production practices in general food and label standards that meet a higher bar.”  I know I expected more from products that were labeled natural because I wanted quality for the price. If I am paying my hard-earned cash on a natural product then I expect everything to be natural and not genetically modified.

Both the U.S. Department of Agriculture and the Food and Drug Administration allow food producers to utilize the word “natural” on labels as long as nothing synthetic or artificial had been added “that would not normally be expected to be in the food” under an informal policy FDA put into place in 1993. The bad thing about this is that the word “natural” sells more than $40 billion worth of food in the United States each year. The US Food and Drug Administration (FDA) doesn’t even have an official definition of what “natural” means but explains that it’s difficult to define natural because the food could be processed and no longer a product of the earth.

I am pretty sure there are consumers and other food safety administrations that are fighting to have the word “natural” banned from food labels and other misleading claims. It is very difficult to picture how a farm is kept and how foods are processed unless you have been there. You may think of a perfectly green and sunny farm with fresh fruit and produce but it turn, it’s infested with pesticides, animals are mistreated and the farm itself is a total dump. I believe in local and neighborhood farming because at least you get an idea of where the product comes from and how the farm looks.

Natural - No Hormones - No Antibiotics

Natural – No Hormones – No Antibiotics

I do believe the FDA should still do their part and make sure all food products are safe with no false claims. If a term cannot be defined then it should not be slapped on a label to misguide consumers into spending their hard earned money on it. So the next time you visit your local produce market, watch out for the foods marked “natural” on the labels and read more about it to find out what it really contains.

Leeman Taylor
Senior Criminal Justice Major
Winter Haven, FL

Sourcehttp://www.washingtonpost.com/blogs/wonkblog/wp/2014/06/24/the-word-natural-helps-sell-40-billion-worth-of-food-in-the-u-s-every-year-and-the-label-means-nothing/