Posts categorized "FDA" Feed


Well this is something interesting?

  • FDA has granted premarket approval to BaroNova for a device to treat obesity that is inserted into the stomach, where it delays gastric emptying. It is removed after 12 months.
  • The device, called the TransPyloric Shuttle system, is placed and removed through the mouth in an endoscopic procedure.
  • Approval was based on the company's 270-patient pivotal study in which people treated with the device lost three times more weight on average than patients who had a sham procedure in the control group.

Dive Insight:

Despite obesity prevalence at 39.8% in 2015-16, affecting about 93.3 million U.S. adults, according to the Centers for Disease Control and Prevention, therapeutic options have not made a dent. Conditions linked to obesity include heart disease, stroke, Type 2 diabetes and some forms of cancer.

Stubbornly high rates globally show the need for an effective treatment, despite substantial public health efforts to address the problem. Optimism at the start of the decade about progress has been tempered, according to a 2018 editorial in the Journal of the American Medical Association. The AMA recognized obesity as a disease in 2013. 

When lifestyle modifications are not enough, physicians may prescribe weight-loss medications or suggest weight-loss surgery. BaroNova's system offers a non-surgical option.

The BaroNova device is indicated to treat obesity in patients with a body mass index of 30-40 kg/m2. The company's clinical study met its primary endpoints for percent total body weight loss 12 months after the procedure and the proportion of subjects in the treatment group achieving 5% total body weight loss. Approximately 67% of people treated with the device lost 5% or more of their body weight, exceeding the pre-specified performance target of 50%. Forty percent (40%) of those treated with the device lost 10% or more of their weight.

The Mayo Clinic lists several surgical options to treat obesity. They include gastric bypass, in which the surgeon creates a pouch at the top of the stomach that is connected to the small intestine, allowing food and liquid to bypass most of the stomach. Other surgical approaches include gastric banding, where bands are placed at the top of the stomach to leave a small portion available for food. Biliopancreatic diversion and gastric sleeve procedures both involve removing part of the stomach.

Last week, FDA granted De Novo clearance to an edible hydrogel capsule that releases absorbent particles that swell in the stomach to create gel pieces with the firmness of plant-based foods, meant to create a feeling of fullness. The mechanical modes of action involve mean it's regulated as a medical device.

In 2015, FDA approved an implantable, vagus nerve blocking neuromodulation device from EnteroMedics, now known as ReShape Lifesciences. A pulse generator implanted under the skin in the abdomen sends electrical signals via wire leads and electrodes to the vagus nerve. 

Also in 2015, FDA approved two intragastric balloon devices sold by manufacturers ReShape and Apollo Endosurgery. In 2016, FDA approved a third balloon system, made by Obalon, that delivers three balloons in a swallowable capsule that are filled with air. 

In 2017, FDA alerted the public to complications with the liquid-filled devices, including four deaths tied to the Orbera balloon made by Apollo and one death linked to the ReShape balloon.

Other device-based treatments on the market include Aspire Bariatrics' AspireAssist that uses a surgically placed tube to drain some stomach contents and PureTech's edible hydrogel capsule, called Plenity, intended to create a feeling of fullness.


Allergan might sell off LapBand Arm - Surprised?

Allergan is considering selling out its Lap-Band arm of weight loss surgical devices -- after a rapid decline in sales and huge public perception fail.  Shocking, right?  Uh, no.


Continue reading "Allergan might sell off LapBand Arm - Surprised?" »

FDA Warns Second LapBand Firm

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And here we go again!

Los Angeles Times -

"The FDA sent a letter to the owners of Lap-Band VIP, warning them to change their billboard and television marketing or face disciplinary action. The allegations were similar to those the agency made in December against 1-800-GET-THIN, another company that marketed Lap-Band weight-loss surgery.

Lap-Band VIP, based in Tarzana, has promoted its weight-loss surgery on television, the Internet and freeway billboards throughout Southern California. One billboard featured a photograph of a thin woman with the pitch:

"Tiffany lost over 100 lbs. Actual patient. Results may vary."

Results DO vary with banding!  

Those ads were misleading, the FDA said in a June 25 letter, because they failed to include adequate warnings about the surgery's risks. The agency said Lap-Band VIP "should take prompt action to correct the violations" or risk "regulatory action."

A fully reversible, NON SURGICAL device for weight loss? Obalon Therapeutics

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Obalon Therapeutics, Inc. received approval from the FDA and has begun enrolling its first clinical study in the United States to begin evaluating the safety and efficacy of a fully reversible device for weight loss.

  • Clinical trial results reported by Dr. Ariel Ortiz showed 34% excess weight loss in a three-month study in Mexico. 
  • Dr. Ortiz also announced preliminary results of approximately 45% excess weight loss in a similar European study.

Those are some amazing numbers.  I promise I am not thinking about adding this to my gastric bypassed belly, much.  I kid.

What is it?  Here's information from the patent application -

An implant configured for ingestion by a patient. After the implant has been swallowed by the patient and is disposed within the target location, e.g. the patient's stomach, an inflation subcomponent causes the implant to expand from a compact delivery state to an expanded, volume-occupying, deployed state.

In the deployed state the implant creates a sensation of satiety in the patient stomach and thereby aids in limiting food intake and obesity.

After a predetermined time a deflation subcomponent is actuated and the implant reduces in size so as to allow it to pass through the remainder of the patient's digestive track. The device may further incorporate tracking and visualization subcomponents, as well as pharmaceutical delivery subcomponents.

SAN DIEGO, Jul 18, 2012 (BUSINESS WIRE) --

Obalon Therapeutics, Inc. announced it closed a $16.5 million Series C private equity financing, began enrolling patients in a U.S. clinical trial, received CE Mark approval and had weight loss data presented at the IFSO European Congress (International Federation for the Surgery of Obesity and Metabolic Disorders).

Obesity is a worldwide epidemic. Although bariatric surgery has demonstrated strong weight loss results, the surgeries are costly, irreversible and used in less than 1% of the eligible population. Physicians, patients and payers all agree there is a compelling need for new products and technologies to address this gap.

Obalon is developing a novel, nonsurgical, fully-reversible device for weight loss. The device consists of a capsule containing a balloon that is swallowed and then remotely inflated. The balloon is intended to occupy space in the stomach to create a feeling of fullness to help people eat less. Additional balloons can be swallowed and inflated during the treatment period as indicated for weight loss. At the end of the treatment period, the balloons are removed.

Your thoughts?  Would you try this device had you not had weight loss surgery already? 


1-800-Get-Thin President Quits - Oops

Robert Silverman, the marketing director and president of all of the 1-800-Get-Thin campaigns has resigned.  

Not surprising.

Hey, maybe bloggers won't be poked to remove posts anymore?  Heh.  


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LA Times - 

The president of the 1-800-GET-THIN marketing company, which has blanketed Southern California freeways and television and radio stations with ads for Lap-Band weight-loss surgery, said he has resigned "to pursue other career opportunities."

In a news release Thursday, Robert Silverman said that his resignation was effective Tuesday. He had served as the firm's president since February 2010, the release said.

"I believed in the mission and I believe that I was assisting individuals [to] overcome their battle with obesity, which has reached world-wide epidemic status," Silverman said in the release.

The 1-800-GET-THIN campaign had come under increasing scrutiny after the deaths of five Lap-Band patients since 2009.

In December, the Food and Drug Administration sent warning letters to the marketing company and its affiliated surgery centers, saying the ads for Lap-Band weight-loss surgery were misleading because they did not adequately display warnings about risks of the surgery.

The California Department of Insurance also has confirmed it is investigating the surgery centers affiliated with 1-800-GET-THIN for possible insurance fraud. In February, Lap-Band manufacturerAllergan Inc.said it had halted sales of the weight-loss device to all firms affiliated with the marketing company.

In addition to his role as president of 1-800-GET-THIN, Silverman, a lawyer, had represented the firm and its affiliated surgery centers in several lawsuits. He said in an email to The Times that he no longer represents them.

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Qnexa has safety risks

Food and Drug Administration logoImage via Wikipedia

The weight loss drug Qnexa has some safety risks.  Um, duh?


Sure, it can can work to help you lose weight, but your heart gets cranky and you forget what you were blogging about.   The FDA says the effects can get worse over time.  Super.

Did I mention that although I couldn't feel my feet or remember my underwear -- I heart Topamax?  Because, since I quit taking it?  I have gained weight.  And, what's this about getting worse over time -- I -- still can't remember anything.

Send Qnexa.  I don't care.  


  • Qnexa drug helped patients lose weight - FDA staff
  • Qnexa tied to heart, memory problems and birth defects
  • FDA staff say long-term safety with Qnexa unknown

Feb 17 (Reuters) - Vivus Inc's obesity drug Qnexa helped people lose weight but may cause long-term health problems in overweight and obese patients, U.S. drugs reviewers said.

Food and Drug Administration staff will ask an advisory panel to consider whether the drug's benefits for obese patients will outweigh its risk of birth defects and heart problems.

The FDA staff, in documents posted online on Friday, said patients taking Qnexa during a clinical trial lost more weight, and kept it off for longer, than patients taking a placebo, or sugar pill. These patients also had lower levels of problems associated with obesity, such as issues with blood pressure and blood sugar.

However, the FDA staff said patients taking the drug had more safety problems than patients on a placebo, including memory loss, and these problems could get worse over time. They also said exposure to one of the ingredients in Qnexa has been linked to a higher rate of birth defects in other studies.

Shares of Vivus rose 2.4 percent to $11.45 in pre-market trading.

An advisory panel of outside experts will vote Feb. 22 on whether to recommend the drug, and the FDA is due to make its final decision by April 17.

Qnexa is a combination of appetite suppressant phentermine and anti-seizure drug topiramate.

A company study in December showed topiramate caused a higher rate of oral clefts in infants of women taking the drug during pregnancy, and the company said it would limit Qnexa to women who are not pregnant.

The FDA already rejected Qnexa in 2010 because of safety concerns -- including elevated heart rate in some users and the potential for birth defects if pregnant women used the drug.

Vivus resubmitted its application in October, proposing to limit the drug to only women who cannot have children. In January, the company broadened the label to just limit pregnant women from taking the drug, in response to an FDA request.


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60 Minutes - Tweaking tastes and creating cravings

This is absolutely RIVETING to me. I know, I know, you are either horrified, disgusted or angry.

How dare they fake it?!  Making your food super-palatable?!  Think of the children -- you're creating food addicts! 

I know, I know.  We're fat.  We don't need super-enhanced and reasons to EAT more or more often.

Anyone who has eaten any lowfat, low sugar, sugar free or specialty diet products has definitely supported the Taste Industry.  *picks up my can of Diet Coke with "natural flavor...* 

But, this makes me tick.  I want to flavor things.  Now.  Hand me the fatty-crusty chicken powder, I'm making savory chewable vitamins.

How much do fruits and vegetables COST?



Yes, we say it, and now it's been studied. 

I find this stuff fascinating, even if I basically fail at life when it comes to fulfilling the fruit and vegetable component of a healthy diet.  I don't eat hardly ANY fruit in any form, and vegetables, some, but not enough, and fibrous foods not cooked to death make me want to scrape my intestines out with a potato peeler!  But, don't you dare tell me how much cheese costs per edible cup!  I know, I know.  Even if I love my greens, I don't love the bowel death.  I puffy heart my WLS!


Anyway - for someone who actually EATS - you know - food?

How Much Do Fruits and Vegetables Cost?

By Hayden Stewart, Jeffrey Hyman, Jean C. Buzby, Elizabeth Frazão, and Andrea Carlson

Economic Information Bulletin No. (EIB-71) 37 pp, February 2011

What Is the Issue?

Federal dietary guidance advises Americans to consume more vegetables and fruits because
most Americans do not consume the recommended quantities or variety. Food prices, along
with taste, convenience, income, and awareness of the link between diet and health, shape food
choices. This research updates previous estimates of vegetable and fruit prices, and estimates
the cost of satisfying recommendations for adult vegetable and fruit consumption in the 2010
Dietary Guidelines for Americans.

What Are the Major Findings?

We estimated the average retail prices of 153 fresh and processed vegetables and fruits, where
processed includes frozen, canned, and dried vegetables and fruits as well as 100% fruit juice. We also estimated the average price per edible cup equivalent for each vegetable and fruit. This is the consumption unit used in the 2010 Dietary Guidelines for Americans, and measures only the edible portion of a food once it has been cooked or otherwise prepared for consumption. In 2008:

• An adult on a 2,000-calorie diet could satisfy recommendations for vegetable and fruit
consumption (amounts and variety) in the 2010 Dietary Guidelines for Americans at an average
cost of $2 to $2.50 per day, or approximately 50 cents per edible cup equivalent.

• The lowest average price for any of the 59 fresh and processed fruits included in the study
was for fresh watermelon, at 17 cents per edible cup equivalent. The highest average price
was for fresh raspberries, at $2.06 per edible cup equivalent.

• The lowest average price for any of the 94 fresh and processed vegetables included in the
study was for dry pinto beans, at 13 cents per edible cup equivalent. The highest average
price was for frozen asparagus cuts and tips, at $2.07 per edible cup equivalent.

• Processed fruits and vegetables were not consistently more or less expensive than fresh
produce. Canned carrots (34 cents per edible cup equivalent) were more expensive than
whole fresh carrots eaten raw (25 cents per edible cup equivalent). However, canned
peaches (58 cents per edible cup equivalent) were less expensive than fresh (66 cents per
edible cup equivalent).

• Retail prices per pound often varied substantially from prices per edible cup equivalent. Fresh broccoli florets and fresh ears of sweet corn both sold for around $1.80 per pound at retail stores, on average. After boiling and removing inedible parts, however, the sweet corn cost almost twice as much as the broccoli florets ($1.17 vs. 63 cents per edible cup equivalent).

Costs in the study are defined as the average prices paid by all American households for a food over a 1-year period, including purchases in different package sizes, under different brand names, and at different types of retail outlets (including, among others, supercenters such as Wal-Mart, wholesale club stores such as Costco, “traditional” grocers such as Safeway, Kroger, and Albertsons, and convenience stores).

How Was the Study Conducted?

We used 2008 Nielsen Homescan data to calculate the average price of a pound (or, for juices, a pint) of 153 fresh and processed fruits and vegetables at retail stores. In order to estimate price per edible cup equivalent for each food, retail quantities were adjusted for the removal of inedible parts and cooking that occur prior to consumption. For example, 1 pound of store-bought fresh pineapple yields 0.51 pound of edible pineapple. Data from the USDA National Nutrient Database for Standard Reference (Release 21) and USDA’s Food Yields Summarized by Different Stages of Preparation were used to estimate edible weights. The MyPyramid Equivalents Database, 2.0 was used to define edible cup equivalents.


For more information, contact: Hayden Stewart, Jeffrey Hyman, Jean C. Buzby, Elizabeth Frazão, and Andrea Carlson

Web administration: [email protected]

Updated date: February 1, 2011

FDA panel approves Lap-Band for the not-so-fat.

The FDA panel has approved the use of gastric banding on lower BMI individuals with one co-morbidity of their obesity.  This is HUGE, no pun intended, 'cause the patients aren't really that big.   (A little bigger than your friendly bypassed blogger here.)

I know I am overweight at 165 pounds, however, this still blows my mind a bit. 

It blows my mind that I (just as an example) could potentially qualify for weight loss surgery so very easily. 

I was at a qualifying weight last winter!  I am sure we'd find a co-morbid too! 

We found one the first time around.  I didn't have any known co-morbidities when I had my roux en y gastric bypass surgery in 2004. 

I am torn.  Is this a blessing or a curse?


Graphic from Florida Bariatric Center

OC Register - FDA panel approves Lap-Band for the less fat

The Lap-Band, made by Irvine-based Allergan Inc., is only FDA-approved for people with a body-mass index of 40 or higher, or 35 if they have associated problems like high blood pressure or diabetes. The panel granted Allergan's request for permission to market the device to people with a BMI of 35, or 30 with related problems.