"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."
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.
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.
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?
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.
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.