Navigation Links
FDA Issues Warning Letters for Misleading Advertising of Lap-Band
Date:12/13/2011

SILVER SPRING, Md., Dec. 13, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced that it has taken action against eight California surgical centers and the marketing firm 1-800-GET-THIN LLC, for misleading advertising of the Lap-Band, an FDA-approved device used for weight loss in obese adults.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

The FDA issued Warning Letters to Bakersfield Surgery Institute Inc.; Beverly Hills Surgery Center; Palmdale Ambulatory Center; Valley Surgical Center; Top Surgeons LLC; Valencia Ambulatory Center LLC; Cosmopolitan Plastic & Reconstructive Surgery; San Diego Ambulatory Center LLC; and to 1-800-GET-THIN because Lap-Band is a restricted medical device that is misbranded as a result of misleading advertising by these groups.

In the letters, the FDA warns that billboards and advertising inserts used by recipients of the Warning Letters to promote the Lap-Band procedure fail to provide required risk information, including warnings, precautions, possible side effects and contraindications. The FDA also is concerned that the font size of information related to risks on the advertising inserts is too small to be read by consumers.

"The FDA takes seriously its responsibility to protect consumers from products promoted without adequate warnings," said Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health. "It's particularly troublesome when advertisements don't communicate the serious risks associated with medical devices."

If the affected companies do not change the advertising and promotion strategies to address the concerns raised by the FDA, the agency is prepared to take further action, which could include product seizure or civil money penalties.

The Lap-Band is a gastric band, an implanted medical device used in a surgical procedure for weight loss in obese adults who have a body mas
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. The First Annual Cervical Cancer/HPV Conference Tackles Controversial Vaccine Issues and Encourages Advocacy
2. European Unions CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
3. European CHMP Issues Positive Opinion for ATRIPLA(R) (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
4. Bayer Issues Additional Guidance to Physicians on Trasylol(R)
5. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on CEL-SCI Corporation
6. QIAGEN and Center for Molecular Medicine Create Research Collaboration for Molecular Diagnostic Markers for Breast Cancer, Other Womens Health Issues
7. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Bioniche Life Sciences Inc.
8. Lupus Under the Spotlight: U.S. Congress Shows Support for Womens Health Issues
9. European Unions CHMP Issues Positive Opinion on Sugammadex
10. Newly Published Study Shows OPKOs siRNA Bevasiranib Is Taken Up by Target Tissues in the Eye
11. Ending Cervical Cancer Featured at Summit; QIAGEN CEO Issues a Call to Global Women Leaders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/29/2014)... Md. , Aug. 29, 2014  United Therapeutics ... the U.S. District Court for the District of ... favor in the company,s case against Sandoz, Inc. regarding ... Peter Sheridan ruled that U.S. Patent No. ... and enjoined Sandoz from marketing its generic product until ...
(Date:8/29/2014)... , Aug. 29, 2014 Diseases largely ... a generation ago are returning. Measles was declared eliminated ... in 2014 as of August 15—the highest incidence in ... public health department declared whooping cough a problem of ... are getting sick and dying from these preventable diseases—in ...
(Date:8/29/2014)... Research and Markets has announced the addition ... report to their offering. Multiple ... in demyelination, axonal transection, and neurodegeneration. The myelin sheath ... immune system, which targets neurons within the central nervous ... which the damage of the myelin sheath causes disruption ...
Breaking Medicine Technology:District Court Decision Received In Remodulin Patent Case 2Vaccines at the Crossroads: Outbreaks On the Rise Across America 2Vaccines at the Crossroads: Outbreaks On the Rise Across America 3Global Multiple Sclerosis Drugs Market 2014-2018: Key Vendors are Bayer, Biogen Idec, Merck Serono, Novartis and Teva Pharmaceutical 2Global Multiple Sclerosis Drugs Market 2014-2018: Key Vendors are Bayer, Biogen Idec, Merck Serono, Novartis and Teva Pharmaceutical 3
(Date:8/29/2014)... famous online supplier of trendy clothes, has unveiled its new ... all these mini outfits are offered at discounted rates, up ... September 14. , The company’s senior spokesman states, “To ... designs, we have listed some of the best-selling items in ... to get high quality, fashionable clothes. Many of our sexy ...
(Date:8/29/2014)... (PRWEB) August 29, 2014 DailyGossip.org publishes ... is an absolutely unique method of curing multiple sclerosis ... program was created by Dr. Gary M. Levin, who ... specialist started to become interested in alternative remedies for ... classical remedies cannot be effective in all cases for ...
(Date:8/29/2014)... Champion boxers Laila Ali and Victor Ortiz are ... annual MDA Show of Strength Telethon this Labor Day ... stations across the country. , Ali, former super ... with Laila Ali," will introduce a performance from American ... Association's nationally broadcast show. , Ortiz will introduce R&B ...
(Date:8/29/2014)... According to a CNN article, entitled Medical Marijuana ... study found that those states who legalized medical marijuana ... in the number of painkiller overdoses seen. By reviewing ... comparing various states with and without legalized medical marijuana, ... a 25% decrease in painkiller prescription overdoses in legalized ...
(Date:8/29/2014)... According to new research presented in a Science Daily article ... Drug Misuse Among Young Adults (8/16), peer pressure should ... it comes to prescription drug abuse. Researchers from Purdue University ... problem which influences misuse of prescription drugs is access to ... to have fun with other using friends. Evidently there is ...
Breaking Medicine News(10 mins):Health News:Cheap Sexy Mini Dresses Added To The Product Line Of Skmen.com 2Health News:New Natural Multiple Sclerosis Treatment Review Reveals Gary M. Levin’s Unique Cure 2Health News:Champion Boxers Fight Back Against Muscle Disease 2Health News:Champion Boxers Fight Back Against Muscle Disease 3Health News:Overdoses on Painkillers Decreased in States With Medical Marijuana 2Health News:Overdoses on Painkillers Decreased in States With Medical Marijuana 3Health News:Peer Pressure Irrelevant in Prescription Drug Abuse for Young Adults 2Health News:Peer Pressure Irrelevant in Prescription Drug Abuse for Young Adults 3
... MA Brandeis psychologist Margie E. Lachman has been awarded ... on Aging to learn more about factors that can ... research will identify modifiable beliefs and behaviors that are ... life. , Many middle-aged and older adults believe that ...
... Lives of Eight Families Living with Autism, NEW ... television premiere of Lauren Thierry,s documentary Autism Every Day,on ... Awareness Day by,the United Nations. The film, which debuted ... day in the lives of eight families,struggling to raise ...
... editors of the Proceedings of the National Academy of ... the 2007 Cozzarelli Prize, an award for papers that ... , The award was established in 2005 as the ... Cozzarelli Prize in 2007 to honor late PNAS Editor-in-Chief ...
... 13 Leading speech,pathologist and autism consultant Valerie ... needs technologies at the "Autism Through,the Lifespan" conference ... "The future is now for an entire generation ... of their lives and becoming young,adults with autism. ...
... Inc. (Pink Sheets: HCFE) has established HEALTHY COFFEE ... distribution of Healthy Coffee,drinks and wellness products through ... About Healthy Coffee USA, Inc., HEALTHY COFFEE ... Coffee by providing an opportunity for the average ...
... With Erectile Dysfunction Are Smokers, NEW YORK, Feb. ... attractiveness, it does the exact opposite when he reaches,the ... recent studies, 60-percent of all men who smoke suffer,from ... more passion. In an effort to dramatically improve upon ...
Cached Medicine News:Health News:Brandeis researcher awarded grant to investigate memory and aging 2Health News:Sundance Channel to Premiere Documentary Autism Every Day on World Autism Awareness Day, April 2nd at 8:00pm et/pt 2Health News:PNAS announces 2007 Cozzarelli Prize recipients 2Health News:A Sneak Peek Into the Special Needs Home of Tomorrow - Renowned Autism Consultant Valerie Herskowitz to Present Latest Findings at 'Autism Through the Lifespan' Conference February 14-17 in Orlando 2Health News:Healthy Coffee International, Inc. Establishes Healthy Coffee USA, Inc. as Its Marketing Arm 2Health News:The Best Way to Stoke Your Valentine's Fire: Don't Light Up 2
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: