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:5/4/2015)... 2015 Dyadic International, Inc. ("Dyadic") (OTCQX: ... proprietary technologies are used to develop, manufacture and ... bio-based chemical, biopharmaceutical and industrial enzyme industries, announced ... for quarter ending March 31, 2015 after market ... host a conference call that day at 5:00 ...
(Date:5/4/2015)... , May 4, 2015 Eli ... two new reports that provide a comprehensive overview ... highlight how Lilly is evolving its approach to ... capabilities in partnership with others to have greater, ... Corporate Responsibility Update offers a thorough look ...
(Date:5/4/2015)...  NeuroSigma ® , Inc. (NeuroSigma), a California ... animal study of its Thin Film Nitinol (TFN) flow diverter ... researchers at the 53 rd Annual Meeting of the ... . A copy of the study abstract can be accessed ... at Mayo Clinic was primarily funded through a Small Business ...
Breaking Medicine Technology:Dyadic International To Announce First Quarter 2015 Financial Results and Host Conference Call On Thursday, May 14, 2015 2Dyadic International To Announce First Quarter 2015 Financial Results and Host Conference Call On Thursday, May 14, 2015 3Lilly Releases Corporate Responsibility, Global Health Reports 2Lilly Releases Corporate Responsibility, Global Health Reports 3Lilly Releases Corporate Responsibility, Global Health Reports 4NeuroSigma's Thin Film Nitinol Flow Diverting Stent Results Presented at the American Society of Neuroradiology Meeting 2NeuroSigma's Thin Film Nitinol Flow Diverting Stent Results Presented at the American Society of Neuroradiology Meeting 3NeuroSigma's Thin Film Nitinol Flow Diverting Stent Results Presented at the American Society of Neuroradiology Meeting 4
... BIOD ) announced today the retirement of Dr. ... is a co-founder of Biodel and will remain a member ... chairman, president and chief executive officer from its founding in ... was named the company,s president and chief executive officer and ...
... 2010 Reportlinker.com announces that a new ... catalogue: Asia-Pacific Markets for ... 2011 http://www.reportlinker.com/p0339835/Asia-Pacific-Markets-for-Cardiac-Rhythm-Management-Electrophysiology--Ablation-Devices-2011.html ... Pacific markets for cardiac rhythm management (CRM), ...
Cached Medicine Technology:Biodel Announces Retirement of Dr. Solomon Steiner as Chief Scientific Officer 2Biodel Announces Retirement of Dr. Solomon Steiner as Chief Scientific Officer 3Biodel Announces Retirement of Dr. Solomon Steiner as Chief Scientific Officer 4Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 2Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 3Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 4Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 5Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 6Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 7Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 8Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 9Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 10Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 11Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 12Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 13Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 14Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 15Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 16Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 17Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 18Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 19Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 20Reportlinker Adds Asia-Pacific Markets for Cardiac Rhythm Management, Electrophysiology & Ablation Devices 2011 21
(Date:5/4/2015)... 2015 TROY Healthcare Solutions is proud ... Regional User Group (RUG) Conference in Baltimore, MD from ... Regional User Group provides an opportunity for clients to ... exhibitor gallery. , In addition to sponsoring the event, ... North Atlantic RUG Conference. Attendees can stop by the ...
(Date:5/4/2015)... (PRWEB) May 04, 2015 The American ... critical state policy reports which identify gaps in coverage ... “After ATA issued the State Telemedicine Gaps Reports last ... how their laws and regulations impact healthcare delivery in ... a result of state actions across the nation, ATA ...
(Date:5/4/2015)... Baptist Medical Center Jacksonville has received ... The Guidelines®-Stroke Gold Plus Quality Achievement Award along ... recognizes the hospital’s commitment and success in ensuring ... according to nationally recognized, research-based guidelines based on ... Gold Plus Quality Achievement Award, hospitals must achieve ...
(Date:5/4/2015)... METTLER TOLEDO has announced an ... Integrity in a GXP Regulated Laboratory ", featuring ... webinar will be presented on May 27, 2015 ... is a critical component of pharmaceutical product quality ... in recent years an increasing number of inspections ...
(Date:5/4/2015)... Now in its seventh year, the IPC ... made outstanding contributions to the company, to their facilities ... and post-acute care settings. The five award categories are: ... Year, Advanced Practice Clinician of the Year, Newcomer Provider ... Recipients are selected by IPC’s senior management team. , ...
Breaking Medicine News(10 mins):Health News:TROY Healthcare to Exhibit at the Cerner North Atlantic Regional User Group Conference 2Health News:TROY Healthcare to Exhibit at the Cerner North Atlantic Regional User Group Conference 3Health News:American Telemedicine Association Delivers New State Report Cards on Telemedicine 2Health News:American Telemedicine Association Delivers New State Report Cards on Telemedicine 3Health News:Baptist Medical Center Jacksonville Receives Top Honor for Stroke Care 2Health News:Baptist Medical Center Jacksonville Receives Top Honor for Stroke Care 3Health News:Baptist Medical Center Jacksonville Receives Top Honor for Stroke Care 4Health News:METTLER TOLEDO Announces Live Webinar on the Importance of Data Integrity in a GXP Regulated Laboratory 2Health News:IPC Healthcare Announces Clinicians of the Year 2Health News:IPC Healthcare Announces Clinicians of the Year 3
... Platform, Michigan Orthopedic ServicesDETROIT, Feb. 2 Huron Capital ... Services ("MOS") has acquired O&P Professional Care as part ... MI. The business will be managed under the ... disclosed. MOS operates a network of 11 patient ...
... a large, ongoing study to improve detection and prevention ... a specific heart rhythm abnormality idiopathic QT interval ... artery disease. , "More than 80 percent of ... who have significant coronary artery disease, but we currently ...
... Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL ) today ... with simultaneous webcast on Tuesday, February 3, 2009 at ... Rigel,s senior management team will provide an update on ... Webcast Information To access the live call, please dial ...
... 2 In celebration of American Heart Month, ... Forum showcasing a live- telecast of the ... disease on Tuesday, February 10, 2009. During ... Medical Director of Arizona Heart Institute and Arizona ...
... current rate of production for new mammography professionals, there will ... woman age 40 years and older over the next 15-20 ... Health and Workforce Studies at the Albany School of Public ... the year 2010 there will be approximately 20.6 radiologists per ...
... SANTA MONICA, Calif., Feb. 2 A national consumer ... lobbying positions on the electronic medical record provisions of ... an independent journalist that Google,s presence on the bill ... public policy team for an immediate answer. The letter ...
Cached Medicine News:Health News:Huron Capital Continues Acquisition Activity 2Health News:Rhythm abnormality of unknown origin strongly predicts sudden death risk in heart disease patients 2Health News:Rigel to Host Conference Call on February 3, 2009 2Health News:Arizona Heart Institute Announces FREE Public Forum Featuring Live Viewing of Surgical Procedures Via High-Definition (HD) Satellite 2Health News:Workforce shortages in mammography could threaten early detection rates for breast cancer 2Health News:Consumer Watchdog to Google: Publicly Disclose Your Lobbying Positions on Electronic Medical Record Provisions in Stimulus Bill 2
This is an Immunological assay intended for the quantitative in vitro determination of haemoglobin A1c (HbA1c) in whole blood....
For the quantitative in vitro determination of Ammonia in plasma...
For the quantitative in vitro determination of Sodium in serum and plasma....
Enzymatic assay for the quantitative in vitro determination of glycated protein (fructosamine) in human serum or plasma....
Medicine Products: