header image

[Sign Up Now] to Receive Our FREE Daily SCVTV-SCVNews Digest by E-Mail

Inside
Weather
Santa Clarita CA
Sunny
Sunny
82°F
 
Calendar
Today in
S.C.V. History
October 3
1918 - Box-office superstar William S. Hart promotes 4th series of Liberty Loan (World War I) bonds, which went on sale Sept. 28 [story]
William S. Hart


Ads lack information on risks of gastric banding, government says
| Tuesday, Dec 13, 2011

[FDA] – The U.S. Food and Drug Administration announced Tuesday 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.

The FDA issued Warning Letters to Bakersfield Surgery Institute Inc.; Beverly Hills Surgery Center; Palmdale Ambulatory Center; Valley Surgical Center (West Hills); Top Surgeons LLC (Beverly Hills); Valencia Ambulatory Center LLC; Cosmopolitan Plastic & Reconstructive Surgery (Valencia); 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 mass index (BMI) of 30-40, with one or more obesity-related medical conditions (such as type II diabetes and hypertension), or in patients with a BMI of 40 or over with or without an obesity-related medical condition.  Gastric banding is used when non-surgical weight loss methods (such as supervised diet, exercise and behavior modification) have not been successful. Patients considering gastric banding must be willing to make major changes in their eating habits and lifestyle.

“The decision to undergo a gastric banding procedure should be done in close consultation between a patient and his or her health care provider,” said Kimber Richter, M.D., deputy director for medical affairs in the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “It is important for the patient to fully understand both the risks and the benefits of the procedure and for the health care provider to be sure the procedure is appropriate for the patient.”

The Lap-Band has not been approved for use in children younger than 18. Only those who are able and willing to follow dietary and other health and lifestyle recommendations should consider the procedure. It’s important that patients and their physicians are aware of and understand the limitations of gastric banding.

Health care providers who choose to promote the gastric banding procedure are required to educate patients about the risks involved, which must also be included in any advertising and promotional materials. Patients considering the surgery should read the patient information provided by their doctor and should ask any questions they have about gastric banding before having surgery.

If you suspect a problem with a gastric banding device, the FDA encourages you to file a voluntary report through MedWatch1, the FDA Safety Information and Adverse Event Reporting program. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

 

ABOUT THE FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Comment On This Story
COMMENT POLICY: We welcome comments from individuals and businesses. All comments are moderated. Comments are subject to rejection if they are vulgar, combative, or in poor taste.
REAL NAMES ONLY: All posters must use their real individual or business name. This applies equally to Twitter account holders who use a nickname.

0 Comments

You can be the first one to leave a comment.

Leave a Comment


Latest Additions to SCVNews.com
For the first time since 2020, the Los Angeles County Child Support Services Department is offering its Employer Workshop on child support requirements live in La Mirada on Thursday, Oct. 13.
Oct. 13: Employer Workshop on Child Support Requirements
Calling all Transylvanians! Join the city of Santa Clarita for a screening of the cult classic “The Rocky Horror Picture Show” at The Centre on Oct. 28 or Oct. 29.
Oct. 28-29: Rocky Horror Picture Show Screening
Join the city of Santa Clarita and explore your creative side this ARTober in celebration of National Arts and Humanities Month.
Santa Clarita Unveils ARTober Lineup
The city of Santa Clarita is honored to once again be named as a 2022 finalist for the prestigious award of “Most Business-Friendly City” by the Los Angeles County Economic Development Corporation.
Santa Clarita Named Finalist for “Most Business-Friendly City”
Happy October. Our September events were so much fun. We had a really great Chat & Chill with guest speaker Syian Wignal of Real Way Foundation.
Message from JCI Santa Clarita Chapter President
The city of Santa Clarita Parks, Recreation and Community Services Commission will hold its regular meeting Thursday, Oct. 6, at 6 p.m.
Oct. 6: Parks, Recreation Commission Regular Meeting
The Santa Clarita Valley Sheriff’s Station, with the help of Los Angeles County Sheriff's Department Tactics and Survival unit, LASD Special Enforcement Bureau, and the Los Angeles County Fire Department, will be taking part in active shooter training Monday at Valencia High School.
SCV Sheriff’s Station Announces Active Shooter Drill at Valencia High School
One of the most anticipated events of the year is coming to the Canyon Country Community Center on Oct. 27.
Santa Clarita Mayor’s Monthly Message – October 2022
The Los Angeles County Department of Public Health confirmed Monday no additional deaths and 48 new cases in the Santa Clarita Valley over the weekend, with a total of 29 deaths and 2,615 new cases countywide.
Monday COVID Roundup: 48 New SCV Cases; No Additional Deaths
The California Nurses Association, a union with more than 100,000 members in the state, applauds California Govenor Gavin Newsom’s decision to sign S.B. 1334 into law, guaranteeing enforceable breaks for public-sector and University of California workers who provide or support direct patient care in a hospital, clinic, or public health setting.
California Nurses Applaud Law Guaranteeing Breaks for Hospital Workers
A federal grant is helping the California Highway Patrol increase pedestrian and bicyclist safety throughout the state.
New CHP Grant Highlights Pedestrian, Bicycle Safety
On Friday, Oct. 1, the California Department of Public Health provided a weekly update on the state’s monkeypox outbreak and response.
State Public Health Officials Provide Monkeypox Update
1918 - Box-office superstar William S. Hart promotes 4th series of Liberty Loan (World War I) bonds, which went on sale Sept. 28 [story]
William S. Hart
1945 - Cattle-rustling "Phantom of Vasquez Rocks" captured [story]
Phantom suspect
1842 - Proof of discovery: New York Observer (newspaper) reports on gold in Placerita Canyon. [story]
New York Observer
Sixteen William S. Hart Union High School District 2022/23 Teachers of the Year were recognized by the Governing Board on Wednesday, Sept. 28.
Hart District Teachers of the Year Honored by Board
The Los Angeles County Department of Public Health confirmed six new deaths throughout L.A. County, 1,682 new cases countywide and 100 new cases in the Santa Clarita Valley.
Friday COVID Roundup: Seven Day Average of County Case Counts Declines 8 Percent
The HOV, High Occupancy Vehicle, or carpool, lanes are open on I-5 in both directions between Magnolia Boulevard and Buena Vista Street.
I-5 Corridor Improvement Work Continues, SR-134  to Buena Vista Street
Two recent graduates of CalArts’ MFA Experimental Animation Program, Moon (Yuezhu) Wang and Dairys Escoto De León, have been selected for the 2022-23 Association for Independent Colleges of Art and Design Post-Graduate Teaching Fellowships.
CalArts Alums Selected for AICAD Teaching Fellowships
Join Route 66 Classic Grill for the longest monthly Classic Car Show in Southern California history. The last show of 2022 will be held Oct. 8 from 5 p.m. to 9:30 p.m.
Oct. 8: Route 66 Classic Grill Classic Car Show
Los Angeles County’s new Veteran Suicide Review Team met for the first time Thursday, Sept. 29, kick-starting an innovative and collaborative approach to reducing veteran suicide in the county.
L.A. County’s New Veteran Suicide Review Team Begins Work
Agua Dulce Winery will host StompFest on Saturday, Oct. 1 at noon.
Oct. 1: StompFest at Agua Dulce Winery
Do you want to create a post on Facebook and Instagram at the same time? Learn to schedule posts, respond to comments and inbox messages from one place by attending this free Small Business Development Center webinar, "Manage Your Social Media Platform, Meta Business Suite."
Oct. 5: SBDC Free Webinar Helps Businesses Manage Social Media Platforms
On Saturday, November 12, 2022, the Santa Clarita Veteran Services Collaborative and Curtiss-Wright Defense Solutions will host a Veteran Career Fair on Saturday, Nov. 12 at the Curtiss-Wright facility.
Nov. 12: Veteran Career Fair at Curtiss-Wright in Valencia
SCVNews.com
%d bloggers like this: