Navigation Links
Advertisements for Medical Devices, Implants Should Carry Warnings of Dangerous Side Effects, Infections
Date:12/17/2007

Consumers Union Petitions FDA to Require Clearer Warnings on DTC Device Ads

WASHINGTON, Dec. 17 /PRNewswire-USNewswire/ -- Consumers Union has filed a petition with the FDA requesting it require all advertisements for implantable devices -- such as knee, hip and heart valve replacements, cosmetic implants and heart stents -- carry a warning about the possibility of dangerous infections or failures of the devices once they are in the body.

Implantable device makers recently have launched a wave of direct-to-consumer advertisements for their products, and Consumers Union said a review of these ads show that most lack basic information about the possibility of severe or fatal side effects.

"There is no question that many of these devices can restore high quality-of-life in patients, but we are concerned that serious and possibly deadly side effects like infections are consistently understated in these device ads," said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports.

"We're asking the FDA to require clear warnings about the dangers of infection during and following such surgery, and information about how long the devices are likely to last once they are in the body," Vaughan said.

To read the full petition to the FDA, go to http://www.ConsumersUnion.org.

In light of the rising rate of MRSA and other hospital-acquired infections for surgical patients, CU is requesting device advertisements disclose the potential risk of infection and urge patients to ask their doctor and hospital about infection rates at the facility where the surgery will be performed. Nearly 100,000 people die each year from hospital-acquired infections, and CU is supporting national infection-reporting and prevention legislation (HR 1174, HR 4214 and S 2278).

The Centers for Disease Control infection surveillance report shows hip and knee prosthesis surgery to be a serious source of infection, in some cases a high-risk source, and in some of the reporting hospitals, the infection rate may run as high as 5 percent or more.

Another recent study of 2003 nationwide data for primary total, partial, and revision hip replacements found the rates of readmission for any cause within 90 days of surgery ran between 9 percent for total replacement to 21 percent for partial.

"We do not want to discourage those in pain and facing loss of mobility from seeking out medical advice on implants. But we do believe that unintended side effects, which can include death, can be minimized if the public is better educated to avoid facilities which are not practicing the highest level of anti-infection practices," Vaughan said.

"Placing information about the danger of infection from surgery in device advertisements will speed the day that America's surgical centers and hospitals address this life-and-death problem," he added.


'/>"/>
SOURCE Consumers Union
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Meth Project Advertisements Selected for National Prevention Campaign
2. MSU engineering team designs innovative medical device
3. ATS Medical to Present at the 2007 Thomas Weisel Partners Healthcare Conference
4. Providence St. Joseph Medical Center, Caregivers Reach Agreement on a Union Contract
5. Owner and Operator of Florida Durable Medical Equipment Company Convicted of Medicare Fraud
6. Father and Daughter From Tanzania Receive Their First Medical Examination in Newport Beach
7. Doctors and medical ethicist discuss whether doctors should participate in capital punishment
8. Preparation for Natural Disasters Critical for People With Diabetes, Chronic Medical Conditions
9. Doctors and Medical Ethicist Discuss Whether Doctors Should Participate in Capital Punishment
10. Symmetry Medical Completes Acquisition Of Specialty Surgical Instruments
11. Milestone Scientific Announces Successful Completion of its Collaboration Agreement With Carticept Medical
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2017)... , ... May 26, 2017 , ... “When the Stars ... Home” is the creation of published author Laura Weigel Douglas, an avid reader who ... in a house that sometimes feels like Green Hills Adventure Camp. She couldn’t be ...
(Date:5/26/2017)... ... 2017 , ... Centennial-based BluSky Restoration Contractors announced that The ... Clays for Kids fundraiser, to be held Friday, Sept. 22, at Kiowa Creek ... of BluSky’s partnership with The Adoption Exchange, BluSky will also share sponsorship with ...
(Date:5/26/2017)... , ... May 26, 2017 , ... “Cactus Jack: Against ... on so many others. “Cactus Jack: Against All Odds” is the creation of ... Walter D. Hubbard is married to Jack Carlisle’s third child Jane. Walter. Walter ...
(Date:5/24/2017)... ... May 24, 2017 , ... Last month, representatives from ... employees, and town officials to celebrate the grand opening of the 87,000 square ... as part of its ongoing relationship with RWJBarnabas Health, New Jersey’s largest health ...
(Date:5/24/2017)... ... May 24, 2017 , ... Dr. Alan I. Benvenisty, MD is dual board ... He is known for his distinguished expertise and experience in the diagnosis and treatment ... training in treating renovascular disease and aortic aneurysm . He is known for ...
Breaking Medicine News(10 mins):
(Date:5/22/2017)... 2017  As the specialty pharmacy industry and ... make the revolutionary shift from volume-based to value-based ... positive patient outcomes and shaping the future of ... away from clinical trials and toward data that ... drug therapy utilization in precise patient populations. Therigy ...
(Date:5/15/2017)... , May 15, 2017 Enterin Inc., a ... and developing novel compounds to treat Parkinson,s disease (PD), ... study is a Phase 1/2a randomized, controlled, multicenter study involving ... It will enroll 50 patients over a 9-to-12-month period. The ... in 10 patients with PD. Participating sites include ...
(Date:5/10/2017)... May 10, 2017 Global Health Intelligence ... Latin America , published its 2017 ranking of the ... based on extensive data analysis from GHI,s hospitals database ... database for the region. The GHI database covers 86% of ... more than 130 data points for each institution in key ...
Breaking Medicine Technology: