Navigation Links
Consumers Union Urges FDA To Require Safety Testing of Metal on Metal Hips and Other High Risk Implants
Date:4/18/2013

ven though they were classified as "high risk."

We also strongly support the proposal's requirement for makers of hip implants in this category that are already on the market to provide critical safety information to the agency within 90 days. However, it is troublesome that MoM hips can continue to be commercially distributed up to 90 days after the FDA order.

This order will finally require manufacturers to demonstrate clinical testing for safety and effectiveness before approval of new metal on metal hips. But at this time we are skeptical that any metal on metal hip implant could be safe for patients. Because of that, we urge the FDA to push all manufacturers of metal-on-metal hips to remove their products from the market, because of the high failure rates and high numbers of adverse events, especially experienced by women.

While the FDA has issued an alert about possible adverse events to the public, this does not guarantee that all affected patients have been given advice on monitoring their metal hips for problems. As was done in the UK, all patients with these implants should be notified about their risks and advised to get yearly tests for cobalt poisoning. Unless the FDA confirms that each manufacturer has done due diligence to notify every patient with these MoM hips, the problem has not been properly addressed.

The New York Times recently reported that a MoM hip sold by Johnson and Johnson had a 40% failure rate but the company continued to sell the remainder of their inventory, despite the knowledge of the failure rate. This kind of irresponsible behavior must stop. Requiring a more thorough review up front, as the current order proposes, will help to keep flawed devices from the market.

In addition, we strongly encourage the FDA to review and re-classify to PMA status all Class III implantable medical devices. Other high risk implanted medical devices like surgical mesh should also be put into the PMA approval tr
'/>"/>

SOURCE Consumers Union
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Healthrageous Unveils Accountable Health The Missing Piece To Engage Consumers In Their Health And Achieve Accountable Care Goals
2. PCMA: New Report Shows Anti-PBM Laws Could Raise Health Care Costs for Oklahoma Businesses, Consumers, Government Programs
3. FastMed Urgent Care and MedVantx Offer Consumers First Ever Access to Free Samples of Medications through an Automated Medication Cabinet Across North Carolinas Largest Network of Urgent Care Centers
4. iPad Altering Interaction between Pharma Sales Forces, Physicians, & Consumers
5. MedVantx Achieves Significant Milestone of Providing Over $600 Million of Specialty Pharmacy Prescription Medications to Consumers
6. New Study Finds Use of Generic Prescription Drugs Saved Consumers and the U.S. Health Care System $1 Trillion over Past Decade
7. Consumers Choosing Organic Alternatives to Traditional Pharmaceuticals
8. NABP Applies for New .PHARMACY Generic Top-Level Domain to Provide a Secure Destination for Consumers
9. Consumers Are Advised to Be Aware of Hidden Costs in Some Discount Dental Plans
10. Baxter And Halozyme Announce Positive Opinion For HyQvia For Treatment Of Primary And Secondary Immunodeficiencies In The European Union
11. Takeda presenta la richiesta di autorizzazione allimmissione in commercio nellUnione Europea per Vedolizumab nella colite ulcerosa moderata-grave e nella malattia di Crohn
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/13/2014)... 13, 2014 Auf ... Tokio veranstalteten F&E-Tagung meldete Astellas ... Neuausrichtung seines Forschungsrahmenprogramms. Die Tagung bot Astellas ... fortgeschrittenen klinischen Programme und die Konzernstrategie des ... bestand darin, aktuelle Meldungen zu den Astellas-Initiativen ...
(Date:7/11/2014)... N.C. , July 11, 2014 ... approaches are evolving across industry sectors to better ... examining better ways to engage with and understand ... inform themselves and make critical purchasing decisions. ... firm, Best Practices, LLC, one area where organizations ...
(Date:7/11/2014)... DUBLIN , July 11, 2014 ... "Global Hypodermic Needles Market 2014-2018" report to ... A hypodermic needle is a hollow needle ... the body or or to extract fluids from it. ... liquids or to inject substances that cannot be ingested. ...
Breaking Medicine Technology:Astellas erörtert Pipeline-Fortschritte auf F&E-Tagung 2Astellas erörtert Pipeline-Fortschritte auf F&E-Tagung 3Astellas erörtert Pipeline-Fortschritte auf F&E-Tagung 4New Technologies Transforming Consumer Marketing Research Playbook 2Global Hypodermic Needles Market 2014-2018: Key Vendors are Becton, Dickinson and Co, Covidien, Retractable Technologies and Terumo Corp. 2Global Hypodermic Needles Market 2014-2018: Key Vendors are Becton, Dickinson and Co, Covidien, Retractable Technologies and Terumo Corp. 3
(Date:7/14/2014)... July 14, 2014 — ... cloud management, governance, and compliance software solutions for ... will be available to customers of Rackspace, ... , The hosting and value-added reseller (VAR) agreements ... solutions to new or existing customers: , Backup: ...
(Date:7/14/2014)... July 14, 2014 “You've probably heard ... exactly does that mean?” This question was posed in ... on Western Washington Medical Group’s blog regarding how people ... health in mind . , According to the article, ... placing themselves at a high risk of dehydration and ...
(Date:7/14/2014)... Sometimes, thinking “inside the box” can be revolutionary. ... product release, Joyboxx™ - The world’s only hygienic and ... Inventor and CEO, Deborah Semer began designing a safe ... for their ‘toys’ after she realized no such product ... Semer met 30-year industry veteran Phyllis Heppenstall, the legendary ...
(Date:7/14/2014)... new analysis has found that rates of testicular cancer ... Hispanic American men, but not among their non-Hispanic counterparts. ... journal of the American Cancer Society, the findings indicate ... of testicular cancer in Hispanic adolescents and young adults, ... cause of this trend. , Testicular cancer is one ...
(Date:7/14/2014)... According to the Blood Pressure Solution book review recently ... a series of new information on high blood pressure ... can help readers understand more about blood pressure. The book ... methods to control hypertension naturally. , Blood ... penned by Ken Burge, a medical researcher and health consultant. ...
Breaking Medicine News(10 mins):Health News:AvePoint Works with Rackspace to Extend Vital Management Features to Hybrid SharePoint Deployments 2Health News:AvePoint Works with Rackspace to Extend Vital Management Features to Hybrid SharePoint Deployments 3Health News:Drink With Your Mental Health in Mind, Advises an Article by Mental Health America Featured by Western Washington Medical Group 2Health News:Passionate Playground launches Joyboxx 2Health News:Passionate Playground launches Joyboxx 3Health News:Testicular cancer rates are on the rise in young Hispanic Americans 2Health News:Blood Pressure Solution Book Review Exposes Ken Burge's Hypertension Treatment Guide – Vkool.com 2Health News:Blood Pressure Solution Book Review Exposes Ken Burge's Hypertension Treatment Guide – Vkool.com 3
... and productivity , , TUESDAY, Sept. 25 (HealthDay News) -- ... program that used a care manager to guide them ... well as greater productivity. , The authors of the ... of the Journal of the American Medical Association ...
... of the Combat Soldiers Recovery Fund, announced that there ... Wednesday evening,September 26, 2007. According to Ms. Miller, "100% ... soldiers or their immediate family, with no,reductions for overhead ... "the Fund has distributed $70,000 so far,and is now ...
... of Boise,s Leadership in the ... Premium and Specialty Papers Market, BENSENVILLE, Ill., ... today announced that Boise(R) BEWARE(TM), an,anti-copy/anti-scan paper is in compliance ... The legislation,will go into affect on October 1, 2007. ...
... Life Sciences, LLC, an,Indiana based company, has introduced ... about the growing health risks associated,with diabetes. This ... and,antioxidant-rich dietary supplement that has been scientifically proven ... two conditions,that most often lead to Type II ...
... Experts in health care and,technology investment discussed objectives, ... growth in Ohio today at the Ohio,Capital Fund,s ... will help,shape Ohio,s future as it rebounds from ... the State of Ohio is changing," said Paul,Cohn ...
... open its doors to area ... youths on September 28, PORTLAND, Ore., Sept. 25 ... to play, learn and grow with,the grand opening of the Regence Boys & ... grant from Regence,the largest in the company,s history. The facility is Portland,s first,completely ...
Cached Medicine News:Health News:Treatment Programs Benefit Depressed Workers 2Health News:Treatment Programs Benefit Depressed Workers 3Health News:Boise(R) BEWARE(TM) Meets New Federal Guidelines Set Forth by Medicaid 2Health News:New Nutraceutical That Stabilizes Blood Sugar Naturally is Introduced 2Health News:New Nutraceutical That Stabilizes Blood Sugar Naturally is Introduced 3Health News:Experts Agree. Ohio's Technology Investment Future Looks Bright 2Health News:Experts Agree. Ohio's Technology Investment Future Looks Bright 3Health News:Grand Opening of Regence Boys & Girls Club Marks a Milestone in Historic New Columbia Community Revitalization 2Health News:Grand Opening of Regence Boys & Girls Club Marks a Milestone in Historic New Columbia Community Revitalization 3
... seamless eliminating the possibility of leakage around glued ... temperature resistant gel trays meaning you do no ... added user friendliness, the Primo tanks come with ... The Primo Gel Systems are designed to be ...
... up and safe to use, the Gel XL ... and running agarose gels. The unit is compact, ... power supply eliminates a tangled mess of leads ... Designed for safety and convenience, the power supply ...
... HE 33 Mini Submarine Unit for nucleic acid analysis ... designed for very fast separations of DNA restriction fragments ... a heat-sink. Fill the base with coolant and seal. ... keeping the unit in a freezer or by immersing ...
... 2000 apparatus and ready-to-use gels are the ... of nucleic acids by submerged gel electrophoresis. ... system, offering full compatibility and optimal performance, ... SEA 2000 and a unique staining tray, ...
Medicine Products: