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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Monthly Archives: December 2013

FDA Recall Safety Alert: Siemens MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels

Posted in Recalls

On August 21st, the US Food and Drug Administration issued a Class-1 recall for Siemens MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels, affecting “78,020 panels distributed in the US between 07/11/2011 and 08/02/2013.” (FDA) These panels come as part of kits used by medical professionals to test a patient’s saliva or tissue for… Continue Reading

NIH: “Gene-silencing study finds new targets for Parkinson’s disease”

Posted in Drug Studies, Public Health

Recently, National Institutes of Health reports that it has possibly discovered certain genes that can be targeted for the treatment of Parkinson’s disease.  Parkinson’s is a disorder of the central nervous system (which includes the brain and brain stem).  Early signs of the disease are shaking and impaired movement, while later signs may include problems… Continue Reading

2013 – “California Firm Recalls Bolognese Sauce Products Due To Undeclared Allergen And Misbranding”

Posted in Public Health, Recalls

An article titled “California Firm Recalls Bolognese Sauce Products Due To Undeclared Allergen And Misbranding”, written by the United States Department of Agriculture’s Food Safety and Inspection Service, reports that the agency has forced the recall of 5,616 pounds of Armanino brand Bolognese sauce products.  The company did not properly label all of their products… Continue Reading

2013 – “FDA lifts constraints on Glaxo diabetes drug Avandia”

Posted in Drug Studies, FDA Regulation

A recent article by Bill Berkrot and Ransdell Pierson (published in Reuters) reports on restrictions being lifted from the use of the drug Avandia.  Avandia is a diabetes drug made by the company GlaxoSmithKline that was thought to increase the risk for heart attacks for people using the drug.  The U.S. Food and Drug Administration… Continue Reading

2010 – Complications seen with ASR hip replacements

Posted in DePuy Hip Replacement

When people experience severe hip arthritis there are a few different surgical options, generally categorized as hip replacement.  The two primary types of procedures are resurfacing arthroplasty and total hip replacement.  The difference between the two is that a total hip replacement involves removal of the head of the femur, and replacing it with a… Continue Reading

2010 – Metal Ions from Metal-on-Metal Hip Implants Passed to Fetus

Posted in DePuy Hip Replacement

Hip arthroplasty is a procedure performed on patients suffering from advanced hip arthritis.  For many years hip prosthetics were made using a medical grade plastic known as polyethylene.  This material oftentimes wore down, and required revision surgery to replace the worn out prosthetic.  Thus metal-on-metal bearing surfaces were invented, as these stronger metallic pieces are… Continue Reading

2010 – Study shows high metal ion levels in blood of metal hip replacement patients

Posted in DePuy Hip Replacement

Hip replacement surgeries are often performed on patients suffering from a damaged hip joint.  The hip joint is a ball and socket joint, which can cause some issues when designing prosthetics.  Ball and socket joints include a bearing, which is a relatively delicate system that often wears down over time.  For a long time, the… Continue Reading

New Law Requires Country-of-Origin Included on Meat Packaging

Posted in Public Health

News Desk at FoodSafetyNews.com recently published an article titled “Mandatory Country-of-Origin Meat Labeling Now In Effect”, that explains that some meat being sold in grocery stores must be accurately labled from where it is from.  The law will require retailers to clearly state on packaging where the animal was born, how it was raised, and… Continue Reading

2013 – New Avenues in Malaria Research Explored

Posted in Drug Studies

Malaria is an infectious disease that affects millions of people throughout the world every year.  Most reported cases come from the Sub-Saharan Africa and Asia.  Thousands of people die each year from this disease, and people living in poor countries are at the highest risk.  Parasites from the genus Plasmodium use the biting of mosquitoes… Continue Reading

2013 – NIH: “Gut Microbes Linked to Rheumatoid Arthritis”

Posted in Public Health

Rheumatoid arthritis (RA) is a condition characterized by systemic inflammation.  People suffering from RA experience pain, swelling, stiffness, and loss of function in their fingers, wrists, and/or other joints in the body.  RA is an autoimmune disease, meaning that it is a result of the body’s own immune system mistakenly attacking its own tissues.  In… Continue Reading

2008 – Complications of meta-on-metal hips evaluated

Posted in DePuy Hip Replacement

Different prosthetic designs have been created for people requiring hip replacement procedures.  Each patient has different needs depending on their activity level, and the nature of their hip disorder.  Younger people can still be more active, and thus require a hip prosthetic that can handle the rigors of more physical activity.  Therefore, metal-on-metal prosthetics have… Continue Reading

2.6% Mortality Rate Seen with DePuy Hip Replacement Surgeries

Posted in DePuy Hip Replacement

DePuy is an orthopedics company that manufactures metal-on-metal articulation systems for hip replacement procedures.  Their product offers low wear and high stability in order to reduce instances of revision surgery.  Revision surgery can be very dangerous; statistically there is a 2.6% risk of death for senior citizens undergoing revision surgery. Metal-on-metal bearings for hip replacements… Continue Reading

2001 – Severe Skin Reactions Seen with Metal-on-Metal Hip Replacement Systems

Posted in DePuy Hip Replacement

Metallic prostheses are increasing in popularity, as an option for hip replacement procedures.  One of the issues with previous hip replacement models was the wearing down of the prosthetic.  Previous prosthetics included a metallic head, and a polyethylene socket.  Polyethylene is a medical grade plastic, but was not particularly durable.  Therefore, metal-on-metal prosthetics were invented… Continue Reading

2009 – Seven Percent of Metal-on-Metal Hip Implant Patients Required Corrective Surgery

Posted in DePuy Hip Replacement

Survival rates for hip implants have not always been guaranteed.  Many times, hip implants fail from the weight they are supporting and correctional surgery may be required.  Better technologies have helped improve some of the problems seen with old school hip implants and the implants greater reliability and life expectancy has given users a better… Continue Reading

New Cholesterol Research Focused on MicroRNA

Posted in Drug Studies

Recently, a report published on the Director’s Blog at the National Institutes of Health website discussed new microRNA research on cholesterol.  Cardiovascular disease is one of the most common medical issues today, and cardiovascular health is heavily influenced by cholesterol levels.  There are two types of cholesterol, high-density lipoprotein (HDL) also known as “good” cholesterol,… Continue Reading

2013 – Scripps/Cornell Team Advance HIV Researsch

Posted in Drug Studies

Human immunodeficiency virus (HIV) infects more than 34 million people worldwide.  HIV is a virus that causes acquired immunodeficiency syndrome (AIDS), a condition, which does not allow the immune system to fight off other lethal infections.  HIV. The immune system functions by recognizing proteins on the surface of viruses and bacteria.  HIV is unique in… Continue Reading

2010 – Metal-on-Metal Hip Implants Associated with Increased Metal Ion Blood Levels

Posted in DePuy Hip Replacement

Metal-on-metal hip bearings are a relatively new option for total hip arthroplasty (THA) and hip resurfacing.  They are preferred over other materials in that they aren’t as likely to wear down and won’t be subject to osteolysis.  Metal-on-metal hip bearings also pose issues.  One issue with these types of bearings is that they are prone… Continue Reading

New Federal Efforts to Curb Salmonella Outlined by FSIS

Posted in FDA Regulation

Salmonella is a food-borne bacteria, typically present in meat and poultry products.  An estimated 1.3 million illnesses can be attributed to Salmonella every year.  To address outbreaks of salmonella, the US Department of Agriculture’s (USDA) Food and Safety Inspection Service (FSIS) has released its Salmonella Action Plan that outlines the steps it will take to… Continue Reading

2010 – 11% of metal-on-metal hip implants required revision surgery

Posted in DePuy Hip Replacement

Hip resurfacing procedures have only been performed relatively recently.  As such, there is limited information available regarding the long-term performance of the hip resurfacing implants.  With more information now available, there is a growing body of data with regards to the long-term outcomes of hip resurfacing procedures. One study followed up recipients of metal-on-metal hip… Continue Reading

2009 – Metal ions found in the blood of metal-on-metal hip replacement systems

Posted in DePuy Hip Replacement

Hip replacement using metal-on-metal bearings has only been performed for a little over ten years.  Clinical results have shown that the procedure is generally highly successful when performed properly, and the patient has been properly selected.  One of the issues with metal-on-metal bearings is the wear of the device.  Wearing down of the metal device… Continue Reading

2009 – Metal poisoning, other complications seen with metal-on-metal hip implant patients

Posted in DePuy Hip Replacement

Published in 2009, medical researcher Joshua J. Jacobs wrote a report titled “Metal on Metal Bearing Surfaces”, that outlines some of the problems currently associated with hip implants.  While metal-on-metal bearings is a popular option for repairing injured hip joints, it is the only option available for surface replacement of an injured joint.  While many… Continue Reading

1998 – High levels of metal ions seen in blood of ASR users twelve years prior to recall

Posted in DePuy Hip Replacement

Published in a 1998 edition of Journal of Bone and Joint Surgery an article titled “Metal Release in Patients Who Have Had a Primary Total Hip Arthroplasty.  A Prospective, Controlled, Longitudinal Study” by J.J. Jacobs et al. suggests that “in the long term, total joint replacement may be associated with adverse local and remote tissue… Continue Reading

2006 – Research shows dangers of metal-on-metal hip implants years before recall

Posted in DePuy Hip Replacement

Metal-on-metal hip replacements, particularly those manufactured by the Johnson & Johnson subsidiary DePuy Orthopaedics such as the ASR and ASRXL, have been associated with a high rate of device failure, requiring “revision surgery” – the surgical implantation of a new prosthetic hip joint. In a 2006 paper titled “Loosening and Osteolysis Associated with Metal-on-Metal Bearings:… Continue Reading