When participants left a two-day public hearing convened by the U.S. Food and Drug Administration (FDA) to discuss metal-on-metal hips (MoM) there were few answers and a lot of questions. The goal of the 18-member FDA advisory panel made up of surgeons, industry reps, and consumer advocates was to try and come […]
Author: Cal Warriner
In the three years since Stryker first introduced the Rejuvenate and ABG II modular hip implant systems, thousands of patients have had these devices implanted. The devices were distributed by Stryker throughout the United States. The promises made about the Rejuvenate seem to have all been false. Since the device […]
For the past few years orthopedic device manufacturers have come under intense scrutiny for selling hip implant devices that fail prematurely. These failures have been due to designing systems that include too many metal parts. It has been determined that when metal touches metal in an implant designed to carry […]
Just how much are consumers of eye care products supposed to take before they have had enough? On the heels of two major disasters in the eye care industry yet another has emerged. Cooper Vision a major manufacturer of eye care products including soft contact lenses has announced the recall […]
CardioGen-82 (Bracco Diagnostic, Inc) is literally the combination of a machine that manufactures a low half-life radioactive tracer, Rubidium-82 (half-life of 76 seconds) from its parent Strontium-82 (half-life of about four weeks) and the Rubidium-82 itself. The FDA terms the machine and the Rubidium-82 combination a “drug” labeled as CardioGen-82. […]
CardioGen-82: Is it business as usual winning over Safety? Between February 17th and February 21st, 2011, two heart patients, one from Sarasota, Florida and the second from Nevada underwent nuclear PET (Positron Emission Tomography) scans to diagnose possible heart malfunctions. After having undergone CardioGen-82 PET scans, the two patients and […]
The evidence condemning Metal on Metal (MOM) implants continues to grow. In a recent announcement by the National Joint Registry for England and Wales (NJR), it was revealed that 30% of MOM implants manufactured by DePuy Orthopaedics, Inc., a division of Johnson & Johnson require removal and revision within six […]
In Big Pharma’s constant search for the magic pill, the one that promises relief or a cure for chronic debilitating disease, concerns about side effects, even potentially fatal ones are often dismissed as aberrations, anomalies or not clinically significant. For type 2 diabetics, the two latest magic pills that promised […]
If life weren’t difficult enough for depression sufferers, now there’s more to worry about. The FDA recently alerted psychiatrists and cardiologists that Celexa (Citalopram) has been linked to potentially fatal cardiac arrhythmias. Those taking doses more than 40mg. were at increased risk of developing Torsade de Pointes syndrome which can […]
As technology continues to make its way into our everyday lives, questions begin to arise about the safety of our new “toys.” I guess there will come a time when we are so saturated with new gimmicks that we will simply just hit the wall. At some point, there just […]
