After a Journal of American Medical Association publication of a meta-analysis suggested that long-term use of the diabetes drug Avandia was associated with an increased risk of myocardial infarction, the maker of Avandia, GlaxoSmithKline, declared there was little difference in the safety profile of their drug, Avandia and the “other” drug for Type 2 diabetes, Takeda Pharmaceutical’s Actos. Further studies however have not completely backed up that declaration.
As more information comes to light regarding the potential safety issues of the transvaginal mesh implants, women across the nation have more questions regarding the device. The FDA has yet to make a final determination on how mesh devices will be approved in the future and whether the current manufacturers will be subject to more rigorous scrutiny regarding the mesh device.
Two weeks ago, the U.S. Panel on Multidistrict Litigation conducted a hearing to discuss where the DePuy Hip Implant MDL should be placed. Today, the Panel announced that the litigation will take place in the Northern District of Ohio.
DePuy hip replacement recall by DePuy Orthopedics, Inc.’s metal-on-metal hip replacement system sent shockwaves through the international medical community. Given the fact that these devices have gained great popularity in recent years among orthopedic surgeons and patients alike, reports that the ASR XL Acetabular System and ASR Hip Resurfacing System were prone to early failure were met with great fear and unease.
It is the fond belief of many Americans that FDA approval is a ringing endorsement of a product's safety, a guarantee that the device has been tested and re-tested by professionals who are presumably trained to put the device through all kinds of rigor.