FDA Plans To Overhaul Medical Device Approval Process
Since 1976, the FDA has been using the 510k process to approve most medical devices. This pathway once was the exception to the rule has now become the bypass standard. Facing growing pressure from the public, the agency says it will now look to overhaul the system but insists it still works. About the 510k
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Holding Manufacturers Responsible for Kia Fires
Consumer groups are pressing the National Highway Traffic Safety Administration to investigate complaints of spontaneous Kia fires. These fires are unrelated to crashes. The group filed a formal petition asking NHTSA to research four models all from the years 2011-2014. The spontaneous fires have injured at least six people. However, there are nearly 200 complaints
Read MoreInvokana Renal Study Stopped Early
The Janssen Pharmaceutical Companies of Johnson & Johnson has ended the phase 3 Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation, also known as CREDENCE. The company did not reveal the reason nor the results of the study. About Invokana Type 2 diabetes is a medical condition affecting over 9% of the
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Invokana Stomach Cancer Warning Signs
As more studies emerge linking the Type 2 diabetes medication, Invokana to stomach cancer, many patients are worried they may have the disease and not know it. It is important to stay vigilant about your health since big pharmaceutical companies are playing with lives. About Invokana Invokana was the first in a new class of
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Study Links Ingredient in Concerta to Suicide in Teens & Adolescents
The Indian Journal of Psychiatry published a study involving teenagers and adolescents taking the ADHD medication, Concerta. Researchers found that the active ingredient methylphenidate caused children in the study to display suicidal ideation side effects. About Concerta Approved in 2000 by the FDA, Concerta was first made by Alza Corporation before Johnson & Johnson purchased it.
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FDA Launches Heart Drug Irbesartan Recall Due To Cancer Risk
The FDA is issuing an irbesartan recall after discovering this high blood pressure medication is contaminated by the cancer-causing chemical N-nitrosodiethylamine (NDEA). This is the second heart medication recalled this year because of NDEA contamination. About Irbesartan Patients use irbesartan alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds
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Michael Brady Lynch Featured in The Wall Street Journal
The prestigious financial publication, The Wall Street Journal recently featured Michael Brady Lynch, lead trial attorney and firm founder for his expertise in annuities. The Wall Street Journal interviewed Michael since for over 20 years as a trial attorney, he has been a passionate consumer advocate for victims. Michael created The Michael Brady Lynch Firm as
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Florida Man Files Depuy Attune Knee Lawsuit
Johnson & Johnson and its DePuy Synthes subsidiary continue to face a growing number of lawsuits over their defective Attune Knee Replacement System. The most recent lawsuit filed was on May 31st in the U.S. District Court, Southern District of Florida. The Florida man received an Attune Knee during a right total knee replacement in March
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FDA Recalls Acon's CyPass Micro-Stent For Glaucoma Patients
The FDA has recalled the CyPass Micro-Stent manufactured by Acon for glaucoma treatment. The CyPass stent is only one of four minimally invasive procedures to treat the eye disorder. Yet, after five years individuals have a greater risk of corneal loss. About CyPass Micro-Stent The FDA approved Acon’s CyPass Micro-Stent in July 2016. The stent
Read MoreCommon Hernia Mesh Complications
As more people come forward with hernia mesh complications, it is important to realize the symptoms of the device failing. Manufacturers don’t want you to know that hernia mesh has these side effects, but knowing the symptoms could save your life. About Hernia Mesh Around 90% of all hernia repair surgeries use hernia mesh. Statistics show that
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