When Kaiser Health News (KHN) first reported on the hidden database of medical device recalls, the news agency submitted a Freedom of Information Act (FOIA) request to the U.S. Food and Drug Administration (FDA). The FDA said at that time that it would take almost two years to fulfill the...
What Are Medical Device Recalls?
The U.S. Food and Administration (FDA) reports on, monitors, and enforces medical device recalls for public safety. But, what does that really mean? What exactly is a medical device recall and how do recalls affect consumers? Let’s take a look. Medical Device Recalls A recall means that the FDA and/or...
The FDA Comes Clean About Millions of Injuries Caused by Medical Devices
On June 21, the U.S. Food and Drug Administration (FDA) published millions of adverse event reports previously concealed within their hidden database. The adverse event reports included information on injuries caused by a variety of medical devices. Six Million Hidden Injuries Caused by Medical Devices On June 21, 2019, the...
FDA Considers Black Box Warning in Lieu of Prohibiting Sale of Breast Implants
After months of conferences and studies on the subject of possibly cancer-causing breast implants, the U.S. Food and Drug Administration (FDA) announced breast implants linked to anaplastic large-cell lymphoma (ALCL) may continue to be sold in the United States. To assure the potential risk of these implants is well-known, the...
Biologic Medications are Causing Widespread Adverse Events
New reports are highlighting concerns about biological medications, which could put patients at risk for certain deadly adverse events. Biological medications, or biologics, are pharmaceutical drugs derived from animal cells. Despite their successful treatment of autoimmune disorders like arthritis and psoriasis, consumers have reported over one million adverse events due...
FDA Warning: Popular Dietary Supplement Can Cause Miscarriage
The U.S. Food and Drug Administration (FDA) issued a warning early in June, 2019 about an ingredient in dietary supplements that can be dangerous for women of childbearing age. The FDA warning concerns the compound vinpocetine. Vinpocetine is an ingredient in supplements that increases cognitive performance, enhances energy, and reduces...
Can Hackers Hijack Medical Devices?
Patients who rely on medical devices now have something more to worry about than just device malfunctions or defects. In today’s digital age, patients now have to worry about hackers compromising their healthcare and safety. At Drug and Device Watch, our goal is to make sure that patients and consumers...
FDA Warns Consumers about Homeopathic Drugs
In April 2019, the U.S. Food and Drug Administration (FDA) published safety warning letters aimed at four companies who manufacture and market homeopathic drugs. Though homeopathic products do not need FDA approval to remain on the market, the federal agency still monitors and inspects the products to ensure compliance with...
Defective Infant Product Linked to Numerous Infant Deaths
Fisher-Price recalled their Rock ‘n Play sleeper amid tragic reports of more than two dozen infant deaths associated with the defective infant product. In what many believe to be an attempt at avoiding a recall, the company initially issued a joint statement with the U.S. Consumer Product Safety Commission (CPSC)...
FDA: Medical Scope Infection Rates on the Rise
After years of improvement in the rate of medical scope infections, the U.S. Food and Drug Administration (FDA) recently began receiving reports of superbug infections associated with contaminated medical scopes. In 2015, the high rate of infections prompted the FDA to require medical scope manufacturers to conduct post-market studies on...
FDA Orders Immediate Stop of Pelvic Surgical Mesh Sales
The latest and final step in an escalating series of warnings and actions about surgical mesh for the treatment of pelvic organ prolapse (POP) came this week as the U.S. Food and Drug Administration (FDA) ordered the manufacturers of some mesh products to stop selling and distributing the devices immediately....
Lawsuits Mount Over Cancer Drug’s FDA Black Box Warning
The manufacturer of a chemotherapy drug called Taxotere is the subject of snowballing litigation after claims that the drug causes permanent alopecia, or hair loss. Though hair loss is a common side effect of cancer treatments, the cancer survivors bringing suit claim the risk of permanency of their hair loss...