Exactech is a global medical device company that creates orthopedic implant devices and surgical instrumentation for joint replacement surgeries. In June 2021, Exactech issued recalls of its knee, hip, and ankle implant systems due to defective packaging that caused the polyethylene inserts to oxidize prematurely. This failure led to rapid device deterioration and early implant...
CONTINUE READINGTeprotumumab (brand name Tepezza) is a United States Food and Drug Administration-approved medication used to treat the effects of thyroid eye disease (TED, also known as Graves’ disease). Historically, FDA approval is a long, winding, and costly process for pharmaceutical companies. New-drug development costs have skyrocketed in recent years to an average of more than...
CONTINUE READINGMary Bayes and her husband Philip Bayes received their holiday presents early this year. A St. Louis federal jury awarded the couple $20 million and $1 million respectively for the injuries Mrs. Bayes suffered as a result of her defective Biomet M2a Magnum metal-on-metal hip replacement. Although the second trial, which ended recently, resulted in...
CONTINUE READINGThe MiniMed 600 series Insulin Pump System (630G and 670G) and its Pro Infusion Sets, in particular, is an example of this device used for diabetes management. Manufactured and distributed by Medtronic, the product appeared to be an effective therapy for diabetic patients. However, in response to numerous adverse reports, Medtronic voluntarily provided its customers...
CONTINUE READINGRecently, attorney Tom Yost sat down with Elsa, from WMAR’s Midday Maryland to discuss the potential dangers of medical devices, specifically Essure birth control and metal on metal hip implants. He talks about the way in which the FDA approves these devices and allows them to be sold. As well as what the next steps...
CONTINUE READINGIn July of 2018, concerns about cancer prompted the FDA (Food and Drug Administration) to issue a voluntary recall for the blood pressure and heart medication Valsartan. Doctors prescribe Valsartan for patients to treat their high blood pressure and congestive heart failure. Pharmacies are sending letters to patients who have been taking Valsartan, advising them...
CONTINUE READINGWhen making an important purchase, such as a mobile device or a vehicle, there are many factors that help in your decision making process. It is important to consider the potential safety risks associated with any product that you purchase. As consumers, we put our faith in manufacturers to deliver safe products and we trust...
CONTINUE READINGThe Food and Drug Administration (FDA) is warning consumers to avoid “Bentonite Me Baby” by Alikay Naturals due to a risk of lead poisoning. “Bentonite Me Baby” is marketed as medicinal clay that can be ingested or applied topically for the treatment of several conditions. However, safety testing of this product revealed that that “Bentonite...
CONTINUE READINGIn the CDC’s most recent Morbidity and Mortality Weekly Report, the agency calls for greater research on antidepressant drug use during pregnancy. The CDC’s research in the past has indicated that there may be a link between the use of SSRI antidepressant medications during pregnancy and an increased risk of serious birth defects in children....
CONTINUE READINGIn late April of 2015, the Food and Drug Administration (FDA) announced drug manufacturer Mylan N.V.’s recall of batches of contaminated Gemcitabine, an injectable drug used to treat ovarian, breast, pancreatic and certain types of lung cancer, after testing revealed that the batches contained foreign substances that can be extremely harmful to patients. Intravenous injection...
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