Most drugs used to treat chronic issues dealing with digestion or heart issues carry some risk of side effects, but some are worse than others. Lisinopril is a angiotensin-converting enzyme (ACE) inhibitor, used to treat congestive heart failure, hypertension, and reduce the risk of heart attack. It has been commonly prescribed since the FDA first approved it for patient use in the early 1990s.
In recent months, the FDA has begun reviewing more information regarding Essure, a transcervical sterilization procedure for women. Essure is a Class III medical device that, according to the FDA, received a high level of review prior to marketing. The procedure had to be vetted through the pre-market approval process used by the FDA. This process includes reviewing data about product labeling materials and a scientific and regulatory review.
Abbott Diabetes Care, a lead developer and manufacturer of glucose monitoring and testing systems and strips has announced that it is issuing a voluntary recall of certain lots of its FreeStyle and FreeStyle Lite Blood Glucose Testing Strips in the United States. The defective medical device recall was issued on November 27, 2013 after the company found that approximately 20 lots of the test strips may return erroneously low blood glucose readings when used with certain types of FreeStyle blood glucose meters.
The U.S. Food and Drug Administration (FDA) has issued a Class I recall of approximately 15,000 Medtronic devices used during heart procedures due to a risk of serious injury or death. The recall affects Medtronic Interventional Guidewires and ATTAIN HYBRID Guidewires. According to the FDA, these are the long, thin wires that are inserted through the artery in order to guide the placement of diagnostics or medical devices such as stents.
Isotretinoin, also known as Accutane and one of the most effective medications for acne, is reported to cause severe birth defects to an exposed fetus. Because of this, the U.S. Food and Drug Administration created the computer-based risk management program iPledge, requiring women to review educational materials, complete tests and pledge to use two forms of birth control prior to using the drug.
If you have ever experienced painful side effects due to a defective medical device, drug or vaccination, you are not alone. Consumer Reports notes that “tens of millions of Americans live with medical devices implanted in their bodies,” including artificial joints, heart defibrillators and surgical mesh. And while Americans may assume that these devices have been tested for safety and effectiveness, Consumer Reports indicates that this is rarely the case.
Johnson & Johnson has agreed to pay $2.2 billion to settle charges with the U.S. Department of Justice over the alleged illegal marketing of Risperdal, Invega and Natrecor. Johnson & Johnson has been accused of improperly promoting the antipsychotic drug Risperdal for the elderly, children, and people with developmental disabilities. The Food and Drug Administration had only approved the drug for limited pediatric uses in 2006.
The Food and Drug Administration recently announced a new regulatory requirement for medical devices. All devices must now have a unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices. The development and safe operation of medical technology is literally of life and death importance, and manufacturers must uphold high standards in both quality and safety.
There are tens of millions of patients in the United States living every day with the help of medical devices. Running the gamut from heart defibrillators to surgical mesh and artificial joints, the foundation of all these creations is that they were designed to make a patient’s life easier. Sadly, however, a lack of standardization across their design and testing has negative impacts when patients and doctors find out too late that these items are defective.
Metallosis is a side effect experienced by some individuals who have metal on metal hip replacements. It results from metal corrosion and release of wear debris from the device into the body of the patient. For the patients who underwent surgery to receive metal hip replacements, what they hoped would make their lives easier could actually end in pain, suffering, and a defective medical device lawsuit.