The benefits and risks of mammography screening have long been debated in the scientific community. According to the National Cancer Institute, while screening may be effective in reducing the number of deaths from breast cancer through early detection of a cancerous tumor, it can, at the same time, cause harm to the woman who is participating.
Consumers and patients who have been in injured by defective devices or other unsafe products frequently report these issues to the FDA, as they should. Recent cases relating to defective medical devices as well as products outside the realm of healthcare demonstrate that while it’s the federal government’s job to investigate these claims and promote safe standards across the board, this process is often a lengthy one.
More research has come out recently that links testosterone therapy to heart conditions. A study published in early January of this year found that men taking testosterone drugs faced a higher risk of heart attack for men over the age of 65. Men younger than 65 but with a history of heart problems also had higher risks for heart attacks, according to the study tracking 56,000 men.
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.
USA Today published a stunning report that reveals that, across the country, there are thousands of doctors who are forbidden to practice in hospitals or other medical establishments, yet have not received any kind of punishment from state medical boards. Those doctors, despite having settled multiple medical malpractice suits, still maintain their medical license.