Medical Devices

DePuy Synthes promised in its marketing campaign for the Attune Knee System that it would give patients the opportunity to enjoy a greater range of motion in a shorter stay in the hospital. Instead, patients have sustained debilitating injuries, necessitating a second revision surgery only months or years after the initial Attune Knee System procedure.…

(This is part of a series, presented by McGowan, Hood, Felder & Phillips, LLC, titled “Life on The Bleeding Edge: How the FDA Won’t Keep You Safe.” To learn more, please read Part One and Part Two.) When we were kids (well, at least for some of us), the future promised it would be filled…

The Food & Drug Administration (FDA) has issued a warning to women who are considering vaginal rejuvenation cosmetic procedures that would use energy-based devices. Per the FDA, “To date, we have not cleared or approved for marketing any energy-based devices” for the procedure. FDA Commissioner Scott Gottlieb made an additional statement about the devices used…

(This is part of a series, presented by McGowan, Hood, Felder & Phillips, LLC, titled “Life on The Bleeding Edge: How the FDA Won’t Keep You Safe.” To learn more, please read Part One.) In the Netflix documentary, The Bleeding Edge, you meet an orthopedic surgeon named Dr. Stephen Tower. He is shown biking around…

Since breast implants were initially introduced onto the market in the 1960s, issues concerning their safety have been debated ever since. The controversy about their safety even led to a 14 year ban by the Federal Drug Administration (FDA) on silicone gel implants for cosmetic enhancement (1992-2006). Today, the most popular type of cosmetic surgical…

The U.S. Food and Drug Administration (FDA) is currently using a flawed regulatory framework to approve medical devices. The current framework has been unsuccessful in protecting people from dangerous drugs and defective medical devices, and it is unclear how an even faster track approval process is going to safeguard American consumers. How does the FDA…

You have likely seen commercials on television for drugs such as Prilosec, Nexium and Prevacid. These proton pump inhibitors come in prescription strength and over-the-counter versions of a drug that reduces acid in the stomach. Though generally accepted as safe and reliable for long-term use, some people who have taken PPIs have suffered injuries, and…

Medical devices such as pacemakers, cardiac stents, surgical mesh, defibrillators, heart valves, artificial joints, and nerve stimulators are given to patients commonly in the United States. In fact, approximately 32 million Americans have one or more medical devices implanted in their bodies. Although, many of these devices provide health saving benefits, too many of them…

3M, the Maplewood-based giant manufacturer, which is well-known for selling innovative office and home improvements supplies, also sells Bair Hugger warming blankets, a forced air patient warming device used in hospitals. The device is designed to keep patients warm during surgery and thus prevent infections and promote overall healing. However, thousands of people have taken…