Defective medical devices are not limited to those implanted in a patient’s body. Patients who must use canes, wheelchairs, or other devices to get around are susceptible to a whole array of device warnings and risks that other Americans are not.
When most patients go in for surgery—especially serious surgeries like knee replacements—they are not concerned with the materials that doctors use. Most patients trust that their doctor is the expert, and will do what is necessary to ensure that the patient can recover quickly and well. Yet sometimes shady business deals are at fault for surgeries gone wrong, and doctors are helpless to remedy them.
It has been several years since Michigan-based medical device manufacturer Stryker issued a voluntary recall of their Rejuvenate and ABH II modular-neck stem metal hip replacements, according to the U.S. Food and Drug Administration. The recall was made after many patients complained that the hip replacement was defective, causing them more pain and suffering than before the implant was surgically inserted.
In mid-January the U.S. Food and Drug Administration approved a first-of-its-kind device to treat obesity, according to a FDA press release. The device, known as the Maestro Rechargeable System, realigns nerve pathways between the brain and the stomach. It’s the first FDA-approved device to fight obesity since 2007, and is approved for patients who have a body mass index of 35 to 45, with at least one other obesity-related condition. One such condition would be Type 2 diabetes.
In what will likely be the first of many settlements to come, Johnson & Johnson has agreed to resolve claims from four Missouri women that its Ethicon Prolift vaginal mesh implant caused serious injuries.
Sometimes a medical device meant to provide relief for patients suffering and expedite healing causes more pain than relief. One of these devices is known as a pain pump, most commonly used in patients recovering from shoulder surgery after a serious shoulder injury.
When new products or medical devices are considered for approval for the consumer market, manufacturers must first undergo a rigorous system to have the device approved. The U.S. Food and Drug Administration (FDA) divides approved medical devices into three categories: Class I, II, and III. Class I devices are not subject to as much regulatory control as Class III—Class III devices are usually those which carry a greater risk to the patient or consumer.
Sometimes prominent drugs are recalled and no one knows about it. This was the case with a 2010 Food and Drug Administration (FDA) recall of the birth control Yaz, a contraceptive approved by the FDA for use among women as young as 14 years old. Yaz and Beyaz—a similar FDA-approved medication made by the same manufacturer, Berlex, Inc.—hit the market when it was approved in 2006, according to Drugs.com.
Having a hip replaced is one of the most risky and complicated surgeries a person can undergo. It is also one of the most common bone replacements that are undergone in the United States. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), there are several reasons why a person would undergo a hip replacement surgery.
Goals of such surgery include: