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.
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.
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.
Last year, a Supreme Court ruling came down that will affect thousands of Americans, even if they were not aware of the ruling. Building on a ruling that declared manufacturers of medical devices could, in some cases, enjoy immunity status if the device turned out to be defective, last year’s case determined that no patient could challenge a manufacturer in state court if it had been approved at the federal level.
With cancer rates at an all-time high and cancer remaining a leading cause of death in the United States, the word biopsy has become a household term. A biopsy, according to WebMD, is the examination of a contaminated tissue that was removed from the body to determine what disease—or to what extent the disease is present—is afflicting a patient. A patient will undergo a biopsy if he or she has abnormal test results or if a medical practitioner suspects that it could identify an unidentified condition.
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.
When complicated medical technology hits the market and is adopted by medical professionals, issues with associated surgeries are bound to occur. There are several reasons for this, and difficulties with the manufacturing of the product itself are not the only ones. By some reports, the U.S. Food and Drug Administration (FDA) does not always fully vet products before they are released to the public. Hence, many devices end up recalled.
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: