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.
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.
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.
Though the manufacturer has come under fire for defective devices in the past, this year the da Vinci Sp Intuitive single port robot system used in surgical procedures is expected to hit the consumer market, according to MedGadget.com. The system is designed to allow for single-incision surgeries, and is a competitor to manufacturing giant Titan.
Lupron is a hormonal regulator that has several dangerous, if not oft-publicized side effects of which every patient should be aware. The drug is prescribed to help slow early-onset puberty in teenagers, to men who exhibit signs of prostate cancer, and to help treat women with endometriosis, a rare condition in which the lining of the uterus grows outside the actual uterus. According to the U.S.
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.
Heart surgery and the implementation of a heart device are very serious procedures. According to the New York University Langone Medical Center coronary revascularization is one of the most risky heart procedures for patients; however, it is recommended for heart failure patients who have a varying degree of severity of heart problems.