Medical devices are vitally important to the industry. They vary in complexity and application, from tongue depressors and disposable gloves to implants and prostheses. Because they are used to diagnose, prevent or treat disease or other conditions, these items are regulated by the Food and Drug Administration (FDA) to ensure their safety and efficacy. However, this does not guarantee the devices don’t have hidden design flaws that can cause serious health risks. Here are three commonly used medical devices that were designed to help people, but ultimately caused more harm that good:
1. Transvaginal mesh – Also known as vaginal mesh or bladder sling, transvaginal mesh is a type of surgical mesh used to treat pelvic floor disorders such as pelvic organ prolapse and stress urinary incontinence. The mesh, which is made by several manufacturers, is inserted through the vagina to hold up organs that have dropped in the pelvis causing symptoms such as pain, discomfort, incontinence and other problems. But in 2008, the FDA warned that it had received more than 1,000 reports of complications caused by the mesh including erosion, infection, pain, incontinence, vaginal scarring, and death. Three years later, the agency issued a second warning stating as many as 10 percent of transvaginal mesh procedures fail and that adverse events were not uncommon. Many women who have had the mesh implanted and suffered ill effects have had to undergo repeated surgeries to have the mesh removed. Some are left with lifelong disabilities.
2. Mirena IUD – Intrauterine devices (IUDs) are flexible T-shaped contraceptives that are implanted in the cervix to prevent pregnancy. Bayer Healthcare’s Mirena IUD has been associated with tens of thousands of adverse event reports, some of which are serious. The device can migrate from its correct location and perforate neighboring organs. Surgery is often required to remove these runaway devices. In some cases, women have hemorrhaged or been left sterile. Lawsuits against Bayer allege the manufacturer knew of these risks but failed to adequately warn women and their doctors.
3. Metal artificial hip implants – Hundreds of thousands of people undergo hip replacement surgery each year. The devices are typically made with ceramic or plastic parts and can last 20 years or longer before needing to be replaced. In the past decade, medical device manufacturers have introduced all-metal hip implants designed to be more durable. However, this proved to be a fatal flaw. These metal-on-metal hip implants were failing at a faster than expected rate – in just five years or less. Not only did they fracture or dislocate prematurely, they were also leaching metal ions into the bloodstream, causing pain and inflammation as well as a type of blood poisoning known as metallosis. The long-term effects are unknown but some researchers say that metallosis can damage DNA, which can cause a variety of health problems including cancer.
Source: Righting Injustice