Millions of people use medical devices to improve their health. Medical devices exist to treat or prevent a host of different conditions. For many patients, the results are entirely successful, but defective medical devices can also lead to injury and serious complications. Learn more about how this issue may affect you with these frequently asked questions.
What are medical devices?
The term "medical device" covers a broad spectrum of equipment related to healthcare. Medical devices can be as simple as a bandage, or as complex and advanced as a new life support machine. Medical devices can help diagnose, prevent, monitor, and treat a wide range of diseases or conditions. The U.S. Food and Drug Administration (FDA) recognizes three categories of medical device, based on the level of control that is necessary to ensure that the device is safe and effective to use.1 These are:
- Class I General Controls (with and without exemptions)
- Class II General Controls and Special Controls (with or without exemptions)
- Class III General Controls and Premarket Approval
Who regulates the sale and use of medical devices?
The (FDA) must approve2 all devices for manufacture, marketing, and use. Medical device makers may find this process easier by following the 510(k) clearance process. These are devices that may be "substantially equivalent" to a device that the FDA already approves for the same use. This can help manufacturers avoid the cost and time of further testing. Consumer groups fear that while this process may speed up the availability of devices on the market, the quality of testing may not be adequate.
How does the FDA deal with defective medical devices?
Manufacturers may recall a defective medical device. Alternatively, the FDA may issue a product recall. The FDA also publishes details of the most serious recalls on its web site.3 These are defective medical devices that could cause “serious health problems or death.” Patients using any medical device should check the FDA database and consult a doctor if there are any concerns. Some notable events include hip implant recalls due to injury and implant device recalls due to the risk of serious complications or even death.
Which are most common?
The FDA maintains a database of all reported adverse events related to the use of medical devices. Some devices show significant numbers of adverse events. For example, transvaginal mesh (used to treat a condition called pelvic organ prolapse) may cause severe and painful complications. Mirena® IUD is a form of hormonal birth control. When placed, the device can cause serious infection and problems with device expulsion. INFUSE® bone grafts are intended to help address problems with joints and bones. Some patients suffer serious problems, however, which can include inflammatory conditions, urinary problems, and cancer. These are just a small number of examples of the complications that defective medical device victims may face.
What should I do if I used a defective medical device?
You should consult your doctor for all advice and information relating to the use of a medical device. Patients suffering injuries or complications may be able to file a class action lawsuit. Patients may be able to file a lawsuit against the device manufacturer for a number of reasons. The manufacturer may not have alerted patients appropriately to the potential risks, or may have used deceptive marketing. If the device is faulty, then it may be possible to show that the manufacturer is negligent. Talk to a competent attorney for more advice.
Will I be able to file a class action lawsuit?
Every case is different, so it is important to consult an experienced attorney for more advice. Any lawsuit will depend on the nature of the injury, as well as the available evidence. A trained attorney will be able to review your case and provide guidance on the likelihood of a settlement. You should always act promptly, however. There are normally limits on the time that you have to file a lawsuit after a doctor first diagnoses the symptoms of an injury.