Medical Implant Devices and the FDA: User Beware? (part 2)

We previously discussed an ongoing public health concern where the FDA’s approval process for medical devices appears to be dangerously lacking—to the point that many devices get released to market without a clinical trial. What does this truth mean for you or your loved ones who might need an implanted medical device? What steps can you take to stay safe?

Do Your Own Research

If your doctor recommends a certain medical device, you don’t have to assume it’s safe because your doctor says so. Find out about the device—not just what it is and what it does, but who makes it. Do some searching on the Internet about the specific device and the manufacturer who produces it. Whenever possible, don’t limit yourself to reading the material written by the company itself, as that material is specifically intended to convince you to use the device. Instead, look for consumer reviews; see who has used the device and if there are any complaints about it. If you don’t feel comfortable with what you see, ask your doctor for a different alternative.

Ask Lots of Questions

How long has this device been on the market? Has the device undergone clinical trials? How many people have used it? Have there been any adverse reactions to it? What are some warning signs that the device isn’t working properly? Before agreeing to any type of implanted device, ask as many questions as necessary in order to feel comfortable that the device is safe. Don’t be afraid to annoy your doctor—after all, she’s not the one whose health may be affected by this device. Be sure before you agree.

Be Your Own Advocate

In a day when medical errors are the third leading cause of death in the U.S. (including deaths due to faulty medical devices), the person best able to protect your health is you. Patients and their families who take personal responsibility for their own health—who ask questions, demand answers and aren’t afraid of using the word no, when necessary—these are the ones most likely to avoid complications due to medical errors. Your healthcare providers may indeed be doing their very best to care for you, but you always have the right to look out for your own health and interests.

Are you concerned that a faulty medical device has impacted your health or the health of your loved one? Our Washington D.C. medical malpractice attorneys can help. Call our office for a consultation.