Authored by: Alicia Lammers
From hip replacements and birth control implants to vaginal mesh products, man-made technologies meant to improve the lives of patients are part of our everyday life. Netflix’s documentary, “The Bleeding Edge” goes into detail about the disastrous system associated with these man-made products including FDA regulations and doctors receiving payouts.
Our friend and client, Eric T. Chaffin writes about how the FDA has a program called the “fast-track” program. This program is a way for medical manufacturers to get their product out quicker. This program is set up so if the product is manufactured like one that has already been in production it will be FDA approved. These companies can still be approved by the FDA even if the product that is manufactured the same way has been recalled. When companies can prove they are similarly manufactured they do not have to go through a clinical trial at all. This impacts patients because no one has tested the products to know if they are safe or what their possible side effects are.
The FDA isn’t the only problem in the system but some doctors are as well. Sales representatives for these medical device companies offer money incentives to doctors so they will use their product. According to the New York Times medical companies have paid doctors more than $2 billion in 2016.
Chaffin also writes patients must be advocates for themselves and highlights that the documentary suggests patients should:
- Do research. If a device is new it doesn’t mean it’s better than an older product. Look into product safety, clinical trials, and possible negative results.
- Get a second opinion. See another doctor to see if you need the procedure or the device the first doctor suggested.
- Check the surgeon’s experience. Ask about how many procedures they have performed and any concerns you may have.
- Don’t go alone to the hospital. Take a friend, family member, or spouse with you so they can also act as your advocate.
For more information on medical devices or the documentary, click here to read Eric T. Chaffin’s article.
Photo Credit: Vadim Guzhva
