We’ve all heard it before. There’s always talk about whether or not certain products or medications are FDA-approved. As someone with little knowledge of the FDA, it may seem that only FDA-approved procedures and medications are safe, but this is sometimes not the case. While it can be confusing to navigate the importance of FDA approval, especially in terms of orthopedic procedures, it is important not to write off all procedures just because they are lacking the FDA stamp. But how can you navigate this safely? What should you be aware of? What questions should you be asking your doctor in order to understand what will be the best option for you? Let’s discuss this question: should you wait for FDA approval on orthopedic procedures?

What is the FDA? What Does it Approve?

The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. This agency is responsible for protecting the public health in many different ways. They do this by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. They also ensure the safety of the United States food supply, cosmetics, and products that emit radiation. They help speed innovations that make medical products more effective, safer, and more affordable and help the public get the accurate, science-based information they need. 

Basically, the FDA regulates the food we eat, the medication we take, the medical products and the procedures that are available to us, along with many other things. But that doesn’t mean that everything has to be approved in order to be sold. In fact, many products don’t go through premarket approval. Sometimes, the FDA may focus on a product after it’s already for sale and already on the market. Even when FDA approval isn’t required before a product is sold, as determined by Congress in establishing the FDA’s authorities, the FDA can still act on a product, especially when safety issues arise.

So what does this mean?

Will All Available Orthopedic Procedures be FDA approved?

The short answer is no. Procedures themselves are not regulated by the FDA, only products are. However, if a procedure uses a medical device, that device can be FDA approved. When a procedure uses a medical device, it can take between one week and eight months to be approved, but that is once it is submitted. Studies show that products typically take 3 to 7 years in total from concept to approval. 

Sometimes it takes a long time for a procedure to be approved. Is it worth waiting until it is or should you undergo the procedure without it? If you are deciding whether or not to move forward with an orthopedic procedure that isn’t yet approved, there are some key factors to consider.

Pros & Cons of Said Procedure

If the procedure you are waiting on has not yet been approved by the FDA, can it still be worth trying? The first thing you might want to consider are the pros and cons of the procedure. Do the cons outweigh the pros? How many studies have been done on this procedure? Exploring the pros and cons is the first step. It is important to speak with your doctor about the possible benefits, the possible side effects of the procedure, the risks and symptoms that may be possible and what the recovery of the procedure may look like. These things are not general and may be different for everyone who undergoes the procedure but getting a good idea of whether the procedure might be safe for you is a good place to start. 

You can also compare this procedure to other available procedures that are approved. How do the benefits and risks compare between the two? Which one does your doctor recommend? Which may be better for you in the end?

Many orthopedic procedures can provide you with benefits, such as pain relief, increased mobility and overall changes in your lifestyle. If you find that the procedure has a good chance to benefit you, it may be worth undergoing the procedure before it is FDA approved. 

The Credibility of the Medical Professionals Involved

Next, you may want to look into the credibility of your doctor or the medical professionals involved in your care. While the procedure might not be FDA approved, your doctor may have a long history in the medical field with years of experience. You should never feel embarrassed or like you are not allowed to ask your doctor about their medical experience.

Before deciding to undergo a medical procedure of any sort, it’s a good idea to make sure you trust your doctor and understand the type of history they have with the procedure. Ask questions and be upfront about your concerns, a good doctor will not be offended. They will walk you through their experience and help you understand why they, and said procedure, might be a good fit for you. Many medical professionals have their backgrounds explained on their website and it should be obvious where and when they obtained their degrees and how long they have been in their field. It is your choice alone whether or not you trust your medical professional and their judgment.

If you do, it may be wise to follow their recommended steps and undergo a procedure, whether it is FDA-approved or not.

The Urgency of Your Condition

Lastly, it can really come down to the urgency of your condition. If your condition is critical, it may be worth undergoing a procedure that is not yet FDA approved. If there are many other options that you can undergo before turning to this procedure, it may be wise for you to take those steps before deciding on it. Your doctor will help you understand the urgency of your condition and what they recommend for you. Everyone with your condition is different and your distinct anatomy and medical history will impact how much your condition will affect you and your quality of life. Some conditions are manageable, while others can be deadly. 

There are many treatment options that can be taken before your procedure if you have the time to take them. If your condition is not critical, ask your doctor what is on the lineup before the procedure is necessary. This might include medication, physical therapy and lifestyle changes. If your condition is critical, ask your doctor about the pros and cons of not undergoing the procedure. What other options are available? Are there any other options?

Should You Wait for FDA Approval on Orthopedic Procedures?

Understand that the FDA and FDA approvals can be an undertaking, but don’t let it be the sole decider in whether you undergo a procedure or not. Undergoing a medical procedure can change your life, many times for the better, so it is very important that you make the right decision. We recommend that you weigh the pros and cons of the procedure, compare it to available procedures that are FDA approved, investigate the credibility of the medical professionals involved with your care and understand the urgency of your condition as well as discuss with your physician. By looking at all of these factors, you should be able to make a confident decision about your orthopedic care.