Before we get into the list of FDA-approved Kegel devices, let’s quickly run through what the FDA actually is and why their approval is important.
If you’d prefer to get straight to the list, feel free to skip the next section.
What is FDA approval?
You might have seen the term FDA-approved next to plenty of Kegel devices – but what does it actually mean? Here are some quick facts:
- FDA stands for the U.S. Food and Drug Administration.
- The FDA are responsible for ensuring that the food, drugs, cosmetics and medical devices sold in the United States are safe to use.
- When a product receives FDA approval or FDA clearance, it means that it is safe and effective.
But given that we’re a healthcare clinic in Ireland, it’s probably worth asking why we would even mention FDA approval. After all, FDA approval only applies to products sold in the USA. However, there are a few reasons why it’s important to us.
Why do we mention FDA approval outside of the USA?
- FDA approval is a similar process as it is in Europe through the European Medicines Agency (EMA). Around 90% of products get approved in both regions. So if we’re selling a medical device here in Ireland, FDA approval is a good harbinger for EMA approval too.
- A lot of the medical devices we use at Dundrum Clinic are simply marketed and sold first in the USA. The manufacturer either may not have sought EMA approval yet, or doesn’t intend to. But given FDA approval tends to be a longer and more stringent process than EMA approval, you can trust in FDA approval regardless of whether you live in the US or not.
- It’s also worth pointing out that the FDA has more regulatory power than the EMA. The FDA can approve medical products to be sold. On the other hand, the EMA can only make suggestions. The European Commission (EC) has the final say on whether a product can be sold in Europe.
In short: FDA approval is very similar to the process here in Europe. An FDA-approved product is very likely to also be approved in Europe. So you can trust FDA approval regardless of whether you live in the US or not.
Now let’s take a look at a list of FDA-approved Kegel devices.
What is it? The BTL Emsella is a chair-like device. When you sit on it, the Emsella uses High‐Intensity Focused Electromagnetic (HIFEM) technology to send electromagnetic waves through your body. This process stimulates contractions in your pelvic floor muscles. The Emsella chair can perform the equivalent of 11,200 Kegels in around 30 minutes.
Does it work? A total of five studies have been carried out on the effectiveness of the Emsella. In one clinical study, 81.33% of patients using the Emsella reported a ‘significant improvement’ in their incontinence symptoms.
What is it? The Yarlap is a device that you insert into your vaginal canal like a tampon. Once you’ve chosen a programme, it then sends low-level electrical signals to your pelvic floor muscles. This normally lasts for up to 20 minutes, depending on the programme you’ve chosen.
Does it work? We couldn’t find any clinical studies that prove the efficacy of the Yarlap.
What is it? The ELITONE uses electrical muscle stimulation to send signals to your pelvic floor muscles, telling them to contract. It is a non-invasive device that you wear under your clothes (where you would put a pad).
Does it work? Although there are limited clinical studies on the efficacy of ELITONE, this study did find that 75% of patients saw an improvement in their condition. However, it’s worth noting that this was an at-home study not performed under controlled circumstances.
What is it? The Perifit is a gamified biofeedback device that you insert into your vaginal canal. It helps you locate your pelvic floor muscles and lets you know if you’re performing Kegels correctly.
Does it work? We couldn’t find any clinical studies that prove the efficacy of the Perifit.
Kegel8 Pelvic Toner
What is it? The Kegel8 Pelvic Toner is a biofeedback device that helps you locate your pelvic floor muscles to ensure you’re doing Kegels correctly. You insert the Kegel8 into your vaginal canal first.
Does it work? We couldn’t find any clinical studies that prove the efficacy of Kegel8 devices.
Although a lot of Kegel devices have been cleared as safe to use by the FDA, only the Emsella has been clinically-approved in multiple studies. They all found it to be an effective treatment for urinary incontinence, with an efficacy rate of around 81%. It still doesn’t offer any guarantees, but it’s as close as you’re going to get to a proven treatment.