What is FDA Approval and What Does it Mean in Aesthetic Medicine?

On August 1, the New York Times reported that the U.S. Food and Drug Administration (FDA) announced it had sent warnings to several companies marketing laser devices and treatments for vaginal rejuvenation. The warning said that marketing these laser devices for the purpose of vaginal rejuvenation or women’s intimate health could be “dangerous and deceptive”.

When news like this breaks patients often contact the clinic with questions and confusion about what FDA warnings and approvals mean, how they are earned and what to do if they have had a treatment or procedure that isn’t FDA approved.

Safety First

At Melinda Menezes, MD our first priority is the health and safety of our patients. We would never offer you a product or procedure we didn’t thoroughly research, trust and use ourselves.

FDA Video Explaining Medical Device Trials and Approval Process

What is the FDA

The FDA is the U.S. Government agency that is responsible for protecting public health and regulates food products, vaccines, human and animal medications, tobacco, cosmetics and medical devices among other things. The FDA also regulates the marketing and manufacturing of products and devices in these categories to ensure that marketing is consistent with what the products and devices claim to do. Up to half of the approvals made by the FDA are for medical devices and about 10% are for cosmetics, drugs and “biologics”.

Cleared, Registered, Listed, Approved – What Does it Mean?

You’ve probably seen all of these words associated with FDA warnings and approvals of medical devices. In general terms, the “FDA-approved” label means that the FDA has determined the benefits of the device or product to outweigh the risks of a specified use.

Not all medical devices or products are subject to FDA approval before marketing and in broad terms the FDA uses a three-tiered system to determine which devices need pre-market approval:

  • Class 1: No approval required. Includes medical products like Band-Aids and gauze.
  • Class 2: Clearance or substantial equivalence. Includes non life-threatening or sustaining devices such as lasers and x-rays. If a medical device manufacturer can prove to the FDA that a similar device for similar use has already been approved the device can be marketed and sold without clearance under the 510(k) section of the law.
  • Class 3: Intense scrutiny and approval required. Includes life-sustaining devices such as implants or defibrillators.

It is important to understand that FDA approval and clearance labels are for specific uses of a device and do not prevent medical professionals from using devices and products in other “off-label” ways. It is legal for doctors to use devices and medications in off-label conditions which can help build the body of medical knowledge that eventually leads to other approved uses.

For example, late last year, BOTOX Cosmetic was FDA approved for the treatment of forehead lines – nearly 15 years after BOTOX was first approved for the treatment of frown lines. At this time, BOTOX is FDA approved for just three uses (frown lines, forehead lines and crow’s feet), but is widely and safely used by medical providers across the country for a variety of cosmetic and medical treatments including eyebrow lifting, TMJ, headache treatment and more.

Vaginal Laser Therapy – Where Do We Stand?

At Melinda Menezes, MD we are proud to be the first clinic in Hawaii to offer patients the Lumenis AcuPulse C02 laser. This device has received pre-market approval for several uses and Lumenis, the maker of our laser, was not one of the companies to receive an FDA warning. However, marketing of the laser as a vaginal therapy device has been temporarily paused at this time because of the off-label designation.

Many medical providers and patients across the country will continue to use C02 lasers and devices to improve vaginal health and contribute to studies and the medical knowledge bank. As with any medical procedure there are always risks involved and you should talk to your provider about them to determine if vaginal C02 laser therapy is the right choice for you. Patients across the country and right here on Kauai have seen symptom and quality of life improvement with vaginal laser therapy. If you are suffering from stress urinary incontinence, painful sex or other vaginal health symptoms let’s talk about your options, the science behind how C02 lasers work and if the treatment is right for you.