11/21/2018 UPDATE – The FDA has closed the inquiry regarding vaginal rejuvenation and the “It Has Come To Our Attention” letter addressed to a variety of device manufacturers.
Original Article From 08/27/2018
In light of the recent US Food and Drug Administration (FDA) warning to device manufacturers, the aesthetic medical business experts at Acara Partners decided to review our financial analysis of the feasibility and profitability of vaginal rejuvenation. Coupling our analysis of the financials with a variety of response statements in the industry has solidified our sustained recommendation – properly trained physicians should continue to add vaginal therapy services to their aesthetic medical practices.
How to Interpret the FDA Warning
The FDA recently released a warning regarding manufacturers’ “inappropriate marketing of their devices” for vaginal rejuvenation services. The warning noted that while these devices are FDA-cleared for certain medical purposes, they are being marketed for services and treatments related to vaginal rejuvenation, for which they do not currently have clearance.
Health care attorneys interpreted the FDA warning in a joint statement by The American Med Spa Association and law firm, ByrdAdatto. They identified that the FDA does not have any control over a physician’s ability to prescribe “off label.” They stated:
“Although the particular devices are approved by the FDA, they are approved for a very specific use which is not the performance of vaginal rejuvenation procedures. What is important for med spas and other health care professionals to understand is that such ‘off-label use’ is subject to the oversight of their medical boards.”
The important thing to note is that a physician can decide to use devices for additional services outside of their FDA-clearance if they have been properly trained for the services, feel strongly about the potential for positive patient results, and are aware of the restrictions within their medical boards or organizations. Individual practices just need to be mindful of how they market devices and vaginal rejuvenation procedures to remain compliant with FDA standards. Focus your messaging around patient reports and actual results from your practice (i.e., “our doctors are seeing XYZ,” “our patients are reporting XYZ”).
Looking at the Financials
In conducting a sensitivity analysis based on existing client comparables and benchmarks, we have identified that practices pricing their vaginal rejuvenation treatment packages (series of 3) at $4,050 can add over $41,000 in profit to their practice in the first year of offering the service. This is only selling 3 packages a month! Acara has some clients who sell up to 5—10 packages a month, which could add upwards of over $450,000 in revenue to your practice.
Is Vaginal Rejuvenation Worth It for Your Practice?
There is no easy answer to this question. It’s important to look for a device which produces excellent results when performing vaginal rejuvenation treatments, and to receive sufficient training to ensure the safety of your patients. Cross-referencing any device purchase with customer testimonials and satisfaction rates on RealSelf.com is an excellent way to guarantee that you are investing into the right product.
Of course, customer demand and sales potential shouldn’t be the sole motivation for using a particular device or providing a specific procedure. You need to believe in the procedure yourself. Go to a demo day or meet with your sales representative in person to see the device in action. Arrange for team training in the device’s FDA-cleared and off-label uses, when appropriate, so you can provide the best possible results for your clients.
For details on which devices Acara believes are producing the best financial results, contact our team today: 203-488-0028.