FDA Advisory
Within recent weeks, the U.S. Food and Drug Administration (FDA) released a statement saying vaginal rejuvenation treatments have been cleared for destroying abnormal or precancerous cervical or vaginal tissue, as well as condylomas (genital warts) and other serious genitourinary (GU) conditions—but not for disorders and symptoms related to menopause, urinary incontinence or sexual function. Furthermore, the Administration claims these treatments “have serious risks and don’t have adequate evidence to support their use for these purposes.”
FDA commissioner Dr. Scott Gottlieb says he is aware of “numerous” reports of vaginal burns, scarring, pain during sexual intercourse and recurring or chronic pain following these procedures and as a result, is asking the manufacturers of the devices in question to address their concerns and reevaluate the marketing of their products.
In light of this statement, we wanted to share with you what we and other industry experts think about the warnig.
Firstly, women seek these treatments for many health and aesthetic reasons both. Vaginal dryness, inability to climax, loss of sensitivity, urinary incontinence - and the list goes on! And we know it works because our clients have shared with us and we celebrated in the success of the results they see. Lasers and Radiofrequency devices have been used for these type of treatments for years, and have a large body of evidence showing unequivocal benefit to women's health. There have been very few and rare reports of burns and complications, and none so far at Silk Touch.
Secondly, this statement lumps all vaginal rejuvenation treatments into one category. Both lasers and Radiofrequency (RF) - which are very different technologies. We offer ThermiVa, a RF device which has less complications and downtime than laser treatments.
The reason these warning letters have been sent out is these devices are not supposed to be marketed for indications they are not FDA-cleared for until they receive approval, and this is where some companies have gone awry, leading to warning letters. Just because something doesn't have FDA-clearing, doesn't mean its unsafe. It's a costly and lengthy process to get something FDA-cleared, which is why its so common to get off label treatments. (Example, Botox in crows-feet, even though its FDA cleared for forehead.)
Here's an excerpt from NewBeauty magazine where Dr. Alexiades & Dr. Canter ( industry leaders in Vaginal Rejuvenation) shares her opinion.
"....these devices do work for many people and it’s important that the FDA is finally discussing women’s health issues after all these years. “The important take home messages are that women need treatments for conditions such as pain with intercourse, urinary leakage and infections, which can result in a poor quality of life,” says Dr. Alexiades. “Approximately 50 percent of postmenopausal women suffer from these conditions, and this new generation of devices offers significant efficacy and excellent safety profiles.”
Reston, VA urogynecologist Maria Canter, MD agrees. “Although I agree with the FDA that the safety and effectiveness of a device should be established prior to it being marketed a certain way, some patients have failed multiple ‘approved’ treatment options and have had significant improvement with energy-based devices. For example, a radio-frequency device I work with, Viveve System, has studies demonstrating safety and efficacy when used to treat vaginal laxity that can lead to decreased sensation during intercourse and urinary incontinence. There is also a prospective randomized controlled trial that was blinded and demonstrated significant improvement in symptoms. This device also currently has 2 FDA IDE trials. To date, there have been no serious adverse events and the benefits have outweighed any risk.”
To wrap it up...
While any FDA warning sounds scary - this one really is more of a warning to the companies to hold off on marketing certain benefits UNTIL they get FDA approval. We stand behind our vaginal rejuvenation treatment ThermiVa, in both the safety of the device and health benefits.
ThermiVa has truly been one of the most gratifying treatments to be able to offer to our clients. It has changed the life of countless women, and even improved marriages. We can't say enough good things about this treatment!
If you would like to learn more about ThermiVa or to see if you are a candidate- visit our website here.
