Relative to the article regarding the FDA and Vaginal Rejuvenation on Monday July 30th in the New York Times. I would like to respond from the trenches. I am a board certified physician practicing gynecology for over 40 years. My practice has grown older with me such that most of my patients are menopausal, the duration of which these days amounts to more than half of their adult life. Statistically half of these patients at least suffer from genito-urinary syndrome of menopause, a condition only recently determined worthy of a diagnosis. A syndrome of vaginal dryness, painful intercourse and urinary incontinence for which we have had generally inadequate treatments. Examples are hormone replacement therapy, other non hormonal medications, all expensive unless they are lucky enough to have an insurance that covers this, which is unusual, and surgery.
In 2012 a vaginal Laser similar to that used extensively for facial resurfacing was shown by Italian gynecologists to be extremely effective in helping many of these symptoms. Histologically proven effects were what convinced me to investigate. This laser was cleared by the FDA for vaginal use in 2014 although not specifically for these symptoms. It required therefore an “off label“ application, perfectly legal. I tried it and immediately had beneficial, life changing effects for my patients. Since that time I have had experience with radio-frequency devices also and having done hundreds of cases without any significant complications, my experience has been with overwhelmingly positive results and many, many grateful patients and their partners.
I applaud the stated aim of the FDA in trying to protect women from harm and inaccurate advertising and encourage companies to be more diligent in their research. This announcement will cause all of us physicians to be cautious and recognize that any treatment carries the risk of complications, I have in fact seen one case of a Laser burn when asked to give an medico-legal opinion on treatment by another provider. A situation where the physician didn’t follow the guidelines.
I would hope this will encourage the companies to only sell this equipment to gynecologists and urologists who have the knowledge and a full spectrum of treatments so that they provide all options for the patient.
And perhaps this attention to the significant and previously ignored, often debilitating condition will inform patients that there can be improvement and often resolution.
On the other hand the FDA may not be protecting women but in fact providing a disservice, frightening them by exaggerating the risks, these are not dangerous procedures. They may therefore be denying these women access to this option. They may also inhibit the research into more efficatious treatments. The FDA have been known in the past to exhibit knee jerk reactions in the guise of protecting women when they are actually doing the opposite.
It is important to note that some purveyors of these technologies are cleared for treatment of these pelvic conditions in many other areas of the world including Europe, Canada and the Southern hemisphere.