Q. Why has the FDA questioned the validity of ThermiVa and other Laser Vaginal Rejuvenation devices?
A. The ThermiVa Generator is a Class II device cleared by the FDA with indications for dermatological and general surgical procedures for electrocoagulation and hemostasis. Thousands of patients have used the device for rejuvenation of the vulva (labia) and vaginal tissues in the European Union (CE-label) and elsewhere in the world.
I have chosen this device because of the clinical safety and efficacy provided for this service.
The FDA has approved the device for marketing in the US for the indications above. The use of the device beyond the indications is at the discretion of the medical provider and is classified as “off-label” use If its clinical results remain safe and efficacious.
One must remember that enhancement for the female genitalia, like any medical procedure and decision making is provided on a spectrum of benefits and risk to be fully explored with your medical provider. The desired results of any procedure must match your expectations and goals including the side-effects, complications, cost, recovery and any other limitations. A proper history and examination by an experienced, Board Certified and knowledgeable physician is recommended. You can always start with ThermiVa and if dissatisfied move onto a more invasive approach or maintain the aging changes of this personal area as discussed with your physician(s).
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This information is not meant as medical advice. It is provided solely for education. Our practice would be pleased to discuss your unique circumstances and needs as they relate to these topics.
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