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  • Tami Bruskotter

Post #12 Vaginal Rejuvenation

Updated: Aug 3, 2019


Erica covers this one in Podcast Episode #8. She got great info from The Cleveland Clinic and the FDA! (Click on each of the underlined sources for the full articles.)

Here are excerpt from both...


Energy-Based Treatments and Vaginal Rejuvenation


Vaginal rejuvenation is a broad term for vaginal corrective treatments. These procedures can be done for cosmetic reasons, to correct problems that can occur after giving birth, or to solve age-related problems, such as lack of vaginal tightness or lubrication and urinary incontinence.


What are energy-based treatments?


Energy-based treatments are nonsurgical procedures that use heat. The treatments are done with a device that focuses the energy and heats the tissue. When used in the vagina, the goal is to enhance collagen, blood vessels, tightness and lubrication. The two main groups of women who get this treatment are postmenopausal women and postpartum women.


Radiofrequency (RF) treatments: Electromagnetic waves are used in RF devices. Similar to the waves used in a microwave – but to a lesser extent – the energy is focused to heat the tissue. Brand names of RF devices include Geneveve by Viveve and ThermiVa.


CO2 Laser treatments: The laser heats up the upper layers of the tissue, causing the tissue in the lower layers to make more collagen. Brand name devices include MonaLisa Touch®, FemTouch™ and FemiLift.


Other treatment options for vaginal rejuvenation can include:

Kegel and pelvic floor exercises: These exercises are meant to strengthen the muscles in and around the vagina.

Vaginoplasty: This surgical procedure tightens the vagina.



Energy-based treatments can be done in your doctor’s office. Little, if any, anesthetic is used during the procedure. Patients can typically continue with their day without needing recovery time. There is typically little irritation during the treatment. The area being treated may feel warm during the procedure. A topical anesthetic may be used if there is discomfort.


Are there any complications?


There is risk of bleeding or infection, but the risk is low. In rare circumstances vaginal or vulvar scarring may result from energy-based treatments. And a patient should wait two to three days to have sex after an energy-based treatment. Obviously, if there are signs of vaginal or bladder infection or significant bright red bleeding, the patient should undergo evaluation.


Energy-based treatments for vaginal rejuvenation are not permanent. For the best results, the treatments will need to be done over several sessions at a time.


Hmmm...maybe, but then here comes the FDA!


FDA Warns Against Use of Energy-Based Devices to Perform Vaginal 'Rejuvenation' or Vaginal Cosmetic Procedures: FDA Safety Communication


Regarging:

Energy-based devices - commonly radiofrequency or laser - that have received FDA clearance for general gynecologic tool indications, including, but not limited to, the destruction of abnormal or pre-cancerous cervical or vaginal tissue and condylomas (genital warts).

Purpose:

To alert patients and health care providers that the use of energy-based devices to perform vaginal "rejuvenation," cosmetic vaginal procedures, or non-surgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function may be associated with serious adverse events. The safety and effectiveness of energy-based devices for treatment of these conditions has not been established.

Summary of Problem and Scope:

We are aware that certain device manufacturers may be marketing their energy-based medical device for vaginal "rejuvenation" and/or cosmetic vaginal procedures. The safety and effectiveness of energy-based medical devices to perform these procedures has not been established.

Vaginal "rejuvenation" is an ill-defined term; however, it is sometimes used to describe non-surgical procedures intended to treat vaginal symptoms and/or conditions including, but not limited to:

  • Vaginal laxity

  • Vaginal atrophy, dryness, or itching.

  • Pain during sexual intercourse

  • Pain during urination

  • Decreased sexual sensation

To date, we have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions, or any symptoms related to menopause, urinary incontinence, or sexual function. The treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.

.

FDA Activities:

We are aware that certain device manufacturers may be inappropriately marketing their energy-based devices for the uses noted above that are outside of their cleared or approved intended uses. We have contacted these manufacturers to communicate our concerns.

The manufacturers contacted to date have responded with adequate corrections. We will continue to actively monitor promotional materials, including materials on the internet, and claims about uses of these products. We will continue to monitor complaints and adverse event reports from patients, health care providers, and industry. We plan to investigate potential violations and take action if appropriate.

In addition, we will continue to monitor reports of adverse events associated with this issue and will keep the public informed if significant new information becomes available.


YIKES!!!!


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