Brigette Honaker  |  March 19, 2020

Category: Legal News

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Nonsurgical vaginal rejuvenation may be unsafeNonsurgical vaginal rejuvenation is a non-invasive method of correcting vaginal problems or improving or changing the look of the vagina.

What Is Nonsurgical Vaginal Rejuvenation?

Vaginal rejuvenation treatments may be surgical or nonsurgical, and are often meant to correct cosmetic or age-related vaginal problems.

According to the American Board of Cosmetic Surgery, cosmetic issues may include lack of tone, asymmetry, and general appearance complaints. Age-related problems may include a lack of vaginal tightness, urinary incontinence, pain during urination or intercourse, lack of sensation, and lack of vaginal lubrication.

Surgical interventions for these issues may include a labiaplasty, vaginoplasty, or reduction surgeries. While some surgical vaginal rejuvenation procedures are invasive, non-surgical vaginal rejuvenation treatments are procedures that use energy rather than surgical tools.

How Does Nonsurgical Vaginal Rejuvenation Work?

Some nonsurgical vaginal rejuvenation techniques rely on injectable hyaluronic acid volumizers, platelet-rich plasma (PRP) injections, and physical devices to address patient complaints. However, the most popular form of nonsurgical vaginal rejuvenation relies on laser or energy-based devices.

Energy-based vaginal rejuvenation treatments are procedures that use heat to treat vaginal issues. These procedures are performed using an energy-based device that uses focused energy to heat the vaginal tissue.

Energy-based devices have been used for other skin treatments for years, and have recently begun to be used for vaginal treatments. According to proponents of nonsurgical vaginal rejuvenation, energy-based procedures enhance collagen and blood vessels in the skin, improving lubrication and tightness.

Although the issues that may be corrected by vaginal rejuvenation procedures are usually caused by age or childbirth and are natural, many women wish to correct these unwelcome changes.

There are two main categories of nonsurgical vaginal rejuvenation treatments. The first kind is radiofrequency treatments. These devices use electromagnetic waves, similar to the types of waves used in microwave ovens. These focused waves heat the vaginal tissue, allegedly leading to tissue changes and improvements.

The other type of nonsurgical vaginal rejuvenation uses CO2 lasers. These lasers heat up the top layers of skin, promoting collagen growth in the lower layers of tissue. This additional collagen may make the skin firmer, tighter, and more youthful in appearance.

These treatments are quick and generally painless. Most energy-based vaginal rejuvenation treatments can be done in a doctor’s office with little or no anesthetic, and no recovery time. Most patients are able to go about the rest of their day as usual following their treatment.

Patients often report feeling a slight irritation or warmth during the treatment, but minimal pain or discomfort. Although nonsurgical rejuvenation treatments may be appealing for women who want to correct cosmetic or age-related vaginal issues without undergoing major surgery, these procedures may have unintended adverse side effects.

What are the Side Effects of Nonsurgical Vaginal Rejuvenation?

According to the FDA, energy-based devices used for vaginal rejuvenation may result in serious injuries and have not been approved for these procedures by the administration. Along with the risk of bleeding, some patients have developed infections following these procedures.

In other cases, women have suffered from vaginal or vulvar scarring due to the use of energy-based devices. According to the FDA, there is no scientific evidence indicating that these procedures work to correct issues such as vaginal laxity and lack of lubrication.

Additionally, these procedures may lead to psychological or emotional harm. Due to these risks, the FDA has advised against the use of these devices and has warned manufacturers and physicians against using false claims to advertise energy-based procedures.

Advancing the health of women is a priority for the FDA,” then-FDA Commissioner Scott Gottlieb said in a statement, according to Medical News Today.

“And as part of [our] efforts, we also watch for, and take action against, bad actors who unfortunately take advantage of unsuspecting consumers by marketing unapproved, deceptive products that may pose safety risks and violate the trust of American consumers.”

Although the FDA warns against these devices, other scientists argue that laser devices for vaginal rejuvenation show “great promise.” A 2019 study found that patients generally respond well to these treatments. However, researchers did conclude that “larger, double-blinded, randomized control trials” are necessary to process of “accepting these devices as standard, preventive, or first-line treatments.”

Regardless of how promising energy-based devices are, consumers deserve to be told the truth about their medical care. Most patients assume that, when they opt into a procedure such as non-surgical vaginal rejuvenation, they are being provided with proven, safe care. If energy-based devices are marketed with false claims about their efficacy and safety, consumers and doctors may have been misled about their role in vaginal rejuvenation.

If you or a loved one has undergone vaginal rejuvenation and experienced adverse side effects, including burning, pain, or scarring, you may qualify to join a vaginal rejuvenation class action lawsuit investigation that aims to hold these companies responsible.

Companies who are allegedly marketing vaginal laser rejuvenation with these devices include:

  • Venus Concept – Venus Fiore
  • BTL Industries – Ultra Femme 360
  • Cynosure – Mona Lisa Touch
  • Alma Lasers – FEMILIFT
  • Sciton – diVA
  • Thermigen – ThermiVA
  • Inmode MD – FormaV, FactoraV

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