Emily Sortor  |  August 8, 2020

Category: Legal News

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woman advertising feminine rejuvenation

Feminine rejuvenation, also known as vaginal rejuvenation, refers to non-surgical procedures used to alter vaginal tissues for cosmetic or therapeutic purposes. These energy-based treatments have become popular in recent years despite warnings by the U.S. Food and Drug Administration (FDA) that some marketers are overstating the benefits and downplaying the risks.

The FDA may step in and formally notify companies or medical practices claiming a particular surgery or feminine rejuvenation energy treatment has more benefits than have been proven by scientific research.

Even though energy treatments have long been on the market for other purposes, they have not been fully evaluated by the FDA to determine the possible risks or benefits for women who choose to use them for feminine rejuvenation.

What is an Energy-Based Feminine Rejuvenation Treatment?

These non-surgical rejuvenation procedures use lasers or other radiant energy with a device that focuses the energy and heats the tissue in the impacted area. For years, energy-based devices have been used for dermatological procedures such as skin tightening or hair removal, and as a treatment for vaginal pre-cancers and general warts. Vaginal rejuvenation with energy-based devices is becoming increasingly popular among women, for a variety of reasons.

Vaginal rejuvenation is a catchall term referring to a host of corrective procedures, such as laxity of the vagina following childbirth, stress urinary incontinence, and vaginal dryness due to aging.

The primary purpose of female rejuvenation procedures is to enhance blood vessels, tightness, collagen, and lubrication. The two primary groups of women who get these treatments are women who are postpartum and postmenopausal.

What are the Different Types of Energy-Based Treatments?

There are two primary energy-based treatments for vaginal rejuvenation, both of which use heat. The first is a CO2 laser treatment which causes tissue in lower layers to produce more collagen when the upper layers of the tissue are heated. This is marketed as tightening and firming the skin. The second type is a radiofrequency treatment. This is similar to the waves used in a microwave, where the energy is used to heat the tissue.

There are other vaginal rejuvenation treatments available as well. To tighten the vagina, for instance, there is vaginoplasty, a surgical procedure, and the non-surgical pelvic flooring Kegel exercises, intended to strengthen the muscles in and around the vagina.

Feminine rejuvenation procedure at doctor's office

Are Vaginal Rejuvenation Processes Safe?

The FDA has recently warned consumers about some of the marketing to promote vaginal rejuvenation, citing the lack of evidence to support its uses for this purpose.

According to Pharmacy Times, the FDA points out the risks of rejuvenation treatments marketed to menopausal women experiencing sexual dysfunction and urinary incontinence. In total, seven different device manufacturers have been notified by the FDA about potentially inappropriate marketing of feminine rejuvenation procedures.

The FDA issued a warning in July 2018 about vaginal rejuvenation treatments that use energy-based devices like radiofrequency or laser, saying the use of these devices “may be associated with serious adverse events” and that the “safety and effectiveness of energy-based devices for treatment of these conditions has not been established.”

The FDA, according to Medical News Today, does not believe that vaginal rejuvenation has been proven to be safe and effective and could cause physiological harm. The FDA commissioner says that some companies have engaged in deceptive feminine rejuvenation marketing practices since the agency has not approved energy-based devices for vaginal rejuvenation or cosmetic purposes, which may be in violation of the Federal Food, Drug, and Cosmetic Act.

Cleveland Clinic explains that energy-based feminine rejuvenation is not permanent and will require several treatments to achieve the best results. 

As with most medical treatments, there are risks to energy-based feminine rejuvenation treatments, even if the procedure goes well. 

Doctors recommend waiting two to three days after a procedure before having sex. Women should also be aware that after one of these energy-based procedures, they may experience adverse reactions such as bright red bleeding or infections, such as a bladder or vaginal infection. If a patient experiences any of these symptoms, Cleveland Clinic advises seeing a doctor as they could be serious.

Cleveland Clinic notes that while some insurance plans may cover feminine rejuvenation, most do not, so it’s a good idea to understand your specific coverage. In addition to energy-based feminine rejuvenation, some women may consider alternatives. For those who prefer a less invasive feminine rejuvenation treatment, there are Kegel and pelvic floor exercises used to strengthen the muscles in and around the vagina. Like feminine rejuvenation, Kegel exercises may help prevent or control urinary incontinence and other pelvic floor issues, the Mayo Clinic explains. However, these exercises do not come with the potential risks that critics worry may be associated with feminine rejuvenation.

Are Feminine Rejuvenation Treatments Common?

The Daily Mail says that the demand for feminine rejuvenation treatments has increased by 40 percent since 2015 and “the market is estimated to be worth at least $2 billion by 2021.”

Vaginal rejuvenation procedures are not cheap. Glamour says treatments from one well-known company cost about $1,000 a pop, and often, women require multiple treatments to get the desired result. 

Part of why feminine rejuvenation is growing in popularity is because it presents an attractive alternative to the more-invasive vaginoplasty or labiaplasty which are surgical procedures used to “tighten” or change the appearance of the vagina and the labia.

The Daily Mail notes that the popularity of these treatments is largely influenced by celebrity endorsements on social media. Though some may assume the treatments are popular with younger women, the client base is mostly women in their 30s and 40s who have had children.

These women are more often seeking a solution to medical problems than they are looking for a cosmetic fix, says the Daily Mail. However, some are indeed attempting to change the vagina’s appearance for cosmetic reasons.

What Companies are Involved?

Companies that may be marketing energy-based devices for vaginal rejuvenation treatment include the following:

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

Can I File a Feminine Rejuvenation Complications Lawsuit?

If you have undergone a labial rejuvenation procedure and have since experienced complications or side effects like burning, scarring, or pain during intercourse, you may be able to file a lawsuit and pursue compensation. Of course, filing a lawsuit cannot take away the pain and suffering caused by these side effects, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Filing a lawsuit can be a daunting prospect, especially while dealing with health issues, so Top Class Actions has laid the groundwork by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.

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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