The FDA reports that some women who have undergone a vaginal rejuvenation procedure experienced unexpected serious side effects. Patients have reported burning, scarring and pain during sex after undergoing a vaginal rejuvenation procedure.

What is a Vaginal Rejuvenation Procedure?

A vaginal rejuvenation procedure is a optional procedure promoted as a way to address physical changes in a woman’s reproductive system following childbirth, menopause, or aging. A vaginal rejuvenation procedure can purportedly tighten vaginal tissues after aging or childbirth has left them loose. It cannot improve sexual feeling, although many medical professionals allegedly make claims that it does.

It can be done surgically or in a non-invasive procedure that includes heating tissues with radiofrequency waves or lasers. It is these non-invasive procedure devices that are under scrutiny.

The FDA itself even says that “vaginal rejuvenation” is an “ill-defined” term. It has been used to describe “non-surgical procedures intended to treat vaginal symptoms and/or conditions including … vaginal laxity, vaginal atrophy, dryness, or itching, pain during sexual intercourse, pain during urination, decreased sexual sensation.”

The Problems with Vaginal Rejuvenation Procedure Devices

The FDA has recently issued a safety communication for the purpose of alerting patients about the use of these vaginal rejuvenation procedure devices for cosmetic use.

Some of these vaginal rejuvenation procedure devices have been approved for the treatment of genital warts and the destruction of abnormal or pre-cancerous cervical or vaginal tissue and condylomas, according to the FDA. But most have not been FDA approved for cosmetic uses like the vaginal rejuvenation procedure.

The FDA warns patients and medical professionals that some of these energy-based vaginal rejuvenation procedure devices used “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 FDA is reporting that the use of these vaginal rejuvenation procedure devices may lead to scarring, vaginal burns, pain during intercourse, and recurring or chronic pain.

Companies that market a vaginal rejuvenation procedure include:

• Venus Concept
• BTL Industries
• Cynosure
• Alma Lasers
• Sciton
• Thermigen
• Inmode MD

Vaginal Rejuvenation Procedure Marketed to Public

NBC News
reports that these vaginal rejuvenation procedures have been heavily marketed to the public via online sources and through the media. NBC alleges, “Some of the companies that make the devices have hired public relations companies to pitch doctor and patient testimonials to newspapers, television and digital news outlets.”

They go on to say that women are encouraged to “take back their health” by undergoing a vaginal rejuvenation procedure. NBC reports that one of the companies that makes vaginal rejuvenation procedure devices, Alma Lasers, claims that their procedure is virtually painless, does not need anesthesia and does not require downtime.

Other companies offer the similar benefits, promising women enhanced self esteem and better quality of life.

The FDA has sent letters to seven companies regarding these claims, including Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.

If you have undergone a vaginal rejuvenation procedure utilizing one of these devices, you may be eligible to participate in a vaginal rejuvenation lawsuit investigation.