Deceptive Health Claims, Significant Risks
On July 30, 2018, the FDA issued a safety communication for laser and other energy-based vaginal rejuvenation treatments due to the serious risks they carry. Women have experienced vaginal burning, serious scarring, and chronic pain. If you have suffered from an adverse event after undergoing a rejuvenation laser treatment, you may have the right to file a vaginal rejuvenation lawsuit.
These dangerous treatments are deceptively being advertised as a way to help with vaginal looseness, urinary incontinence, and pain during intercourse. These rejuvenation treatments are being carried out by spas, cosmetic facilities, gynecologists, and obstetricians.
However, there are no conclusive studies to suggest that these procedures can do what is being promised. In all of the published trials to date, only several hundred women have been studied and most of these studies last only 12 weeks. No long-term safety information is available for women.
What is Vaginal Rejuvenation?
Vaginal rejuvenation is a term that covers essentially anything that alters the vaginal anatomy. This includes both internal and external structures.
The procedure in question is one in which energy-based devices (i.e. lasers), using thermal or nonthermal energy, aim to correct and restore the optimal structure and tightness of the vagina and surrounding tissues by inducing contraction of collagen and elastin.
These are outpatient procedures, do not require anesthesia, and take 15 – 30 minutes. There are generally three treatments spaced 6 weeks apart.
There is a more invasive rejuvenation procedure known as vaginoplasty or posterior colporrhaphy, where the separate muscles of the vagina are brought together and the extra mucosa skin from the back side is removed. If there is external skin protruding, this can be removed so the vagina looks better aesthetically. This procedure does require either local or general anesthesia.
Dr. Adeeti Gupta, a board-certified gynecologist based in New York, has talked about the procedures and said, “these don’t actually make your vagina ‘tighter’ per se. Instead, the laser procedure causes your below-the-belt tissue to become inflamed, creating scar tissue. This can look like a tightening of the vaginal canal.”
Vaginal Rejuvenation Therapy Not FDA Approved
Rejuvenation procedures are becoming more and more popular among young women, especially after childbirth, but, to date, laser and other energy-based devices have not been FDA approved for any type of vaginal rejuvenation, menopause symptoms, or sexual function.
The FDA is specifically looking at procedures that use CO2 lasers and other energy-based devices used to destroy or reshape vaginal tissue.
In regards to their investigation, the FDA commissioner Dr. Scott Gottlieb said, “these products carry serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.”
These devices have only been approved for the treatment of abnormal or pre-cancerous cervical or vaginal tissue, genital warts, and hysterectomies.
Vaginal Rejuvenation Side Effects:
- Vaginal burning
- Painful scarring
- Bleeding
- Pain during sexual intercourse
- Recurring or chronic pain
- Loss of sensation, numbness
- Swelling
Women may also experience nerve damage after undergoing a treatment, and because it is very hard for nerves to regenerate, this side effect may be permanent.
The full extent of the risks these procedures carry is still unknown, but there have been at least 14 reports of adverse events. If you, or anyone you know, has experienced side effects after a vaginal rejuvenation treatment, we urge you to report the adverse event to the FDA.
7 companies Issued FDA Warning Letter
These companies were warned because of their “inappropriate marketing” for vaginal rejuvenation treatments:
- Alma Lasers (FemiLift, Pixel CO2 Laser System)
- BTL Industries, Inc (Exilis Ultra 360 System)
- Cynosure (MonaLisa Touch, DEKA Smart Xide Laser System)
- Inmode (FormaV and FractoraV lasers)
- Sciton (JOULE Multi-Platform System)
- Thermigen (THERMIva)
- BTL Aesthetics (Venus Fiore RF Ablation System)
The letters sent are requesting that these manufacturers address these serious concerns regarding vaginal rejuvenation treatments within 30 days. If the concerns are not addressed, the FDA will consider potential enforcement actions next.
Can I File A Vaginal Rejuvenation Lawsuit?
TruLaw is looking into vaginal rejuvenation lawsuits now. If you have suffered from any side effects after having a laser vaginal rejuvenation treatment, please fill out the Contact Us form on this page so we can discuss your legal options. We will also make sure to keep you updated on the activity of the FDA actions as well as the status of these cases.