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Vaginal Rejuvenation Lawsuit

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Filing a vaginal rejuvenation lawsuit may be an option or women who suffered serious harm following use of energy-based devices in cosmetic procedures such as “designer vaginoplasty,” “revirgination” or “G-spot amplification”.

Contact a Vaginal Rejuvenation Attorney for a Free Case Review

The nationwide law firm of Bernstein Liebhard LLP is offering free, no-obligation lawsuit reviews to women who suffered injuries and complications associated with the use of unapproved vaginal rejuvenation devices, including:

• Severe vaginal burns
• Vaginal scarring
• Pain during sexual intercourse
• Recurring/chronic vaginal pain

To get in touch with a vaginal rejuvenation lawyer today, please contact our office by calling (888) 994-5118.

Vaginal Rejuvenation Devices: What’s the Problem?

Energy-based vaginal rejuvenation devices typically use lasers or radiofrequency waves and  are marketed for use in non-surgical, cosmetic procedures to treat:

• Vaginal laxity
• Vaginal atrophy
• Dryness or itching
• Pain during sexual intercourse
• Decreased sexual sensation

Such procedures are often offered to women who are suffering vaginal symptoms related to menopause, incontinence, or sexual dysfunction.

Some of the devices that have been marketed for vaginal rejuvenation include:

• Alma Laser’s FemilLift
• BTL Industries’ Exilis Ultra 360
• Cynosure’s Mona Lisa Touch
• InMod’s Forma V and FractoraV Lasers
• Sciton’s JOULE Multi-Platform System
• ThermiGen’s THERMIva
• Venus Concepts’ Venus Fiore System

In July 2018, the U.S. Food & Drug Administration (FDA) issued letters informing the above companies of concerns regarding the marketing of their devices for use in vaginal rejuvenation surgery. The letters pointed out that the agency had never approved any energy-based devices for this purpose. In fact, they were only cleared for the treatment of abnormal or precancerous cervical or vaginal tissue, as well as condylomas (genital warts) and other serious conditions.

“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” the FDA’s commissioner said in a statement dated July 30th. “We are deeply concerned women are being harmed.”

Injuries and Complications Associated with Unapproved Vaginal Rejuvenation Devices

The FDA has received more than a dozen reports of injuries and complications associated with unapproved, energy-based vaginal rejuvenation devices.

“Everyone is talking about vaginal rejuvenation. I was invited to a thermiva event by my friend. The sales rep told us that the product could be used for urinary incontinence. So i decided to get it done,” one women wrote to the FDA. “I was in so much pain. I decided to do more research and saw that the website talks about urinary incontinence and how it can cure it. So i decided there must be something wrong with me and went to my obgyn and she then informed me that i had bruising and she looked on the fda website and told me that the product is not approved from fda. So how can they sell it?”

“Two days after the procedure, i developed severe and debilitating bladder/urethral pain,” another wrote following a procedure with the Mona Lisa Touch laser.

“There is no viable research on the internet regarding this procedure and virtually no negative comments, feedback, or threads, which leads me and my physicians to wonder if the internet is being “scrubbed” by the manufacturer,” she continued.

What Should Patients Do?

In a Safety Alert dated July 30^th, the FDA advised patients and doctors against the use of energy-based devices for vaginal rejuvenation. Among other things, the agency recommended that they:

• Be aware that the safety and effectiveness of energy-based devices to perform vaginal “rejuvenation” or cosmetic vaginal procedures has not been established.
• Understand that the FDA has not cleared or approved any energy-based medical device for vaginal “rejuvenation” or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function.

Women who have experienced painful injuries and complications following treatment with an energy-based device for vaginal rejuvenation have been asked to report their experiences to MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Learn More About Filing a Vaginal Rejuvenation Lawsuit

Women who have been harmed by an unapproved, energy-based vaginal rejuvenation device may be entitled to compensation for medical bills, lost wages, and other injury-related damages.

To learn more about filing a vaginal rejuvenation lawsuit, please contact Bernstein Liebhard LLP to arrange for a free, no-obligation legal consultation by calling (888) 994-5118.