In a matter of years, vaginoplasty and related procedures have grown into a multi-million dollar a year industry that is ripe with celebrity hype, misleading advertisements, and dangerous devices that have never been cleared for use in this way. Devices like MonaLisa Touch, FemiLift, DiVa Laser Vaginal Therapy, Ultra Femme 360 and others are being used in vaginal procedures called vaginal rejuvenation, vaginoplasty, vaginal renewal and as treatments for stress urinary incontinence and the symptoms of menopause. The problem is, these devices have not been proven safe for procedures inside the vagina, nor have they been cleared by the FDA for these uses. If you were injured during a procedure, you may be entitled to seek justice and compensation through a vaginal rejuvenation lawsuit.
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In 2014, the MonaLisa Touch laser device was advertised as approved by the FDA for the treatment of vaginal atrophy. The problem is, the device has never been approved by the FDA as a treatment for vaginal atrophy, and it has never been approved for breast cancer patients.
The problem has become so wide-spread that the FDA just recently issued “It Has Come to Our Attention” letters to numerous device makers questioning why they are marketing and promoting their devices as approved by the FDA when they have never received approval for the treatment of urinary incontinence, decreased sexual please, vaginal dryness, or vaginal atrophy.
Letters were sent to ThermiGen, Alma Lasers, Cynosure, Sciton, BLT Industries, and Venus Concept, who were given 30 days to respond to the FDA before the government agency will decide the next step.
Some of these devices have been involved in small trials involving a handful of women who underwent vaginal procedures. Unfortunately, most of these trials only followed up to a year or less, and none involved large groups of patients. What these trials have shown is a need for further clinical studies to determine how effective they are, what exactly they are effective for, and in for what situations their use is considered safe.
Devices May Cause Injuries
The FDA has issued a warning to women alerting them to the risks and dangers of these devices and said that reports of injuries have been received, including reports of pain and bleeding. Other injuries reports include complications that should never happen, such as:
- chronic pain
- scarred vaginal walls
- pain during sex
- reoccurring pain
- severe burning of vaginal tissue
Victims are Seeking Justice
Women who have undergone these procedures only to suffer severe burns, pain, bleeding, and scarring want to know why they were not informed of these risks. They want to know when the device makers knew or should have known that these tools could cause serious internal burns that result in pain and scarring that can make normal activities, including sex, painful.
If you underwent a vaginal rejuvenation procedure and suffered serious injuries and complications, contact us today. We have a long reputation for fighting for the rights of patients injured by defective or dangerous medical devices, and we will fight for you. For decades we have helped our clients hold device makers accountable for their products and the injuries they cause, and we can help you too. Contact us today to learn more, including whether you are eligible for financial compensation.