Unfortunately, women are again being thrust into a wild west of products and drugs that are advertised as whole new solutions to age-old problems. Procedures are being performed on women with devices that have never been approved for these uses, and women are getting hurt. If you suffered an injury from a vaginal rejuvenation procedures, speak with a vaginal rejuvenation lawyer today.
What’s Going On?
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Vaginal rejuvenation is a relatively new concept for the common problems associated with menopause: vaginal dryness, itching, and atrophy and as a treatment for stress urinary incontinence. It involves using an energy-based device inside the vagina. The biggest problem is that not one single device on the market today has been approved for vaginal rejuvenation procedures.
Makers of devices like the Ultra Femme 360, Venus Fiore, MonaLisa Touch, Fractora V, DiVa Laser Vaginal Therapy, FormaV, and ThermIva are advertising and promoting their products as FDA approved, safe for use, and virtually without side-effects. However, women are reporting injuries after undergoing vaginal rejuvenation procedures, also called vaginoplasty, or vaginal renewal, including suffering vaginal burns, pain, bleeding, and scarring. These injuries can lead to decreased sensation, the development of non-flexible scarring, ongoing pain, and even infection.
Yet, device makers continue to market their devices as safe even though they have offered no adequate proof to the FDA regarding their effectiveness or their safety. The FDA reports that it has received complaints from women who have suffered complications from these procedures, including reports of pain and bleeding.
It Gets Worse
Not only are these devices still being advertised and used in the treatment of the dryness and itching that can come with menopause, and for cosmetic reasons, the people who are doing these procedures aren’t all doctors who normally perform procedures in the vaginal area. These procedures are being done by plastic surgeons and dermatologists – doctors who aren’t trained in vaginal operations.
ACOG – the American College of Obstetricians and Gynecologists issued a Position Statement that reminded doctors of their ethical responsibility to give patients accurate and up-to-date information regarding treatments and procedures. The statement also clearly warned doctors to look beyond marketing and advertisements before using new technologies and methodologies on their patients.
Were You Injured During Vaginal Rejuvenation?
Vaginal rejuvenation injury claims are being filed on behalf of women who underwent a procedure only to suffer vaginal damage such as scars, burns, bleeding, pain, and decreased sensation. These women say they were never informed of the risks of injury or complications before having the procedure and they want to know why.
Device makers have a high duty to ensure their products are safe before putting them on the market. Included in that duty is the obligation to inform the medical community and patients of any adverse events, side effects, complications, or precautions that have been associated with their products. But plaintiffs say they were never warned of risks or dangers, and now they are demanding answers.
If you suffered injury from a vaginal rejuvenation procedure contact us today. We have helped countless victims hold device manufacturers accountable for injuries, and we can help you too. Contact us now to learn more about how we help and whether you are entitled to significant compensation for your injuries.