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Were You Injured by a Nonsurgical Vaginal Rejuvenation Device?

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Used as a non-surgical solution for the vaginal dryness and laxity that occurs during menopause, vaginal rejuvenation procedures are also marketed as solutions for painful sex and painful urination, vaginal shrinkage, decreased sexual pleasure and even to improve the appearance of the vulva and vagina. To perform vaginal rejuvenation, also called female genital reconstruction, vaginoplasty, and vaginal renewal, doctors use energy-based laser or radio frequency devices.

Unfortunately, none of the energy-based devices used in these procedures have been proven safe for vaginal rejuvenation. In fact, these devices have never been approved for this use, and some women who are having the procedure done are suffering burns, scars, and other serious internal injuries. The FDA has warned that it is deeply concerned with women being harmed.

If you were injured from a vaginal rejuvenation procedure, you have rights, including the right to hold device manufacturers liable for the injuries you sustained, and we can help. Contact us today to learn more about how we can help you get the justice and compensation you deserve.

The time you have to pursue a claim is limited. Contact us for more information.

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Bad Actors Targeted by the FDA

As marketing and promotion for these types of procedures increased, so have claims from celebrities and others about how safe these procedures are and how wonderful they can make you feel. But what they don’t tell you is that these procedures aren’t permanent and long lasting, and that you may have to have them performed again and again to maintain results. Nor do they tell you that doctors and the government are warning women to stay away from these procedures until they can be proven safe.

Women must be on guard and aware that procedures that are being touted as safe and effective have little to no science to prove those statements. Unfortunately, women across the country are falling prey to the claims that the nonsurgical procedures work as good as other methods and procedures that have proven effectiveness. However, the FDA has received more than a dozen reports of complications including pain and bleeding.

Over the past few years, vaginal rejuvenation has bloomed into a multi-million-dollar industry that includes celebrity hype, deceptive and misleading advertising and promotion, and even doctors who have nothing to do with that area of the body performing these procedures and pushing them as safe. So much misleading and false advertising is going on, that the FDA caught wind of it and issued “It Has Come to Our Attention” letters to Alma Lasers, BLT, Industries, Cynosure, InMode, Sciton, ThermiGen, and Venus Concept questioning why they are marketing and advertising their products as approved for the treatment of menopausal symptoms, decreased sexual pleasure, and urinary incontinence when they have never been approved for those uses.

Products involved in the FDA letters include:

  • DiVa Laser Vaginal Therapy
  • FemiLift
  • FormaV
  • FractoraV
  • MonaLisa Touch
  • THERMIva
  • Ultra Femme 360
  • Venus Fiore

These devices are being marketed and promoted as a safe way to improve the appearance of female genitalia, stop stress urination incontinence, and vaginal shrinkage and dryness often caused by menopause, with virtually no side effects.

But what isn’t being advertised is that there have been no large clinical studies proving these devices are safe for vaginoplasty or that they are even as effective as approved treatments. They aren’t telling women that the vaginal walls of some women have been burned, that women may be left bleeding and in pain, or that these devices may cause internal scarring. These device makers are using women to sell products and improve their profit margins, while patients are suffering injury.

A History of Vetting Failures for Drugs and Devices for Women

According to Everyday Health, Dr. Stephanie S. Faubion, Director of the Women’s Health Clinic in Rochester, MN suggests that before having a procedure, women demand the science behind the procedure and the tools used to perform them because of what she calls a history of lack of vetting of drugs and devices for women. She calls using devices for procedures that lack scientific data the “wild west,” and says women have to start fighting back.

And she is far from the only doctor who is warning patients away from unproven procedures. In 2016, a Position Statement was issued by the American College of Obstetricians and Gynecologists after media outlets advertised that vulvovaginal procedures with devices such as the MonaLisa Touch laser were safe and approved by the FDA for post-menopausal symptoms. The ACOG Statement made clear that the devices used in vaginoplasty or vaginal rejuvenation have not received clearance by the FDA for these uses.

Further, ACOG warned physicians to look past marketing and promotions of a technology before using new methodologies and offered a reminder that doctors have an ethical responsibility to provide their patients with accurate information regarding treatments and procedures. However, some doctors continue to offer these treatments despite these and other warnings.

Including dermatologists and plastic surgeons who offer treatment with these devices. Some question why these types of doctors are offering cosmetic procedures involving the vagina. Some, like Dr. James Brown, medical director of St. Joseph’s Hospital’s Women’s and Children’s Services, say some doctors are “doing things in an area they are not used to being. They don’t work down there.”  He said he tells patients to stick with the treatments and therapies that have been proven effective at improving symptoms.

Vaginal Rejuvenation Injuries

Some women who underwent vaginal rejuvenation procedures and suffered serious injuries are questioning why these devices are being used when the FDA has not given its go-ahead. They are questioning why they were never told their vaginal walls may be seriously burned and they may be left with internal and external scarring. In fact, some women who have experienced one or more vaginal rejuvenation procedures have reported:

  • chronic pain
  • bleeding
  • development of vaginal scar tissue
  • pain during sex
  • reoccurring pain
  • severe burns to vaginal tissues

These women want to know when the device makers knew or should have known that their products could damage the vulva and vagina and why these device makers failed to inform the medical community about these risks and dangers. These women underwent vaginal rejuvenation procedures to enhance their sex lives, reduce urinary incontinence, and improve their menopausal symptoms, but were left with burns, and scars, and pain.

Women are Fighting Back

Women who experienced adverse events and serious injuries are fighting back against device manufacturers who are willing to risk the wellbeing of patients to improve their bottom lines. These victims are demanding to know why the manufacturers of these energy-based devices are continuing to market and promote their products as safe and effective for vulvovaginal procedures but are yet unwilling to conduct the long-term studies necessary to prove their safety and effectiveness with these procedures. They want to know why the FDA had to issue warnings alerting women to these dangers when device manufacturers have a high duty to report all known dangers and risks.

Now, women who went in for quick and simple procedures and were left with internal burns, the formation of non-flexible scar tissue, and recurring and chronic pain are seeking justice and demanding answers. We are filing lawsuits on behalf of any woman who underwent a vaginal rejuvenation procedure with an energy-based device and suffered serious injuries that left them bleeding, in pain, and with burns and scarring of their vaginal walls.

We Can Help

We are filing vaginal rejuvenation injury claims on behalf of women who suffered serious injury from the procedures no matter where they live in the country. If you or a woman you know was burned, suffered scarring, or was left with repeating or constant pain after undergoing vaginoplasty, vaginal renewal, vaginal reconstruction or vaginal rejuvenation using devices such as the Ultra Femme 360, Mona Lisa Touch, FemiLift , DiVa Laser Vaginal Therapy, FractoraV, Venus Fiore, THERMIva, FormaV, or another energy-based device, we want to hear from you.

For decades, we have stood by countless patients who were injured by devices that were supposed to help. And we will stand beside you to ensure you get the maximum compensation available by law.  No patient should ever be the victim of greed, yet we hear about it all the time. From the medicines you take to the products you use, we help patients and consumers get the compensation they need and the justice they deserve for the injuries and losses they suffer, and we can help you too.

If you were burned, scarred, and left with pain after one or more vaginal rejuvenation procedures understand that you have the power to hold these device manufacturers accountable for promoting these devices as safe and effective but not providing proof of these claims, and you can hold them liable for the injuries you suffered and the losses you experienced because of those injuries. Contact us today to learn more about how we help, your legal rights, and whether you are entitled to significant financial compensation for your injuries and losses.

Injured by a Dangerous Medical Device or Drug?
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