Joanna Szabo  |  October 12, 2018

Category: Legal News

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FDA Releases Warning About Vaginal Rejuvenation TreatmentVaginal rejuvenation treatment has grown increasingly popular in recent years, but the U.S. Food and Drug Administration (FDA) has recently released a warning about the dangers of this relatively new treatment.

Vaginal rejuvenation treatment is, according to the U.S. Food and Drug Administration, an “ill-defined” thing. It’s an umbrella term that actually encompasses many kinds of treatments for a variety of vaginal problems. These issues may include dryness, laxity, itching, atrophy, and pain during sex or urination. Patients choose to undergo vaginal rejuvenation treatment to alleviate any number of these issues, but may then face several serious complications as a result.

These treatments use equipment approved by the FDA to help with abnormal or precancerous cervical or vaginal tissue, as well as general warts. While vaginal rejuvenation treatment is sometimes used for other conditions, the FDA has not yet approved vaginal rejuvenation treatment for problems like vaginal atrophy, urinary incontinence, or reduced sexual function.

The FDA commissioner, Scott Gottlieb, referred to vaginal rejuvenation treatment companies as using “deceptive” marketing. Manufacturers of these treatments have allegedly made bold claims in their advertising, some suggesting that vaginal rejuvenation treatment with lasers can treat issues from the vaginal wall, canal, and pelvic floor to breast cancer treatment complications.

The American College of Obstetricians and Gynecologist has not supported vaginal rejuvenation treatment, noting that, “no adequate studies have been published assessing the long-term satisfaction, safety, and complication rates for these procedures.”

The FDA warns that vaginal rejuvenation treatment using energy-based devices may lead to major issues like burning, scarring, and chronic pain.

“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” FDA Commissioner Gottlieb said, according to Medical News Today. “We are deeply concerned women are being harmed.”

The American Society of Plastic Surgeons has noted an increased number of healthy women requesting vaginal rejuvenation treatment with the use of an energy-based device for aesthetic purposes rather than a real health issue.

The FDA has received at least 14 reports of adverse events related to vaginal rejuvenation treatment, including burning and significant pain. The agency has sent letters to a number of manufacturers, expressing concern about their marketing of these devices for use in vaginal rejuvenation procedures.

Indeed, while the initial cost of vaginal rejuvenation treatment may be cheaper than more traditional surgery, this does not take into account the risk of potentially severe complications, which could add on medical expense as well as long-lasting side effects.

Filing a Vaginal Rejuvenation Treatment Lawsuit

An investigation has been launched into the claims manufacturers of these energy-based devices have made regarding vaginal rejuvenation treatment. Experienced attorneys are seeking to help people who have suffered side effects of vaginal rejuvenation treatment, which may include problems like burning, scarring, or pain during sex.

If you or someone you love has suffered from complications from vaginal rejuvenation treatment, you may be able to join a class action lawsuit investigation. While filing a lawsuit cannot undo the damage caused by vaginal rejuvenation treatment gone wrong, it can help to alleviate the financial burden caused by medical expenses and lost wages.

If you or a loved one has undergone vaginal rejuvenation and experienced adverse side effects, including burning, pain, or scarring, you may qualify to join a vaginal rejuvenation class action lawsuit investigation that aims to hold these companies responsible. Fill out the FREE form on this page for more information.

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Join a Free Vaginal Rejuvenation Lawsuit Investigation

If you qualify, an attorney will contact you to discuss the details of your potential case at no charge to you.

PLEASE NOTE: If you want to participate in this investigation, it is imperative that you reply to the law firm if they call or email you. Failing to do so may result in you not getting signed up as a client or getting you dropped as a client.

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