Vaginal Rejuvenation Lawsuit
A vaginal rejuvenation lawsuit may be an option for women who suffered serious complications associated with cosmetic vaginal procedures. According to the FDA, certain device manufacturers could be marketing energy-based medical devices to perform vaginal rejuvenation (non-surgical procedures intended to treat certain vaginal symptoms). However, the safety and effectiveness of such medical devices to perform these procedures has not been established. Affected patients and their families may be eligible to pursue compensation for damages with the help of a defective medical device attorney.
If you or a loved one have been adversely affected by a potentially defective medical device, contact Attorney Group to learn about your options. We offer free, no obligation consultations. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated attorney who can assist you throughout the legal process.
Have You Seen a Vaginal Rejuvenation Lawsuit Commercial?
You may have seen a vaginal rejuvenation lawsuit commercial on television and wondered whether you or a loved one have been affected by the potentially defective medical devices used in vaginal rejuvenation treatments and, if so, whether you are eligible to pursue a claim against the manufacturer or distributor. The purpose of this article is to provide you with additional information about warnings, lawsuits and settlements involving potentially dangerous vaginal rejuvenation procedures used to treat conditions and symptoms related to menopause, urinary incontinence, or sexual function so that you have a better understanding of your options.
What is Vaginal Rejuvenation?
According to the American College of Obstetricians and Gynecologists, an increasing number of clinicians and practitioners have been offering various types of vaginal surgical procedures marketed as ways to enhance appearance or sexual gratification. These procedures are often labeled as vaginal “rejuvenation,” “designer vaginoplasty,” “revirgination,” and “G-spot amplification.”
Vaginal rejuvenation is often used to describe non-surgical procedures used to treat vaginal symptoms and/or conditions including:
- Vaginal laxity
- Vaginal atrophy, dryness, or itching
- Pain during sexual intercourse
- Pain during urination
- Decreased sexual sensation
Additionally, vaginal rejuvenation may be used to treat symptoms related to menopause, urinary incontinence, or sexual function.
Energy-Based Medical Devices
Energy-based medical devices are surgical instruments used to apply energy to a specific surgical site, potentially providing pin-point control over the surgery. Laser, light and radiofrequency devices are the most common energy-based devices and are used across various areas such as dermatology, plastic surgery and other minimally invasive procedures.
As minimally invasive surgical procedures have become more popular with both surgeons and patients, the market for energy-based devices has increased as well. In some cases, device manufacturers may have been inappropriately marketing their energy-based devices for vaginal rejuvenation and similar treatments although the devices have not been cleared or approved for those uses.
According to a Position Statement issued by the American College of Obstetricians and Gynecologists, fractional laser treatment (fractional carbon dioxide laser) is neither approved nor cleared by the FDA for the specific indication of treating vulvovaginal atrophy despite several reports that the treatment has been “approved” or “cleared” by the FDA.
Although there are a number of indications for this technology, the specific indication for the treatment of vulvovaginal atrophy is not listed.
Complications Associated with Vaginal Rejuvenation
Vaginal rejuvenation is often offered as a way to enhance appearance or increase sexual gratification. In some cases, the procedures may be used to treat symptoms associated with menopause, urinary incontinence or sexual function. However, some government agencies and other health care professionals have warned against the procedures as they may lead to serious complications. To date, the FDA has received at least a dozen reports of adverse events related to the treatments.
Complications related to vaginal rejuvenation may include:
- Vaginal burns
- Pain during sexual intercourse (dyspareunia)
- Recurring/chronic pain
- Altered sensation
The American College of Obstetricians and Gynecologists also warn that “patients who are anxious or insecure about their genital appearance or sexual function may be further traumatized by undergoing an unproven surgical procedure with obvious risks.”
On July 30, 2018, the FDA issued a safety communication notifying patients and health care providers that “the use of energy-based devices to perform vaginal ‘rejuvenation,’ cosmetic vaginal procedures, or non-surgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function may be associated with serious adverse events,” including “vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.”
According to the safety communication, the FDA is aware that “certain device manufacturers may be inappropriately marketing their energy-based devices” for vaginal rejuvenation and other treatments “that are outside of their cleared or approved intended uses.”
The FDA has sent letters to the following companies regarding their devices:
- Immode MD Ltd. – FormaV and FractoraV lasers
- Thermigen, Inc. – THERMIva
- Sciton, Inc. – JOULE Multi-Platform System
- Alma Lasers – Alma Lasers Pixel CO2 Laser System (FemiLift)
- Cynosure, Inc. – DEKA SmartXide2 Laser System (MonaLisa Touch)
- BTL Industries – DEKA SmartXide2 Laser System (MonaLisa Touch)
- Venus Concept, Ltd. – Venus Fiore System
These devices were in potential violation of the Federal Food Drug & Cosmetic Act because, in some cases, they had not been approved for internal vaginal restoration, labia skin tightening, mons pubis reduction, and other vaginal rejuvenation procedures.
Lauren A. on May 16, 2016
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Has There Been a Recall on Devices Used for Vaginal Rejuvenation?
At the time of this article’s publication, the FDA has not notified the public of a recall involving vaginal rejuvenation or medical devices associate with the procedures.
Medical device recalls may be conducted by the drug manufacturer, by FDA request, or by FDA order.
Potential litigation could possibly claim that the device manufacturers failed to disclose known side effects of the device and that patients suffered damages as a result.
Is There a Vaginal Rejuvenation Class Action Lawsuit?
At the time of this article’s publication, a vaginal rejuvenation class action lawsuit action has not been filed. Affiliated attorneys are uncertain that a class action will be certified for patients who are adversely affected by the device. Instead, if multiple lawsuits are filed against the manufacturers, alleging injuries and other damages caused by adjustable valves, shunts and similar medical devices, it is anticipated that these potential lawsuits will be consolidated for discovery and other pretrial proceedings.
When cases are consolidated in this way in federal court it is called multidistrict litigation (MDL), and on a state level it is known as a state court consolidated proceeding. MDLs are distinct from class actions, and it is generally agreed that consolidating cases instead of proceeding in a class action is a more efficient and effective way of handling claims arising from injuries caused by defective medical devices.
In most cases that proceed in an MDL or state court consolidated proceedings, after a certain period of time initial trials, also known as bellwether trials, take place. The purpose of these trials is for the parties to get an idea of the types of evidence and arguments that will made, as well as to see how juries will respond to the evidence and arguments. After a certain number of cases have been tried, the parties are in a better position to determine whether a case can be settled.
Have There Been Vaginal Rejuvenation Lawsuit Settlements?
Some defective medical device lawsuits may settle early in the claims process. However, it is not expected that there will be any settlements associated with vaginal rejuvenation procedures at this time. Instead, it is expected that adjustable valve and shunt lawsuits will be consolidated in federal court through an MDL. Vaginal rejuvenation lawsuit attorneys note that the outcome of any case is never guaranteed, and past results are not necessarily predictive of future outcomes.
Vaginal Rejuvenation Lawsuit News
- August 2018 CDRH sends an “It Has Come To Our Attention” letter to Venus Concept, Ltd., stating that the agency had conducted a review of their files and have been unable to identify FDA clearance or approval for the Venus Fiore System as marketed on the manufacturer’s website.
- July 2018FDA issues a safety communication alerting patients and health care providers of the serious adverse events potentially related to the “use of energy-based devices to perform vaginal "rejuvenation," cosmetic vaginal procedures, or non-surgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function.”
- July 2018CDRH sends an “It Has Come To Our Attention” letter to BTL Industries, stating that the Exilis (Exilis Ultra 360 System) device had been cleared for the primary treatment of dermatologic and general surgical procedures for non-invasive treatment of wrinkles and rhytids, but not for the claims listed on the manufacturer’s website.
- July 2018CDRH sends an “It Has Come To Our Attention” letter to Cynosure, Inc., stating that the company had made certain claims about its DEKA SmartXide2 Laser System (MonaLisa Touch) when, in fact, the FDA had not approved nor cleared the device for such uses.
- July 2018CDRH sends an “It Has Come To Our Attention” letter to Alma Lasers, stating that the company had made certain claims about its Alma Lasers Pixel CO2 Laser System (FemiLift) when the device had not been cleared by the FDA for such uses.
- July 2018CDRH sends an “It Has Come To Our Attention” letter to Sciton, Inc., stating that the JOULE Multi-Platform System had been cleared as a laser/light powered device for multiple general uses, but had not been cleared for uses specified on the manufacturer’s website.
- July 2018CDRH sends an “It Has Come To Our Attention” letter to Thermigen, Inc., stating that the THERMIva had been cleared “for use in dermatological and general surgical procedures for electrocoagulation and hemostasis and to create lesions in nervous tissue when used in combination with Neuro Therm (previously Smith&Nephew) thermal/coagulation probes,” but not approved for uses related to vaginal rejuvenation.
- July 2018CDRH sends an “It Has Come To Our Attention” letter to Immode MD Ltd., stating that the agency had been “unable to identify any Food and Drug Administration (FDA) clearance or approval for the FormaV and FractoraV lasers” as currently marketed on the manufacturer’s website “for therapeutic use in the treatment of sexual dysfunction, vaginal rejuvenation and urinary stress inconsistence.”
How a Vaginal Rejuvenation Lawsuit Attorney Can Help
Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
Likewise, companies that promote vaginal laser rejuvenation and other procedures using unapproved energy-based devices related to vaginal plastic surgery could potentially be deceiving the public and exposing women to unknown, serious health complications.
People injured by a defective energy-based device or vaginal rejuvenation may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those killed may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.