Vaginal Rejuvenation Lawsuit

Medical device manufacturers are prohibited from advertising their medical devices for uses other than those approved by the Food and Drug Administration (FDA), yet that is just what some manufacturers have been doing.

According to an FDA safety communication, some manufacturers of energy-based radiofrequency and laser devices meant to treat certain gynecologic conditions have been marketing their products for “vaginal rejuvenation” procedures. The FDA has not approved these devices for vaginal rejuvenation and is warning women and doctors about the risks.

“These products have serious risks,” FDA Commissioner Scott Gottlieb, M.D., said in a press release, “and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.”

Women who are considering vaginal rejuvenation procedures to deal with symptoms related to menopause, urinary incontinence, or sexual function are advised to be aware that the FDA has not established the safety and effectiveness of energy-based devices for these purposes. There have been reports of these therapies leading to serious side effects, including vaginal burns, scarring, and pain.

Chaffin Luhana is investigating cases in which energy-based devices caused harm while being used for non-approved procedures.

FDA Warns that Energy-Based Devices are Not Approved for Vaginal Rejuvenation

In July 2018, the FDA sent warning letters to all manufacturers advertising the use of their energy-based devices for vaginal rejuvenation.

“We recently notified seven device manufacturers of our concerns about the inappropriate marketing of their devices for ‘vaginal rejuvenation’ procedures,” said Gottlieb.

The seven companies include:

Alma Lasers (FemiLift)
BTL Industries (Exiils Ultra 360)
Cynosure (MonaLisa Touch)
InMode (Forma V and Fractora V)
Sciton (JOULE Multi-Platform System)
Thermigen (THERMIva)

In each letter, the FDA writes that “it has come to our attention” that the company is marketing energy-based devices “in a manner that potentially violates the FD&C Act.” They go on to explain that these devices were not approved for vaginal rejuvenation, or similar procedures like “Improving vaginal irregularities” or assisting in “vaginal mucosa revitalization.”

The FDA gave the companies 30 days to address the concerns. If they fail to do so, the FDA will “consider what next actions, including potential enforcement actions, are appropriate.”

The FDA has two concerns:

First, the FDA has not approved these devices for vaginal rejuvenation, so it violates applicable regulations for the marketers to advertise them for that purpose. The FDA states that the safety and effectiveness of these devices “hasn’t been evaluated or confirmed” by the FDA, and that deceptive marketing “of a dangerous procedure with no proven benefit” is egregious.

The FDA emphasizes that it has not cleared or approved for marketing “any energy-based devices to treat these symptoms or conditions, or any symptoms related to menopause, urinary incontinence, or sexual function.” They’re especially concerned that the manufacturers have been promoting these products to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause.

The second concern raised by the FDA is that women may be harmed by these procedures.

Serious Side Effects Associated with Vaginal Rejuvenation Procedures

So far, the FDA is aware of reports showing that energy-based procedures for vaginal rejuvenation may lead to serious adverse events, including recurring pain: “In reviewing adverse event reports and published literature,” Gottlieb stated, “we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.”

According to one report to the FDA’s adverse event report system, a sales representative told a patient the “Thermiva” energy-based device made by ThermiGen could help her with her urinary incontinence. Based on that information, she decided to get it done.

“I was in so much pain,” she wrote. She thought there was something wrong and went to see her gynecologist. The doctor informed her that she had bruising in the vagina, and after doing some research, noted that the FDA had not approved the product used for the procedure. “So how can they [the manufacturer] sell it?” the patient wondered.

In another report, the patient states that she had a vaginal rejuvenation procedure using the “Mona Lisa Touch” laser made by Cynosure. Two days after the procedure, she says she developed “severe and debilitating bladder/urethral pain.” She went back to the doctor twice and had a urinalysis performed. The results were negative both times. She went to a urologist and got the same results.

The patient changed gynecologists and started using an estrogen cream, hoping it would help. At the time of the report, she was still experiencing pain. She researched the device and noted that there was “no viable research on the Internet regarding this procedure….” She added, “Had I had access to full disclosure, I would have chosen not to have this procedure performed.”

Because of these and other risks, the FDA is encouraging women not to use these devices and to report any issues to the FDA’s MedWatch program. They have also warned doctors about the risks and suggested they discuss with patients the benefits and risks of all treatment options for vaginal symptoms. Meanwhile, the FDA will continue to monitor reports of problems with these devices and will inform the public of any new information.

Typical Injuries Associated with Vaginal Rejuvenation

Vaginal rejuvenation with energy-based devices has been linked to the following injuries:

Vaginal burns
Scarring
Pain during sexual intercourse
Recurring/chronic pain

What Are Vaginal Rejuvenation Procedures?

Vaginal rejuvenation is a marketing (not a medical) term used by companies to advertise their products to women seeking to remain youthful as they age. Childbirth, weight changes, and menopause can change a woman’s vagina, causing dryness, laxity, loss of tone, and decreased sensitivity. These changes can result in difficult side effects, including urinary incontinence, vaginal dryness, pain during intercourse, vaginal itching, and reduced sexual enjoyment.

Women who want to reverse these changes may be drawn in by advertisements that promise to “rejuvenate” the vaginal area, tighten the muscles, improve appearance, and ease symptoms of vaginal dryness and urinary incontinence. Though there are a number of invasive cosmetic surgeries that actually addresses the size and shape of the outside of the vagina—and which are also lumped under the category of “vaginal rejuvenation”—these aren’t the ones at issue, here.

Instead, these are so-called “non-surgical” vaginal rejuvenation techniques that are supposed to help tighten and tone the vagina via the use of “energy” devices.

What Are Gynecological Energy-Based Devices?

The FDA has cleared several energy-based devices for gynecologic treatments. These devices typically use laser or radiofrequency energy to treat conditions like pre-cancerous cervical or vaginal tissue, and genital warts. These devices have not, however, been approved by the FDA for other treatments related to vaginal rejuvenation.

That hasn’t stopped the manufacturers from advertising procedures using these devices to women who want to look and feel more youthful. Women who have been influenced by cultural trends and media coverage of what a “young-looking” vagina should be are likely to welcome non-surgical procedures touted by celebrities that promise to help them feel more confident.

Manufacturers play on that desire by offering these treatments and touting their supposed benefits. They have even referred to small scientific studies “proving” their devices work for these procedures, even though the devices did not go through the required safety and efficacy testing the FDA usually requires. Yet reputable scientists have not yet confirmed that these treatments are effective.

In a 2016 study, for instance, researchers noted, “A new trend gaining momentum is the advent of energy-based devices for vaginal rejuvenation that apply thermal [laser] or nonthermal [radiofrequency] energy to the various layers of the vaginal tissue, stimulating collagen regeneration, contracture of elastin fibers, neovascularization, and improved vaginal lubrication.”

The researchers went on to review the technologies, noting that the laser and radiofrequency energy heats the connective tissues in the vaginal wall, “aiming” to induce collagen contraction and other processes that revitalize and restore the elasticity and moisture to the vaginal tissues. These therapies have been shown to be effective in rejuvenating other areas like the face, neck, and décolleté, but “their application in the vaginal canal is a fairly new concept with a paucity of clinical studies currently available to validate their efficacy.”

Nevertheless, several of these devices are now available and marketed to women for these purposes. The researchers concluded that though these devices may offer another option to women seeking vaginal rejuvenation, there is a lack of quality studies evaluating the use of these devices for vaginal rejuvenation.

That’s what the FDA says, too. In fact, they have gone so far as to warn the manufacturers of these devices to stop marketing them for these uses, not only because of the lack of studies on them but because of the reports indicating they can cause serious side effects.