Medical Policy: 04.01.11
Original Effective Date: May 2015
Reviewed: April 2020
Revised: April 2019
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Vaginal atrophy, also known as atrophic vaginitis, vulvovaginal atrophy and urogenital atrophy, is a condition that causes the vagina and tissue near the vagina to get dry, thin and inflamed. There is a reduction of blood flow, normal vaginal fluid, and an increase in the pH balance of the vagina, which leads to reduction of natural Lactobacilli (heathy bacteria in the vagina). Vaginal atrophy is often caused by lack of a geno typical woman’s ability to produce estrogen due to the following:
Symptoms associated with vaginal atrophy include dyspareunia, vaginal burning, itching, dryness and laxity. Urge incontinence, frequency dysuria and stress incontinence have also been reported.
Treatment options for vaginal atrophy includes fractional CO2 laser therapy which delivers controlled energy to the vaginal tissue leaving the surrounding tissue intact this allows faster healing as the mucosa of the vaginal wall is rejuvenated. This micro-ablative process contracts existing fibers and stimulates the formation of new collagen, rejuvenating the target tissue. This procedure can be performed in the office or in an outpatient setting, it does not require anesthesia or down time ensuring the geno typical women can return to their normal routine post procedure. This procedure may require 3 treatments over an 18-week period and will require annual maintenance treatment once completed.
Vaginal relaxation syndrome (loose vagina) is defined as the increase in the inner diameter of the vaginal wall. It can result in loss of friction and sexual satisfaction for both a geno typical woman and her partner.
The most common cause of vaginal relaxation is the overstretching of the vaginal wall during childbirth, which can increase with the number of births. Other causes are congenital connective tissue weakness and natural aging.
Until now, effective results could only be achieved through invasive surgical treatments such as anterior and posterior vaginal plastic surgery. There are many post-operative complications associated with these procedures and high degree of dissatisfaction with the results. With advances recently available with non-surgical lasers, vaginal canal tightening is becoming more mainstream and far more easily contemplated. Usually two sessions are recommended. There is no special pre-op preparation or post-op precautions necessary. Patients can immediately return to their normal everyday activities.
Radiofrequency laser technology also is utilized as a treatment option for vaginal tightening. The radiofrequency technology induces collagen contraction without damaging the epidermis. The result is skin tightening via soft tissue coagulation. The radiofrequency technology emits energy in the form of electromagnetic waves, which creates a heated treatment zone. Increased resistance causes heat buildup at the subdermal junction. The heat induces collagen denaturation and collagen contraction. Protein stimulation causes new collagen formation and production in the dermis which results in epidermal tightening. A series of 3 treatments done 7-10 days apart is recommended for optimal results. May also require maintenance on an annual basis.
Fractional CO2 laser therapy can also be utilized for vaginal tightening as well.
A new technology approved in the United States, the MonaLisa Touch is a CO2 laser that delivers controlled energy via side firing probe inserted into the vaginal canal. At the point of contact, the laser dot removes a tiny area of tissue. This creates a pinhole around the diameter of a human hair. As the body repairs itself, it stimulates cells to create healthy tissue at the site of the dot and the area immediately surrounding it. This device promotes and stimulates the regeneration of collagen fibers and restores hydration and elasticity within the vaginal mucosa i.e. vaginal rejuvenation.
The MonaLisa Touch is an in-office procedure typically performed by an obstetrician/gynecologist. The procedure requires 3 treatments over a 12-week period, treatments take less than 10 minutes. The patient should expect to come back annually for maintenance treatment.
Stretching of the vagina and introitus can occur from vaginal delivery or be a part of the natural aging process. MonaLisa Touch laser acts directly on the mucosa of the walls of the vagina to tighten, reshape, tone, stimulate tissue and regenerate collagen.
Treatment with MonsaLisa Touch will:
Based on the peer reviewed medical literature there has been a multisite study conducted at The Christ Hospital, Cincinnati, OH and Stanford University Medical Center, the trial assessed the use of CO2 fractional laser therapy on 30 women with vaginal health issues due to natural or induced menopause. All of the patients in the trial were treated with the MonaLisa Touch laser. Preliminary findings show positive results. However, the safety and effectiveness of vaginal rejuvenation and tightening procedures have not been documented. There is lack of data supporting the efficacy and that these procedures are medically indicated. Randomized controlled trials or comparative effectiveness trials with long term follow up, comparing MonaLisa Touch laser treatments to established procedures/treatments are necessary to evaluate the effectiveness of this technology. The evidence is insufficient is insufficient to determine the effects of the technology on net health outcomes.
Alma FemiLift™ is a minimally invasive outpatient solution that incorporates CO2 laser technology to provide results for various female concerns. Life processes such as childbirth, weight fluctuations and hormonal changes may overstretch and damage vaginal tissue, damge the pelvic floor and alter the mucosal tone of the vaginal wall. These physiological changes can lead to conditions such as involuntary urine leakage, vaginal laxity, dryness and recurring infections which negatively affect a woman’s quality of life and self-confidence.
FemiLift™ is utilized to treat the following indications:
The FemiLift handpiece is a unique, single use hygienic probe, which is uniquely designed to fit varying vaginal sizes and ensure maximum patient comfort. During the treatment the physician rotates the probe in a 360-degree pattern to cover the entire vaginal wall, providing optimal coverage.
The new and hygienic, single use FemiLift Slim Probe was designed to fit women with inherently narrower anatomical structures, as well as those who have experienced anatomical or histological changes such as vaginal atrophy or tissue damage resulting from oncology treatments. Working with this slender probe follows the same protocol as with the standard probe.
FemiTight is a CO2 probe that was created for the treatment of labia majora tightening. Treatments conducted with this probe use a low power CO2 laser that gently heats the tissue, restoring and reviving collagen growth.
CO2 RE Intima is a non-surgical CO2 laser procedure used to restore vaginal health.
CO2 RE Intima is used for the following:
Syneron Medical LTD announced on November 5, 2015 the US FDA granted numerous additional indications for CO2 RE device which included gynecology applications (including vaginal treatments).
IntimaLase® is Er YAG laser therapy for incisionless, non-invasive photothermal tightening of the vaginal canal. The indication for IntimaLase is vaginal relaxation syndrome, which is the loss of the optimum structural form of the vagina. This condition is generally associated with overstretching of the vaginal canal during childbirth as well as with natural aging.
Fotona’s 2940 nm Er YAG non-ablative laser with proprietary “smooth mode” technology thermally affects the vaginal tissue, stimulating collagen remodeling and the synthesis of new collagen fibers in the vaginal mucosa tissue and collagen–rich endopelvic fascia. The final result of collagen neogenesis and remodeling is tightening of the vaginal canal.
Usually two sessions are recommended. There are no special pre-op preparation or post-op precautions necessary. Patients can immediately return to their normal everyday activities.
IntimaLase and other aesthetic gynecology treatments can be performed with the following Fotona laser systems:
Protégé Intima is a FDA-approved device utilizing radiofrequency (RF). RF thermally excites the fibroblast and subcutaneous structures of the skin, reaching temperatures of 40-42 Celsius. The body’s natural healing process will produce new collagen fibers. This procedure is done in the office, requires no needles, involves no down-town and patients can return to their regular activities as soon as they leave the office.
Protégé Intima remodels the external labia and internal vagina improving the appearance. This painless radiofrequency device also tightens the vagina and increases blood flow which may lead to an increase in sexual satisfaction. An additional reported benefit is improvement and often elimination of urinary stress incontinence.
A series of 3 Protégé Intima treatments are required, done 7-10 days apart for optimal results.
Pellevé® S5 System uses radiofrequency technology that emits energy in the form of electromagnetic waves, which creates a heated treatment zone. Increased resistance causes heat buildup at the subdermal junction. Heat induces collagen denaturation and collagen contraction. Protein stimulation causes new collagen formation and production in the dermis which also results in epidermal tightening.
ThermiVA utilizes radio frequency waves via a special probe (wand) that produces heat which stimulates the vagina to produce natural moisture on its own, providing women the relief from dryness. Heating the tissue will stimulate the body’s own production of collagen. This technology also provides internal and external tightening of the labia, an increase in sensation, reduces urinary leakage and urgency for women. A series of 3 ThermiVa treatments about four weeks apart are required for optimal results.
Based on review of the medical literature in all published trials to date, only several hundred geno typical women have been studied and most studies are only 12 weeks in duration. Another limitation of these short-term studies is that the potential risk of long-term complications, such as scarring is not addressed. Patients were not monitored for concurrent use of intravaginal products or systemic medications that could affect vaginal and vulvar health. Over-the-counter moisturizers, lubricants, prescribed local estrogen products, or systemic hormones could have contributed to any observed improvements with these treatments.
Many of the laser companies claim on their websites that the CO2 fractional laser may be a treatment for a variety of post-partum/lactational incontinence, and dyspareunia in geno typical women with breast cancer, even though no data have been published on these unique patient populations, nor are there any high-quality clinical trials to support these claims.
The safety and effectiveness regarding vaginal rejuvenation and tightening have not been documented. There is lack of data supporting the efficacy and that these procedures are medically indicated. Randomized controlled trials with long term follow up, including comparative effectiveness trials to established procedures/treatments are necessary to evaluate the efficacy of these technologies. Therefore, vaginal rejuvenation and tightening for any indication regardless of the device utilized is considered investigational. The evidence is insufficient to determine the effects of the technology on net health outcomes.
In 2007 (reaffirmed 2019), ACOG issued a Committee Opinion (number 378) regarding vaginal “rejuvenation” and cosmetic vaginal procedures that states: “So-called “vaginal rejuvenation,” “revirgination,” and “G-spot amplification” are vaginal surgical procedures being offered by some practitioners. These procedures are not medically indicated, and the safety and effectiveness of these procedures have not been documented. Clinicians who receive requests from patients for such procedures should discuss with the patient the reason for her request and perform an evaluation for any physical signs or symptoms that may indicate the need for surgical intervention. Women should be informed about the lack of data supporting the efficacy of these procedures and the potential complications, including infection, altered sensation, dyspareunia, adhesions, and scarring.” No adequate studies have been published assessing the long-term satisfaction, safety and complication rates of these procedures.
In 2016, ACOG issued a position statement on fractional laser treatment of vulvovaginal atrophy and U.S. Food and Drug Administration Clearance which states the following:
Several media outlets have described fractional carbon dioxide (CO2) laser as “approved” or “cleared” by the U.S. Food and Drug Administration (FDA) for the treatment of vulvovaginal atrophy. The purpose of this Position Statement is to advise obstetrician–gynecologists and patients that this technology is, in fact, neither approved nor cleared by the FDA for the specific indication of treating vulvovaginal atrophy.
Under its 510(k) process, the FDA has cleared a fractional CO2 laser (DEKA SmartXide2 CO2 laser) for the indications of “incision, excision, ablation, vaporization, and coagulation of body soft tissues in medical specialties, including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery”. In addition, another laser system (Cynosure Inc., RevLite Q-Switched Nd: YAG Laser System) has been cleared by the FDA for incision, excision, ablation, vaporization of soft tissue for general dermatology, and dermatologic and general surgical procedures for coagulation and hemostasis. It is important to note that although there are a number of indications enumerated for this technology, the specific indication for the treatment of vulvovaginal atrophy is not listed.
Preliminary observational data have shown some potential benefits with the use of this technology in treating patients with vulvovaginal atrophy 3–5. However, these observational trials do not evaluate the use of concomitant treatments, and they lack long-term follow-up (trials assessed follow-up at 12 weeks). No randomized trials or comparative effectiveness studies have been published. Although initial data indicate potential utility, additional data clearly are needed to further assess the efficacy and safety of this procedure in treating vulvovaginal atrophy, particularly for long-term benefit.
Obstetrician–gynecologists should be cognizant of the evidence regarding innovative practices, and should be wary of adopting new or innovative approaches on the basis of promotions or marketing. It is critical that patients are provided with accurate information regarding the efficacy and safety of treatment options, particularly when considering emerging technology. One component of this information is an accurate description of the FDA’s clearance or approval terminology. Obstetrician–gynecologists have an ethical responsibility to provide accurate and current information to patients in order for them to be fully engaged in the informed decision-making process.
In 2013, the Society of Obstetricians and Gynaecologists of Canada issued a policy statement on Female Genital Cosmetic Surgery that included the following recommendations:
As with any surgical consultation, counselling for FGCS is an essential part of the process and a woman’s motivations for treatment should be carefully explored. The possibility of coercion or exploitation or requests for surgery at the behest of a partner or parent, should be ruled out. A complete medical, sexual, and gynaecological history should be obtained, and the absence of any major sexual or psychological dysfunction should be ascertained. If any psychological concerns are identified, counselling should include appropriate referral for assessment prior to consideration of genital cosmetic surgical procedure.
There is little evidence to support improvement in sexual satisfaction or self-image from cosmetic “rejuvenation” of the vagina or vulvar cosmetic surgery. Evidence from studies thus far for labioplasty is all either Level III or anecdotal. Studies for “G-spot augmentation” are only anecdotal. Recently, there have been two non-previewed publications regarding the use of laser procedures for treating “vaginal relaxation syndrome” including stress incontinence. Neither paper presents robust evidence, and many concerns arise regarding longer term effects. Of the 21 patients in the pilot study by Gaviria et. al. 8 were nulliparous and 19 were pre-menopausal: follow-up was limited to 3 months. The small study by Fistonic et. al. claimed increased muscle contraction with only 6 of 39 patients followed to 6 months. One published study that addressed colpoperineorrhaphy, and included level II-3 evidence from women who made a decision to get surgery after appropriate counselling, reported a very high satisfaction rate at 6 months postoperative. Physicians choosing to proceed with these cosmetic procedures should not promote those surgeries for the enhancement of sexual function.
Women considering these surgeries should be informed of the risks of the procedure, including bleeding, infection, scarring, dyspareunia, alteration in sensation, pain, wound dehiscence, decrease in sexual pleasure and possible dissatisfaction with cosmetic or other results. There is no available long-term data on the safety or efficacy of these procedures. Additional, three is currently no evidence available regarding the effects of the physiological changes associated with pregnancy and childbirth or menopause on the postoperative outcomes of perineal or vaginal cosmetic surgeries.
Many women will be satisfied with the information and reassurance they receive from the care provider and may not proceed to surgery.
Physicians who choose to undertake cosmetic procedures to the vagina and vulva should be appropriately trained in the gynaecologic and/or plastic surgery aspects of cosmetic surgery of the lower genital tract. This is not a skill set currently required by the Royal College of Physicians and Surgeons of Canada for accreditation of postgraduate training programs in obstetrics and gynaecology.
MonaLisa Touch was developed in Milan, Italy and received marketing clearance from the U.S. Food and Drug Administration in September 2014.
Syneron Medical LTD announced on November 5, 2015 the US FDA granted numerous additional indications for CO2 RE device which included gynecology applications (including vaginal treatments).
Viveve Treatment - Viveve Medical – is not for sale in the U.S.
ThermiVa – Thermi Aesthetics are FDA cleared for use in dermatological and general surgical procedures for electrocoagulation and hemostasis and to create lesions in nerve tissue.
Lasers intended for medical purposes have been marketed in the United States for more than 20 years. Carbon dioxide and argon lasers were among the earliest laser technologies used in medicine. With the enactment of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act in May 1976, all new devices, including new medical lasers, became subject to FDA premarket clearance. There are two forms of premarket clearance procedures. The premarket notification (510(k)) procedure is principally used for those devices that are documented to be substantially equivalent to legally marketed Class I and Class II devices. The 510(k) procedure can also apply to devices which are substantially equivalent to a Class III device for which the effective date of the requirements for premarket approval has not yet been established. The premarket approval (PMA) process applies to devices in Class III.
July 30, 2018 the FDA issued a warning against the use of energy-based devices to perform vaginal rejuvenation or vaginal cosmetic procedures: FDA safety communication, which stated the following:
Primary Care, Obstetrics and Gynecology, Plastic Surgery, General Surgery
Energy-based devices - commonly radiofrequency or laser - that have received FDA clearance for general gynecologic tool indications, including, but not limited to, the destruction of abnormal or pre-cancerous cervical or vaginal tissue and condylomas (genital warts).
To alert 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. The safety and effectiveness of energy-based devices for treatment of these conditions has not been established.
Summary of Problem and Scope:
We are aware that certain device manufacturers may be marketing their energy-based medical device for vaginal "rejuvenation" and/or cosmetic vaginal procedures. The safety and effectiveness of energy-based medical devices to perform these procedures has not been established.
Vaginal "rejuvenation" is an ill-defined term; however, it is sometimes used to describe non-surgical procedures intended to treat vaginal symptoms and/or conditions including, but not limited to:
To date, we have 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. The treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.
Recommendations for Patients:
Recommendations for Health Care Providers:
We became aware that certain device manufacturers may be inappropriately marketing their energy-based devices for the uses noted above that are outside of their cleared or approved intended uses. We have contacted these manufacturers to communicate our concerns.
The manufacturers contacted to date have responded with adequate corrections. We will continue to actively monitor promotional materials, including materials on the internet, and claims about uses of these products. We will continue to monitor complaints and adverse event reports from patients, health care providers, and industry. We plan to investigate potential violations and take action if appropriate.
In addition, we will continue to monitor reports of adverse events associated with this issue and will keep the public informed if significant new information becomes available.
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with procedures marketed as vaginal "rejuvenation". If you experience adverse events associated these procedures, we encourage you to file a voluntary report through MedWatch, the FDA Safety and Adverse Event Reporting program.
Vaginal rejuvenation and vaginal tightening procedures including but not limited to the following are considered investigational for all indications:
Based on the available published peer reviewed medical literature the safety and effectiveness of these devices for the treatment of vaginal rejuvenation and vaginal tightening cannot be established. The evidence is insufficient as currently there are no published studies that assess the clinical utility, long-term outcomes, safety and complication rates of these procedures. Further randomized controlled trials with long term follow up and comparative effectiveness to established procedures and treatments are necessary to evaluate the efficacy of these technologies. The evidence is insufficient to determine the effects of the technology on net health outcomes.
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