Rethinking the Techno Vagina: A Case Series of Patient Complications Following Vaginal Laser Treatment for Atrophy

Catherine Gordon, MD; Savanah Gonzales; Michael L. Krychman, MD

Disclosures

Menopause. 2019;26(4):423-427. 

In This Article

Discussion

To our knowledge, this is the first case series discussing complications from laser treatment for GSM. We undertook this publication not to minimize the importance of laser as a potential innovative intervention for GSM, but to report that no intervention is without potential consequence or adverse effect. These cases demonstrate the importance of prospective follow-up because complications have occurred with laser technology. Given that vaginal lasers create microtrauma and abrasions inciting the body's natural repair process, it is feasible that, as seen in case 1, vaginal agglutination, laceration, and hemorrhage could be a possible result from the laser treatment. As seen in case 2, the patient did not respond to the therapy or had a suboptimal response. She may have already had a concurrent vestibular disease that was not addressed, and her hypertonus was likely exacerbated by the laser treatment, resulting in post-laser dyspareunia.

Laser therapy for the vagina certainly shows good promise for the treatment of GSM in some women and many case series have been performed showing excellent results. Salvatore et al[10] published a pilot study assessing the efficacy of fractional CO2 treatment for patients with GSM which demonstrated improvement in symptoms and quality of life measures, with no adverse events being reported. Fifty women were included and followed for 12 weeks. Salvatore et al[11] demonstrated and published an expanded trial with similar findings in a prospective study involving 77 patients (this article represents the initial pilot population [50 participants] plus an additional 27 participants) followed for 12 weeks. Similar studies by Pitsouni et al[12] and Perino et al[13] demonstrated similar results in 53 versus 48 patients followed for 12 weeks versus 30 days, respectively, but also showed improved vaginal health index scores. Most recently, Samuels and Garcia[14] evaluated 43 patients for a total of 12 months and demonstrated improved atrophy symptoms and histologic scoring with no long-term adverse events.

In addition, there are multiple studies demonstrating improvement in GSM symptoms and quality of life scores following vaginal laser treatment, but often these studies included fewer than 100 patients, and most are only followed for up to 12 weeks, and one for up to 1 year. Many of these studies are case series and prospective with lack of placebo controls. In addition, most studies report no adverse events. No clinical evaluation or intervention is without potential for injury or adverse event. The notion that there are no adverse events brings into question the validity and integrity of the data. It is important that investigators include the appropriate participants and monitor them carefully throughout the study. All adverse events should be recorded and reported. Following patients closely will undoubtedly yield adverse events in both the placebo and treatment groups. Adverse event reporting is critical for data evaluation and assessment of both placebo and interventional safety.

Although the FDA has cleared multiple laser systems for use in aesthetic and gynecologic conditions for "incision, excision, ablation, vaporization, and coagulation of body soft tissues,"[15] the lasers have neither been approved for "vaginal rejuvenation procedures" nor are they approved for the treatment of GSM. Importantly, the FDA commissioner has recently issued a communication to health care providers and patients regarding the use of such lasers in this setting. One statement reads: "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." They comment on specific risks that may occur, stating "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."

The trials published on laser treatment for GSM include only a few hundred patients and most only follow patients for up to 12 weeks, others to 1 year. Because the potential for adhesive fibrosis and scarring takes time to develop, a 3-month follow-up may not be sufficient to address longer-term complications. One small study of 43 patients, with up to 12 months follow-up, only reported adverse events of edema, erythema, and mild bleeding with treatments, which resolved after 24 hours, and some isolated reports of itching or soreness following the first treatment which also resolved.[14] Longer-term and more thorough follow-up is warranted, especially due to the potential mechanism of action of vaginal lasers (eg, ablation and thermal injury of vaginal tissues). Other studies reported pain for 2 to 3 days postprocedure, or vaginal bleeding for 1 day, but were not excluded from the study[16] and other studies note that patients were unable to be treated due to narrow vagina and intolerance of the laser probe.[10,11] The current published data lack robust research vigor, and further randomized sham-controlled clinical trials are warranted.

As early as 2007, the American Congress of Gynecologists and Obstetricians (ACOG) issued a statement on vaginal rejuvenation procedures, including labial remodeling, hymen reapproximation, and collagen injections.[17] The committee opinion stated, "these procedures are not medically indicated, and the safety and effectiveness of these procedures have not been documented." This holds true for the newly marketed laser treatment options. In 2016, and again reaffirmed in 2018, ACOG released a position statement advising providers that fractional CO2lasers are not cleared by the FDA for treatment of vaginal atrophy and there is insufficient evidence for the long-term safety of these treatments.[18] The ACOG Committee Opinion on Ethical Guidelines with innovative practice mentions that providers should be wary of adopting new treatment options simply on the basis of promotional marketing.[19] Safety and efficacy of novel approaches must be evaluated and confirmed, and appropriate counseling and education of patients is essential. It is important to keep these ethical pillars in mind when assessing the still rather-novel technology of laser treatment.

There remains little research assessing the long-term efficacy of vaginal lasers, and repetitive laser procedure over conventional FDA approved treatments. Minimal published studies to date have included a control arm with sham laser treatment. In the field of technology, there is one radiofrequency device (the Viveve System) that executed a randomized, sham-controlled clinical trial in which 186 patients were followed prospectively for 6 months. Placebo (63 sham participants) and treatment arms (123 active participants) were followed, and adverse events were similar in placebo (35.1%) and in the treatment arm (32.5%).[20] There is a high placebo response reported in most sexual dysfunction trials, so it is important to consider the prevalence of placebo effect in laser treatment.[21] There is a double-blind, randomized, placebo-controlled trial ongoing in Australia comparing Mona Lisa Laser (DEKA Laser, Calenzano, Italy) treatments to placebo.[22] This will offer some information on the efficacy of the procedure.

Another limitation regarding efficacy is assessing concurrent use of intravaginal products or systemic medications that may alter vulvovaginal health. There is only one recent study looking at vaginal estrogen, but none to date comparing systemic medications or vaginal moisturizers and lubricants. The recent clinical trial out of Brazil by Cruz et al[23] compares therapeutic response to vaginal laser with sham estrogen cream versus vaginal estrogen cream with sham laser versus laser with vaginal estrogen cream. Forty-two patients were followed for a total of 20 weeks and patients with laser and vaginal estrogen cream had the most improved GSM scores followed by vaginal estrogen alone, followed by laser alone. Of note, the laser alone patients had worsened pain scores after treatment. In the United States, there was an ongoing multicentered, randomized, prospective, single-blinded clinical trial comparing CO2 fractionated vaginal laser therapy and vaginal estrogen cream but it has been suspended.[24] Further research is needed to determine the efficacy of laser treatment over conventional treatment and combining the two treatments.

There remain many unanswered questions concerning laser use, including but not limited to the high cost and affordability (it remains uncovered by medical health insurance), long-term efficacy and safety, and patient access to treatment. Optimal patient selection criteria remains to be determined. A responders analysis of which patients are most likely to respond to the laser treatments has yet to be completed. Notwithstanding, many healthcare professionals of various medical specialties are currently performing laser gynecological procedures. Which professional is most qualified to implement and use this technology still remains to be determined. Is it the dermatologist and plastic surgeons who may have a better comprehension of the laser technology, due to extensive experience with this technology, or the obstetricians/gynecologists and urologists/urogynecologists more familiar with the genitopelvic anatomy and identification of confounding pathology? Obstetricians and gynecologists may indeed be late adopters to newer technology given their tumultuous history with a variety of technology including electronic fetal monitoring, mesh issues, Essure, and robotic surgery.

In addition, many women are receiving annual laser therapy; there is limited data to determine the optimal interval between procedures to avoid the potential for scarring complications. Women are now reporting psychological concern due to suboptimal results and there is growing concern among patient advocates about being misled by marketing fraud. Two class-action lawsuits are currently underway: one by patients, the other brought by health care professionals concerning marketing and/or messaging from laser companies.

Although clinicians should embrace and foster science-based innovation, cautious optimism should be the appropriate path forward. Evidence-based medicine with randomized, sham-controlled, well-designed studies and follow-up should remain the criterion standard. Although lasers may prove beneficial in the gynecological field for a subset of patients, the patient's medical situation should be considered to offer the best treatment options. Health care professionals and patients should advocate for a thorough and ongoing database of adverse events and encourage voluntary reporting to the MAUDE database. Consumer advocacy coupled with sound scientific research should be standard.

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