As you may already know, the FDA released a Safety Communication on July 30 which provided a public warning regarding the use of “Energy-Based Devices to Perform Vaginal 'Rejuvenation' or Vaginal Cosmetic Procedures.” It was very clear in addressing this warning to patients considering undergoing the treatments, and to health care providers who offer them. The statement outlines the imprecise nature of the term “vaginal rejuvenation,” and reiterates that, while the FDA is aware of the use of devices such as a CO2 laser for a variety of surgical applications, it has not approved their use for any specific gynecologic indication. The Communication goes on to point out the limits of the scientific support for claims of safety and efficacy of these devices.
It should be pointed out that ACOG, in 2016, released a position statement pointing out to its membership that the CO2 fractionated laser listed no specific indication. ACOG reaffirmed this Position Statement last month.
Last week, the FDA also sent individual letters to the manufacturers of such energy-based devices, including the Venus Fiore, Exilis Ultra Femme, MonaLisa Touch, FemiLift, JOULE, THERMIva, and FormaV/FractoraV systems, which challenged the marketing claims made, and requested information about how they came to their conclusion that they were NOT required to seek FDA approval.
It is important to note that these treatments are currently not covered by insurance, and as such, do not have a CPT code. The absence of this process of coding and billing really changes the entire conversation. With most of the services we provide, there has been an extensive process of evaluation (literally, placing a value) by the entity – be it governmental body, private insurance – that will wind up paying the bill. Providers know that they will have to provide support to justify the cost, and patients have the expectation that this evaluation has occurred. In the cash-for-service arena, the conversation changes; it is just the doctor, who (one certainly hopes) truly believes in the treatment but will also profit from it, and the patient, who has only the opinion of the provider upon which to rely.
These recent events come on the heels of our learning from a recent article in the Green Journal that, among OB/GYN providers, those in FPMRS have received more compensation from manufacturers of drugs and devices than our colleagues in any of the other subspecialties. Let me be clear - this is not in and of itself an indication of wrongdoing; I certainly would prefer that manufacturers get good advice from the providers in the field, and experts in any arena deserve compensation for their work. But as we collectively recover from an era when doctors were accused of supporting mesh-based kits, power morcellators, and a variety of other technologies because of monetary gain or other benefit, we need to approach any similar controversy with a willingness to be honest, transparent, and accepting of our fiduciary responsibility to the patient.
As providers in the subspecialty of FPMRS, we are well-positioned to evaluate and manage issues of GSM and vaginal atrophy. Many of our members currently provide these services to their patients, and there is a small but growing body of evidence with which to develop scientific opinion.
As was the case with mesh – AUGS is not pro-laser, or anti-laser; AUGS is pro-science. AUGS recognizes that medicine needs to continue to develop, that innovation continues to be needed, and that our current therapies and standards will evolve over time, to the benefit of our patients. However, we need to be honest with our patients, with each other, and with ourselves, about the various motivations that drive that evolution. AUGS does not hold the policy that all therapies should be withheld from patients until Level I evidence is available; such a policy is impractical, and would result in good therapies not being available for long periods of time.
AUGS does, however, seek to support its members in providing evidence—based care and consistent informed consent from our patients. As we did with the Transvaginal Mesh Informed Consent Toolkit, as we are doing with the Midurethral Sling Informed Consent Toolkit (in development), AUGS will be engaging a two-fold approach to this issue.
1. AUGS will review the available data specific to each technology, and develop a Consensus Statement that provides a synopsis of the state of the science, and the limitations thereof. AUGS will do a call for experts to serve on the writing group for this Consensus Statement.
2. AUGS will develop an Informed Consent Toolkit for Energy-Based Vaginal Therapies, which will be specific to energy modality and to clinical indication. These documents, written for patients, will be open about where the gaps in evidence are, and what that means for an individual making these decisions. It will also include a checklist to demonstrate that sufficient information to obtain informed consent has been delivered.
We are neither endorsing nor condemning these technologies; we seek only to help our members to provide consistent and sufficient informed consent to each individual patient. If we can engage this process well, consistently, and as a subspecialty, then we can help to incubate new technologies as they arise in a thoughtful, even-handed and patient-centered manner. I believe this is central to AUGS’ mission.