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FDA warning – Vaginal Rejuvenation

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The Women’s Health Clinic (TWHC) agrees with U.S. Food and Drug Administration
(FDA) warning – “Vaginal Rejuvenation” and potential health risk

  • Vaginal rejuvenation procedures are becoming more popular to relieve painful sex, dryness and stress incontinence. There is an inherent confusion in relation to the medical nature of the treatment and as a result the Regulatory System is being taken advantage of by non-medical aesthetic professionals
  • The FDA issued a stern warning the industry highlighting the non-compliance and the very serious nature of the risk involved in such procedure.
  • FDA Commissioner Scott Gottlieb said the agency was “deeply concerned women are being harmed.”
  • The Women’s Health Clinic welcomes the FDA report and requests UK Authority to bring in Legislation to introduce basic safety net in the system in order that these treatments can only be performed by qualified medical professionals with proper knowledge of the technology
  • TWHC however identified serious weaknesses in the FDA report as it failed to address the subject with due care and sensitivity it deserves.
  • Coincidentally British Menopause Society released a consensus statement within 24 hours of the FDA report advocating the use of LVR for improvement in sexual response.
By: Emma Louise RN | Aly Dilks RN | Mr Vivek Nama Consultant Gynaecologist MBBS, MD, DNB, MRes, MRCOG
Referencing – Laser Vaginal Rejuvenation (LVR) with CO2 lasers (Nu-V)
31 July 2018
UK’s only Nurse Led medical clinic (TWHC) today reacted positively to the concerns of the FDA in highlighting the need for a tougher regulatory compliance regime to tackle the growing problems of “Vaginal Facelift”, “Designer Vagina” and similar cosmetic treatments available in the US, UK and elsewhere.

“…as female only nurses with revived sexual health following their own Nu-V treatment, all our nurses fully understand the psychological, emotional and physical distress most women endure in their lives. It is therefore a “no-brainer” that Nu-V is only delivered by medically led Women Health Professionals with full knowledge of the LVR technology and its safety, efficacy and potential risks…” says Emma Soos, CEO and founder of TWHC.

Although TWHC welcomes the bold FDA approach in relation to stopping “deceptive marketing”, it is broadly in agreement with the UK Regulatory Authority’s decision to de- regulate cosmetic lasers in 2008 which was prompted by a review of the overall risk and benefits to patients.

The UK Department of Health’s stated “The levels of risk involved in the use of lasers/IPL equipment for non-surgical purposes leads us to believe that the current regulatory regime ( as of 2008) is not proportionate to the risk of harm to patients,”.

In the UK The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the regulation of therapeutic products in the UK.

Paul Banwell, consultant plastic surgeon and member of the British Association of Aesthetic Plastic Surgeons, shared the FDA’s concerns:

“There has been an exponential rise in the interest in women’s health and sexual well- being and whilst this should be encouraged, it is vital that any educational and treatment initiatives are provided in a sensitive manner free of any misleading or marketing hyperbole.”

Aly Dilks, Clinical Director of TWHC is very critical of “Designer Vagina” and does feel that UK should align with the FDA in clearly including such treatment under the Care Quality Commission’s “Regulated activities”.
“…it is a complete and utter madness to allow non-medical aesthetic professionals and therapists with very little knowledge of Women’s Health to be inserting laser heads inside the vagina. At TWHC we carefully select our nurses to ensure that they have specialist knowledge in Gynaecology, Urology, Sexual Health, Menopause, Midwifery and other Women’s Health matters.” says Aly.

TWHC has successfully carried out over 2000 Nu-V treatments under a rigorous process where patients are fully educated about Nu-V to prevent misplaced expectations, over- selling and unfair advantage being taken on their vulnerability.

TWHC advocates a holistic approach to women’s health whereby it gathers a wide range of data in relation to patients physical, sexual and mental wellbeing. During the consultation all such information along with the notes are carefully considered in accordance with our strict guidelines. Only appropriate patients are offered a Nu-V treatment and clearly given the choice to go back and consider her options including alternative treatments outside LVR. This very important process is repeated at the second consultation (face to face) and again; the patient is advised to go back and reconsider.

“Screening for female sexual dysfunction with validated questionnaires, a simple vaginal examination to identify vaginismus or pelvic floor abnormalities and education about of one’s own body structure, anatomy, and ageing process are prerequisites to treatment. Treatment is only carried out upon full consent process that clearly explains the treatment, science, “no-guarantee” result and acceptance along with many other factors. We take

pride in what we do and how we do it. I believe this sets us apart from the rest both ethically and commercially…” says Vivek Nama – TWHC Consultant Gynaecologist

While TWHC shares FDA’s concerns, it disagrees with some of the negative statements made in its report. According to FDA

“These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.”

This statement is not entirely correct as CO2 lasers have a long history of 35 years and there is ample evidence on its safety of use in various parts of the body. There are many more studies regarding other modalities, such as medical needling, chemical peeling, dermabrasion, radio frequency and high frequency ultrasound etc, that all aim to create a controlled injury to collagen. The use of CO2 lasers in the vagina is not a new concept and has been proposed for over 15 years. The comparison of a surgical laser used for specific roles such as cancerous cells to these lasers used for rejuvenation is misleading at its best. Although they are all lasers, they are different in their power output, modality and wavelength. Comparing a car to a bike is appropriate if you are discussing a mode of transport, but not when discussing safety.

The very fact that FDA states

“the safety and effectiveness of these devices hasn’t been evaluated or confirmed by the FDA for vaginal rejuvenation.”,

is testament to the inadequacy in its argument. The innovative LVR technology should not be assumed to be unsafe and ineffective purely because FDA did not have the opportunity to evaluate it thoroughly. Current Nu-V CO2 technology is FDA approved as a CO2 laser and not yet registered for LVR. TWHC will invite FDA to review all its clinical data and evidence for the Nu-V from TWHC.

A BMS (British Menopause Society) Consensus Statement released on 31 July 2018 regarding Urogenital atrophy has stated

“Vaginal laser therapy is now being proposed as an outpatient medical treatment which is free from side effects and provides a marked improvement in sexual response. The theory is based on a thermoablative effect on the vaginal wall which triggers an improvement in collagen production within the vaginal submucosa”

With a CO2 laser the effect on collagen is twofold. There is a mechanical damage to the surface (in the case of the Nu-V a fractional ablation) followed by a biological response. Due to the affinity of the lasers to moisture the heat generated on the vagina is not beyond 45- 60 degrees Celsius, hence the possibility of thermal damage is illusory. In terms of the statement regarding “serious risks’ most trained and suitably qualified laser and medical practitioners would agree that the risk is not in the laser itself, but more so, the practitioners using the device. The benefit from lasers is mainly from the biological response of neovascularization (formation of new vessels) and deposition of collagen. This is based on one’s own response. In our experience the response could be suboptimal, where 28-30 % of the patients achieve no benefit. After 2000 treatments we are yet to see a patient with an amplified response leading to vaginal scarring.

Nu-V is a safe and effective technique in improving symptoms. We acknowledge that Nu- V does not treat significant pelvic floor abnormalities but we have noticed a significant improvement in patients with mild symptoms with no obvious pelvic floor descent.

On retrospective analysis of patient data and follow-up that new collagen deposition of the vaginal wall and labial area have resulted in improvement in vaginal moisture, reduction or resolution of symptoms of mild stress incontinence, improved pelvic floor tone, heightened sensation, and reduction in atrophy and laxity all leading to relief of psychological distress. This is supported by the independent reviews of the service and the treatment we offer and the patients comments as broadcasted on various channels like BBC and ITV.

Overall this report has raised some valid concerns in relation to the false claims and promises being made by many non-medical organisations and for that we very much welcome it. However, we believe the report has the weakness to create false alarm and unnecessary distress to patients (past and present) worldwide. FDA has unparalleled power and with it comes responsibility, not only to protect but also to facilitate innovation and choice. At TWHC we believe that all patients have the right to make an educated and informed choice provided that all risks are mitigated.

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