FDA Update

On July 30, the FDA issued a vaginal laser safety communication. Click here for the the full notice.

FDA Warning: "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."

Comment: We respectfully disagree. There are numerous peer-reviewed published articles in the medical literature that demonstrate safety and efficacy of the Mona Lisa Touch vaginal laser for the treatment of symptoms caused by loss of estrogen. A partial listing is presented at the bottom of this web page.

FDA Warning: The warning also states "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."

Comment: The Mona Lisa Touch is not FDA approved for the indication for which it is being used but it is approved as safe. The FDA approves drugs for medical indications and approves devices for safety. On September 5, 2014 the Mona Lisa Touch laser received 510K (K133895) marketing clearance for "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."

The practice of medicine goes far beyond what the FDA does or does not approve. Medication approved for one condition is widely used for other conditions and the same thing can be said about devices. The FDA does not determine what the standard of care of the practice of medicine is. This is determined by the consensus of a large number of experienced practicing physicians.

FDA Warning: The warning states "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. 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.

Comment: We agree. We do NOT use the term vaginal rejuvenation because it does not have a clear definition. However the diagnosis of post-menopausal vaginal atrophy is quite clear, which is symptoms of painful sex, vaginal dryness, vaginal burning, and/or urinary urgency associated with the loss of estrogen due to menopause. Furthermore this condition has been proven to be safely and effectively treated using the Mona Lisa Touch vaginal laser (see references).  We further agree that laser manufacturers are known to make exaggerated claims in order to sell their devices and the FDA should crack down on this.

FDA Warning: The FDA warns that "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."

Comment: In the FDA warning,  they said they have received 14 adverse reports. In all likelihood, hundreds of thousands of vaginal laser procedures have probably been performed in the U.S. in the past 4 years, since the device appeared. Thus, this is actually an extremely low rate of complications. It would be easy to list medical devices in wide use that have a far higher rate of complications, such as weight loss surgery implants, liposuction and breast implants, but for reasons we cannot explain the FDA has decided to go after vaginal laser devices. There is no such thing as a 100% safe drug, device or treatment. Patients know this and doctors never promise or guarantee that anything we do is 100% safe or 100% effective.

In addition, Dr. Jick has performed more than two hundred vaginal laser procedures in the past 3 1/2 years, has had no complications and the great majority of his patients have received significant benefit in terms of improvement of their symptoms of vaginal atrophy and an improved sex life.

FDA throws breast cancer survivors under the bus

The worst part of this entire "Alert" is the following paragraph, taken from a letter signed by the FDA Commissioner.

"In some cases, these devices are being marketed for this use to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause. The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious."

Later in the letter is this comment: "The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions. These products may be particularly appealing to women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and thus are seeking alternative, non-hormonal options. Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options. FDA is committed to helping advance the development of safe, effective treatment options for these conditions."

Comment: I would like the FDA Commissioner to tell me what other FDA approved treatment options are available for the millions of breast cancer survivors who suffer from vaginal atrophy. I am not aware of any. Vaginal estrogen is FDA approved for the treatment of vaginal atrophy, but I guess the FDA Commissioner is unaware that breast cancer survivors are told by their oncologists to stay away from estrogen. Osphena is a form of estrogen. Intrarosa is a vaginal androgen (male hormone) that likely converts to estrogen in the vagina. Are any of these medications FDA approved for use in breast cancer survivors? The answer is no.

What other non-hormonal options are available for this painful disorder? Vaginal lubricants perhaps? Every breast cancer survivor we have treated will tell you that the lubricants stopped working a long time ago! Before  vaginal laser, breast cancer survivors had NO OTHER treatment options for their vaginal atrophy. They eventually stopped having sex altogether and marriages and relationships suffered. The vaginal laser gave these women hope !

Here is what is egregious. Vaginal laser therapy has helped thousands of breast cancer survivors. It has restored their sex life, given many couples a "second honeymoon" and now the FDA is trying to take this away. Maybe with enough public feedback, the FDA will modify its position. Until then Fair Oaks Women's Health will not be able to perform the Valayza (Mona Lisa Touch) procedure. We are greatly disappointed at this situation and are hopeful things will change in the near future.

References:

Salvatore S, Digesu G, Siesto G, et al. Vaginal collagen remodelling after fractional carbon dioxide laser surgery [abstract 233]. Presented at Annual Meeting of the International Continence Society, Glasgow, United Kingdom, August – September 2011.

S. Salvatore et al. A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study. Climacteric Aug 2014, Vol. 17, No. 4: 363–369.

N. Zerbinati et al. Microscopic and ultrastructural modifications of postmenopausal atrophic vaginal mucosa after fractional carbon dioxide laser treatment. Lasers Med Sci (2015) 30:429–436.

S. Salvatore et al. Sexual function after fractional microablative CO2 laser in women with vulvovaginal atrophy. Climacteric 2014 Oct 21:1-21.

Karram M and Sokol E. A new and novel therapy for vulvovaginal atrophy: results of the first U.S. trial. Presented at 2014 Pelvic Anatomy and Gynecologic Surgery Symposium (PAGS), Las Vegas, NV.

Stefano Salvatore, MD, et al. Histological study on the effects of microablative fractional CO2
laser on atrophic vaginal tissue: an ex vivo study. Menopause: The Journal of The North American Menopause Society.Vol. 22, No. 8, pp. 845/849.

J. Hutchinson-Colas, S. Segal, Genitourinary syndrome of menopause and the use of laser therapy,
Maturitas (2015), http://dx.doi.org/10.1016/j.maturitas.2015.08.001