FDA Statement about Vaginal Laser Therapy, as explained by Patricia Geraghty NP, Director of Women’s Health at Comprehensive Wellness

By | In the News, Women's Health

Patricia Geraghty NP, Director of Women’s Health at Comprehensive Wellness explains her take on the recent FDA Statement about Vaginal Laser Therapy.

On August 1, 2018 the FDA issued a warning regarding devices for treating vaginal conditions. I read the FDA warning itself, not just the news articles. The warning has also already received an endorsement from the North American Menopause Society. However, the news articles and reports that I have seen so far, and FDA commissioner Scott Gottlieb’s comments, are much more sensationalistic than the actual FDA statement. There is certainly no  call for Mr Gottlieb to call this a “dangerous procedure with no proven benefit.” Let’s review the evidence.

There are two different technologies covered in the FDA statement; CO2 fractional laser also known as ablative procedure and with a brand name of Mona Lisa Touch, and the radiothermal procedure also known as non-ablative. I can only speak to the laser therapy, the therapy offered at Comprehensive Wellness.

The warning states that there have been no “sham” studies done. This is where some subjects get the treatment and others get all the trappings but an actual treatment (the laser) is not delivered. These studies are underway at this time.

The warning also states that there is not enough research on the long term effects. This is true. The longest duration study to date is 12 months. Of course we want to know if the effects last longer and if there is later development of problems. A study was published just last month, a study not reviewed in this warning, showing for some women there is a sustained effect and failing to identify any adverse events.

The warning also said that there can be long term scarring, burns, and pelvic pain. I have read the studies carefully as I just completed one presentation on vaginal laser therapy for the cancer doctors and am submitting another presentation to the state NP association. None of the studies on the CO2 fractional laser report adverse events and this would be required for publication. I am in the process of searching for case reports, which are individual reports rather than subjects from formal studies. None have shown up in either the PubMed National Library of Medicine or the Google Scholar search engines.

Again, I can’t speak to the radiothermal procedure which appears to have a deeper effect (though no comparison studies have been done) and might then theoretically have higher risk for adverse events. Any procedure needs to be done by clinicians not only with knowledge of the technique, but with gynecological expertise to select the appropriate patient.

I also find the statement’s implied criticism of the word vaginal “rejuvenation” puzzling. This is actually the word that the FDA insisted upon and approved when the promotional material was formulated.

Most concerning to me is the warning citing a 2016 American College of Obstetricians and Gynecologist guideline. This guideline did not raise safety concerns and could not include reviews of the most recent and longest duration studies. The FDA statement also does not include information from a joint guideline issued by the North American Menopause Society and the International Society for the Study of Women’s Sexual Health just last month. This recent guideline included oncology experts as well as women’s health experts in the authorship. They carefully reviewed the data for all vaginal treatments, including laser therapy, for women at high risk for or with breast cancer.

So, in summary, more research is called for. That is something everyone, including the North American Menopause Society, can support. Finally, although I agree with the criticisms cited in the statement, these criticisms can also apply to any therapy in the first 5 to 10 years of use. We have to be careful to neither prematurely adopt therapies while also not applying unfair standards to women’s health care.

Special Offer: 45% Off SculpSure® Package

By | Aesthetic Medicine, Promotion

Getting rid of stubborn fat in problem areas can be a big challenge, even with diet and exercise. SculpSure®, a non-invasive body contouring laser procedure, offers a safe way to permanently eliminate fat in these areas. In as little as 25 minutes, up to 24% of fat cells can be eliminated from the love handles, abdomen, bra roll, thighs and other areas. SculpSure® is the new gold standard for non-invasive fat reduction.


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Call (925) 464-3916 to schedule your SculpSure® sessions. 

Impactful Techniques for Managing Anxiety & Feeling Good with Food

By | Events, Nutrition, Therapy

Join us for a presentation perfect for college bound students—Impactful Techniques for Managing Anxiety & Feeling Good with Food.

Thursday, July 19

$65 per participant

Going to college, whether around the corner or across the country, can be a very anxious time in one’s life.  We will share strategies for stress/anxiety management, as well as talk about how foods enhance how our brain works and how we feel. Students will learn about:

• Relaxation techniques for focus and creativity

• Strategies for calm confidence through transition

• Foods that improve our mood and give us the most energy

• Foods for individual benefits including alertness, better sleep, clear skin, and better digestion

• The knowledge of blood sugar “highs and lows” to manage your personal diet

• Plenty of ideas for snacks, dorm food, eating at the cafeteria and eating out on the run


Passionate about educating young adults about the power of food, Celeste’s goal is to empower young people to make healthy choices that will benefit them for a lifetime.   

Mindfulness Specialist/Hypnotherapist

Rebecca Berke has spent decades treating issues with stress, sleep, and weight management.

Before you operate, regenerate!

By | Events, Musculoskeletal Health

Stem cell treatments aren’t the future, it’s today! 

Orthobiologic regenerative injections may be an option for these conditions:


    Knee injuries (ligament sprains, meniscus tears)

    Shoulder injuries (rotator cuff or tendonitis)

    Achilles tendonitis

    Plantar Fasciitis

    Tennis or Golfer’s Elbow

Join us for a question and answer seminar at Comprehensive Wellness, with our Director of Musculoskeletal Health, Nancy Rolnik, MD.

Wednesday, May 16


Space is limited. Call (925) 464-3916 to reserve your spot.

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Spring into Summer!

By | Aesthetic Medicine, Events

Are you Ready to Spring into Summer?

Wednesday, May 23

Join us for an evening of wine, snacks, information, a SculpSure® demonstration, and fun!  Lighten, tighten, and brighten just in time for summer!

Join us for an evening of wine, snacks, information, SculpSure® demonstration, and fun!  The night won’t be complete without a chance to win a PicoSure® FOCUS skin revitalization facial treatment!

RSVP today!

Space is limited.  Call (925) 464-3916 to RSVP and book your Botox® appointment. 

Are you ready to spring into summer?Are you ready to spring into summer?LadiesNightOut_May2018Are you ready to spring into summer?Are you ready to spring into summer?LadiesNightOut_May2018




Are you ready to spring into summer?


Join us for Mindfulness Mondays!

By | Events, Therapy

De-stress, Center and Energize your Mind and your Body

Comprehensive Wellness is pleased to be offering a four-class series of mindful meditation with board-certified hypnotherapist, Rebecca Berke. Rebecca Berke is a Hypnotherapist and Mindfulness Specialist who has spent decades working with the mind/body connection. 

Mondays, 10:00am-12:00pm
April 9-30, 2018

Registration includes mindful meditation recordings and all class materiasl.
Cost: $300 for four sessions

Tired of Type 1: Tips for Dealing with Diabetes Burnout

By | Diabetes | No Comments

Is type 1 diabetes getting you down? If so, that is understandable and even to be expected. How many other physical health conditions necessitate so closely monitoring every carb that goes into your body? Not to mention the constant blood sugar checks, insulin injections, endo visits, and the ridiculous comments from well-meaning friends. Whether you use pens, pumps, or syringes, managing type 1 diabetes is a full-time job. For children and teens with type 1 and for their parents, the challenges of managing the condition can be even more daunting. Continue reading via goodtherapy.org