What are the Differences Between ThermiVa Radiofrequency and FemiLift/MonaLisa/IntimaLase
Lasers for Use in Aesthetic Vulvovaginal Therapies?
From the Perspective of a Full-Time Aesthetic VulvoVaginal Surgeon
November 5, 2015
Red Alinsod, MD,
FACOG, FACS
South Coast Urogynecology
Alinsod Institute for Aesthetic Vulvovaginal Surgery
I am writing this piece to an audience of both lay person
(or potential patient) as well as clinician (MD, RN, PA) to give my personal
views on the new ThermiVa technology and how it stacks up to the numerous laser
devices for the purpose of feminine rejuvenation. These are my views and do not necessarily
reflect the views and opinions of Thermi, the company. This was written as response to an article
Dr. Steven Gitt wrote on September 28, 2015 and published on LinkedIn Pulse. I believe it best to review Dr. Gitt’s
written opinion and compare and contrast it with mine to get a balanced take on
this important emerging topic.
There has been an amazing and rapid growth in the field of
non-surgical feminine rejuvenation. In
2005 we were perhaps the first center to provide non-surgical tightening of the
vulvar structures using CO2 lasers and later on Erbium 2940 lasers. We used ablative settings and progressed to
fractional ablative and non-ablative methods.
We were able to get tightening of the labial and internal vaginal skin
but at quite a cost in terms of pain and recovery and skin discoloration. The tightening obtained with the most
effective CO2 lasers on external vulva were impressive for a short period of
time until gravity and aging effects wore out the effects in a few months. Using the highest powered CO2 lasers intravaginal,
tightening effects were obtained but the downtimes were many many weeks to
months. Depending on where you focused
the lasers and what tissue you shrunk down you would get some improvement in
continence in some patients. But these
ablative lasers were not known to improve vaginal moisture or help atrophic
vulvovaginitis. Todays lasers, both CO2
and Erbium, are used with less power and with less to no ablative effects but
are better in improving vaginal moisture with very little downtime. They give enough tissue tightening effects to
help reduce incontinence also when the pubocervical fascia are treated. This is the case with FemiLift or MonaLisa,
both fractional CO2 lasers. This is also
the case for IntimaLase using 2940 Yag lasers.
These three systems, released in the US within the past year or so, are
the state-of-the-art for the laser arm of feminine rejuvenation. They will battle for laser supremacy in the
market filled with over a dozen laser copycats.
However, when looking objectively at choices, ThermiVa radiofrequency
technology is rapidly becoming the standard by which all feminine rejuvenation
devices are being compared to and judged by.
Why such a little company is making huge headways in the industry
dominated by laser titans? There are
many reasons why Thermi is the fastest growing small company in the
industry. As the director of the team
that put ThermiVa together I would like to share my views that will be based on
my personal clinical use of ThermiVa since its inception as an idea in
2009.
Laser companies have known for some time now that the
tightening effects of lasers on skin were not satisfactory and not
impressive. They have focused their
energies on skin smoothing, skin texture, wrinkling, treating sun damage, and
blood vessels. Since the advent of
Thermage RF treatments and less so infrared devices, the swing for skin
tightening has convincingly swung away from lasers. Clinical research and experience has proven
radiofrequency to be the winner at this point in time when it comes to
consistent and non-surgical/non-ablative treatments for skin tightening not
just in the face and body but in the feminine regions. There is a reason large laser companies like
Cynosure have purchased RF companies like Ellman. To obtain RF technology for tissue
shrinkage.
Enter ThermiVa, a unipolar radiofrequency device with FDA
clearance for dermatologic use. It has a
broad FDA clearance purposely obtained because of the wide spectrum of clinical
effects it is able to bring to treated skin.
This is not the radiofrequency system that “many feel that their
effectiveness remains unsatisfactory.”
Early RF systems were known to cause lots of pain with little consistent
clinical effects. Those systems blasted
RF heat and used cooling measures to reduce the pain. There was not sustained heat given to
tissues. They were “blast and cool”
devices. In contrast, ThermiVa applies
heat (40-45 Celsius) that is sustained and comfortable because it is
“Temperature Controlled.” ThermiVa uses
very smart software and technology that is able to slowly heat tissues to
targeted temperatures and then maintain the temperatures there to obtain the
tissue contraction “blast and cool” methods could not achieve
consistently. RF science and use on
vulvovaginal tissues started around 2009 in our office, years before any
vulvovaginal laser technology was used in the U.S. to treat vulvovaginal
issues. It is not accurate to say that
there is little research regarding long term results of RF devices. I have reported on the results of RF use on
vulvovaginal tissue and its safety and excellent efficacy almost every year
since 2009 at my yearly CAVS meetings (Congress on Aesthetic Vulvovaginal
Surgery). Every year I showed dozens of
photos and clinical studies. More
recently my Pilot Study has been published and the ThermiVa multi-site IRB has
been completed. Safety has been established
clearly as no blisters or burns or adverse events have occurred since 2009. Blister and burn temperatures at 55 Celsius
are not reached by ThermiVa.
So what can ThermiVa do?
It can do two things well. First,
it can tighten vulvovaginal tissues uncontestably better than any laser system
on the market. Hands down. No contest.
It can tighten the labia majora sagging dramatically to levels not seen
by laser systems both CO2 and Erbium, both ablative and non-ablative, both
fractional and non-fractional. There are
dozens of photos on the thermiva.org website and
other websites showing the amazing tightening effects externally with the use
of ThermiVa. Go try to find a single set
of photos showing the Before and After tightening effects of any laser system
and compare them to ThermiVa. They will
be hard to find because the laser systems, like FemiLift or MonaLisa or
IntimaLase, are not routinely used to shrink the labia majora. In fact, you need a separate hand piece and
anesthesia if you choose to use it for the labia majora. There is significant downtime with that
ablative treatment. Common sense
dictates that laser companies with good results of their tightening would be
proud of their outcomes and show them off on their websites and brochures. Common sense would also find owners of laser
systems proudly displaying the results of FemiLift or MonaLisa or IntimaLase. Good luck finding those photos of their
results. Here is the kicker, RF is known
to shrink moist mucosal tissues even better than external dry skin and that is
exactly what we find. ThermiVa’s internal
treatments of the vagina are superior in tightness than any currently available
laser system geared for vaginal rejuvenation.
This is from my personal examination of hundreds and hundreds of women
who have received ThermiVa treatments and comparing them to my years of laser
use. This has been clinically confirmed
by dozens of ThermiVa users. One more
thing, with the tightening of vaginal tissues, you can target the tightening
effects to the area of the urethra called “pubocervical fascia.” This results in the amazing reduction in
leaky bladder. Both stress incontinence
(leaking from increased pressure such as a cough, sneeze, jump) and overactive
bladder are relieved consistently. The
tightening is immediate and many are dry after just one treatment. Dribbling goes away, urge symptoms
subside. In fact, the effects of
radiofrequency on the bladder are just about as good as any of the
anticholinergics drugs available without the dry mouth and constipation. Urogynecologist who have ThermiVa have reported
dramatic reduction in number of slings needing to be placed and number of
prescriptions written for overactive bladder.
No mesh, no drugs. I have not
seen this type of dramatic effects with laser based systems though some do
claim to be able to help.
Secondly, Thermiva increases blood flow. This is perhaps the “Biggest Deal.” It is true that vaginal and vulvar biopsies
have not been published to show the microscopic effects and those studies are
not quite complete yet. But on visual
exam, a macro exam, you can see vessels forming on labial and vaginal
tissues. The increased blood flow is
real as evidence by the increased transudate from arterioles going into the
vaginal canal and resolution of the dry vagina.
This effect is one of the few things in my practice that I can say is
100% since not a single patient has failed treatment for atrophic
vulvovaginitis (dry vulva and vagina).
Along with the increased blood flow also comes the improvement in the
sensitivity of the vulvar structures, the clitoral region, and internal
vagina. Akin to “Female Viagra” due to
the increase in blood flow to the genital structures treated. Treatment of the G-Spot areas have increased
sensitivity there and have improved orgasmic response consistently. Because of this increased blood flow there is
increased production of collagen.
Tighter new collagen that is more pliable and soft. This is both from patient report and physical
exam. For example, even the most
atrophic vagina with a pinpoint hole for entry (not at all amenable to the
large FemiLift or MonaLisa laser hand pieces) will get softer, more pliable,
and moist that will even allow for comfortable sex after 3 treatments! ThermiVa’s thin and gently curved hand piece
allows for such delicate treatments.
Because of blood flow ThermiVa does result in collagen regeneration that
is needed for thickening of the vaginal lining and resolution of painful
intercourse. Again, for clinical proof,
look at the photos on the thermiva.org website. Lots of photos on the improved blood flow
resulting in increased moisture.
What about the comment that ThermiVa is not able to get hot
enough and “heats tissue to 50 Celsius, which may be too hot for a Jacuzzi but
quite insufficient to cause collagen generation.” This lacks clinical truth. There are many studies that show that tissue
tightening occurs at around 42 Celsius and that it is both temperature plus
time of exposure to heat that matters.
ThermiVa can comfortably bring vulvovaginal tissues to 40-45 Celsius for
3-5 minutes and cause immediate tissue contraction you can see during the
treatment then tighten even more over the next 3 months. Again, look at the pictures. There is significant collagen
regeneration.
Is FemiLift and other lasers like MonaLisa and IntimaLase
really less expensive over the long haul over ThermiVa? Let’s do some math. First, you can but 2-3 ThermiVa systems for
the price of one laser system. ThermiVa
costs the doctor $65,000. MonaLisa is
$175,000. FemiLift and IntimaLase are
somewhere in between. Those prices are
going down because of pricing pressure ThermiVa has exerted on the market. A good thing for doctors and patients
both. So who has the larger lease
payments and may need to charge more per treatment? For the patient, the average cost of 3
ThermiVa treatments is $3500 in Southern California. Laser treatments are more expensive at some
places and less in others. ThermiVa
does need maintenance about once a year as do laser treatments. There is zero price advantage for laser
systems over Thermiva for both the doctor and the patient. It is inaccurate to say that ThermiVa
treatments will be more expensive in the long run. I have had many calls and emails from doctors
across the country asking me if there is a way to part with their expensive
lasers and trade up to cost effective ThermiVa systems. They see the tsunami wave of ThermiVa
damaging their laser vaginal rejuvenation business. I have not heard of a single ThermiVa user
trading for a laser system. Just does
not happen with happy doctors with a device that is game changing. The acceptance of ThermiVa has been
widespread from OBGYNs, Plastic Surgeons, Dermatologists, Cosmetic Surgeons,
and even bread and butter Primary Care doctors.
You do not have to own a laser center or be a plastic surgeon to use
ThermiVa successfully. When treatments
are completed properly you cannot tell if it was done by a gynecologist or
plastic surgeon.
So let’s go point for point on a few things now:
1.Costs: ThermiVa is significantly cheaper for the
doctor to use and probably about the same for the patient. The single use hand piece is cheap and
disposable. The system warrantee costs
are a fraction of what laser companies charge.
2.Availability: ThermiVa is rapidly growing in
availability worldwide because it is more affordable and fits the practice of
gynecologists better than laser systems.
Even plastic surgeons are opting out for ThermiVa over lasers since they
own so many already.
3.Safety: No known adverse reactions or
complications with ThermiVa. No blisters
or burns. No need for a special laser
room with signage, no need to use laser glasses or smoke evacuators or masks
for the venereal wart viruses that may get in the air with laser systems when
they smoke tissues.
4.Simplicity: ThermiVa is a simple lightweight box
that can be carried or pushed from room to room or office to office quite
easily. About the size of a small gym
bag. No reticulating arms or smoke
evacuator or mirrors to align and worry about.
You press button to start it, raise or lower the temperature, use a
simple disposable wand. Super simple
controls without having to worry about watts, spot size, depth of penetration,
patterns.
5.Convenience: ThermiVa has a single use
wand. No cleaning of wand. No cross contamination. No sharing of vaginal hand pieces. You know it is a brand new and clean wand
when you open the package yourself. Plus,
with not having to switch hand pieces, there is no downtime when you go from
external to internal treatments and no need to disconnect and reconnect
anything. It is a totally seamless
procedure.
6.Anesthesia: ThermiVa does not need any type of
anesthesia. Laser systems typically do
not need anesthesia for internal vaginal treatments but will most likely need
anesthetic cream for treatment of the vaginal opening and labia majora. ThermiVa treatments feel like a warm stone
massage while laser treatments are known to give prickly and pokey sensations
during treatment.
7.Downtime: Zero downtime for ThermiVa. You can have sex, go to the gym, do anything
you want to immediately after treatments.
There is no abnormal discharge after treatment. Laser systems claim no downtime also but
there is a discharge from the ablative or resurfacing effects for 5-7
days. It is not appropriate to claim
that there is no downtime or discharge with the use of FemiLift or MonaLisa or
IntimaLase.
8.Versatility: Excellent for
a.Labia Majora Laxity: Non-surgical treatment
b.Vaginal Laxity: Non-surgical treatment
c.Atrophic Vulvovaginitis: Non-hormonal treatment
d.Stress Incontinence: Non-mesh treatment for mild
to moderate incontinence
e.Overactive Bladder: Non-drug treatment
f.Pelvic Prolapse: Can reduce a fallen bladder or
fallen rectum about one stage so that surgery may be avoided
g.Orgasmic Dysfunction: Average reduction in time
to achieve orgasm is 50% in those with a problem achieving orgasms
h.Repetitive Vaginitis: Normalizes vaginal pH
i.Repetitive UTI: Normalizes vaginal tissues and
vaginal pH
j.Lichen Sclerosis and Hyperplastic Dystrophy:
Adjunct to steroid and PRP
9.Results: Patient satisfaction is very high with
ThermiVa and the stories told are simply amazing. It is more than just tightening of the
feminine structures! ThermiVa addresses
the complete spectrum of feminine rejuvenation.
Pelvic pain and discomfort from atrophy or dryness improves. Everyone who is dry and atrophic gets moister
(even irradiated pelvis). Results for
incontinence are similar to surgery and drugs.
Improvement in orgasmic response is consistent for those who suffer with
orgasmic dysfunction.
10.Doctor
Training: No laser training needed with ThermiVa. Simple procedure. If you can do a Dilation and Curettage you
can do ThermiVa.
11.Doctor
Support: ThermiVa support is rapid and immediate and the reps are always
available. They provide on-site training
by their nurse instructors and also offer free webinars and live training at
established centers such as mine.
I hope the time I have given thoughtful comments on this
subject of ThermiVa versus lasers helps
bring out facts and straighten out inaccuracies on what ThermiVa can and cannot
do and shed light on the marvelous new non-invasive therapies now available to
our beloved women. That is in fact 100%
of my practice and 100% of my focus.
Warmest regards,
Red Alinsod, MD