FDA (American Food and Drug Administration) published a warning on lasers and other energy based systems on 30th of July. Some of our colleagues spoke about their concerns on the topic in some doctor groups. I would like to share my opinion on the topic with you. My words are a little long, so excuse me in advance. In comments section of this topic, fellow colleagues may share their experience and any adverse effects.
First of all, Laser and RF technologies have been used in cosmetic dermatology for many years. Applying these systems to genital region started at the beginning of 2000s. In cosmetic dermatology, laser is generally used for treatments of acne, verruca, nevus, skin rejuvenations and so on. RF is also used in face and decollette rejuvenation, body contouring, local obesity, and many physiotherapy applications. Us, gynecologist, have met these systems via their vaginal probes relatively late –about 10 years ago-. In reality, laser and RF Technologies are quite old. And they already have FDA approval for genital warts and hemostasis.
Laser is obtained by coherent, same wavelength-frequency and dense light waves. Lasers are classified as solid, liquid and gas based on the medium that used in that system. For instance CO2 lasers work by dense energy light obtained by a gas (CO2) medium transferred to the tissue. Each type of laser has a specific target chromophore. CO2 and Er:YAG lasers like water molecule, and they create a thermal effect when laser meets water within the tissue. For example lasers absorbed by melanin pigment bleach the skin color, or the lasers affecting oxyhemoglobin are used for treating vascular lesions.
Radiofrequency is different. Electrical current in wavelength at certain frequency (similar to Radio-TV frequencies, which named actually after those), meets water within tissue creating thermal effect as well.
The main ideas in Laser and RF are similar: “creating a temporary injury on the tissue”. An inflammation starts within the tissue by these tiny injuries, especially TGF-Beta and many certain cytokines are activated, and to restore the tissue fibroblasts are sent to region, as a result, new collagen and elastin synthesis starts again (remodelling).
The ‘rejuvenation’ used in laser and RF actually means reclaim and restore. The same term used for many body parts such as face, hands, neck and so on. Laser vaginal tightening or narrowing are wrong terms. The reversible injury that we created starts a rapid restoration process. This is more of a regeneration or rejuvenation process rather than tightening or narrowing.
Laser penetrates in the tissue quite shallow (reaches at epidermal lamina propria), at higher temparature (60-65 degrees).
In radiofrequency, penetration is deeper (subcutaneous tissue), at lower temparature (40-46 degrees).
Both applications are performed without anesthesia, patient is completely awake, it is completely painless except for perineum and introitus. Since patient is awake, there is no risk of any burns. Some of RF systems have even thermal sensors so that the heat is controlled at all times, providing going over a certain level. Some RF systems even stops by itself at certain temparature points.
There is a big competition among laser and RF companies. We use in İstanbul and Ankara clinics both technologies, so I can look those systems objectively. There are similar differences in terms of their indications.
Up until so far, in my last 5 years of almost 2000 laser and RF treatments, I haven’t seen any burn, scar formation or fibrosis, as FDA mentioned as potential risks. Indeed, there is NO any major complication in literature either. The adverse effects which FDA mentioned are based on what ground is questionable, since these are totally non-invasive procedures.
On the other hand, laser is slightly ablative whereas RF is completely non-ablative. That is why intercourse may be recommended just after RF treatments. By laser, there is a 7 days intercourse avoidance.
We use laser and genital RF for stress urinary incontinence, vaginal dryness, lichen sclerosis, menopausal atrophy and such, other than vaginal rejuvenation. It is supportive in vulvar vestibulitis. They are also used for cosmetic purposes for majora rejuvenation (tightening, to get plumper). Laser is used for vulvar bleaching and cutting in labiaplasty as well. After vaginal rejuvenation, tightening effect can be felt by woman and her partner after 3 weeks.
It is important to use the systems properly, considering the indications and certain energy limits. For instance , we widely use cortisone despite all its adverse effects. Because pros/cons ratio is in favor. Even the life source “water” in huge amount can have toxic impact.
On the other hand, it is important to question judgement of FDA. For instance, FDA approved synthetic meshes first time in 2001 for vaginal mesh applications. In 2008, indicated the complications such as mesh erosion, and underlined pain and urinary problems. Mentioned about dysparenuia risks. In 2016, changed their opinion in 2001 and classified meshes as high risk, and warned the producers. We will see further declarations of FDA later.
Again, FDA approved ‘Vioxx (Rofekoksib)’ pain killer in 1999. However, over 2000 articles this medicine mentioned for its effect on heart attack. Merck didn’t retract from market until 2004 by FDA’s decisions. Result is over 140.000 heart attacks and a medicine retracted afterwards. There is a similar situation for ‘Troglizatone’ indicated for diabetes. Many people have died of liver failure because of this medicine approved by FDA. It is not hard to understand FDA’s leery attitude against new technologies when FDA has so many mistakes.
Misoprostol for abort induction, cervical ripening is used in many countries world wide for many years. It has no FDA approval.
Half of the women of 60 years age have urinary incontinence. This is a huge social problem. 12% of women 80 years old being operated because of POP (genital organ prolapse). We are faced with recurrence of the situation and defects surgical methods and operation techniques. Midsling meshes have 16% risk of dyspareunia. Permanent pelvic pain risk is at 12%. That is why this technique is still trying to be developed constantly.
We can perform non-invasive Laser and RF treatments on obese, elderly, diabetic and even generally compromised health patients suffering from incontinence at office conditions, instead of copmplicated surgeries. These procedures need NO anesthesia, NO surgical risk and takes only about 20 minutes. They are indicated for SUI treatments without POP or slight POP. If we consider the phrase “surgery is shortcoming of medicine”, can we save at least some SUI patients from surgery? It needs to be considered carefully!..
Technology use in genital aesthetics is mostly done in private clinics. University and training hospitals are approaching this field very conservatively. That is why we lack RCT data. Most of the studies performed are case studies. The FDA committee is struggling because of the limitation of evidence based data and the studies are mostly likely white papers many supported by technology companies.
It is a huge injustice to turn against new technologies too soon. Similar mistakes were done by WHI study. Because of falsely designed study and news in media terminated all menopause treatments.
Starting by this year, we intiated evaluating our data in hand. We started new studies. We are open to fellow colleagues or institutions that want to collaborate with us. We can perform controlled studies.
Süleyman Eserdağ, MD, Gynecologist, FECSM
President of the ISAGSS (International Society of Aesthetic Genital Surgery and Sexology)