This article was originally published on LinkedIn on August 30, 2018.
I just got off the phone from two calls. The first was a surgeon seeking vaginal rejuvenation training and the second was a patient seeking a vaginal rejuvenation procedure. They sought my expertise on two completely different things. The never-been-lucid definition of vaginal rejuvenation is growing in many directions unimagined in years past. On a regular basis, it takes twists and turns as educated proponents, ignorant proponents, and detractors add narrative- and agenda-loaded meanings to this volatile term.
Why is this happening? I see a few major reasons: Foremost is large-scale marketing. Second, is the catalytic effect of social media on a level unknown when the first iteration of vaginal rejuvenation made its debut in the late 1990s. A public whose sole education on the term arises from repetitive marketing to their smartphones and whose knowledge of their bodies appears quite limited has no filter with which to distill whatever the Oprahs and Dr. Ozs of the world feed them via colorful Hollywood-quality vignettes. Their “research” is overwhelmingly a collection of marketing materials dressed up with pseudoscience. It’s time to separate fact from fiction.
Vaginal childbirth has been has been destroying vaginas since the beginning of time and modern pelvic floor research has been confirming what mothers have known for generations. Focus has been on the vaginal supports, bladder and bowel dysfunctions, and prolapse. Curiously, vaginal laxity is excluded from this conversation in medical circles, in the gynecologic literature and at meetings of large academic gynecologic societies. I invite you to search the term “vaginal laxity” on the websites of ACOG and FIGO, the two largest gynecologic academic societies in the world and that of AUGS, the largest urogynecologic society in the world to witness this void personally.
I have yet to find a female patient who states that sex improved after vaginal childbirth. These women have gynecologists who deliver babies every day. Many gynecologists are mothers themselves. They see the vaginal trauma of childbirth day in and day out and experience the aftermath personally. Sadly, I would have trouble swinging a cat in a room full of academic gynecologists without hitting an opponent to the concept that tightening the vagina might improve sex after vaginal childbirth.
You can live without treating it. It’s a lifestyle issue they say. True. That was the world pre-1996. But what else can we live without treating – fertility, infertility, unwanted pregnancy, foreskins. All of the latter are essentially lifestyle issues on which the specialty is deeply rooted.
The Day Sex Got Better
A patient underwent gynecologic anterior and posterior vaginal repairs for medical indications in Beverly Hills, California, in 1996. A few months later she told her surgeon, David Matlock, that her sex life had also improved; she said that it was because her vagina felt tighter. She referred a friend to him for the same operation. She had no medical indications, but she had a lax vagina that she wanted tighter to improve her sex life too. Dr. Matlock acceded to the request. Her sex life improved. Vaginal rejuvenation was born. (ref: conversation with Matlock, 1999)
David Matlock, MD, became David Matlock, MD, MBA. In the process, he learned about marketing, intellectual capital, and trademarks. In 1998, he labelled his operation Laser Vaginal RejuvenationTM and added Designer Laser VaginoplastyTM (a labiaplasty procedure despite the name), and the G-shotTM (a dermal filler injection for the G-spot) to his repertoire.
Why Laser? Two reasons: Matlock preferred the laser scalpel to the steel scalpel for his anterior and posterior repairs having learned to use the technology in his residency training. Lasers were introduced to the field of gynecology in the early 1970s and were a topic of intense academic and private practice interest and study well into the 1980s and 1990s. Second reason: To this day, “laser” has unparalleled marketing power to patients.
A Bodacious Adolescence
When you launch Laser Vaginal Rejuvenation in the epicenter of aesthetic culture and entertainment media, it gets noticed. Matlock became a global celebrity. Women added Laser Vaginal Rejuvenation to their Mommy Makeover bucket lists and other surgeons, naturally, wanted in on the action.
Matlock saw the potential market and created the Laser Vaginal Rejuvenation Institute of America to train surgeons in his techniques and license his trademarks. He utilized a franchise model and Laser Vaginal Rejuvenation began its widespread growth. Competitors emerged and, unable to use the trademarked terminologies, created their own nicknames for their versions of these procedures. The most common of these was simply vaginal rejuvenation.
The End of the Beginning
Gynecologic academia had consistently stayed out of the aesthetic/cosmetic arena and periodically reaffirmed this stance in public statements. However, the emergence of social media (Facebook 2004, YouTube 2005, Twitter 2006, iPhone 2007) created a wave of global attention on vaginal rejuvenation on which the academics were forced to offer commentary. In September 2007, the prominent American College of Obstetricians and Gynecologists (ACOG) released ACOG Committee Opinion No. 378: Vaginal "Rejuvenation" and Cosmetic Vaginal Procedures – a document which was parroted by academic societies around the world.
A brief five paragraphs and one reference long, this document has been misquoted, misinterpreted and misused widely by people at all levels of intelligence ever since it came out. The opinion attempts to define vaginal rejuvenation, yet opens with the admission that the authors are unclear of the exact nature of the procedures upon which they are opining. It lists Dr. Matlock’s trademarked portfolio procedure-by-procedure sans the word “laser,” yet they neither interviewed Matlock nor observed his work (ref: conversation with Matlock 2007; conversation with ACOG committee members 2008).
The second paragraph reiterates the trademarked terminology, questions its safety and effectiveness, and adds that it lacks data. Perhaps, if they had learned that Laser Vaginal Rejuvenation was an alias for gynecologic vaginal repairs with over a century’s worth of robust data, they might have concluded differently.
The third paragraph disparages the businesses of franchising, marketing, and paying for education. This is a direct objection to Matlock’s business model, but it didn’t apply to anyone else in the vaginal rejuvenation arena. Hypocritically, most if not all college and postgraduate educational programs require payment to the educators and most if not all academic societies, ACOG included, demand annual fees for the right to use their letters of distinction.
The fourth paragraph is best characterized as The Insanity Plea: a woman requesting these procedures needs a long talk to convince her that she’s normal. The lone reference in entire opinion is attached to this paragraph - a study that found that labia minora came in different shapes and sizes in 50 British women.
The concluding paragraph complains that women are being misled, that the procedures are not routine, reiterates the lack of data misconception, and out of thin air adds a list of potential complications that may arise from procedures on which the authors already stated they are unclear.
The Rise of the Machines
For the first decade and a half of it’s existence, vaginal rejuvenation was a surgical procedure for vaginal tightening with a steep barrier to entry - expertise in internal vaginal surgery – skills limited to gynecologists, urogynecologists, and some urologists. Then, the game changed.
Beginning in 2009, pioneering gynecologists in Argentina and Italy began developing techniques for nonsurgical laser treatments of the vagina aimed initially at vaginal atrophy. Working in conjunction with the industry’s standard laser platforms, they devised equipment and protocols for fractional carbon dioxide laser ablation based on existing dermatology protocols. Over the next few years, other groups began clinical investigations into the treatment of urinary incontinence and vaginal laxity working with a variety of lasers. This era culminated with the entry of Deka (MonaLisa) and the Alma (FemiLift) CO2 lasers for noninvasive vaginal ablation into the US market in late 2014. From then until now, the market has literally exploded and almost every major laser manufacturer makes a vaginal probe for their platform and radiofrequency technologies have followed suit.
The Marketing Paradox
How do you market a vaginal laser in the US? This was the challenge for the industry in 2014. Most lasers owners were plastic surgeons, dermatologists and other aesthetic professionals who hadn’t done a pelvic exam since medical school. All of the applications for vaginal lasers to date were purely gynecologic in nature – atrophy, incontinence, and laxity, but most gynecologists weren’t early adopters and wouldn’t buy a laser unless they were sure of a steady market for the service and saw homegrown proof of its efficacy from experts in the field irrespective of the overseas experience.
Marketing took a two-pronged approach: For existing aesthetics based laser owners, the theme became nonsurgical vaginal rejuvenation to get a piece of the vaginal laxity market and leave the rest to the gynecologists. For gynecologists, it was marketed first to academically inclined urogynecologists to establish credibility of efficacy. Since many in the gynecologic academic community had been mentally “poisoned” to the term vaginal rejuvenation in 2007 and eschewed any mention of vaginal laxity treatments, vaginal atrophy and urinary incontinence were the exclusive focus. For patients, the terms vaginal health and feminine health were created for direct marketing.
Mass Confusion Wins
By mid-2015, gynecologists and non-gynecologists alike were marketing laser vaginal rejuvenation, vaginal rejuvenation and nonsurgical vaginal rejuvenation online as synonyms for a variety of surgical and nonsurgical procedures well beyond the original meaning and intent of Matlock’s vaginal repairs. To confound matters further, patients doing online research on incontinence and vaginal atrophy were finding themselves in the offices of non-gynecologists without the benefit of a gynecologic assessment. The confusion persists to this day and continues to worsen as the number of devices and treatments continue to grow. At the present time, vaginal rejuvenation has so many possible meanings that it has no specific meaning.
When a woman tells me that she wants vaginal rejuvenation today, I have absolutely no idea what the term means to her and what issues she is seeking to address. It might be a gynecologic issue. It might be an aesthetic issue. It might be surgical. It might be nonsurgical. I also have no idea what her expectations might be as her judgement may have been seriously clouded by whatever “research” she has chosen to believe.
Vaginal rejuvenation in 2018 is a conversation starter, an icebreaker. The challenge in the conduct of this conversation is to understand that the average patient is clueless about her body, jaded with the expectations of mass media marketing hype, and completely at the mercy of the physician’s ethical compass.
This article was originally published on LinkedIn on August 17, 2018.
Recently, the MAUDE database has been cited as a source of “numerous” reports of adverse events associated with the use of transvaginal energy-based devices (tv-EBD). However, those who have cited the MAUDE database have failed to provide specifics regarding the quality, the quantity, and the nature of these reports. Seeking to satisfy my own curiosity, I conducted a search of the MAUDE database for adverse events for every vaginal EBD device and every manufacturer of such devices since they first appeared on the market in late 2014.
The search was conducted online via the FDA’s MAUDE search engine page. The name of each manufacturer, US distributor where relevant, and device was searched individually from 2014 to the present. The number of reports parameter was set to 500, the maximum. Some events had been reported more than once – some by personnel associated with manufacturers, some by physicians, some by patients. I then classified each device by it’s technology: Radiofrequency (RF), Radiofrequency with Active Cooling (RFAC), Carbon Dioxide Laser (CO2), Diode Laser (D) Erbium:Yag Laser (ER), Erbium:YAG + Diode Laser (ERD).
These are the results of this search:
Alma Lasers: FemiLift (CO2): no adverse events reported
BTL Aesthetics: Ultra Femme 360 (RF): no adverse events reported
Venus Concept: Fiore (RF): no adverse events reported
Inmode: Votiva (RF): no adverse events reported
Eufoton: LadyLift (D): no adverse events reported
Cutera: Juliet (ER): no adverse events reported
Lasering-USA: V-Lase (CO2): no adverse events reported
Syneron CO2RE Intima (CO2): no adverse events reported
Thermi: Thermiva (RF):
1 report: Gynecologist bruised her patient with device
Cynosure: DEKA: MonaLisa Touch (CO2)
3 reports of 1 event dated 3/31/2016 of UTI symptoms after treatment by gynecologist
3 reports of 1 event dated 8/23/2017 of urethral pain after treatment #3 by urologist in patient with hx of chronic urethral pain before tx, positive response with first 2 treatments
2 reports of 8/10/2017 & 9/4/2017 of 1 event: physician burned his own hand b/c assembled laser improperly
1 report 2/11/2016 of pt who had pain after treatment by gynecologist and had medical treatment at local urgent care clinic with vaginal creams and oral pills
Sciton: DiVa (ERD): 1 report of two non-physician medical staff who gave each other external burns unsupervised event 2/20/2018
Viveve: Geneveve (RFAC):
2 reports of 1 event: patient experienced multiple symptoms with “trial” handpiece after popping noise
Lumenis: FemTouch (CO2):
1 report of patient getting eye infection from eye protection after treatment by gynecologist
1 event of issues cleaning the handpiece
The total number of reports in this search was 15. The total number of events was 9. Two of these were non-physicians burning themselves while "playing doctor" with a laser. The total number of events involving patients undergoing treatment was 6. One of these was an eye infection from dirty eye protectors. This leaves 5 relevant events of vaginal issues.
Let’s examine these five adverse events involving patients undergoing vaginal treatments with energy based devices.
1. The Thermiva RF bruise event: In 2016, a woman noticed discomfort after treatment by an unspecified operator then went to her gynecologist who diagnosed bruising. Bruising is not a known complication of any low temperature radiofrequency technology used in the vagina, but it is a common occurrence with excess pressure on the vulvovaginal area. I would suspect the latter. The procedure itself involves a gentle massaging motion of a plastic handpiece and does not involve the application of excess pressure.
2. The MonaLisa UTI event: In 2016, a woman noticed urethral burning and discomfort beginning two days after treatment by her gynecologist and persisting for several weeks. Although urinalysis was performed 3 times, no urine culture was performed and no antibiotic therapy was given. The risk of urinary tract infection exists with any manipulation of the vulvovaginal area and is not unique to any procedure or any device. Procedures in the vagina and vulva are categorized as Class II: Clean Contaminated by the CDC with an infection rate of 4 to 10 percent (ref). Up to 20 percent of UTIs have been reported to show a negative urinalysis and culture is the gold standard (ref). One of the 3 reports of this event states that this patient had an active yeast infection that was being treated at the time of her procedure.
3. The MonaLisa urethral pain event: In 2017, a urologist attempted to treat the symptom of chronic urethral pain with CO2 laser fractional ablation. The patient’s symptoms vacillated in response to treatment and overall there was no long term detrimental effect documented. The main issue here was lack of knowledge in the techniques, technology and indications. There is no literature anywhere to support the use of fractional CO2 laser ablation to treat urethral pain and there is no protocol for doing so. This is an example of experimentation.
4. The MonaLisa post-procedure discomfort event: In 2016, A woman experienced discomfort after her procedure and went to an urgent care clinic to have her issue addressed. This report was provided by the manufacturer and was reported because the patient sought and received care from an urgent care clinic. It is not uncommon for patients to seek out care at urgent care clinics. Reasons for doing so may include inadequate pre/post procedure counseling, an inability to contact their treating physician, the suggestion of friend or family member, or convenience.
5. The Geneveve pain event: In 2017, a non-gynecologist treated a woman who had never undergone the procedure before at twice the standard energy dose with a “trial” handpiece that hadn’t been used before. A strange “popping” noise was documented during the procedure, but the procedure was continued. The patient reported pain, sensation issues and urinary incontinence. This event suggests a complete lack of professional judgement and a lack of knowledge of energy based devices on the part of the operator. Although I have no experience with the use of this product, I have 27 years of experience with lasers. Every laser case invokes a strict checklisted laser protocol that involves equipment checking and test firing outside the human body. The latter applies to equipment that is in it’s final form, not a trial device. In the case of a trial device, a trial procedure is done outside the human body on a suitable model where the device can be tested. At that stage, it might be ready for a human trial or not. It is not offered as reasonable treatment to anyone as this is purely experimentation. Arbitrarily doubling the energy dose in a treatment-naïve patient is without precedent in any energy-based therapeutic intervention that I am aware of and cannot be justified. Ignoring an inexplicable noise during operation of the device is unfathomable. This unfortunate event can be deemed a compounding of errors stemming from extremely poor clinical judgement.
This analysis of the MAUDE database brings several issues to light. First, is the need to distinguish the number of events from the number of reports of singular events. Every year, my birthday is reported “numerous” times by my Facebook friends. This happy birthday effect does not elevate the magnitude of this singular event. Second, is the need to educate “rookies” to EBD in the technologies they are using, to the indications of the treatments they are providing, and to the counseling and postprocedural support that their patients may require. All of these five adverse events can be classified as human factor errors. My colleagues from other specialties suggest that I am inciting a turf war. To the contrary, I am offering simple advice for staying out of trouble. So many “skin experts” that I know offer elaborate skin imaging and mapping technologies prior to facial EBD treatments, yet offer no vaginal assessment whatsoever prior to firing a laser or other EBD in the vaginal canal blindly. Third, is the need to establish a collective database of experience with the devices. The MAUDE system does not and cannot track the number of procedures performed. It can only offer a glimpse into the issues of reported events and it is severely limited at that. When estimating the unknown frequency of true adverse events, pundits against EBD will exaggerate the numerator and dwell on the few available sad vignettes while those who favor EBD will stress that there is no denominator, but that it’s probably large.
So...where's the storm?
This article was originally published on LinkedIn on August 5, 2018.
One week ago, tomorrow, the FDA issued a Safety Communication slamming the use of energy-based devices for the indications of "vaginal rejuvenation" - "an ill-defined term" - "sometimes used to describe non-surgical procedures intended to treat vaginal symptoms and/or conditions including, but not limited to:
Vaginal atrophy, dryness, or itching
Pain during sexual intercourse
Pain during urination
Decreased sexual sensation"
The document stated that there are two problems:
1. "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."
2. "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."
The document lists two references:
The first of these references was written in 2007, almost a decade before these energy-based devices ever existed. It obviously makes no mention of any energy-based device nor any mention of the treatment of any of the vaginal symptoms listed in the current FDA document.
The second reference, published in mid-2016, was essentially a clarification of the FDA approval language for fractional CO2 lasers in gynecology drafted by the American College of Obstetricians and Gynecologists. This document stated that the FDA had not approved these lasers for the indication of vulvovaginal atrophy (VVA) and that preliminary observational data had shown some potential benefits with the use of this technology in treating patients with VVA. It made no mention of any adverse events. This document listed 6 references, 3 of which were short term clinical studies of this technology for VVA, and none of which made mention of any of the adverse events listed in the current FDA document.
To summarize, the FDA has proof that energy-based devices are being marketed for indications that were not part of the FDA approval, and the FDA has no proof that the use of these energy-based devices for these indications is causing any of the serious adverse events listed in their Safety Communication.
I have been involved as both a user and a consultant to the industry on these devices since their FDA approval. I have extensive training, education, and experience in the treatment of vaginal atrophy, urinary incontinence, vaginal laxity, and lasers. I am consulted when physicians have problems with these technologies and the problems have never been related to adverse events. I have witnessed the explosion of marketing for these indications by the industry and I am very well aware of the paucity of data to support the use of these technologies for these indications. However, in my experience, these technologies work well in carefully selected patients. I haven't seen the serious adverse events listed in the Safety Communication. I have conducted and attended professional conferences on the topic of these technologies, constantly review the literature, and constantly consult with both experts and neophytes in these technologies and haven't heard of physicians experiencing the serious adverse events listed in the Safety Communication.
So from where did this list of adverse events originate? I can only speculate that this list has been carried over from other applications of CO2 laser technology that did not involve fractional ablation or the relatively low energy settings used in the vagina. These machines have the capability to do more than fractional laser ablation of the vagina. They are designed for multiple uses all over the body. Certainly, if misused intentionally, they hold the capability to burn tissue severely. However, and despite the fact that out-of-control marketing has put these devices into the hands of physicians with little or no training in the indications or the technologies in question, there is no evidence that I am aware of that we are in the midst of a laser vagina trauma epidemic. One would expect a perfect storm of morbidity under such conditions. To the contrary, the current lack of adverse reports would suggest that these devices used as recommended are idiot-proof.
Would the FDA withhold proof of serious adverse events in a Safety Communication? Highly unlikely. There would be no motive. Especially, at the present time, when the FDA is proudly launching it's Medical Device Safety Action Plan. If anything, such proof would only add emphasis to their statement. A relevant example, would be a recent Safety Communication against injectable silicone published 9 months ago where the references offer ample proof of serious adverse events associated with that product.
In my opinion, the main risk of these technologies to patients, is the lack of an expected treatment effect. Expectations should be based on both personal and published experience, patient counseling, and intimate knowledge of the conditions being treated and of the techniques and technologies being considered. This is the essence of solid clinical judgement.
In their own words, "The FDA does not have the authority to:
Regulate a physician's or nurse's practice. FDA does not tell providers what to do when running their business or what they can or cannot tell their patients.
Make recommendations for individual doctors, clinics, or home care agencies.
Conduct or provide a rating system on any regulated medical devices."
However, it is their duty to make physicians and the public "aware" and "understand" issues related to product safety and effectiveness for the uses for which they are approved. An overzealous allusion to adverse effects unsubstantiated by data is out of place and does not a perfect storm make when all that can be seen are clear skies.
Marco A. Pelosi, III, MD, is a cosmetic gynecologist, surgeon, lecturer & cofounder of the ISCG. You may contact him directly at firstname.lastname@example.org