Listen to the Expert Panel Discussion from the 2019 ISCG World Congress of Cosmetic Gynecology conducted on January 29, 2019, in Orlando, Florida. Nine world experts with extensive experience in the use of nonsurgical lasers and radiofrequency devices discuss the concerns raised by the FDA regarding the use of these technologies and share their insights and experience. Moderator: Marco A. Pelosi, III, MD. Expert Discussants: Alexander Bader, MD (UK), Rafal Kuzlik, MD, PhD (Poland), Michael Krychman, MD (USA), Michael Goodman, MD (USA), Oscar Aguirre, MD (USA), John Miklos, MD (USA), Red Alinsod, MD (USA), Adrian Gaspar, MD (Argentina), Jorge Gaviria, MD (Venezuela & Spain).
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.
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.
This lecture was given as the finale to the 2018 ISCG World Congress in Las Vegas. It summarizes trends in the specialty and comments on issues and criticisms.
This is a lecture delivered to the New Jersey Obstetrical and Gynecological Society at their 66th Annual Meeting. It is a complete introduction to the field of cosmetic gynecology and covers the major issues and controversies.
I wrote a review article on cosmetic vaginal surgery for the short-lived internet journal US Obstetrics & Gynecology a while back. With their website gone, the links to this fine manuscript have evaporated into the abyss of The Cloud. Back from the ashes, here it is slightly updated:
A variety of procedures are available for the cosmetic enhancement of the female genitalia. Despite controversy, they continue to grow in popularity. Familiarity with the terminology and spectrum of the aesthetic options described herein permits a realistic assessment of the ways in which the female patient’s concerns may be addressed. There are important aspects of patient evaluation and counseling unique to cosmetic surgery that must be learned by those contemplating the delivery of these services.
Cosmetic vaginal surgery encompasses aesthetic procedures directed at the appearance of the vulvar structures and tightening procedures directed at the reduction of vaginal caliber. The most commonly treated areas are the external vulvar structures. These include the mons pubis, the labia majora and the labia minora which includes the clitoral prepuce. The perineum and the lower third of the posterior vaginal wall are the areas typically operated in vaginal tightening procedures. The anterior vaginal wall does not play a role in vaginal tightening. Hymenoplasty is performed when requested for cultural reasons.
Like cosmetic procedures of the face, the breasts and the body, vaginal procedures focus on the elective alteration of normal structures. They are not treatments for medical conditions and offer no health benefits. Unlike these other established cosmetic procedures, the first public wave of cosmetic vaginal surgery emerged from the work of corporate-style entities which branded their procedures and treated their technical knowledge as private intellectual property. Over the past decade, cosmetic vaginal surgery has reached public awareness on par with other cosmetic procedures and a growing number of gynecologists, cosmetic surgeons and plastic surgeons are offering these services to their patients.
The reasons behind the increased demand for this type of surgery has been postulated by many groups, but not established by any type of scientific analysis. Many have used this information vacuum as an opportunity to advance or regurgitate chronic agendas against cosmetic surgery in general. Our impression as surgeons performing this type of surgery as well as a wide range of established cosmetic procedures is that the rapid growth of these procedures is due to three factors. First, is timing. The first half of the past decade witnessed the greatest surge in cosmetic medical and surgical volume in history. Yearly statistics monitoring the cosmetic activities of ENT, dermatology and plastic surgery specialists demonstrated a six-fold increase in total cosmetic procedures between 1997 and 2006 (ASAPS, 2007). Cosmetic vaginal surgery emerged during this era and became a component of the intense media coverage which brought cosmetic surgery onto television shows and other media. Second, is the global cultural shift into social media communications as the internet and advanced mobile devices created a level of awareness and information access unprecedented in human history. It is not only possible, but simple, for anyone anywhere to access media on any topic at any time without censorship. Access to services is relatively unimpeded. Third, depilation of the mons pubis has become as popular as that of the legs and axillae in the United States. Once depilated, these areas have now become targets of decoration with tattoos, piercings and surgical modification.
A background in gynecology is ideal for evaluating the prospective cosmetic vaginal surgery patient because gynecologic disease or dysfunction may be aggravated if a procedure is performed at the wrong time (e.g. vaginal tightening in a woman who plans on delivering vaginally in the near future or in a woman who has significant pelvic floor defects). However, the evaluation of the cosmetic patient also warrants attention to psycho-social factors which might lead to unrealistic or unachievable expectations such as the presence of body dysmorphic disorder, immaturity, a perfectionist mentality, a cosmetic surgery addiction, a belief that surgery will cure interpersonal problems or a desire to have surgery for the benefit of a partner. These issues are common screening criteria for all cosmetic surgical procedures, but gynecologists who enter this field with a broad knowledge of gynecology, but little familiarity with the cosmetic patient may find these issues to be a new dimension previously unexplored.
The Cosmetic Gynecologic Assessment
Unlike the medical patient who seeks relief from disease, deformity or dysfunction, the cosmetic patient must meet be completely healthy in order to be an appropriate candidate for a procedure which offers no health benefit. The well-chosen patient fall into either category ASA I or ASA II of the American Society of Anesthesiologists Physical Status Classification System, but those with specific diseases with a known predisposition to poor healing or increased surgical morbidity such as diabetes or hypertension are best avoided. Hospitalization costs associated with cosmetic procedures, planned or unplanned, are not covered by conventional healthcare insurance.
Following the initial conversation regarding the cosmetic request and the requisite psycho-social analysis, the physical examination is conducted. For cosmetic requests involving the vulvar structures or mons pubis, the physical examination is best conducted with the patient standing before a full-length mirror because this is typically the position in which they wish the appearance to be altered. The standard gynecologic dorsal lithotomy position is then assumed to better examine the full extent of the vulvar structures and to conduct a full gynecologic examination include an assessment of any infection which may interfere with the surgical procedure. For vaginal tightening operations there is no need for the standing examination unless there is suspicion of pelvic organ prolapse. However, there is a need to assess the existing width of the levator hiatus and the quality of the puborectalis muscle tone since this will be the focus of these procedures. A common practice is to measure the hiatus in fingerbreadths with the muscles at rest and with the muscles contracted then convert this data to centimeters.
Anesthesia requirements for cosmetic vaginal surgery are no different than those for any other vaginal procedure and can be either general, epidural, spinal or intravenous sedation with local block. Prophylactic antibiotics are routinely employed immediately before surgery. Patients are positioned in dorsal lithotomy with the legs supported in boot-type stirrups with mild flexion of the knee. Intermittent pneumatic compression stockings are routinely employed. Indwelling bladder catheterization is employed during most operations. Bladder catheterization is maintained postoperatively for 24 hours in cases where periurethral swelling is anticipated and in cases in which vaginal packing is placed.
The Mons Pubis
Three common cosmetic treatments are available for the mons pubis. The first of these is simple depilation of the pubic hair. The techniques and technologies are the same as those used elsewhere on the body and include laser or intense pulsed light (IPL) treatments administered in a series of sessions over an interval of several months. Multiple sessions are necessary because hair follicles are sensitive to therapy at only certain points in their growth cycle and at any given time, only about 25% of these follicles are in the requisite phase. Modern depilation technologies do not result in total depilation, but greatly reduce the density of hair follicles and the frequency with which any additional depilation maneuvers (shaving, waxing) are needed. The technologies are limited by the degree of melanin and skin pigmentation present and are not advisable for the darkest skin types.
Liposuction of the mons pubis is a common procedure for the treatment of excess adiposity and is usually performed in conjuction with abdominal liposuction. The treatment tapers off into the anterior margin of the labia majora. Tumescent local anesthesia – a solution of saline, lidocaine, epinephrine and sodium bicarbonate – is the most common type of anesthetic used for this procedure. Mild postoperative swelling and slight temporary bruising extending to the labia majora are common in the first week after surgery. Mons pubis liposuction is also performed as an adjunct to abdominoplasty when the inferior edge of the incision line is significantly thicker than superior flap.
The mons pubis lift is a derivative of abdominoplasty techniques and targets significant laxity in the mons pubis region and sagging of the labia majora as viewed in the standing position. The procedure entails careful controlling of the central tension vectors when planning the resection pattern at the time of abdominoplasty. Whether the procedure is isolated or part of a larger abdominoplasty, excess tension at the lateral angles of the pubic triangle and curving the center of the scar cephalad are two aspects of the surgery which need to be avoided to generate an optimal cosmetic result. These goals are best accomplished with a high lateral tension-style excision pattern. The pubic lift integrates well with mons pubis liposuction.
Mons pubis lift with abdominoplasty. A. Surgical markings demonstrate incision line (red) and bikini lines (black). B. Traction is applied to mons pubis after preliminary liposuction has been completed and vectors are studied for adequacy. C. Vectors are reassessed at time of flap closure. D. Appearance at six months post-surgery.
The Clitoral Region
Loose, redundant folds of skin lateral to the clitoris are the target of cosmetic excision in this region. This tissue is contiguous with the skin of the clitoral hood (prepuce), but does not function to protect the glans clitoridis. These skin folds may be as large as the main clitoral body and precise dissection in a direction and depth that avoids the path of the clitoral sensory nerves is essential to maintain full sensation. Maintenance of symmetry is another essential aspect of the surgery as the resection of too much skin may pull the clitoral alignment away from the midline. Since this is cosmetic surgery, camouflage of the suture lines is desirable. To this end, incisions across the dorsum of the prepuce along the clitoral shaft should be avoided because they will be visible when the patient is viewed in the standing position. Maintaining incision lines parallel to or within the natural skin folds produces an effective camouflage and is very difficult to detect. When planning surgery of this type in combination with an abdominoplasty or a mons pubis lift, the lift is done first because it frequently produces a tightening of the prepuce in the vertical axis when the mons pubis is placed on cephalad traction.
The Labia Minora
Reduction labiaplasty of the labia minora is one of the most commonly requested cosmetic vaginal surgery procedures. Common presenting complaints include dissatisfaction with elongated, asymmetric or hyperpigmented labial tissue. Less frequently, patients will request repair of chronic torn labial tissue years subsequent to vaginal delivery. A thorough examination of the labia minora, from a cosmetic perspective, necessitates splaying them laterally onto the labia majora to determine the degrees of hypertrophy, hyperpigmentation and asymmetry which may be present. Proposed excision lines are marked and demonstrated to the patient with a hand mirror. Anteriorly, the planned excision lines may end inferior to, at or beyond the clitoral frenulum. Posteriorly, the excision line may extend toward the fourchette in the midline. When combined reduction labialplasty and vaginal tightening procedures are planned, vaginal tightening is performed first because it involves the resection of the existing fourchette. Laterally, resection should never extend beyond the natural crease between the labium minus and the labium majus because the tension which results may produce gaping of the vaginal introitus and expose the urethra. Suture lines are dressed with topical tissue sealants at the conclusion of surgery and patients are instructed to avoid tight clothing for the first two weeks, to avoid inserting anything in the vagina for six weeks, and to avoid prolonged sitting on the suture lines for six weeks. Local edema and bruising are common in the first two weeks following these operations.
Left labia minoraplasty for the relief of sports-related traction pain at the time of a bilateral procedure. Inset illustrates the natural crease between labium minus and labium majus which must be preserved to prevent gaping of the vaginal introitus. Larger photo demonstrates appearance labial base. The left clitoral crus and bulbocavernosus muscle are clearly demonstrated.
Right sided reconstructive labia minoraplasty for chronic second-degree tear with associated traction dyspareunia. A. Arrow indicates defect which involves the insertion of the clitoral hood to the labium minus dorsum. B. With the corners of the defect on traction, the scar tissue has been excised in preparation for repair. C. Appearance immediately following a three-layered reconstruction.
The Labia Majora
Loose sagging skin, loss of volume, varicosities and unwanted hair are the common complaints of women seeking alteration of labia majora appearance. Redundant skin is best managed by longitudinal ellipsoid resections of skin and subcutaneous fat. Aggressive dissection along the course of the sensory nerve supply to the labia and clitoris should be avoided. Absolute hemostasis is critical in this highly vascular and very elastic tissue as large hematomas can easily develop. Volume loss is addressed by autologous fat transfer into the subcutaneous fat layer. Fat is harvested from any convenient site using conventional liposuction techniques and typically requires less than 50cc for a bilateral augmentation. Fat injections are performed with specialized blunt-tipped needles to avoid the risk of cannulating blood vessels inadvertently. As the fat is injected into the area, it is molded into the desired shape by pressure and massage. Some loss of the implanted fat volume is expected and the need for multiple fat transfer sessions is anticipated.
Varicose veins of the vulvar region respond to sclerotherapy in much the same manner as those of the lower extremity. Not infrequently, these varicosities are a source of pelvic pain and a gynecologic workup for pain should rule out other etiologies prior to treatment. Common sclerosing agents such as sodium tetradecyl sulfate are used and administered via small-guage needles attached to tuberculin syringes. The veins are targeted in the standing position and injected in the supine position. The technique is identical to sclerotherapy of the leg varicosities working from proximal to distal veins. A pelvic compression garment is worn for the first week post-injection.
Left sided reconstructive labia majoraplasty for a non-communicating hydrocele. A. The extent of the distortion is demonstrated. B. The skin resection margins were marked in the standing position and are demonstrated in dorsal lithotomy. C. Mobilization of the cyst extended along the canal of Nuck and ended at the level of the pubic symphysis. D. Appearance immediately after layered cosmetic reconstruction and Dermabond dressing.
Patient presented for augmentation labia majoraplasty with fat injections and treatment of isolated vaginal laxity. A. Attenuation of the perineal body is demonstrated and marked for resection. B. Fat was harvested from the inner thighs using syringe liposuction. C. Following the completion of a modified posterior colpoperineorrhapy, approximately 20 cc of purified fat was injected into each labium majus using a blunt-tipped fat transfer cannula inserted through a needle track incision. D. Immediate post-surgical appearance.
Vaginal Tightening (Vaginal Rejuvenation)
Procedures for tightening the vaginal caliber are derivations and variations of posterior colporrhaphies and perineorrhaphies. Unlike therapeutic operations targeting significant rectoceles, the focus of these operations is less on the repair of the endopelvic fascia than it is on achieving a reduction of the levator hiatus. The fascial repairs remain important ot the durability of the results, but they are not the technical endpoint for the surgeon. In the absence of advanced degrees of pelvic organ prolapse, mild to moderate degrees of vaginal laxity can be corrected quite adequately by targeting the lower third of the posterior vaginal wall and the perineal body for plication. We do not recommend anterior colporrhaphies for vaginal tightening because they do not add significant tightening at the sites most commonly noted by patients to be loose. Also, gauging the degree of tightening can be tricky in inexperienced hands and those considering offering these surgeries to their patients are well advised to seek specific training in these operations from experts.
A variety of procedures are available for the cosmetic enhancement of the female genitalia. Despite controversy, they continue to grow in popularity. Familiarity with the terminology and spectrum of the aesthetic options described herein permits a realistic assessment of the ways in which the female patient’s concerns may be addressed. There are important aspects of patient evaluation and counseling unique to cosmetic surgery that must be learned by those contemplating the delivery of these services.
1. Pelosi MA III, Pelosi MA II. Breast augmentation. Obstet Gynecol Clin N Am 2010;37:533-46.
2. Pelosi MA III, Pelosi MA II. Liposuction. Obstet Gynecol Clin N Am 2010;37:507-19.
3. Matlock DL. Letter: Cosmetic therapies in obstetrics and gynecology: putting a toe in the water. Obstet Gynecol 2008;112:703.
4. Pardo J, Sola VD, Ricci PA, Guiloff EF, Freundlich OK. Colpoperineoplasty in women with a sensation of a wide vagina. Acta Obstet Gynecol Scand 2006;85:1125-7.
5. Miklos JR, Moore RD. Labiaplasty of the labia minora: patient indications for pursuing surgery. J Sex Med 2008;5:1492-5.
6. Laube DE. In reply to: Indman PD. Letter to the editor: Cosmetic therapies in obstetrics and gynecology practice: putting a toe in water. Obstet Gynecol 2008; 112: 704-5.
7. DeSousa A. Concerns about cosmetic surgery. Ind J Med Ethics 2007 Vol. 4, No. 4: 171-3.
8. Cosmetic Surgery National Data Bank. 2007 Statistics. New York (NY): American Society for Aesthetic Plastic Surgery; 2009.
I wanted to share a small sample from an upcoming chapter entitled Cosmetogynecology
Note: I took a few liberties with the official version of my work as it will appear in the published version to provide you, the blog reader, with some behind-the-scenes perspectives and anecdotal observations that I usually omit for both brevity and lack of published references from more "learned" discussions. Also, I have included images that exceed those of the to-be-published work because there are no restrictions on quantity here.Dr Shirith Sheth
Shirith S. Sheth, FRCOG Ad Eundem, FACOG (Hon), is an exquisitely skilled, renowned and celebrated gynecologic surgeon from Mumbai, India. He is also a good friend to my surgical team and an individual whom we see much too infrequently. Over a decade ago, we contributed chapters to his excellent book entitled Vaginal Hysterectomy which he co-edited with Dr. John Studd.
Several months ago, Dr. Sheth decided that his masterpiece was due for an overhaul and asked if we would be so kind as to update our chapters. He also asked if there was "anything new" that might add to the appeal of the book. Ergo, a chapter on cosmetic gynecology, to be released early next year. We hope you'll like it.
The labia minora display a wide range of shapes, sizes, pigmentation and frequent asymmetry. Controlled precise resections are employed to reshape the labia and the skin around the clitoral hood. Some requests are purely cosmetic, others address pain or irritation associated with certain activities such as sex, horseback riding and other sports. Symmetry, balance and comfort are the most common reasons why women request cosmetic alterations of the labia minora. In some instances, treatment is unilateral.
Two of these cases presented with complaints of traction pain with various activities. The other two simply disliked the appearance. Can you match the symptoms with the images? - of course not!
Myriad techniques for labia minoraplasty abound. They can be categorized into three general groups:
(1) linear excisions parallel to the labial edge,
(2) wedge excisions perpendicular to the labial edge, and
(3) partial-thickness excisions.
All of these approaches have been described with variations on the shape and extent of the basic concepts.
Linear Labia Minoraplasty
Modern linear excisions are radically evolved from the simple amputations of antiquity which were originally preferred for their speed in the pre-anesthetic era. The refined cosmetic approach involves a layer-by-layer contoured dissection with hemostatic adjuncts such as vasoconstrictor injections and frequently electrosurgical, radiofrequency or laser coagulation.
Linear excisions offer the ability to remove and reshape the entire length and profile of the labial edge. They also allow for precise tension adjustments and typically yield a low-tension suture line and do not generate posterior traction on the clitoral frenulum.
If there is a marked color discrepancy between lateral and medial labial skin, this style of labiaplasty may leave an unnatural color transition line along the new labial edge if an aggressive excision is performed. In a full-length excision, 3 to 4 small arterioles will be encountered and require surgical control.
Wedge Labia Minoraplasty
Marc Laufer (pictured), and William Galvin, pediatric gynecologists at Children's Hospital/ Brigham & Women's Hospital, Boston, Massachussetts, published a 2-case report introducing the wedge labiaplasty technique in 1995 (Adolescent and Pediatric Gynecology 1995;8:39-41).
Three years later, Gary Alter, a plastic surgeon from Los Angeles, published a 4-case series introducing the wedge labiaplasty technique. (Annals of Plastic Surgery 1998;40:287-90).
In fairness to Alter, I was unable to find Laufer's paper in any medical database using 2013 search technology with a copy of Laufer's paper right in front of me. So how did I find Laufer's obscure paper? He self-referenced it in a 2011 article on pediatric labiaplasty.
Wedge excisions offer the ability to preserve the natural labial edge, but cannot reshape the full length of the labial margin. The approach was originally conceived in an effort to reduce scarring and discomfort associated with improperly performed linear excisions (Laufer 1995; Alter 1998). They are a reasonable option when the tissue targeted for excision is limited to a narrow segment of the labium. In a typical wedge excision, a single arteriole is encountered.
Wedge excisions near the clitoris have a tendency to draw the frenulum and clitoral hood posteriorly.
Attempts to extend the aesthetic reach of this style of labiaplasty by either wider wedging or creative flapping are met by an unacceptably high rate of either incisional dehiscence or tissue necrosis.
Partial-Thickness Labia Minoraplasty
Partial-thickness skin-only excisions of the labia minora have been proposed with the goal of preserving the labial edge. Two techniques have been described. One of these entails triangular epithelium-only excisions parallel to the long axis of the labium on the medial and again on the lateral aspects. The stroma and vascular supply are not disturbed (Choi et als.).
A second approach consists of the resection of a skin-only wedge from the central portion of the labium and consistently leaves a thickened appearance.
Essentially a component of the labia minora aesthetic unit, the clitoral hood (prepuce) varies greatly in anatomy. Frequently, one finds reduplication of the labia minora extending laterally or bilaterally parallel to the shaft of the clitoris. In other instances, the clitoral hood itself displays loose, redundant folds. Targeted, superficial direct excision of this redundant tissue is individualized. The best cosmetic results are achieved by maintaining suture lines parallel to the clitoral shaft.
A cosmetic error, frequently seen with improperly designed linear excisions, is the abrupt termination of the labiaplasty scar at the clitoral hood, leaving a loose redundant mass of periclitoral skin. These require revisionary surgery to essentially complete the procedure.
If you want more, you'll have to buy the book or see me in person.
This was the topic of a recent lecture I gave at the American Society of Cosmetic Breast Surgery annual meeting in Newport Beach, California. The slide show sans narration is available here. It is also the topic of an upcoming chapter in a book edited by Melvin Shiffman.
Breast augmentation with injections of autologous fat harvested by liposuction was first described in the mid 1980s (2). Early enthusiasm worldwide was soon tempered by concern, albeit speculative, that such transplants would confound or delay the radiologic diagnosis of breast cancer (3). Ongoing critical analysis over recent years has demonstrated, however, that these concerns do not appear to be heightened in comparison to other cosmetic breast procedures and these findings have stimulated a renewed interest in this type of breast augmentation (4,5). To date, this procedure appears best-suited for small-volume augmentation and for cosmetic tissue remodeling around existing synthetic breast implants and sometimes requires multiple treatment sessions to achieve a desirable lasting result (Figure 1). The terms lipofilling, lipomodeling, and lipoinjection are synonyms used to describe autologous fat transfer. Structural fat grafting refers to a specific technique of autologous fat transfer (4).
There are two indications for breast augmentation: (1) a cosmetic desire to have larger breasts, and (2) reconstruction of congenital or acquired breast deformity or absence.
The best candidates for breast augmentation by any modality are nonobese women displaying relatively symmetrical breasts, a symmetrical frame and lacking breast ptosis. Ptosis is evaluated with the patient standing and is defined as descent of the center of the nipple-areola complex (NAC) below the level of the inframammary fold (IMF). Grading systems are described elsewhere (6).
The best candidates for cosmetic breast augmentation by autologous fat transfer are those seeking a modest increase in size, who (1) have adequate fat deposits for harvest by liposuction, (2) understand that an unpredictable proportion of the transplanted fat and associated volume, will resorb during the healing phase, (3) are aware that multiple sessions may be required to achieve a suitable size increase, and (4) are aware that saline or silicone implants are options that deliver predictable size augmentation and they reject those options.
A subgroup of patients requesting breast augmentation with autologous fat are primarily interested in liposuction body contouring. Their motivations for breast augmentation lie more in the financial convenience of combining the body contouring procedure with autologous fat transfer and are less interested in attaining a specific increase in breast size. Nonetheless, they should always be counseled regarding the limitations of the breast augmentation with autologous fat and of the other common breast augmentation options.
The correction of contour irregularities around existing saline or silicone breast implants is a less common, but effective application of autologous fat transfer to the breast. It is prudent in such cases to be fully prepared to perform an implant exchange at surgery in the event of accidental implant perforation. Rippling and upper pole volume deficiencies respond well to fat transplantation. Capsular contracture has been reported to improve after fat grafting around the constricted capsule (4).
Screening & Evaluation
General screening criteria for liposuction, then specific criteria for breast surgery are employed. Since breast augmentation by autologous fat transfer typically generates only a modest increase in breast volume, it essential to determine that the patient is not seeking a larger increase in breast volume. Otherwise, the patient will be dissatisfied with the result and with the surgeon for not offering an alternative better suited to her desires.
The ideal cosmetic breast patient has no breast symptomatology, pathology, or risk factors for breast disease. Breast specific screening begins with a thorough history and family history followed by a complete physical examination of the breasts with attention to any masses or lymphadenopathy. A history of breast cancer treated by conservative resection is an absolute contraindication to the procedure. Mammography is performed on patients meeting either medical diagnostic or routine screening criteria. Some surgeons prefer to screen all cosmetic breast patients with mammography prior to surgery because of concern that postsurgical changes may obscure subsequent breast cancer screening. All patients are counseled that cosmetic breast surgery may produce calcifications, cysts or palpable lumps that may require diagnostic imaging and interventions including biopsy and can never be assumed to be benign.
Medications, supplements, herbs and other substances with the capacity to impair coagulation should be discontinued in advance of surgery. Substances which interact negatively with anesthetic agents and perioperative medications should also be withheld. If they cannot be discontinued or substituted, the surgical plan will need to be modified, delayed or withheld. Cigarette smoking is not a contraindication to liposuction nor to autologous fat transfer, but smokers typically display an atrophic dermis and less skin elasticity which both increase the likelihood of postoperative skin wrinkling. They also demonstrate greater resorption of transplanted fat.
Photography of the breasts prior to surgery, before and after marking their measurements, completes the preoperative process. Written release forms specific to photography are mandatory. A routine that includes frontal, oblique and lateral views with arms both at rest and elevated provides an accurate record of asymmetries and of any preexisting scars or contour deformities.
External Tissue Expanders
Breast augmentation with external tissue expanders was introduced in 1999 (7). The method, currently known as the Brava system, utilizes a pair of self-sealing rigid polyurethane domes which are applied directly over the breasts to create a negative pressure which causes tissue distraction which, in turn, stimulates tissue growth.
Although the technology is effective, it has not gained popularity because it requires a minimum of ten hours of continuous daily use for a minimum of ten weeks to produce results and the results, under the best of circumstances, are typically less than a one-cup size augmentation.
More recently, however, the Brava device has been utilized as a means of expanding the superficial planes of the breast in preparation for autologous fat transfer allowing for more fat to be injected under less pressure. The protocol under study involved 4 weeks of pre-operative Brava use for 10 hours daily followed by postoperative use as a shape-supporting stent for the first 7 days (8).
Adipose-Derived Stem & Stromal Cells (ADSCs)
Multipotent stem cells present in adipose secrete potent growth factors which have been shown to enhance tissue survival in certain settings (9). These findings have stimulated novel techniques of autologous fat transfer that enrich the concentration of stem cells in the harvested fat in preparation for injection (10). Theoretical benefits of adding ADSCs to the harvested fat include: (1) ADSC differentiation into adipocytes, (2) ADSC differentiation into endothelial cells with subsequent increase in blood supply, (3) ADSC release of angiogenic growth factors, (4) ADSC-mediated protection from graft ischemia, and (5) accelerated wound healing (9). Theoretical concerns that ADSC-enriched grafted fat might stimulate the development of breast cancer in vivo have not been supported by clinical findings to date (11). Presently, the use of ADSC-enriched fat in breast augmentation remains in its infancy and there is no clinical data to suggest that it outperforms non-enriched fat in vivo.
Platelet-Rich Plasma (PRP)
Recent commercial marketing of platelet-rich plasma (PRP) as an aesthetic filler and as an agent with the potential to enhance “handling characteristics of autograft” (12) has prompted the development of multiple techniques and applications of PRP-enriched autologous fat. PRP contains growth factors active in the initiation of wound healing which, in theory, might prove beneficial to the survival of grafted fat. However, the only data currently available relates to in vitro studies (13). A recent small retrospective review of 42 women augmented with autologous fat, 25 of whom received PRP-enriched fat, demonstrated no effect of PRP enrichment on aesthetic outcomes or rates of liponecrosis (14). In our experience, we find that the addition of PRP to centrifuged fat in a 1:10 ratio thickens the consistency of the fat and helps in maintaining the contours of the recipient site in the immediate postoperative period whether it be breast or other sites.
The breasts are marked with the patient standing and the arms down. The margins of the breast mound are marked circumferentially. The breast is divided into quadrants with radial lines drawn from the areolar edge to the margins of the breast mound at the 12:00, 3:00, 6:00, and 9:00 positions. Areas within these quadrants requiring extra volume are then marked and photographed.
Breast augmentation by autologous fat transfer and fat harvesting by liposuction is typically performed under tumescent local anesthesia (TLA) with or without supplementary intravenous sedation; the latter is employed to calm unusually anxious patients and is conducted by an anesthesiologist. General anesthesia is unnecessary because TLA results in total anesthesia of the targeted tissues. However, techniques which also target fat injection into the pectoralis major muscle utilize general anesthesia (4).
Broad spectrum prophylactic antibiotics targeting skin flora are administered intravenously immediately prior to surgery and the patient is positioned in the supine position with the arms away from body. Continuous noninvasive monitoring of blood pressure, pulse oximetry and 3- or 5-lead EKG are instituted. The skin is scrubbed with chlorhexidene or betadine and latex free drapes are applied.
The procedure begins with TLA infiltration of the harvest areas and of the breasts. The harvest sites are infiltrated to a tumescent level of tightness by standard techniques described elsewhere (15). TLA is administered via infusion pump and a long spinal needle (18G x 6”, Quincke tip). TLA concentrations per liter of normal saline are as follows: lidocaine 750mg, epinephrine 1mg, sodium bicarbonate 10mEq (8.4% x 10ml). The total lidocaine dose should not be allowed to exceed 50mg/kilogram of body weight. We prefer sharp spinal needles over reusable blunt-tipped infiltration cannulas because (1) they pass through the dense breast connective tissue with far less resistance and tissue drag which results in smoother and more precise guidance by the surgeon, and (2) by the nature of their design, spinal needles deliver the anesthetic fluid wave ahead of the sharp instrument tip thereby minimizing any painful needle tip sensation by the patient.
TLA infiltration of the breast in preparation for autologous fat transfer is distinct: A low-volume infiltration of TLA is administered superficially over the entire breast mound approximately 1-cm in thickness. A deeper infiltration is not carried out because the autologous fat is injected superficially. A larger volume infiltration will distort the tissues and impede the accuracy of the augmentation.
TLA infiltration begins in the center of the breast mound at the 12:00, 3:00, 6:00, and 9:00 positions at the areolar margin. The skin at these sites is anesthetized with a small wheal of TLA delivered through a small needle (30G) prior to inserting the spinal needle. The spinal needle is then advanced parallel to the skin changing direction in a fan pattern at a low infusion rate.
Once the breasts and the harvest sites have been anesthetized adequately, liposuction fat harvesting is carried out using standard technique (15). Cannulas of 3-mm diameter or narrower are preferred because they deliver small fat parcels which are easy to inject through narrow fat transfer cannulas and produce a smoother fill. Fat is collected in either a syringe
or in a sterile large-volume glass canister connected to the working cannula via sterile tubing and to the liposuction aspirator pump via a second sterile tubing line. It is important to keep the aspirator suction pressure low (300-330mm Hg) during harvesting to minimize barotrauma to the adipocytes.
Centrifugation of the aspirated fat helps to remove blood and excess fluid in order to achieve a more accurate fill of the breast. Centrifugation is carried out in 10-cc syringes at 3,000 rpm for three minutes; oils and fluids are decanted from the top and bottom of the syringe, respectively
Centrifugation typically results in the reduction of the apparent volume of fat in the lipoaspirate by one half. Thus, we target a fat volume collection endpoint of twice the desired fill volume. Since we usually inject a maximum of 200ml of fat per breast, we seek to collect 400ml of fat per breast in the lipoaspirate whenever feasible. Naturally, in leaner patients this target may not be reached.
The centrifuged fat is transferred to small syringes in preparation for injection. We prefer 5-10cc syringes. Blunt-tipped 14G x 15cm injection cannulas with single side ports (Coleman Type II) are attached to the syringes for the injection process.
Injection is carried out superficially in a fan-like pattern through the same points on the areolar margin (12:00, 3:00, 6:00, 9:00) through which the spinal needles were inserted during TLA infiltration. In most instances, the needle track is sufficient to admit the cannula; if not, a 1-mm dermapunch incision is made. When necessary, additional injections are made along the periphery of the breast margin. The injection cannula is inserted to reach the level of the breast margin marks and fat is injected evenly as the cannula is withdrawn. Typically 1ml of fat is deposited per pass. Large volume deposits are avoided in order to maximize contact with of the transplanted fat with the native recipient tissues. In the event that contour deformities or tissue distortion resist volumetric expansion, tension in the injection planes is released by focal undermining with V-tipped dissection cannulas, disruptor cannulas or microscissors
The injection process can be done with the patient supine or with the table flexed and the patient in the semi-recumbent position or they can be alternated as needed to assess the contours as they develop.
It should be noted that current techniques of autologous fat transfer to the breast intentionally avoid direct injection into the breast parenchyma. While the injection of the superficial planes usually gives sufficient size enhancement, some surgeons seeking to achieve increased breast mound projection target additional injections into the pectoralis major and the prepectoral layers.
At the conclusion of the procedure, the areolar injection points are covered with steri-strips. Absorbent pads and compression garments are placed over the harvest sites. The breasts are fitted with a tight conforming bra and the patient is discharged home.
The patient is seen for follow-up at 24-48 hours post-surgery primarily for surveillance of the harvest sites. Active fluid expression of these areas, if necessary is conducted by the nursing team. The breasts are examined for signs of excess bruising or infection; the latter is rare. Oral broad spectrum antibiotic coverage for skin pathogens is maintained for the first seven days after surgery. Analgesic needs are typically minimal and NSAIDs are usually sufficient. Patients are able comfortably to return to a desk job by 48 hours post-surgery. Additional postoperative surveillance is conducted on a bi-weekly, then monthly basis as deemed appropriate. The final breast volume stabilizes by approximately three months after surgery.
Damage to the chest wall is unlikely with autologous fat transfer to the breast because the injection is limited to the superficial plane. Of more concern, but rare, would be infection of the transplanted fat. We have not seen this complication on the breast, but in other areas such as the buttocks, infection of transplanted fat is managed by the expression of the transplanted fat through the sites of injection either manually or with the assistance of liposuction cannulas in conjunction with aggressive antibiotic coverage and may require more than one session.
Significant loss of augmented breast volume is common especially in cigarette smokers. The patient needs to be counseled thoroughly prior to surgery that a noticeable portion of the immediate postoperative fill volume represents anesthetic fluid within the breast and fluid within the transplanted fat. Interventions which promote the healing process include adequate caloric intake and smoking cessation, but these no offer no guarantee of superior results. Repeat sessions of autologous fat transfer to the breast should be scheduled at an interval that allows for complete healing and revascularization of the recipient site; typically three months or more.
One small case series from Japan, of patients presenting with palpable indurations six months to six years post injection by “untrained individuals” reported pain, infection, breast discharge, lymphadenopathy, and cysts requiring surgical excision (16). They and others have postulated that possible large volume mass injection is a contributing factor to large areas of fat necrosis (16-18).
Mammographic changes observed in breasts subjected to autologous fat transfer include various calcifications, cysts, and tissue remodeling in less than half of patients (17). It has been argued that these changes may interfere with breast cancer screening (16, 19), but it has also been argued that the incidence and significance of these findings are no worse than those following other cosmetic breast procedures (4, 20). Furthermore, it has been stated that radiographic multimodal follow-up evaluation is effective at discerning the characteristics of injected fat over time and that no increase in the increase of breast cancer has been reported to date (17, 21).
Breast augmentation with autologous fat transfer is an option for some women seeking a modest increase in size and/or the correction of breast contour deformities. Partial loss of injected volume and the need for multiple treatment sessions are common. The current literature demonstrates low complication rates in experienced hands, mammographic changes distinct from cancer at a rate no higher than that of other cosmetic breast operations, and no apparent effect on the incidence of breast cancer. The use of adjuncts including external tissue expansion, adipose derived stem cells and platelet-rich plasma has not been proven superior, but has not been studied adequately.
1. Cosmetic Surgery National Data Bank. 2008 Statistics. American Society for Aesthetic Plastic Surgery 2009. P. 3.
2. Bircoll MJ. Case report: Cosmetic breast augmentation utilizing autologous fat and liposuction techniques. Plast Reconstr Surg 1987;79:267-71.
3. ASPRS Ad-Hoc Committee on New Procedures. Report on autologous fat transplantation. September 30, 1987.
4. Coleman SR, Saboeiro AP. Fat grafting to the breast revisited: Safety and efficacy. Plast Reconstr Surg 2007; 119:775-85.
5. Gutowski KA. Current applications and safety of autologous fat grafts: A report of the ASPS Fat Graft Task Force. Plast Reconstr Surg 2009;124:272-80.
6. Pelosi MA III, Pelosi MA II. Breast Augmentation. In: Rayburn WF, Laube DW, eds. Cosmetic Procedures in Gynecology. Obstetrics and Gynecology Clinics of North America 2010 December; Vol. 37, No. 4: 533-46.
7. Khoury RK, Schlenz I, Murphy BJ, Baker TJ. Nonsurgical breast enlargement using an external soft-tissue expansion system. Plast Reconstr Surg 2000;105:2500-12.
8. Khoury RK, et al. Brava and autologous fat transfer is a safe and effective breast augmentation alternative: Results of a 6-year, 81-patient, prospective multicenter study. Plast Reconstr Surg 2012;129:1173-87.
9. Mizuno H, Hyakusoku H. Fat grafting to the breast and adipose-derived stem cells: Recent scientific consensus and controversy. Aesthet Surg J 2010;30:381-9.
10. Yoshimura K, et al. Cell-assisted lipotransfer for cosmetic breast augmentation: Supportive use of adipose-derived stem/stromal cells. Aesthet Plast Surg 2008;32:48-55.
11. Fraser JK, Hedrick MH, Cohen SR. Oncologic risks of autologous fat grafting to the breast. Aesthet Surg J 2011;31:68-75.
13. Eppley BL, Pietrzak WS, Blanton M. Platelet-rich plasma: A review of biology and applications in plastic surgery. Plast Reconstr Surg 2006;118:147e-159e.
14. Salgarello M, Visconti G, Rusciani A. Breast fat grafting with platelet-rich plasma: A comparative clinical study and current state of the art. Plast Reconstr Surg 2011;127:2176-85.)
15. Pelosi MA III, Pelosi MA II. Liposuction. In: Rayburn WF, Laube DW, eds. Cosmetic Procedures in Gynecology. Obstetrics and Gynecology Clinics of North America 2010 December; Vol. 37, No. 4: 507-19.
16. Hyakusoku H, et al. Complications after autologous fat transfer to the breast. Plast Reconstr Surg 2009;123:360-70.
17. Veber M, et al. Radiographic findings after breast augmentation by autologous fat transfer. Plast Reconstr Surg 2011;127:1289-99.
18. Delay E, Garson S, Tousson G, Sinna R. Fat injection to the breast: Technique, results, and indications based on 880 procedures over 10 years. Aesthet Surg J 2009;29:360-76.
19. Spear S, Al-Attar A. Discussion: Mammographic changes after fat transfer to the breast compared with changes after breast reduction. Plast Reconstr Surg 2012;129:1039-41.
20. Rubin JP, et al. Mammographic changes after fat transfer to the breast compared with changes after breast reduction: A blinded study. Plast Reconstr Surg 2012:1029-38.
21. Carvajal J, Patiño JH. Mammographic findings after breast augmentation with autologous fat injection. Aesthet Surg J 2008;28:153-62.
Nature abhors a vacuum
Preparing a chapter on Cosmetogynecology, I reviewed a mountain of material and reflected on the basic and complex issues that arise repeatedly. One of the very first, and very basic, things which came to mind was the blatant absence of a guide to the terminology of cosmetic gynecology. Even the topic goes by a half-dozen names, some of which you're seeing in these first few sentences. So, without further elaboration, I present you with the first description of the current lexicon of cosmetic vaginal surgery, aesthetic vaginal surgery, female genital cosmetic surgery, or cosmetic female genitoplasty:
Preface: Learn a Little Greek
The terms aesthetic, cosmetic, and plastic are related, but they are not synonymous. Grasp this and your ability to articulate your message will improve instantly.
Aesthetic derives from the Greek word aisthetikos which means to perceive and judge sensory input as beautiful. When used as an adjective (i.e. an aesthetic contour), it defines the subject as beautiful. When used to describe interventions that enhance beauty, the term is inherently flawed. For instance, the term aesthetic surgery, defines the subject, surgery, as that which is aesthetic, or beautiful. However, the intended meaning of the phrase is something else - that the intention of the surgery is to enhance the aesthetics of he/she who is being operated upon. Not only is this poor grammar, but it also renders any surgery which happens to beautiful to watch, in any field of surgery, as robbed of its proper adjective.
Cosmetic derives from the Greek word kosmetikos, which means to adorn or to make beautiful (aesthetic). Here, we have a term that precisely defines the intent to beautify. Cosmetic surgery thus, properly and accurately identifies any surgical process which intends to enhance the aesthetics of the person being operated upon irrespective of whether the surgical process is itself aesthetic. In brief, a cosmetic process creates an aesthetic product, while an aesthetic process creates an undefined product.
Plastic derives from the Greek word plastikos, which means to reshape. Plastic is a nonspecific concept that does not define the reason for the action. When applied in the term plastic surgery, further classification is required when specificity is desired (i.e. reconstructive plastic surgery). Adding complexity to the confusion are the observations that plastic surgery is the common name of a surgical specialty with both noncosmetic and cosmetic subdivisions (which some refer to as aesthetic plastic surgery), that many operations in many surgical specialties outside of plastic surgery reshape the body for various reasons, and that surgeons from many specialties provide cosmetic surgery.
The Lexicon of Cosmetic Gynecology 2013:
Clitoral hood reduction, excision of excess prepuce, or excision of periclitoral labial reduplication, are procedures which target redundant, loose skin at, and around the clitoral prepuce either alone or at the time of labiaplasty. These procedures lack a uniform descriptive term. "Hoodectomy" is a poor terms for these procedures because it implies that clitoral hood proper is being degloved either partially or in its entirety - maneuvers that are not done in the conduct of cosmetic gynecology.
Clitoroplasty refers to surgical alterations in the shape of the clitoris proper, either glans or shaft, done for conditions associated with clitoral hypertrophy rather than for the cosmetic enhancement of normal anatomy. Partial excision is termed clitoral reduction or partial clitoridectomy and is not done for cosmetic reasons.
Dermalipectomy is a term frequently used in cosmetic and plastic surgery to describe the en bloc excision of skin and fat. It is usually performed in tandem with the development of a flap of adjacent tissue for the purpose of reducing tissue laxity. Common applications include abdominoplasty, thighpasty, and in cosmetic gynecology, mons pubis "lift" procedures and labia majora volume reductions.
Designer laser vaginoplasty™(DLV™) is a term trademarked by Dr. David Matlock’s franchise business which references the entire category of labiaplasty procedures as well as alterations of the loose skin at and near the clitoral hood all performed with laser techniques. Confusion is generated by the inclusion of vaginoplasty in the term despite the fact that it does not reflect the performance of a vaginoplasty in the procedure.
Genitoplasty refers to any procedure which reshapes the male or female genitalia. It does not imply cosmetic or therapeutic intentions. Thus, it must be further classified whenever it is used. The most common utilization is feminizing genitoplasty which describes procedures intended to give ambiguous genitalia a female appearance.
Hymenoplasty describes procedures designed to create a pseudo hymenal membrane from either existing hymenal tissue or nonhymenal local soft tissue usually with the intent to provoke bleeding at subsequent coitus when the membrane is caused to tear. Synonyms include hymenorrhaphy, hymen reconstruction, and hymen restoration. Revirgination is a poor term because the loss of virginal status is a matter of history, not of anatomy.
Labiaplasty or labioplasty, can refer to any procedure which alters the contours of either the labia majora or the labia minora whether it involves reduction, reconstruction or augmentation. Commonly it references labia minora reduction by excision which is the most requested labial alteration. Labial reduction is sometimes used synonymously with labia minora reduction. The most frequently performed labia majora alterations are augmentation by autogolous fat injections and excisional reduction. The more specific terms labia minoraplasty and labia majoraplasty are less frequently used.
Laser vaginal rejuvenation™(LVR™) is a term trademarked by Dr. Matlock’s franchise to reflect vaginoplasty procedures performed with laser techniques. Others have taken to using the term vaginal rejuvenation to indicate vaginoplasty with or without the use of lasers.
Monsplasty refers to any procedure which alters the contours of the mons pubis. These include liposuction procedures which reduce perceived excess adiposity as well as resections of skin and subcutaneous fat (dermalipectomy) performed alone or in conjunction with abdominoplasty. The use of any technology to assist in the liposuction process such as laser, ultrasound, etc., typically is indicated by use of the technology as a prefix (i.e. laser-assisted, ultrasound-assisted, etc.).
Nymphectomy and nymphoplasty are terms synonymous with labia minoraplasty. They are less commonly used in contemporary English literature, but are sometimes used in French (nymphoplastie), and commonly in Spanish (ninfectomia, ninfoplastia), respectively.
Vaginoplasty refers to any procedure targeted at reducing the vaginal caliber. These include approximations of the perineal body (perineorrhaphy or perineoplasty), and posterior colporrhaphies with or without plication of the levator muscles. In most cases, both procedures are performed together to produce a longer section of reduced vaginal caliber.
Marco A. Pelosi, III, MD, is a cosmetic gynecologist, surgeon, lecturer & cofounder of the ISCG. You may contact him directly at email@example.com