Medical Device Daily Contributing Writer

LAS VEGAS, Nevada — The 37th Global Congress of Minimally Invasive Gynecology, sponsored by AAGL (formerly the American Association for Gynecologic Laparoscopists; Cypress, California) was held here last week with as much enthusiasm as ever regardless of precipitous stock price declines for many of this sector's players.

One would never know by the hustle and bustle of this town and this annual meeting it is hosting that an economic crisis was occurring throughout the rest of the world. The focus here was on new technologies and new procedures, often to improve the quality of life as opposed to length of life for women.

Research performed by this group of gynecologic surgeons instigated years ago has led to advancements in materials and techniques in minimally invasive procedures leading to improvements in the patient's quality of life.

Just one week before this meeting, the FDA published a warning regarding the use of mesh for use in incontinence and prolapse surgeries. Based on this news, a few stock analysts downgraded some of the companies who manufacture mesh kits. The FDA cited 1,000 incidents reported to the MAUDE database over the last three years, a period during which an estimated 800,000 procedures were performed, representing an event rate of just over 0.1%.

In a recent article published in the Journal of the American Medical Association (JAMA), the weighted prevalence of at least one pelvic floor disorder occurring among women was 23.7% and increased with age; forecasting that more women will seek treatment than ever before.

With this information, the question became: "How safe is it to use these mesh kits?" To which this elite group had the answers.

In a day-long postgraduate course, "Pelvic Floor-Anatomy, Function, Reconstruction and Use of Mesh Kits in Vaginal Reconstructive Surgery," several leading surgeons currently using mesh collectively explained to the audience that "mesh is not our enemy" and pointed out that evidence-based studies have continually shown that the use of mesh in both incontinence and prolapse surgeries consistently shows better outcomes, with fewer recurrences using mesh over native tissue alone.

According to a show of hands in the audience, 90% of the surgeons in this course are currently using mesh — the thinking being that if weakened tissue fails, even if re-attached, it will fail again, thus the reason to use mesh reinforcement.

In a poster presentation seemingly in response to the FDA warning, but obviously submitted long prior to it, R.D. Moore, MD, of Atlanta Urogynecology Associates (Alpharetta, Georgia), concluded after studying 262 patients' reports from 19 practices in the U.S.: "While mesh extrusions do occur, they have not resulted in any long-term sequalae nor has it been necessary to remove the entire mesh kit on account of an extrusion. High anatomic success and quality of life are similar to patients who have not experienced an extrusion."

These sentiments were echoed throughout the day in various versions of the theme.

Vincent Lucente, MD, medical director of the Institute for Female Pelvic Medicine and Reconstructive Surgery (Allentown, Pennsylvania), said that "the health of an older woman's pelvis has not been at the forefront of manufacturers' concerns" and that up until recently many of the mesh products used for pelvic kits were re-designed from hernia repair kits or other such procedural kits.

Now that the female pelvic repair market is large and growing, manufacturers along with surgeons are designing products specifically for women's pelvic procedures (see Table 1).

Lucente cited the evolution of mesh for use in the pelvis, which includes different varieties such as knitted or woven, non-knitted or non-woven, micro or macro-porous, mono-or multi-filament — all in search for the perfect material.

He said he currently suggests macro-porous mono-filament, but said that "material science has been slow to meet the special requirements of the vaginal environment." Lucente said he feels that "if mesh is not used, there will be re-occurrence."

Noting that the number of mesh erosions goes down with experience, he said the real challenge" is sexual function. "Mesh wasn't designed for placement in the vagina and with intercourse in mind," he said. "The underlying mesh could contribute to reports of dysparunia."

In Lucente's opinion, sometimes there may be a less-than-perfect anatomic outcome, but if the patient is satisfied and there are no return of symptoms, then the physician should leave it be.

On the other hand, even if there appears to be a perfect anatomic outcome, if the patient complains of dysparunia (painful intercourse), then one cannot consider that procedure "perfect."

He reiterated: "Mesh is not our enemy: dysparunia is."

Lucente's closing remarks regarding the used of mesh in female pelvic reconstructive surgery were: "Do not abandon the best thing that has come along in 19 years, but do use caution."

Collectively gathered from all the panel members were several suggestions for use of mesh (see Table 2).

Audience interaction session

There is nothing like real-time market research. In the opening general session, each audience member was handed a remote control and was asked to answer questions posed by Patrick Yeung Jr., MD, of the University of Louisville (Louisville, Kentucky).

A sampling of the questions and responses:

Demographics of attendees

Gender of audience members: Men, 71%; women 29%.

Age: 20-30, 4%; 30-40, 23%; 40-50, 32%; over 50, 41%.

U.S. citizens: 68%.

Hysterectomies

What type of hysterectomy is best for the patient? Laparoscopic, 30%; total vaginal hysterectomy, 35%; they are equivalent, 35%.

Percentage of laparoscopic hysterectomies you perform: 30% perform fewer than 25% of their hysterectomies laparoscopically; 41% perform more than 75% of their hysterectomies laparoscopically.

Percentage of total vaginal hysterectomies you perform: 61% perform fewer than 25% of their hysterectomies TVH.

Percentage of total abdominal hysterectomies you perform: 69% perform fewer than 25% of their hysterectomies total abdominal

Minimally Invasive Surgery

What is your main concern when performing laparoscopic procedures? Dissection, 35%; bleeding, 20%.

Do you believe minimally invasive surgery benefits the patient? Yes, 92%; no, 1%; sometimes, 7%.

Do you see an increase in patient demand for minimally invasive surgery? Yes, 79%; no, 6%; somewhat, 15%.

Plastic surgery moves below the waist

At this congress sponsored by the AAGL, vaginal rejuvenation became legitimized, with four poster presentations and one device company touting the patient benefits.

Many disagree with the nomenclature that was coined early on because the reconstructive surgeries encompass more than just the vagina and can include nine distinct procedures, not all of which are performed within the vagina.

Innogyn (Sonoma, California) currently holds the only official spot on the registry specifically for vaginal rejuvenation. The company offers surgeons a turnkey operation for performing vaginal rejuvenation procedures.

For $58,000, a surgeon can take a comprehensive three-day course on the various procedures, get a diode laser, and receive the entire business model for marketing, incorporating these procedures into the practice, and getting paid for them. About 250 surgeons worldwide currently are trained and using the company's system.

Some gynecologists have been performing these procedures for years — primarily to correct congenital defects or trauma cases. Now that surgery for incontinence and pelvic organ prolapse are becoming common, more patients are requesting repair of their external organs as well.

Jack Pardo, MD, of the obstetrics and gynecology department at Clinica Las Condes (Santiago, Chile), displayed a poster presentation "Cosmetics Gynecological Surgeries Associated to Mid-Suburethral Slings."

He performed a retrospective analysis of 400 patients selected for suburethral slings and found that 177 of them had an associated gynecologic cosmetic surgery done at the same time, including colporraphy, labioplasty and labia majora lifting. No complications were observed.

Pardo concluded, "In our practice, gynecological cosmetic procedures associated with correction of urinary stress incontinence are frequent and safe."

With the recent onslaught of post-bariatric surgery body remodeling, the requests for gynecologic cosmetic surgery also appear to be increasing. Vaginal rejuvenation, or cosmetic gynecology, is predicted to bloom for many reasons.