(c) L. Romanzi 2010

After I complete this Harvard Humanitarian Initiative (www.hhi.harvard.edu) sponsored mission for fistula, prolapse, incontinence training and teaching, surgical technique exchange, and clinical protocol development at Panzi Hospital (www.panzihospitalbukavu.org) next week, I’ll attend the International Society of Obstetric Fistula Surgeons (ISOFS) 4th annual meeting in Dakar, Senegal (isofs). ISOFS a surgical society is founded and run by African surgeons taking care of African problems and setting the standard for non-African participation in evaluating, treating and preventing fistulas in Africa. I can’t tell you how fabulous this is, and I can’t wait to be at this meeting.

Dakar, Senegal

They’ve distributed a Direct Relief International (www.directrelief.org) questionnaire on fistula priorities among the meeting registrants – I thought you might like to take a look at some of the questions and my responses:

Obstetric Fistula Surgeons

Treatment Capacity Questionnaire

Information collected from this questionnaire will be used to create a mapping tool to help understand and visualize the existing treatment capacity, resources, and priority needs for improving fistula services.

We want to underscore that this questionnaire is simply a starting point in this collaborative process which will evolve over time. The data from this initial questionnaire and the resulting map will be made available to all respondents at the ISOFS Conference in Dakar, Senegal, December 7-9, 2010.

We value your input and thank you very much for your participation.

If you have questions about this questionnaire, please contact Direct Relief International at: MCHPrograms@directrelief.org.

(NB: the following is a partial excerpt from the questionnaire)

Please prioritize the following fistula issues from 1-10:

Please describe what you believe are the most pressing issues which require greater attention and support:

Prevention prevention prevention. “TURN OFF THE TAP” Train nurses in remote and outlying areas to follow partographs, provide prenatal care and perform forcep and cesarean deliveries. Improve communication with and transport to cesarean-ready facilities. Community outreach to educate and disempower the mythologies surrounding fistula, prolapse and intact bladder incontinence. Transport and psychosocial rehabilitation. Expansion of “fistula center” paradigm to ‘”Pelvic Floor Disorders Center’, since women suffering prolapse and intact bladder incontinence in nations with high obstetric fistula rates are usually equally ostracized, excommunicated, shunned and abandoned as are women with fistula, and as fistula prevention efforts take effect, women with prolapse and incontinence will continue to need help. This pelvic floor disorder concept allows all the funding and beaurocracy that depend on the perpetuation of fistula to embrace the possibility of a “post-fistula-era” future, and helps undermine any incentive to perpetuate the preventable tragedy of fistula in order to justify jobs and salaries. Do not permit any organization to fund fistula treatment unless it provides equal funding for fistula prevention.

(Not exactly ’nuff said, but it’s a start.)

November 22, 2010

(c) L Romanzi 2010

Getting to Democratic Republic of Congo-DRC (formerly Zaire and not to be confused with the adjacent country of Congo)from the States is a bit like a triathlon, each part run concomitantly. –There’s the physical stamina test – how many connections and super tight/painfully long layovers can you successfully perform? Then the humanity tolerance component– how much yanking on the back of one’s seat (yes, I’m talking 28 hours of steerage here), piercingly painful body odors and airline corporate culture idiosyncrasies can you gracefully outwit without raising your voice, pulse or blood pressure? Lastly the cognitive function challenge – as your body and soul run out of gas, confusion invades and travel complications erode your preemptively organized carry on gear, will you manage to avoid losing your passport, your single-print/triple function receipt= round trip boarding pass from RwandAir, remember not to leave your eye drops, lip balm and breath mints in the seat pockets of oh-so-many seats, and pull out just enough Franglais to get the information you need about the 50 lb bag that didn’t make the connection when the 5 hour layover turned into a 20 minute sprint for the connecting flight because of a cake?

Yes, I said a cake.  A gorgeous affair marking the pre-boarding celebration of Ethiopian Airlines virgin flight of their very first, brand new Boeing 777. It’s a glorious bird, each coach seat with foot rests and movie screens. And yes, it did have that “new plane smell”. Having checked in at the gate after a quick flight from JFK (where this sort of flight belongs, by the way – ahem…) to Dulles (puhleeeze, really, all the way from Addis just base this flight in JFK WHERE IT BELONGS), and checking in at the gate, the party started.  In lieu of a boarding announcement there was a podium, speakers, movie crew, finger food, slivers of champagne, any number of dignitaries, VIP’s, square jawed pilot-types, glamour girls and cake  – a glorious edible frame around a Polaroid-style image of said brand-new, gleamingly logo’d Boeing 777 in flight at a dramatic 23 degree banking turn.

Several hours after scheduled boarding and take-off, we boarded, and about 90 minutes after queuing on the tarmac, we took off.  What was to be a 5 hour, book reading layover in Addis Ababa turned into landing with 40 minutes to make the connection, the slowest de-boarding in recorded flight history, and in my elite-triathleticism, I was given the extra challenge of being all the way at the back of this plane full of what seemed to be an endless supply of arthritic, first-time-air-travel Ethiopian grandmothers, who, having survived any number of bathroom lock-ins where they wait 15 minutes, then finally find the knob that they used to lock themselves in there, but somehow managed to urinate or defecate the skill set needed to manipulate said airplane bathroom door lock down the airplane toilet, resulting in each giving up and resort to knocking from the inside, so that the 12 people on line have to talk to them LOUDLY for another 7 minutes before each managed to extract herself from the trick toilet, (like I said, I was the back, you know, for the elite challenge championship), so as we prepared to de-plane, each one of these grandmothers suffered a group flare of said arthritis, preventing them from exiting the plane at anything faster than a snail’s pace. No problem, game on.

Then I remember the checked bag, but I was reassured that since the connecting flight was also Ethiopian Air, of course the bags would be transferred, absolutely no doubt, no problem, no worries. I was reassured by every flight attendant all the way from the back of steerage to the door, where I realized, as my descent down the 45 steps to the tarmac began, that the fate of the bag was sealed by the fact that the plane-cake-party was still going on, as we de-planed into a 30 pair gauntlet of lovely Ethiopian Air staffers handing each of us a rose, while the VIP/dignitary/glamour girl posse proceeded to their full-on tarmac party, banquets overflowing with food and drink,  a live band and candle-lit, canopy covered tables. No one was touching that cargo door. That bag, and the others connected to the connectors, were going nowhere except the Addis Ababa lost and found baggage area.

One bag gone, but eyes on the prize; where’s the connecting flight?  I jump on the packed (this is good, it ought to leave soon, especially since an empty one is sitting right behind the packed one) airport shuttle and watch the driver get on (yes!) then get off (noooooo!) then almost get back in (no words for this one), then get on (yes!), back off again (crying, would loud crying, you know sobbing interspersed with undulant gasps get that driver into the driver’s seat to do some driving?) then back on, sits down, shuts door, then starts a conversation replete with jokes and laughter out the driver side window then finally, when the last joke has been properly chortled over, the shuttle bus commences to shuttle.

It stops in front of a building with people waiting in the vestibule.  The vestibule people are waiting for a shuttle to someplace else, so I run up the stairs, grab the first official looking person I can find and am told gate 5. At gate 5 there is a flight to Cairo. There I’m told gate 1A (here’s the cognitive function obstacle course) so of course, since no other gate has an ‘A’ version, I queue up to gate 1, wait, wait, wait as each passenger goes through gate security, just about watch my bag disappear into the x-ray when I ask, to make sure, if this the Kigali flight (no gate postings, you see) and in the knick of bag-retrieval time am told no, this flight is going to Johannesburg. Grab bag, pivot, dash, scan, see gate 1A waaaay down the hall but I see heads on the security line so yay! I sprint like a lunatic anyway, just in case 1A is not the Kigali flight, requiring another dash to some other gate, but it’s all good. Kigali plane, gate 1A,  3 seats to myself.  Sweet.  I take a proper nap.

This flight arrives in Kigali at 1:30 am, and the flight to the Congolese border leaves at 8 am, so I planned to lounge around the airport for 6 hours until it boarding time. But there’s a delay, then another delay, and another, each without explanation as my brain turns to laundry lint.  When the 8 am flight finally opens for boarding at 11 am, we stampede through 2 x-ray security checks and a passport stamp. A last-minute conversation with RwandAir gate attendant Celine netted her phone number and the luggage commander at the final airport in Kemembe and a guarantee that she would personally secure my late bag from the Ethiopian Air flight and put it on the  RwandAir flight to Kemembe next day. The flight over Rwanda to the border airport in Kemembe was a carpet ride over an emerald field, so lush are the tea and banana plantations covering every Rwandan hill.

Next day, post-coma, I awake to a phone call from Celine – she secured the bag and put it on the plane to Kemembe, and 3 hours and 4 border crossings later (check out, check in, check out, check back in), bag full of supplies secured, I make my way to Panzi Hospital to begin the 2 weeks of endeavor. To date, Celine of RwandAir is the best lost bag commandant I’ve ever run across. Were said bag lost in transit to JFK or LaGuardia, I’d likely never see it again. Thank you Celine, Queen of RwandAir Customer Service, for making my travel triathlon a success.

courtesy beachtrek.fortunecity.com

Dyspareunia is the latin word for “pain with sex”. The true prevalence of women who have pain with sex is unknown, since many women believe the pain to be “normal” or something for which nothing can be done. Various conditions can contribute to the symptom, including vestibulitis (here I recommend a visit to my colleague Dr. Andrew Goldstein’s website on this difficult condition www.cvvd.org), interstitial cystitis (painful bladder syndrome), and endometriosis, for instance. Once the pain begins, the muscles of the pelvis, called the levator muscles (A.K.A. Kegel muscles and vaginal muscles) often spasm, creating a “TMJ of the vagina” type syndrome where everything hurts. The clenching of these muscles can be measured with a perineometer, a gadget that quantifies muscle tension during intentional contractions and at rest. In women with painful sex, the muscles often relax poorly, or not at all. Just like TMJ (temperomandibular joint/jaw pain), it’s important to be evaluated and managed by specialists with a track record of success. My colleague Andrew Goldstein (Washington DC and NYC) is one, and the authors of this fabulous paper, Susan Kellogg PhD and Kristene Whitmore, MD (Philadelphia) are two others. Susan and Kristene (www.sexandahealthieryou.org) are the authors of a timely paper recently published in the International Urogynecology Journal on management of this unhappy syndrome, the root of which includes Valium vaginal suppositories to relax the levator/Kegel/vaginal muscles. No joke. They work. Read a synopsis of the paper below:

Rogalski MJ, Kellogg-Spadt S, Hoffmann AR, Fariello JY, Whitmore KE. Retrospective chart  review of vaginal diazepam suppository use in high-tone pelvic floor dysfunction.  Int Urogynecol J (2010)21:895-99.

The authors review 26 charts of patients with levator hypertonus and sexual pain.  Evaluation included completion of the female sexual function Inventory (FFI) and visual Analog Scale of Pain (VAS-P). Levator muscle evaluation included perineometry and vaginal palpation exam.

21 women were premenopausal, 5 menopausal and 18 nulliparous. 85% reported dyspareunia, 81% chronic pelvic pain, 61% interstitial cystitis,  and 46% hypoactive sexual desire disorder.

Interventions included pelvic floor physical therapy, injection of trigger points with Traumeel and lidocaine, and 10 mg diazepam vaginal suppositories, inserted nightly for 30 days.

25 of 26 patients reported improved sexual function with 6 of 7 women who entered therapy abstinent due to pain resumed intercourse. Perineometry baseline muscle pressures decreased significantly, both at rest and post-voluntary contraction return to rest. Visual analog pain ratings decreased significantly for the majority of pelvic girdle muscles evaluated pre and post-therapy.

The authors propose that vaginal diazepam suppositories are a useful adjunct for the treatment of high – tone pelvic floor dysfunction, and announce plans to initiate a randomized crossover study from placebo to diazepam (valium) in newly diagnosed high-tone pelvic floor dysfunction patients.

In 2008 the FDA posted a warning (FDA warning on use of mesh in prolapse and incontinence repairs) on the use of prolene mesh in reconstructive female pelvic surgery.  This warning came from the plethora of complaints registered with the FDA from patients with prolapse repaired with various formulations of a plastic mesh called Prolene.  The weft and warp of this mesh has been tweaked by the surgical supply corporations that develop and market “mesh kit” procedures to reconstructive pelvic surgeons worldwide in an effort to address these concerns and assure surgeons and patients that plastic mesh is safe for use in pelvic organ prolapse and urinary incontinence repairs.

Personally, I love using prolene mesh at the top of the vagina for an old-school operation used for decades called a sacrocolpopexy (or its uterine-preserving cousin, the sacrohysteropexy),  and I love using tiny ribbon sized prolene mesh slings for stress urinary incontinence.  When the application for cystocele and rectocele repair first came into the surgical marketplace, I jumped right on board, believing that I’d get superior durability and the same complication rate (almost none) that we see with the older sacrocolpopexy and urethral sling applications. I was wrong, as my first dozen patients quickly began to demonstrate all varieties of complications delineated in the FDA warning that came years later. Immediately pulling it from my armamentarium, I notified the company of my concerns, and was summarily ignored.

I find the bigger, palm-sized surface areas of mesh used in these super-thin layers between bladder/vagina to lift fallen bladders (cystoceles) and rectum/vagina to support bulging rectums (rectoceles),  to be a source of “more harm than good”  since these prolapse “kits” first came out in the late 90′s.  But I love using this material for incontinence slings, and I love using it for supporting uterine prolapse or vaginal vault prolapse after hysterectomy, and I worry that this nightmarish application in the more delicate front and back walls of the vagina (where cystoceles and rectoceles occur) will end not with a “no cystocele or rectocele” limitation on Prolene mesh in the female pelvis, but a wholesale, full on FDA recall of all Prolene mesh for reconstructive pelvic surgery including my beloved urethral sling and sacrocolpopexy applications. Such a complete FDA recall would be,  in my opinion, akin to throwing the baby out with the bathwater. I hope to be wrong, because it sure looks like a recall of some sort is in the making.

Reconstructive pelvic surgeons borrowed the concept of “large surface area prolene grafting” for cystocele and rectocele from our hernia surgeon colleagues, who found Prolene mesh helpful in reducing the recurrence of abdominal wall (groin, inguinal, femoral, incisional) hernias. Cystoceles and rectoceles are, in essence, hernias of the vagina, so borrowing this application from hernia surgeons made since. We did not realize that the thin vaginal skin would not react so obligingly as the abdominal wall does to the presence of plastic mesh, and in short order, we’ve found that Prolene mesh in the vagina erodes, constricts, degrades, and generally wreaks havoc in women whose bodies don’t tolerate it.  Nor does Prolene mesh for cytoceles and rectoceles eliminate prolapse recurrence – I’ve taken prolene mesh for cystocele and rectocele repairs out of many a vagina where not only is the plastic mesh eroding through the vagina, the bladder and/or the rectum, but also hanging out of the body, attached to the recurrent cystocele (dropped bladder) or rectocele (bulging rectum).

The kit-making corporations have responded by initiating all sorts of changes to various mesh parameters, each claiming new-found superiority, most if not all of which can be best categorized as “wishful thinking” or truth by consensus opinion, or the emperor wears no clothes, or whatever other label you’d like to apply.

Below find a review from the founder of Urogynecology, Dr. Donald Ostergard, who continues to champion what’s best over what’s fashionable.

Ostergard, D. Polypropylene vaginal mesh grafts in gynecology. Obstet Gynecol 2010;116:962-6.

This review presents the basic concepts for the use of polyporpylene mesh in the treatment of prolapse and incontinence, discussing clinical and biomechanical prolene mesh factors that contribute to mesh infection, inflammation, scar, contraction, erosion and dyspareunia.

The review begins by pointing out that the use of these mesh grafts gained clinical traction without the benefit of evidence based clinical trials. The factors contributing to complications include infection, pore size, multi vs mono filament mesh, low vs high density mesh, pore depth, neovascularization variability, surface area, rigidity, elasticity, shrinkage, encapsulation wicking, surface character, degradation, toxic prolene compounds, weight, brittleness, oxidation, patient variability (high vs low responders), and surgical technique.

The known pathophysiology of prolene mesh bacterial colonization is detailed to demonstrate the unpredictability of infection risk regardless of technique and manner of antibiotic use, including quiescent infections that can occur even when the mesh is optimized for filament and pore size.

Electron microscope images illustrate degradation of in situ mesh that occurs in response to body heat and macrophage secretion of H202 and hypochlorous acid. Such oxidation may instigate autoimmune rejection and increase mesh brittleness.

Lack of data for the impact of low estrogen levels on rates of erosion and poor healing after prolene mesh insertion is reviewed, as are the lack of evidence that prolene mesh is improved by coating it with other materials, such as porcine derivatives.

The 30-50% shrinkage rate is reviewed as a major factor in neuroma formation, vaginal distortion and dyspareunia that is often clinically challenging to treat successfully once so induced, to the degree that the FDA issued a warning in 2008 stating that patients should be warned that complications of mesh insertion may not be correctable.

Prolene mesh configurations that reduce degradation are reviewed, including monofilament (33% degradation vs  75% multifilament),  and low density (21% vs 48% high density).

Interestingly, one synthetic permanent material, polyester, was found to have no degradation after 3 years implantation in one recent study included in this review.

The need to optimize pore and filament size, reduce degradation,  shrinkage infection and stiffness while allowing for variability among patients (low vs high responders) must all be concomitantly considered and properly evaluated as the development of new mesh grafts continues.