Concerns about the use of graft material, particularly Prolene mesh, continue to mount after the most recent FDA warning on mesh in vaginal surgery.  These diligent authors from Michigan, Texas, Massachussetts, Washington State, New Mexico and Israel combed the international medical literature in all languages from 1950 to present, looking for data on adverse events when graft material is used at the time of vaginal prolapse repair. Three common problems, erosion (graft eroding through the vaginal skin so that it is palpable to touch and/or visible to the examining eye), granulation tissue (“proud flesh” commonly found in wounds as they heal inside and outside of the body), and dyspareunia (painful sex) were the key factors under review.

Granulation, Erosion, Dyspareunia and Prolapse Organ Prolapse Surgery with Graft Materials

What they found is that rates of each of the three complications did not differ between synthetic (such as non-absorbable Prolene or absorbable  Vicryl mesh) vs non-synthetic (such as porcine [Surgisis] or bovine [Xenform] or human cadaver-based) graft material, and that reportage with regard to sexual problems was so spotty and incomplete that it was difficult to figure out if women with sexual pain after surgery had sexual pain before surgery with the problem persisting after reconstruction, or whether it was clear that the surgery definitely caused the dyspareunia (sexual pain).

Of the more than 2000 mauscripts considered, less than 200 were included and most did not report on all three of these possible complications. In more recent years, the reportage tended to be consistent with our modern-day concerns, as one might expect the case to be.

Bottom line: there are no guarantees. Grafts reduce prolapse recurrence rates, but come with their own set of headaches.

To mesh or not to mesh?

Synopsis for the Journal of Sexual Medicine from original manscript published in the July 2011 issue of the International Urogynecology Journal:

Abed H, Rahn DD, Lowenstein L, Balk EM, Clemons JL, Roberts RG

Incidence and management of graft eriosion, wound granulation and dyspareunia following vagianl prolapse repair with graft maeriasl: a stematic review.

Int Urogynecol J (2011) 22:789-98.

This metanalysis reviewed global data published from 1950-2010 from papers  reporting adverse events after vaginal prolapse repairs using graft materials. 2260 citations were identified using Medline search terms including vaginal or uterine prolapse, rectocele, surgical mesh, cystocele, and similar pelvic  floor terms. After review of each, data from 196 manuscripts was included in this analysis. Graft erosion was reported in 110 studies (10.3%) with similar rates for synthetic and biologic grafts.  Diagnosis of erosion occurred between 6 weeks and 12 months. The most common risk factor for erosion was concomitant hysterectomy, as well as patient age, smoking and diabetes, surgeon experience, and use of T incision of vaginal skin during dissection. Granulation tissue as reported in 7.8% of the 16 papers reporting on this outcome in series using a single type of graft material. While not statistically significant, the reported rate of granulation was higher with biologic graft material than with synthetic/permanent graft material (9.1% and 6.8%, respectively). Spontaneous resolution of granulation tissue and resolution with suture removal and silver nitrate treatment were reported treatment options.

Dyspareunia was reported in 71 papers with overall incidence of 9.1%, rates similar between synthetic and biologic grafts, with risk factors including posterior repair and mesh erosion. Listed treatments included vaginal estrogen cream and excision of eroded mesh. The authors point out that many of these studies did not limit reportage to sexually active women, nor make clear whether the painful sex was persistent or de novo. They also remind the readers that dyspareunia is known to occur with native tissue repairs also, operations where no graft material of any sort is used. The authors go on to report that most of the studies did not including what proportion of women sere sexually active, how may had pre-existing sexual dysfunction and how many benefited from improved sexual function. They state that as more studies use the validated quality of life Pelvic Organ Prolapse / Urinary Incontinence Sexual Questionnaire, the quality of  data on the impact of pelvic floor surgery on sexual function will improve in accuracy and clinical relevance.

Content is copyright protected on date of online publication. Content herein does not represent medical advice. To learn more about pelvic floor disorders such as fistula, pelvic organ prolapse, dropped bladder, dropped uterus, hysteropexy uterine resuspension, vaginal laxity, rectocele, postpartum rehabilitation, vaginal rejuvenation, labiaplasty, vaginoplasty, Kegel exercise or incontinence please visit other posts in this blog and the Urogynics website at www.urogynics.org.

This is another manuscript I reviewed for the Journal of Sexual Medicine, published by colleagues from The Mayo Clinic in the International Urogynecology Journal July 2011 issue. These authors looked carefully at the possibility of change in vaginal contour resulting from pelvic organ prolapse surgery with regards to female sexual function. They measured vaginal length and width before, immediately after (patient still in the operating room under anesthesia, case finished), and 6 months after surgery. The women completed a validated questionnaire for prolapse, incontinence and sexual function in women called the PISQ-12 before and 6 months after surgery. In summary, vaginas were a bit shorter and a bit narrower after surgery, and sexual function quality of life questionnaire scores did not change, nor did sexual satisfaction or lack thereof correlate to vaginal measurements either before or after surgery.  This helpful study will no doubt be repeated in various fashion as we in the field of urogynecology do our best to adhere to the mandate of “primum non nocere” (first, do no harm).

Once you’ve done this:

Childbirth - good thing they're so cute

You might need this:

Cutting & Sewing - 2 darts and a dash of facing, voila!

To get back to this:

Anatomy in 3-D - the vagina in relation to the rest of you

Journal summary:

Ochhino JA, Trabuco EC, Heisler CA, Klingele CJ, Gebhart JB.

Changes in vaginal anatomy and sexual function after vaginal surgery.

Int Urogynecol J (2011) 22:799-804

The authors enrolled 92 women undergoing vaginal reconstruction prolapse surgery in study including pre- and post-surgery completion of a validated sexual function questionnaire (PISQ-12) and in measurement of vaginal contour before, immediately after, and 6 months after surgery in order to determine whether changes in vaginal length and caliber correlate to changes in sexual function. All but one of the women was white. 72.8% were menopausal and 16.3% had undergone one prior prolapse operation. 47.8% were sexually active before surgery with a preoperation PISQ-12 score of 33.5. Pre-operation vaginal length was 10.4 cm on average with mean caliber 3.2 cm. Some women had intentional coning (narrowing) of the top of the vagina to correct excessive laxity and some did not – those undergoing coning (N=14) were evaluated separately from those who did not (N=78) for post-op vaginal contour measurements.

Immediately after surgery while still anesthetized, vaginal length of women with no coning was reduced to 7.9 cm with caliber 3.0 cm while coned patients measured 6. 8 cm length with caliber 2.8 cm. At 6 months postop, the no-cone women measured 8.7 cm length with 2.8 cm caliber while coned women continued to measure 6.8 cm length with .2 cm caliber.

74 women completed the PISQ-12 prolapse-incontinence-sexual function questionnaire at 6 months post-surgery, with 52.6% sexually active. Only 34 sexually active women completed the questionnaire before and after surgery, and in this group no change in score was demonstrated (33.4 vs 34.7). Further, no correlation was found between pre0operation score and vaginal length or caliber or between post operation score and vaginal length or caliber. The authors did not comment on the drop-out rate for questionnaire completion. They point out that, according to this data in this first study to look at changes in vaginal contour as correlates to sexual function, changes in vaginal dimensions does not seem to affect sexual function in women who were sexually active before and after the pelvic organ prolapse operation.

Level of evidence: III Count: 325 words

Content is copyright protected on date of online publication. Content herein does not represent medical advice. To learn more about pelvic floor disorders such as fistula, pelvic organ prolapse, dropped bladder, dropped uterus, hysteropexy uterine resuspension, vaginal laxity, rectocele, postpartum rehabilitation, vaginal rejuvenation, labiaplasty, vaginoplasty, Kegel exercise or incontinence please visit other posts in this blog and the Urogynics website at www.urogynics.org.

The Center for Disease Control attests that at least 77% of American adults don’t get enough Vitamin D. And while that’s bad news for everyone, it’s often WOMEN who suffer most.

Vitamin D - good for bones, prolapse, incontinence, autism, ...

Vitamin D is involved in regulating up to 2,000 different genes in the human body.

Considering that this amounts to 10% of our makeup, it’s disturbing that so many adults are D deficient.

Recent research shows that women in particular should be concerned about getting adequate levels of vitamin D.

A study at Boston University School of Medicine recently found that pregnant women who are vitamin D deficient are FOUR TIMES more likely to require delivery by cesarean section.

Similarly, the risk for both preeclampsia, which is dangerously high blood pressure, and pre-term labor, is significantly increased when a mom-to-be is lacking the nutrient.

And risks from a mom’s D-deficiency extend to an infant, as well.

Vitamin D is important for the proper development of a fetus’s brain, and it’s a significant factor in preventing respiratory infections and wheezing after birth.

Vitamin D deficiency is also being investigated as a potential culprit in the development of autism!

Low levels of the nutrient can also make it more difficult to conceive a pregnancy in the first place, according to findings reported in the American Journal of Clinical Nutrition.

And even if you’re not trying to conceive, researchers at Creighton University in Omaha found that women who get adequate amounts of vitamin D are up to 60% LESS likely to get breast, skin and lung cancer.

Plus, multiple studies have linked vitamin D deficiency in women to mood disorders such as premenstrual syndrome, seasonal affective disorder, major depressive disorder, and non-specific mood disorder.

Postmenopausal women should be aware that low levels of the nutrient may lead to osteoporosis, or thinning bones.

Women of all ages with vitamin D Deficiency are more likely to suffer urinary incontinence and pelvic organ prolapse.

No matter what your age or stage of life, ensure that you’re getting enough of this VITAL nutrient by asking your doctor to test your blood levels.

Women who are deficient may benefit from a daily supplement or increased sun exposure.

To learn more about essential vitamins and minerals, check out this video on Vitamin D and Womens Health, courtesy HealthGuru.com

Content herein does not represent medical advice. To learn more about pelvic floor disorders such as fistula, pelvic organ prolapse, dropped bladder, dropped uterus, hysteropexy uterine resuspension, vaginal laxity, rectocele, postpartum rehabilitation, vaginal rejuvenation, labiaplasty, vaginoplasty, Kegel exercise or incontinence please visit other posts in this blog and the Urogynics website at www.urogynics.org.

PELVIC ORGAN PROLAPSE:

NO DIFFERENCE IN SEXUAL QUALITY OF LIFE BETWEEN PROLAPSE PATIENTS CHOOSING PESSARY VS SURGERY.

Ladies, it's all about choice

Pelvic organ prolapse is a condition where the organs around the vagina are out of place – bladders drop (called cystocele), rectums bulge forward and sometimes out of the vaginal opening (rectocele), and/or the uterus drops down, literally falling out of the vagina turning everything inside out when its severe (uterine prolapse).  When prolapse is so bad that things are bulging out between the vaginal labia (yup, it happens) most women are uncomfortable to want to do something about it.
With severe prolapse, whatever the prolapsing part(s), and it’s usually more than one thing out of place, there are 2 choices – reconstructive surgery, or a vaginal prosthesis called a pessary.  A pessary is a vaginal widget that holds things up where they need to be when it’s inside. They come in all shapes and sizes – the easiest pessaries are ring-shaped. They’re easy because women can remove and insert them easily and reliably without assistance. Ring pessaries are sort of like contraceptive diaphragms in terms of insertion and removal. But sometimes, due to weak, thin Kegel muscles or uterine prolapse so severe that it pushes the rings out, sturdier pessaries, such as Gellhorns, donuts and Gehrungs, are the only ones that stay in.

Some women don’t like pessaries – or can’t find any that fit comfortably. They usually opt for prolapse surgery that puts all the organs back into position. The surgery can be complicated and, as with all surgeries, results can be less than perfect, making pessaries a viable option for women who are poor surgical candidates or simply don’t want to undergo extensive soft-tissue reconstructive surgery.

These British researchers undertook the task of looking at whether or not either treatment choice, surgery or pessary, affected sexual quality of life.  In data published in the March 2011 issue of the International Urogynecology Journal, they  found some interesting trends – women choosing surgery were younger, and at first glance seemed to have better sexual quality of life than their pessary using sisters, but when the statistician removed age differences, the sexual quality of life was the same between the two groups. Interestingly, 31 women who started with pessary didn’t like it and switched to surgery. Not much is said about them as the study design excluded data of patients who switched groups after the initial choice of treatment.

Here’s the study summary written for the June 2011 literature review for Journal of Sexual Medicine:

Abdool Z, Thakar R, Sultan AH, Oliver RS

Prospective evaluation of outcomes of vaginal pessaries versus surgery in women with symptomatic pelvic organ prolapse.

Int Urogynecol J (2011)22:273-78.

A prospective, non-randomized design compared women with prolapse opting for pessary management vs reconstructive surgery of pelvic organ prolapse, using baseline  and 1 year quality of life data, including but not limited to sexual function (Sheffield Pelvic Organ Prolapse Quality of Life questionnaire-SPS-Q).

Women referred to the Urogynaecology unit of Mayday University Hospital in Surrey, England were evaluated and counseled regarding prolapse management.  Each completed the SPS-Q, a 13 item quality of life assessment tool addressing impact of prolapse on bladder, bowel and sexual function using four-point ordinal response scales (never, occasionally, most of the time, all of the time), validated and sensitive to changes in clinical status. Women choosing pessary were first fitted for ring pessaries; the most user-friendly. If rings did not work, gellhorn or donut pessaries were fitted for sexually inactive women, and cubes fitted for sexually active women, as cubes are easily removed for sexual activity.

Patients were excluded if they underwent incontinence surgery or switched from pessary to surgery (N=89) either due to use of pessary as interval measure in preparation for surgery (N=58), or because pessary was too problematic, prompting a change of heart in favor of prolapse surgery (N=31).

554 women entered the trial, 359 with pessary and 195 choosing surgery. Women excluded from final analysis numbered 195 in the pessary group and 88 in the surgery group.  The final analysis was carried out on women completing questionnaire at 1 year who either underwent surgery as first option or were still using pessary at 1 year, 46% of the pessary group and 55% of the surgical patients.

Mean age was higher in the pessary group (68 vs 60 yrs). Other demographic measures were equivalent. At 1 year there was statistically significant improvement in sexual function in both pessary and surgery patients, in addition to similar improvement in bladder, bowel and prolapse symptoms. Frequency of intercourse was better in the surgical group (54% vs 46% p=0.028), however this sexual frequency difference faded when controlling for age.

Content herein does not represent medical advice. To learn more about pelvic floor disorders such as fistula, pelvic organ prolapse, dropped bladder, dropped uterus, hysteropexy uterine resuspension, vaginal laxity, rectocele, postpartum rehabilitation, vaginal rejuvenation, labiaplasty, vaginoplasty, Kegel exercise or incontinence please visit other posts in this blog and the Urogynics website at www.urogynics.org.

Cystocele, rectocele, erosions, sex, mesh shrinkage, folding and thickening

You can’t make this stuff up.

Prolene mesh is the product name for a permanent plastic mesh with many implantation applications in reconstructive surgery. Prolene mesh is used to fix large and small abdominal hernias, inguinal hernias, hernias of the diaphragm; it’s used to resuspend kidneys (nephropexy) rectums (rectopexy), uteri (aka uterus’ plural) (sacrohysteropexy), prolapsed vaginas after hysterectomy (sacrocolpopexy), chin augmentations (mentoplasty), chest wall repair in certain thoracic surgeries, (abdominal hernias (inguinal, umbilcal, ventral) and both male and female urethral sling operations for stress urinary incontinence, to name a few.

Over the last 8-10 years, the use of prolene mesh for vaginal prolapse surgery has expanded to include cystocele and rectoceele repair, In an effort to standardize application and, arguably, make it easier for gynecology, urogynecology and urology surgeons to use the mesh, and, definitely, to market the new pelvic organ prolapse mesh kits effectively, Prolene mesh companies have tweaked mesh pore size (degree of laciness), thickness, and density; they’ve mixed it with other graft materials, impregnated it with various materials, each in an effort to reduce horrific complications and claim clinical superiority. The industry cannot advertise or market superiority without data, so they sponsor scientific clinical trials hoping for favorable data that will legally permit them to claim product  superiority in marketing activities, via studies paid for in part or in full by the companies manfacturing the mesh, often but not always recruiting surgeons who work as paid advisors and consultants, much the same way pharmaceutical companies use paid advisors to participate in clinical drug trials. I know, I’ve been, at various points in my career, one of those advisor/consultants. It is a very fine ethical tightrope clinicians walk when participating at that level. The perks are large. The rewards many. It’s an elite group of clinical industry insiders that trumpet the merits of these meshes. Those surgeons publishing outside of the advisory board arena compete for journal space along side industry funded trials.

A few times a year, I and a few colleagues comb the literature for the Journal of Sexual Medicine, fashioning reviews of research with a sexual function implication. This month, I found three that “turn me on” – 2 of which focus on Prolene mesh for vaginal implantation in pelvic organ prolapse surgery for cystoceles (dropped bladders) and rectoceles (back wall vaginal hernias).

Here are the two trials on 2 different Prolene mesh kits: AMS Perigee and Gynecare Prolift.

The first study, using Prolift, found that young sexually active women were more likely to suffer vaginal erosion of mesh, literally mesh showing where the vaginal skin over it has eroded away. A bit of a problem, if your young, like sex, have prolapse, and use Prolene mesh, at least with this particular kit, to have it fixed. Prolene mesh in the vagina creates a mechanical risk of sexual dysfunction; your sex life could, quite literally, hit the skids. Forget carpet burns, we’re talking penis-meets-sand paper. Woops.

The second study, using a different brand of Prolene mesh vaginal prolapse kit for dropped bladder (cystocele) repair called Perigee, claims a close-to-zero mesh erosion rate, each erosion “minimal and easily remedied” with a bit of tinkering in the office. The investigators report some interesting ongoing changes in the sonographic appearance of the mesh once implanted in the vagina. In this study, Prolene mesh demonstrated folding in a few, and continued to shrink or shorten and thicken more and more at each of three sonograms done in the first year after implantation. Makes you wonder how it’s behaving after, say, 5  or 10 years.

I’ve said before and I’ll say again here, Prolene mesh ribbons for uterine suspension, vaginal cuff suspension after hysterectomy and female urethral sling operations for urinary incontinence have been around a long time and really do seem, in my experience and in my opinion, to work very well with low rates of minimally bothersome, easy to fix complications. BUT I’ve seen nightmares with Prolene mesh kits used for cystocele and rectocele repair – full recurrence of the prolapse, sometimes worse that before surgery, along with horrific, painful, bleeding mesh  vaginal or bladder erosions, kinking of ureters (the tubes that drain urine from your kidney to your bladder) glued to the mesh requiring ureteral re-implantation into a diffierent part of the bladder (this is big surgery, not a quickie), in addition to mesh bundles eroding into the vagina creating bleeding vaginal wounds that make sex impossible. Explanting (removing it in full) Prolene mesh from the anterior and posterior walls of the vagina is no easy task.  Not to mention, who wants a vagina literally lined on all’round with plastic mesh? Pore size, shmore size – it’s a Franken-vagina. How can that be good?

To date, I use this paper by Dr. Donald Ostergard as the yardstick by which all Prolene mesh graft products are to be measured, including the uses I consider acceptable and continue to employ. I don’t see any similar works coming from other surgical specialties about Prolene mesh as a surgical graft material. Urogynecology seems to be the lightning rod specialty for Prolene mesh graft considerations.

In 2008 the  FDA issued an official warning about Prolene mesh implantation in the vagina, and continue to express concern, as we see here in this Feb 2009  FDA newsletter posting:

Serious Complications with Surgical Mesh for Gynecologic Surgery

The FDA is alerting healthcare professionals about rare but serious complications associated with the surgical mesh used to treat pelvic organ prolapse and stress urinary incontinence. The mesh is usually placed transvaginally using minimally invasive techniques.

Over the past three years, FDA has received over a thousand reports of complications. The most frequent included erosion of the mesh through the vaginal epithelium, infection, pain, urinary problems, and recurrence of the prolapse or the incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in quality of life due to discomfort and pain, including dyspareunia.

Treatment of the complications included IV therapy, blood transfusions, drainage of hematomas or abscesses, and additional surgical procedures, in some cases to remove the mesh.

Clinicians using mesh for treatment of pelvic organ prolapse and stress urinary incontinence should:

• Obtain specialized training for each mesh placement technique, and be aware of its risks.

• Be vigilant for potential adverse events from the mesh, especially erosion and infection, and also from the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.

• Inform patients about the potential for serious complications and their effect on quality of life, including scarring and pain during sexual intercourse. Patients should also be informed that implantation of surgical mesh is permanent, and that some complications associated with the mesh may require additional surgery that may or may not correct the problem.

• Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if it is available.

So here’s some of the latest research data on both sides of the Prolene mesh fence – 1st up – if you’re young and like sex and need cystocele/rectocele prolapse repair, beware Prolene mesh. Second up – a study showing that kit- Prolene for bladder lift/cystocele repair is great stuff, no major problems, the authors reporting great results and almost no complications! However, sonographic evaluation of Prolene mesh over the first year showed that folding might occur early on, and mesh shrinkage and thickening increased steadily at each sonogram evaluation. These papers were back-to-back in a recent issue of a major urogynecology journal. Kudos to the editorial board of the International Urogynecology Journal.

Sorry for the confusion – this is the world we live in:

Prolene mesh kits for cystocele and rectocele repair: erosion correlates to young age and sexual activity

Kaufman Y, Singh SS, Alturki H, Lam A.

Age and sexual activity are risk factors for mesh exposure following transvaginal mesh repair.

Int Urogynecol J (2011)22:307-13.

A prospective, observational study evaluates safety and complication risk factors of the Prolene mesh prolapse surgery product, GYNECARE PROLIFT.  Polypropylene mesh kits are available for cystocele, rectocele and global (total vaginal lift) prolapse repair, each marketed as a more reliable method of prolapse repair with lower recurrence rates. This study evaluated 114 consecutive Gynecare Prolift patients for graft exposure (erosion of prolene mesh through the vaginal wall). Women were excluded if they were unwilling to undergo risks of polypropylene mesh vaginal grafting, or had severe vaginal scarring from prior operations. Exposure was further divided into early (< 6 weeks post-op) and late > 6 weeks post-op) categories, comparing each to demographic factors to determine what patient characteristics are associated with Prolift prolene mesh vaginal erosion.  Standardized pelvic floor/sexual function quality of life questionnaires were used in addition to pre-and post operation examination. Age, parity and demographic factors were collected.

114 women met criteria for inclusion, average age 61, BMI 26, parity 3. Follow-up ranged from 6.3-7.4 months, average 7.4.  19 underwent cystocele Prolift, 14 rectocele Prolift, and 81 Total (cystocele and rectocele) Prolift.  Only 58 (51%) of participants were sexually active before surgery, 18 (31%) of whom reported dyspareunia before surgery. 52 women were sexually active after surgery, 14 (27%) reporting de novo dyspareunia and 9 (17%) with persistent dyspareunia.  Four (3.5%) demonstrated early mesh exposure and 10 (8.8%) late mesh exposure with 6 (5.3%) repair procedure failures, all of which carries implications for sexual function.  Mesh exposure was higher in overweight women and women of higher parity. Early mesh exposure correlated to greater degree of pre-surgery prolapse and higher parity. Younger age and sexual activity were risk factors for late mesh exposure, most commonly on the anterior vaginal wall.  The authors found no correlation between mesh exposure and dyspareunia, postulating that painful sex may reduce mesh exposure by paradoxically deterring sexual activity, the erosion-risk behavior. The authors further caution that sexually active, especially younger, patients must be cautioned as to the potential for Prolift polypropylene mesh exposure, a complication with severe negative implications for sexual quality of life.

Prolene mesh kits for cystocele repair: mesh erosions and prolapse recurrence minimal, mesh shrinkage and thickening seen on sonogram.

Lo TS, Ashok K.

Combined anterior transo-obturator mesh and sacrospinous ligament fixation in women with severe prolapse-a case series of 30 months follow-up.

Int Urogynecol J (2011)22:299-306.

A prospective, observational study evaluates efficacy and safety risk factors of the anterior Prolene mesh prolapse surgery product, PERIGEE. In women with severe pelvic organ prolapse.  Polypropylene mesh kits are available for cystocele, rectocele and global (total vaginal lift) prolapse repair, each marketed as a more reliable method of prolapse repair with lower recurrence rates. This study evaluated 128 Perigee patients for recurrence of prolapse, mesh erosion, mesh folding and mesh shortening, shrinkage and thickening. No exclusion criteria are reported.   Standardized pelvic floor/sexual function quality of life questionnaires were used in addition to pre-and post operation examination, urodynamics evaluation of bladder function,  and post-operation introital sonography to evaluate in situ mesh characteristics. Age, parity and demographic factors were collected.

120 women met criteria for inclusion, average age 63, BMI 25, parity 4. Follow-up ranged from 12-47 months, average 30 months. Post-operation evaluation included  prolapse examinations for recurrence, and introital sonograph measurement of distance from edge of mesh to bladder neck, length and thickness of mesh, plus thickness of vaginal wall at 1, 3 and 12 months and urodynamics evaluation before and 12 months after Perigee implantation.

Recurrence of prolapse was minimal with only 2 recurrences to severe prolapse and an overall 93.3% success rate at 30 months median follow-up. Urodynamics data showed significant changes consistent with relief of prolapse-related bladder outlet obstruction. Graft evaluation showed only 5 (4.1%) cases of mesh erosion, all occurring between 3 weeks and 3 months, each small, and all responded to trimming and outpatient wound management with no further cases of Prolene mesh exposure noted over the course of the study. With regard to sonographic evaluation of  in-situ mesh, 5 (4.1%) demonstrated frank mesh folding beneath the vaginal skin, one with mesh erosion into the vaginal space. Mesh both thickened and shortened significantly and increasingly over the one year of post-surgery sonographic monitoring, average 20%, shortening consistent with other reports of ongoing changes in Prolene mesh morphology after vaginal implantation.

This careful and detailed report did not include specific evaluation of sexual function.  Prolene mesh erosion rates were low, consistent with prior reports for this Perigee Prolene mesh product. Prolene mesh vaginal grafting for pelvic organ prolapse continues to be a force in the clinical marketplace. The vast difference in reported safety and complication outcomes between permanent Prolene mesh products warrants careful scrutiny by clinicians and surgeons when counseling patients, particularly with regard to vaginal sexual function. This study, showing steady ongoing changes in implanted mesh morphology (folding, thickening, shortening), highlights the bio-active dynamics of in situ vaginal Prolene graft.

Content herein does not represent medical advice. To learn more about pelvic floor disorders such as fistula, pelvic organ prolapse, dropped bladder, dropped uterus, hysteropexy uterine resuspension, vaginal laxity, rectocele, postpartum rehabilitation, vaginal rejuvenation, labiaplasty, vaginoplasty, Kegel exercise or incontinence please visit other posts in this blog and the Urogynics website at www.urogynics.org.

(c) L. Romanzi, 2011

Uterine prolapse affects 30% of ALL women, so there’s a good chance that it will touch you or someone you know. But before you can comprehend uterine prolapse, you need to have a basic understanding of a woman’s pelvis.

The vagina is the foundation of female anatomy, while the cervix sits above the vagina, and the uterus above the cervix. Connective tissue called uterosacral ligaments hold the uterus and cervix in place.

When it comes to uterine support, it's all about the uterosacral ligaments...

As the primary support system for the entire female pelvis, the uterosacral ligaments are extremely important! Uterine prolapse occurs when collagen fibers in these ligaments stretch or weaken, causing the cervix and uterus to drop down to the vaginal canal. If it drops far enough, it’s possible to feel and see the cervix, which looks like a small pink donut.

Although this is not usually painful, a woman may experience feelings of heaviness or pulling in the pelvis. Other symptoms of uterine prolapse may include painful sex, low backache, frequent urination, or even vaginal bleeding, although the converse is not always true, i.e; every women with frequent urination or low back pain or vaginal bleeding does not necessarily suffer uterine prolapse, as there are many reasons, prolapse among them, for each of these conditions. Your gynecologist can help sort out whether or not you are suffering uterine prolapse.

Like I said, it's all about the ligaments

A number of things can contribute to uterine prolapse. Women who give birth vaginally are more likely to experience thinning and stretching of the supportive uterosacral ligaments,especially those who experience long labors or deliver big babies. Prolapse is also more likely in women over 50, because muscle tone and onnective tissue integrity decreases with age.

Research also suggests that some women may be genetically predisposed to uterine prolapse. In other words, you can’t always PREVENT uterine prolapse, but you CAN learn about treatment options.

One effective treatment choice is a pessary, which is a vaginal support made of rubber, plastic, or silicone. A doctor fits a woman’s pessary to her body to hold the prolapse comfortably in place.

Surgery is another option, which, unlike a pessary, actually REPAIRS the prolapse. As with all surgeries, complications, including but not limited to recurrence of prolapse, are possible so make sure you understand both the risks and the benefits if you are considering prolapse surgery.

According to US Dept of Health data, one in nine cases of uterine prolapse is severe enough to warrant surgery. The good news is that uterine prolapse IS fixable without resorting to hysterectomy, so if you’re suffering uterine prolapse, understand that you don’t have to choose between hysterectomy or pessary, you have the option of uterine resuspension, hysterectomy-type prolapse repair, or pessary support.

To learn more about this and other pelvic floor conditions, visit Dr R video on HealthGuru.com.

In the Hausa/Fulani region of Northern Nigeria and Southern Niger, “Gishiri” is the term for salt, for “tasty” and slang for the genitalia of both sexes. “Yankan” is the word for cutting, and “Yankan Gishiri” (cutting with salt) has been used for generations as a local remedy for all sorts of ailments and conditions, including:
Pain with sex (dyspareunia)

Infertility

Pelvic Organ Prolapse (dropped bladder, rectocele, uterine prolapse…)

Boils

Itching

Urinary Retention (inability to urinate)

Prolonged Labor

Episiotomy

This remarkably harsh home remedy involved rock salt in it’s traditional form, but now, in the new millenium, Gishiri cuts are made either by a barber with a knife, or a local birth attendant with a razor. Seems a bit backwards- you might expect the barber to use the razor and the lay midwife to use a knife, but this is not the case, according to today’s presentation of “Yankan Gishiri” data at the 4^th annual meeting of the International Society of Obstetric Fistula Surgeons by Dr. Amir Yola from Kano, Nigeria.

As you can imagine, these cuts can do damage, including urinary or fecal incontinence from damage to the urethral or anal sphincters, or full thickness holes, or fistula, between bladder and vagina, urethra and vagina, or rectum and vagina.

Fistula after Gishiri cuts result from deep cuts that heal open, creating a fistula defect. Of 1372 fistula patients treated by Dr. Yola and his team in Kano, Nigeria, 78 (5.7%) of the fistula were the result of “Yankan Gishiri”.

How’s that for “pouring salt on the wound”?

A Yankan Gishiri-free view with which to recuperate from this blogpost

It’s not easy being a girl.

Uterine Prolapse happens worldwide

I’m  here in DRC (Democratic Republic of Congo) where I and my American colleagues usually help the Panzi Hospital gyn and fistula surgeons fix fistulas and figure out ways to deal with less than perfect fistula repair results or how best to care for the “unfixables” – women with fistula so large and soft tissue damage so far gone that the fistula cannot be fixed in a way that restores normal anatomy. The overwhelming majority of fistula comes from obstructed childbirth, and if there’s anything good about fistula, it’s that fistula rates plummet to near zero with access to rudimentary obstetric care during labor and timely access to cesarean section if the baby doesn’t fit through the pelvis. In short, it is possible to prevent obstetric vaginal fistula, to eradicate it from the face of the earth (or close to it) by simply bringing obstetric care in poor countries up to the standard of care found in the late 1800′s in North America and Europe. “Modern obstetrical techniques” of the late 1800′s (not 1900′s, that’s right I said 1800′s) made the world’s first fistula hospital, located on Park Avenue in New York City, OBSOLETE, closing its’ doors somewhere in the vicinity of 1893, when it was torn down to make way for today’s Waldorf Astoria Hotel. So we can make fistulas go away, and we will, all over the globe, with a little strategizing and a lot of common sense.

Other common pelvic floor disorders, however, will continue to plague women even after the advent of modern obstetrics in deprived, impoverished nations. These persistent pelvic floor conditions, such as uterine and pelvic organ prolapse (dropped bladder/cystocele, rectocele, vaginal laxity, uterine prolapse) and urinary incontinence are a growing problem all over the world, even, and especially, in developed, wealthy nations in North America and Europe, where the incidence of conditions like prolapse are increasing rapidly as these well- fed, well-cared for populations age.

What we’ve found in DRC is that the women of poor nations, life expectancies around 41 years, also have a (probably – no one knows for sure. It’s not like this country maintains a national database on health conditions.) high incidence of pelvic organ prolapse and urinary incontinence, or at least that’s how it seems to the fistula surgeons who also care for women with all manner of pelvic floor disorders, fistula and otherwise, in Eastern DRC.

This fistula-prolapse paradox makes sense if you think about it – if your connective tissue is super elastic, the babies will “come out” no problem, but this exact same life-saving elasticity also makes you prone to pelvic organ prolapse, either due to genetic predisposition (there’s all manner of fascinating data on the genetic markers and metabolic nuances found in women with prolapse compared to their non-prolapsing sisters), lifestyle activities (heavy lifting, high impact repetitive strain injuries, birthing big babies that take a long time to push out in labor…) or both.

The Daily Commute, DRC-style

In short, the female pelvis connective tissues that support all the organs surrounding and attached to the vagina have been self-selecting for elasticity, because elastic connective tissues allow women’s bodies to stretch during childbirth so the baby doesn’t get stuck on the way out. If you have this super elastic connective tissue, you’re more likely to successfully birth a live baby and survive to raise it. If you don’t your prone to obstructed labor and vaginal fistula. In a place like Democratic Republic of Congo (DRC), where women do lots of heavy lifting and birth babies in villages without a modern clinician of any sort available, the severe conditions makes EITHER prolapse (for the good elasticity group) OR vaginal fistula (for the poor elasticity group) a very likely result of pregnancy. In this incubator of extremis, we find a high prevalance of both conditions, one, fistula, acknowledged with international support for eradication, and one, prolapse, ignored, both conditions with identical impact on the women affected.

One might argue that, in these impoverished nations, women with fistula are getting the lion’s share of international sympathy, charitable funding, and institutional attention, while their prolapsed sisters are virtually ignored by these same entities, even though they often suffer the exact same consequences of abandoment, excommunication, starvation and despair.

25 yrs old DRC woman with procidentia, a condition that happens worldwide

On this mission sponsored by HHI www.hhi.harvard.eduand EngenderHealth www.engenderhealth.org, I chose to forego fistula repair in order to work with the Panzi surgeons on expansion of prolapse repair techniques.According to my colleagues, prolapse is quite common, and it often occurs in young women. The most common prolapse techniques include hysterectomy for reasons that, literally, escape reason, as we now know that removing the uterus does nothing whatever to improve the durability of prolapse repair surgery. It turns out that the uterus is a victim of prolapse, rather than the oft-held-forth “perpetrator”.  I’ve been able to share a technique called “vaginal uterosacral uterine resuspension” that spares the woman a hysterectomy by including resuspending the uterus to the native uterosacral ligaments using a vaginal incision to access those ligaments located deep in the pelvis. This technique avoids abdominal incisions (quicker healing, no risk of keloid scar), doesn’t require fancy equipment like laparoscopy or  robotics (an automechanic’s headlight, pelvic retractors and a few long needle holders are all you need), and holds up just as well as uterine resuspension done by any other modern technique. This uterine resuspension to the uterosacral ligaments has the same durability as the hysterectomy-based version, where the top of the vagina is suspended to the ligaments when the uterus is removed.

Vaginal Uterosacral Uterine Suspension aka Hysteropexy

If a hysterectomy is necessary for non-prolapse indications, the same uterosacral suspension may be done to the vaginal cuff

We’ll do 8 uterine-resuspensions based total prolapse repair (so that the bladder lift, rectocele repair and perineoplasty are done at the same time as the uterine resuspension) during this November 2010 mission.The surgeon teams rotated to allow as many surgeons as possible to learn the techniques. These colleagues include Drs. Musimwa, Binti, Kubuya, Ruboneka, Shangalume, Mushengszi, Busingisi, Mukwege, Tchango and Raha of Panzi Hospital in Bukavu, DRC www.panzihospitalbukavu.org. Next week, these surgeons will operate in teams that I will supervise, each doing the entire procedure with minimal intervention from me as needed. As a result, they will have an effective, minimally invasive method of repairing pelvic organ prolapse without resorting to hysterectomy. In a setting such as rural DRC, removing the uterus of a young woman brings equal devastation as does prolapse and fistula. She’s no longer a woman, and she’s sure to suffer as a result. Anything that allows these young women with prolapse to restore normal anatomy without removing their organs of reproduction is sure to, quite literally, save lives.

Kidogo Kidogo is Swahili for “little by little”, a common phrase around Panzi Hospital. With these first uterine resuspensions, we slowly turn the tide away from devastation and toward restoration, the true purpose of reconstructive pelvic surgery.

(c) L Romanzi 2010

The Step-Sisters of Fistula – Minimally Invasive Uterine Resuspension- Hysteropexy C’est Arrive au DR Congo.

The Stuff of Prolapse *image courtesy of "Women of the Shadows"

It is difficult to express how impressed I am during each and every Harvard Humanitarian Initiative mission (www.hhi.harvard.edu) by the  skilled, motivated, and wise  pelvic floor – fistula surgeons at Panzi Hospital in Bukavu, DRC.  On these many fistula-repair missions, I’ve come to understand that one of the most important ways to add value to colleagues upon whom we descend in our zealous compulsion to fix every woman with a fistula, is to realize that, in addition to the tragic, fashionable and international charity-funded fistula women found in every developing nation on the planet, there are women in these same villages suffering equal stigma, ostracism, divorce and abandonment as their fistulous sisters because they suffer incontinence of urine or stool, or waddle about in a state of severe pelvic organ prolapse. The prolapsing cervix can look a lot like the head of a penis, and many’s the woman accused of infidelity by the husband to whom she birthed all the children and for whom she’s carried all the loads of wood, water and supplies on her head that caused the prolapse in the first place. As if she had a single ounce of energy with which to seek out and fornicate with a man other than her husband – peeleeze.  Anyhow, this sort of tragi-comic mythology surrounds many medical and surgical conditions when the people suffering said conditions do so without the benefit of education and absolutely zero comprehension of internal anatomy. You have a fistula because you are possessed by evil spirits, you have prolapse because you cheated on your husband, you died from hemorrhage after your clitoris and labia were cut off ritualistically to transform you into a marriageable chattel because you were committing the ultimate sin of pleasuring yourself to the always dangerous female orgasm. Things like that.  Feel free to throw the conditions and myths into a hat to play the game of “mix and match”. It’s all the same, as are the personal ramifications – you’re divorced, thrown out of your house, often permanently separated from your children, and excommunicated from your village, this being the only home you’ve ever known and the only people that ever mattered to you since the day you were born.

The uterosacral/cardinal ligament complex holds the uterus in place

Unlike the condition of fistula, prolapse and incontinence don’t “go away” with modern medicine, new world economics or robust personal health and wealth. Even the well-healed at the Hampton Classic include wealthy ladies who are wetting their pants and wishing their parts would stay all up in there where they belong. While fistula vanished with the advent of ether anesthesia in the mid-1800’s, rendering vaginal fistula nearly obsolete in Europe and North America well in advance of the 1900 centennial, (the world’s first fistula hospital was in New York City, torn down when rendered obsolete by access to Cesarean section, replaced by the still present Waldorf Astoria Hotel on Park Avenue), prolapse and incontinence continue to plague even the wealthiest, best educated, most fashionable of women on the planet.  But fistula virtually disappeared as anesthesia made Cesarean section the cornerstone of optimal obstetrical practice and stellar reduction in Euro-American maternal mortality and morbidity statistics, because fistulas come from obstructed labors, and no one in a developed nation is allowed to suffer through a 2 week labor resulting in a dead baby and a destroyed, fistulous vagina. We just do a Cesarean if it’s taking too long. The luxury of quick, routine, easy access to Cesarean section remains unavailable to the majority of women in Sub-Saharan Africa and other impoverished nations.

So this time, rather than play the “American fistula heroine” game, I decided to back it up into the unglamorous territory of plain old US/European style pelvic floor disorders, these being pelvic organ prolapse and urinary incontinence. While these un-funded (they’re not on UNFPA’s radar at all) women have no international advocate, yet they are equally tortured and punished for these conditions that are beyond their control as is any fistula victim’s.

We started with prolapse patients today. Magically, (there’s a lot of magic in DRC), after being informed that there was only a single prolapse patient, 10 emerged from the ether, each with the most severe form of prolaase, called procidentia. Procidentia (remove the children from the room and erase this link from your laptop history, quickly!) is a total pelvic disaster easily diagnosed by visualizing the cervix dangling between the patient’s thighs, turning the bladder upside down and kinking the urethra and rectum in the process. It’s mortifying.

From Beverly Hills to Bukavu, uterine prolapse is all about the uterosacral ligaments

We started the day with a lecture-discussion where we engaged in robust, healthy debate about current theory and principle held true among international pelvic floor disorder specialists – with the exception of avoiding hysterectomy by utilizing uterine resuspension – in the States, with rare exception, uterine prolapse = hysterectomy unless the woman can find a pelvic floor specialist who understands that the uterus is the victim of prolapse, not the cause.

This notion of preserving the uterus even though it’s falling out my Congolese colleagues understood, given the large number of young women whose lives would be equally destroyed by hysterectomy as they are by the prolapse.  Here at Panzi they use a large abdominal incision to resuspend the uterus by shortening the round ligaments of the uterus, a somewhat dated technique used very rarely inEurope and North America currently because it tends to fail and distorts pelvic and vaginal anatomy. These round ligaments contribute little (or so we believe) to the vector support of the uterus, the starring role of which falls to the ligament pair known as the uterosacral (US) ligaments. These US ligaments are like 2 cables, holding up the uterus and cervix by suspension at the top of the vagina much like a chandelier is held up by cables in the ceiling of a room.

We talked about compartment analysis, evaluating the support of the uterus (Apex), followed by evaluation of the stuff of vaginal prolapse and vaginal laxity below the level of the uterus, bladder for cystocele (Anterior) and rectum for rectocele and perineocele (Posterior), and evaluation of the levator (a.k.a. Kegel) muscles separately. We reviewed the role and evaluation of the Kegel muscles and the support and potential childbirth damage to the all-important and under-appreciated perineal body (connective tissue separating vagina from rectum). We debated and evaluated each continent prolapse patient for occult stress incontinence by filling the bladder, holding the prolapsed parts in proper anatomic position as the might be after surgical reconstruction, and asking the patient to cough and strain to see if urine leaks with abdominal exertion – the finding consistent with stress incontinence. Shocker, just like we find in the States, 40% of these women with bad prolapse and no incontinence symptoms leaked like sieves with full bladders and the prolapse temporarily corrected with vaginal support, and these women will undergo incontinence sling for stress incontinence at the time of their prolapse reconstruction. Tomorrow, in the OR (operating room), the Congolese fistula surgeons of Panzi Hospital (www.panzihospitalbukavu.org) will be the first to perform vaginal uterosacral uterine resuspension (a.k.a. hysteropexy) in Central Africa.

Pelvic organ prolapse, the medical term for vaginal bulges caused by damage to the connective tissues supporting the organs above and around the vagina (the uterus, bladder, rectum and vaginal opening), is a silent epidemic affecting women worldwide. Common terms include dropped bladder, dropped uterus, rectocele and vaginal laxity. Recent estimates using US Census population projections anticipate a 46 percent increase in pelvic organ prolapse among American women over the next 40 years, from 3.3 million in 2010 to 4.9 million. According to a recent study from Duke University, it is possible that the number of women with prolapse will be even greater than this, up to 9.2 million. Prolapse may occur to varying degrees in up to 50 percent of women who’ve given birth. Prolapse can even cause depression.

Childbirth contributes to most prolapse conditions, however genetics, medical disorders such as connective tissue disease, diabetes and obesity, and lifestyle habits have all been shown to contribute to pelvic organ prolapse risk. I’ve had many young women in their 30′s with prolapse who’ve never been pregnant, or found themselves suffering a dropped bladder after an easy and quick delivery of their first normal (or even low) weight baby. Even cesarean section is no guarantee against pelvic organ prolapse, with 5% of women in one recent study suffering severe, palpable and visible prolapse even though they delivered by cesarean section before going into labor. The role of Kegel fitness and Kegel exercise in the prevention of treatment of pelvic organ prolapse is just recently getting the research attention it deserves, and Kegel exercise may well play a role in prevention and treatment of prolapse. But for certain, if you suffer prolapse that looks like the image below, no amount of pelvic floor Kegel exercise, or any other kind of exercise, will pull your parts back into place.

Prolapse surgery often comes with a recommendation for hysterectomy, but the latest trends highlight new techniques that fix the prolapse just as well without removing the uterus. When the uterus prolapses it can be resuspended by one of several techniques, and the surgery holds up just as well as when a hysterectomy is included in prolapse repair surgery. This uterine resuspension concept is an exciting new option that allows many women to undergo prolapse repair surgery without removing any organs.

While many women with prolapse believe just one single body part is out of postion, most commonly, prolapse involves hernia-type displacement of several organs. When the bladder drops, formally called a cystocele (siss-toe-seal), it is often accompanied by a rectal bulge, called a rectocele (wreck-toe-seal).  Laxity at the vaginal opening, called a perineocele (pear-in-ee-oh-seal) results when the perineum loses connective tissue bulk as a result of childbirth.  Uterine prolapse is called, well, uterine prolapse. But behind a prolapsed uterus, it is common to find an internal small intestine hernia called an enterocele (en-tare-oh-seal).

When you put all these prolapse possibilities together at their absolute worst, it looks like this:

Courtesy WomensVoicesForChange.org

My role as guest blogger gives me the opportunity to demystify this deeply troubling malady.  For more information, check out this first of 2 posts on pelvic organ prolapse done for my friends at Sweet Talk on The Spot:

Dr R covers Prolapse, Part 1 for Sweet Talk on The Spot

To review Dr R’s book on prolapse, see www.plumbingandrenovations.com

If you have any questions, send in your comments on this post or post your own question to Ask Dr R.

(C) Lauri Romanzi, 2010