Vaginal prolapse surgery with synthetic and non-synthetic graft material -

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.

Vaginal Prolapse Surgery, Vaginal Contour and Female Sexual Function

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.

Cesarean on Demand

More women than ever before are showing up at the hospital in labor and asking for a cesarean section.

According to the National Institutes of Health, the rate of c-section delivery has increased 40% since the mid-90s, a trend reflected in these NIH summary statements:

Between 1996 and 2007, the C-section rate rose by 53 percent, with similar rises seen among all age, racial and ethnic groups, according to the report released Tuesday from the U.S. Centers for Disease Control and Prevention’s National Center for Health Statistics, which used birth certificate data to arrive at this conclusion.

and:

After a slight dip in the late 1990s, C-section rates began marching relentlessly upward again. The pace of the increase has accelerated since 2000, with the overall rate surging from 23 percent to 32 percent in 2007

That translates to about one in four American babies being born via cesarean section.

So why has “cesarean on demand” become so popular?

One frequent reason is today’s mom-to-be believes avoiding a vaginal birth will reduce her risk of incontinence and pelvic organ prolapse down the road.

Pelvic organ prolapse is a condition that occurs when a woman’s bladder, rectum, or uterus shifts from its proper location, and moves into the vaginal canal.

But giving birth via cesarean section is NOT NECESSARILY the 100% protection from protection that some women think it is.

If only we came with zippers

Pelvic Organ Prolapse and Pregnancy

There’s new research on this topic, reflected in a new study published in the International Urogynecology Journal that examined the impact of a woman’s first pregnancy on pelvic support and found that less than one year after giving birth via c-section without labor, 21% of women experienced moderate organ prolapse and 5% of women who had cesarean deliveries experienced severe prolapse.

Since cesarean delivery did not necessarily prevent prolapse, the study’s authors suggest that simply BEING PREGNANT can increase a woman’s likelihood of prolapse, regardless of delivery mode!

This coincides with data showing that 50% of women who have borne children will experience prolapse at some point,  compared with 30% of ALL women, including women who’ve never been pregnant.

It IS important to note that women who gave birth vaginally DID experience higher rates of prolapse, according to the same Urogynecology Journal study.

But are these numbers significant enough to warrant cesarean on demand?

Maternal and neonatal mortality, uterine rupture, placenta previa & obstetric hemorrhage

Maternal mortality rates from cesarean are THREE TIMES higher than in vaginal delivery, according to Obstetrics and Gynecology.

Moreover, Birth magazine reported that babies are more than twice as likely to die when delivered via cesarean.

Knowing this, it makes sense NOT to opt for c-section delivery unless there is a legitimate medical reason for the best health of the mother or the baby.

Once the uterus heals from cesarean, future pregnancies are at risk for uterine scar separation, called uterine rupture, that can be deadly for the baby, and for problems with placenta previa, where the placenta is low and can hemorrhage at any time, further risking the life of the baby. Uterine rupture and obstetric hemorrhage are two good reasons to take cesarean section very seriously.

Thinking about elective cesarean section? Be a smart mother – make a wise choice with your obstetrician.

For a video on this topic, visit HealthGuru.com video on the truth about childbearing and cesarean on demand

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.

Understanding Rectocele, Levatorplasty and Site-specific Rectocele surgery techniques

You may be unacquainted with the term “rectocele,” but for almost 19% of women, the condition is all too familiar!

In a normal female pelvis, the rectum rests behind the vagina.

The two are separated by a thin wall of fibrous tissue called fascia.

When the fascia becomes weakened or damaged, the front of the rectum can bulge into the vagina. This is known as rectocele.

Rectocele - how it looks to the patient

Pregnancies and childbirth, chronic constipation and the natural aging process are the most common causes, but other factors can contribute to weakening of the fascia, too, including: chronic cough or bronchitis, repeated heavy lifting, and being overweight or obese.

Whatever the cause, rectoceles may induce a sensation of rectal pressure or fullness.

Difficulty having bowel movements and a feeling that the rectum has not fully emptied afterward are also common.

Severe rectoceles may even become visible, appearing as a ballooning bulge protruding through the vaginal opening.

For more mild cases of rectocele, a vaginal pessary may effectively treat the problem. Pessaries are removable supportive devices that hold the rectum in place.

More often than not, though, treatment for a severe rectocele requires surgery, performed through a small incision in the back wall of the vagina. .

The most common type of rectocele surgery is a levatorplasty, using sutures to bring the inside edges of the levator ani, or Kegel, muscles closer together, reducing the rectocele bulge back to a normal contour.

This method works because the levator muscles support the entire pelvic floor like a sling, and they’re often pulled apart with rectocele.

Some specialists believe, and some clinical research shows, that levatorplasty rectocele surgery may be more likely to result in pain than other rectocele repair techniques.

Knowing this, some doctors choose to do a newer procedure called site-specific rectocele, which uses sutures to close ONLY the holes in the connective fascia tissue, bypassing the levator muscles completely.

Although LESS likely to cause pain, site-specific rectocele techniques are MORE likely to result in recurrence of the rectocele.

Because each procedure has its good and bad points, it’s important to discuss the best rectocele repair for YOU with your surgeon.

For more information, see this video on Understanding Rectocele, 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.

Prolene Mesh and Pelvic Organ Prolapse

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

KEGEL EXERCISE: THE FACTS

If you have a vagina and you’re old enough to vote, then Kegel Exercise belongs in your feminine fitness daily routine. Before you dive into pelvic fitness, it’s important to know what Kegel muscles actually DO. Kegels—or the levator ani muscles—wrap around a woman’s most important parts: her bladder, vagina, and rectum.

Research shows that toned levator ani muscles can reduce urinary incontinence, prevent problems with vaginal laxity and help a woman achieve a stronger orgasm. Clinicians and researchers in urogynecology also suspect, but have yet to prove, that these muscles help prevent pelvic organ prolapse, a condition in which  a woman’s bladder, rectum, or uterus falls into her vagina.

For women looking to live their best lives, strengthening your Kegel muscles—or pelvic floor fitness—just makes sense!

HOW TO CHECK YOUR KEGEL EXERCISE ACCURACY:

To get started, sit in bed relaxed against pillows, knees up and separated, using a hand mirror to look at your perineum,which is the skin between your anus and vagina.

Pull in using the muscles you use to urinate, as if you’re trying to stop urine midstream.

If you’re Kegeling correctly, you’ll see your perineum retract into your body.

You should feel the pull in your urethra and anus, NOT your butt or abs.

If you have trouble with proper Kegeling, talk to your gynecologist about pelvic floor physical therapy.

Pelvic floor physical therapy involves working with a Kegel coach, using biofeedback, and/or pelvic muscle electrical stimulation, each designed to “train” your pelvic muscles to perform correctly.

Once you’ve got the art of Kegeling down, get in the habit of doing tKegels daily.

Here’s Dr. Romanzi’s “Starter Set for Kegel Beginners”:

For the first set, perform 10 controlled, sustained contractions, holding each for five seconds, relaxing out of each slowly, and contracting into the next one without taking a break in between. Don’t forget to BREATH. If you find yourself holding your  breath, count softly or sing while contracting the levator muscles.

For the second set, perform 30 quick contractions, holding for just one second each.

There’s no need for a break between the two sets. Simply move from one right on to the next.

Do 2-3 of each set per day. Be creative! There are many ways and settings in which one can Kegel – no one will know if you’re Kegeling on the bus or in a meeting or while driving your car (at a stop sign, preferably).

In terms of where you should do your Kegel exercises, there’s only one rule: NEVER do them on the toilet!

Not only is 8 seconds of urination too short to really benefit your muscles, but it’s also distracting to your bladder, which has an important job of its own to do!

Other than that, you can fit in a Kegel routine whenever—and wherever—you prefer!

For more information, check out this  video \”Kegel Exercise: The Facts\”, 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.

DROPPED BLADDER: CYSTOCELE FACTS

Image of the Bladder on X-Ray

At birth, a female’s bladder rests in front of her vagina and just behind the pubic bone. The bladder and vagina are separated by connective tissue called the vesicovaginal fascia. This fascia is anchored to each hip bone by tendons known as the arcus tendineus fascia pelvis.

Vesicovaginal connective tissue is NOT particularly strong. Even in a young woman who has never given birth, the tissue layer is only about as thick as five sheets of paper! When a woman gives birth, the vesicovaginal fascia can weaken and stretch. Other factors that can contribute to the weakening of this and other pelvic supportive tissue include: being overweight or obese, engaging in recurrent heavy lifting, the normal aging process, and repeated coughing or constipation.

Weakened vesicovaginal connective tissue may result in a vaginal hernia that allows the bladder to drop, a condition called cystocele. If the vesicovaginal space wears out in the center, the bladder may bulge into the vagina in what’s called a CENTRAL cystocele. Meanwhile, if the tissue disconnects from the arcus tendineus inside the hip bones on either side, the result is a PARAVAGINAL cystocele.

Cystocele Symptoms

But no matter the type, cystocele can cause unpleasant symptoms, like a vaginal bulge coming out between the labia, or make urinary incontinence worse, or prevent the bladder from emptying fully. Women may also experience chronic pressure in the pelvis or vagina that may be worse when coughing, bearing down, or lifting. Severe cystoceles may even emerge through the vaginal opening, causing a soft bulge that may feel like sitting on an egg.

Cystocele Treatment

While it can be uncomfortable and embarrassing, treatment options DO exist to repair cystocele, or dropped bladder . In mild cases, a removable support device called a pessary can push the bladder back into place. More severe cystoceles may require surgery. Traditionally, bladder lift surgery involved tucking stitches into the remnants of the supportive tissue between the bladder and the vagina during a procedure called anterior colporrhaphy.

This surgery has a recurrence risk as high as 30%, so many surgeons may prefer to insert a graft, which is a thin sheet of body-friendly material, as extra support between the bladder and the vagina. The trade-off for the graft’s sturdier hold is a slightly higher risk of complications including prolonged healing inside of the vagina and slightly longer time on the operating table. The recurrence rate of cystocele repaired with graft material is much lower than traditional colporrhaphy repairs.

Because each procedure has its pros and cons, talk to your doctor about the best repair option for YOU!

For more information on cystocele, visit Cystocele and Pelvic Organ Prolapse information and see this video on Understanding Cystocele, 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.

Worldwide, “cesarean on demand” continues to increase. In the hopes of avoiding pelvic floor damage associated with birthing, some women have bought into the the trend for elective cesarean before onset of labor. Called “cesarean on demand” because patients demand it in the absence of a maternal or fetal indication, it’s the obstetric equivalent of Erica Jong’s “Zipless F**k”; the maternity version of having your cake and eating it too.

Well, guess what? Just BEING PREGNANT is a risk for all the unhappiness that pelvic floor mayhem can bring, including incontinence and its painfully un-sexy cousin, pelvic organ prolapse. One beautifully executed study evaluated vaginal anatomy before and after 1st pregnancy in three groups of mothers; one who had an easy vaginal birth, another who had a difficult vaginal birth with deep vaginal tearing that required lots of stitching, and third who, whatever the reason, had cesarean before going into labor. Understand that there are medically legitimate reasons for a woman to have cesarean without labor, such as toxemia (pregnancy induced high blood pressure), placenta previa (low-lying placenta blocking the cervix – natural labor with this condition results in the baby bleeding to death before it can be born), or breech presentation (at least in the States, due to out of control obstetric malpractice and the fact that breeches born vaginally have a small but real risk of birth injury that can be almost totally avoided with a cesarean, breech = cesarean until further notice), to name a few.

Looking at the pelvic floor support of these women after first birth, they found NO DIFFERENCE in moderate prolapse between the three groups. Severe prolapse was equivalent in the two vaginal birth groups and much higher than in the cesarean without labor group. But… the cesarean without labor group had a 5% incidence of severe prolapse – I’m talking cervix sticking out of the vagina prolapse, bladder bulging down pushing the labia apart when you walk prolapse.  Thinking a cesarean is the answer to your “I want to be a mother but I don’t want any physical changes in my body anywhere, especially in my vagina” dreams? Think again…

Here’s the study summary prepared for the Journal of Sexual Medicine:

Handa VL, Nygaard I, Kenton K, Cundiff GW, Ghetti C, Ye W, Richter HE. Pelvic organ support among women in the first year after childbirth. Int Urogynecol J (2009)1407-1411.

Increased public awareness of changes in pelvic floor anatomy related to pregnancy continues to foster the growing phenomenon of cesarean on demand, requested in the hopes of maintaining pre-pregnancy sexual function and reducing risk of prolapse and incontinence, two conditions known to negatively impact sexual quality of life in the majority of women so-affected. The true impact of pregnancy on pelvic support may be due to pregnancy itself, regardless of delivery mode, as stated by these authors; “cesarean delivery as a potential prevention strategy remains unproven.” This study prospectively evaluated the impact of first pregnancy on pelvic organ support of 256 women with three pregnancy outcomes – vaginal delivery without anal sphincter tear, vaginal delivery with anal sphincter tear, and cesarean delivery without labor. Pelvic support evaluation done at 6-12 month post-delivery showed stage 2 prolapse in 38% of women delivered vaginally with sphincter tear, 29% in those delivered vaginally without sphincter tear, and in 21% of women delivered by no-labor cesarean with no statistically significant differences between groups.  It is remarkable that 1/5 of the cesarean patients showed clinically significant stage 2 prolapse.  When looking further at stage 3 (true bulging past the hymen, clearly visible and palpable through the vaginal opening), there was a significant difference between vaginal birth and cesarean without labor, with 5% of cesarean women showing visible prolapse as opposed to 14-15% in both of the vaginal delivery groups.  Still, this 5% bulging prolapse despite non-labor cesarean raises the possibility that optimal patient counseling for women seeking elective cesarean for sexual function and pelvic organ protection may best include the realistic prediction of “a small but real risk bad prolapse even if you undergo cesarean before going into labor”. Letting women know that cesarean is NOT a 100% guarantee of avoiding pelvic floor consequences of pregnancy, along with the other risks of cesarean: peri-op morbidity, increased risk of placenta accreta, and increased risk of uterine rupture with subsequent pregnancies. This work adds to the data revealing that the impact of pregnancy on the pelvic floor may not be thoroughly negated by cesarean on demand.

Level of Evidence: IA