Scope of the Problem
Over half of women will develop incontinence of urine, gas, or other symptoms of pelvic organ prolapse (POP) during their lifetime.
Pelvic organ prolapse is a general term used to describe the “falling” of the vagina, bladder, rectum, and uterus (ACOG patient education pamphlet on POP: complete definitions and illustrations).
POP symptoms often arise at a young age, (20′s or 30′s), may remit, only to occur in mid-life in more dramatic forms. The age at which most women present for treatment of incontinence is the early to mid-fifties. Most women report experiencing symptoms for years or decades before seeking treatment.
The Numbers
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400,000 = number of incontinence surgeries per year in the United States
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$26.9 billion (2005 dollars) = annual societal costs of incontinence (includes costs for treating, e.g. surgery, and managing, e.g. pads).
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11.1% = a woman’s lifetime risk of undergoing incontinence surgery
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29% = the re-operation rate for women with prior incontinence surgery (i.e. nearly 1/3 of incontinence surgeries fail to the extent women seek re-operation); some studies report as high as an 80% failure rate at three years of follow-up
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$751/year = annual cost (in 2006 dollars) for absorbant pads, laundry, related expenses
Is surgery a sustainable solution or is there a better way?
The short answer to this question is there’s not enough evidence to have a definitive answer. But here are some clues:
Nearly 1/3 of women who undergo incontinence surgery require re-operation for the problem
This is no surprise, as the traditional method of performing surgery or incontinence involves taking the patient’s tissue and “weaving” it together using various surgery techniques to plicate (reinforce) the areas of weakness.
Prolapse (falling) of the uterus, bladder, vagina, and rectum is frequently the result of a combination of factors, many of which are modifiable* by patients:
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years of trauma (from pregnancy/birth),
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prior pelvic surgery (e.g. hysterectomy)*,
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aging of the vaginal tissues, loss of estrogen to the tissues, weakening of the vaginal support structures
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weight gain (overweight/obesity quadruples the risk for incontinence)*
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smoking*
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chronic lung disease*
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failure to adequately exercise the pelvic support muscles*
Mesh has not solved the problem of weak tissue; and has created its own problems
The high failure rate of prolapse surgeries has been attributed to the use of the patient’s already damaged (i.e. prolapsed, stretched, weakened, thinned, denervated) tissue in an attempt to restore youthful anatomy.
The use of synthetic mesh, similar to abdominal hernia repairs, was thought to be a work-around to the poor tissue problem. The concept was simple: use the same principle applied to abdominal hernia repairs to vaginal prolapse. Logical–right?
The hitch is the vagina is a completely different environment than the abdominal wall. The vaginal skin is thin, is not buffered by fat tissue, is more fragile than external skin, and has to contend with more trauma and different bacteria than external skin (e.g. with intercourse). As with real estate, the problem with mesh is location, location, location. The vagina copes with repeated “traumatization” of sexual intercourse, and it does not have the same type of skeletal muscle just beneath the skin, as does the abdominal wall.
In October 2008 the FDA issued a “Public Health Notification” on “Serious Complications Associated with Transvaginal Placemen of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence.”
What I find most disappointing about the FDA’s report is Duh! Why weren’t the long-term effects of mesh studied before the devices were unleashed on the unsuspecting public?–doctors and patients. (As usual Big $$$$$ from medical device companies and Big Pharma contributed to that blunder–yet again American women are the subjects for uncontrolled experiments for the drug companies–I’ll save this rant for another post, though.)
The Infuriating Lack of Data
Urinary incontinence and pelvic organ prolapse have received serious study since the 1950′s. So why don’t we have better answers?
A majority of the studies are plagued by lack of clear definitions, small numbers of women in the study, inadequate randomization, inadequate ways to measure outcome, and a host of other issues integral to “sub-optimal” scientific research. One of the BIG QUESTIONS to which I could not find and answer is: Why is there no randomized clinical trial comparing long- term outcomes for incontinence of pelvic floor exercises with and without the use of pessary versus surgery for incontinence?
We don’t even have a basic answer to the simple question: how does conservative therapy (i.e. Kegels + Pessary) compare to surgery?
A “Clinical Practice Guideline” published for Ob-Gyns by the Society of Gynecologic Surgeons reported in November 2008 on the strength of evidence for use of various treatments for POP:
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Native tissue repair versus synthetic graft: WEAK
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Non-absorbable surgical mesh may improve outcomes but is associated with increased risk: WEAK
and the real kicker:
There are no comparative studies to guide any recommendation on the use of non-absorbable synthetic graft in multiple compartment repair when compared with native tissue repair.
What a difference 7 years make:
- 2001: The year the FDA approved the use of synthetic mesh in repair of vaginal prolapse
- 2008: The year a comprehensive clinical practice guideline was published for Ob-Gyn’s on the use of mesh in vaginal repairs.
Does something seem backward to you?
Check out these other posts on incontinence:
- Reduce Urine Leakage by 50% with an 8% Weight Loss
- The Genital Hiatus: What is it and Why Should You Care?
Get these upcoming posts: (you can subscribe to this blog for free–see home page)
- Conservative management of incontinence: more promising than you think
- How to do Kegel’s (pelvic floor muscle training) to achieve maximal effect in six weeks
Weigh in with your opinion:
- Have you had surgery for incontinence or prolapse?
- If so what convinced you to have the surgery (i.e. doctor’s recommendation, research on the internet, scientific studies, etc.)
- Were you satisfied with the surgery? Why or why not?
{ 5 comments… read them below or add one }
Open any peer reviewed journal written for gynecologists and urologists and it won’t take long to uncover one of the largest controversies concerning women’s health. Synthetic mesh kits for the treatment of urinary incontinence and pelvic organ prolapse has rapidly become a routine procedure in surgical centers and hospitals throughout the United States. The mesh kits are associated with serious complications such as erosion and chronic pain syndromes, reported by some at rates of 53% and 30% respectively1. It is these and other major complications that have fueled a heated debate among pelvic floor specialists, gynecologists and urologists.
The US department of Health and Human Services released a report on Urologic Diseases in 2004. According to the report nearly three-fourths of adult women report the symptom of urinary incontinence. Additionally 1 in 10 women will undergo surgical intervention for urinary incontinence or pelvic organ prolapse2. Device manufacturers have recognized this as a tremendous opportunity for profits, bombarding the market with synthetic mesh products.
Many of these products have been approved through the US Food and Drug Administration’s 510(k) process. In 1996, the ProtGen sling was approved after a 90 day study in rats. After high rates of erosion and complications the sling was withdrawn from the market in 1999. The ObTape by Mentor corporation was approved as “equivalent” to the Tension-Free Vaginal Tape made by Ulmsten. Despite these recalls many comprable devices approved by the FDA as “equivalent” remain on the market without undergoing rigorous studies3.
Although the rates of major complications continue to rise, the media and women devastated by synthetic mesh remain relatively silent. The reticence of women experiencing complications must be understood in context. The experiences of these complications are frequently marginalized by gynecologists and urologists practicing in tertiary care centers and smaller hospitals. Many women are told that such complications are very rare and that they are just incredibly unlucky. Women experiencing chronic pain from synthetic mesh are often told that mesh isn’t causing their pain. These women are frequently referred to general surgeons, physical therapists, orthopedists, psychiatrists and pain clinics. It is unclear if these gynecologists and urologists are oblivious or deliberate in their lack of transparency.
Another reason for the silence of women experiencing chronic pain is the very personal nature of the complications. Women are conditioned by society to not speak of intractable rectal spasms, mesh eroding through the vagina, urethral pain, excruciating intercourse, groin and buttock pain or of urinary retention and incontinence.
A significant amount of women will undergo multiple procedures to remove the mesh. Women of privilege may find surgeons experienced in mesh removal by flying across the country and paying the out-of-network fees. Women of fixed incomes or deteriorating health who are unable to travel for surgery end up in a continuing experiment in the hands of inexperienced surgeons lacking the technical capabilities to remove the mesh effectively.
As many gynecologists and urologists refuse or fail to recognize some mesh complications and patients are referred out, it is unlikely that complications are accurately reported. It is a reasonable assumption that the totality of complications, are grossly underrepresented in the literature. A study in Neurourology and Urodynamics, reports major complications are estimated to occur 20-fold higher than reported12. Others have reported that chronic pain, dyspareunia and erosion commonly occur more than three years postoperatively1. The delay in onset of major complications compromises the accuracy of many studies reporting lower complications as they commonly follow patients for 1 year or less.
Several experts report rising rates of disabling complications necessitating complete removal of synthetic mesh4,5,6. The delay in onset of complications and failure to report is very likely contributing to the high variability of complications among studies. Reports of chronic pain following sling placement range from 0-30%7.
In a blistering editorial published in the International Urogynecology Journal, Lewis Wall, M.D. and Douglas Brown, PhD. assert the American College of Obstetrics and Gynecologists unethically altered the practice bulletins, eliminating the word “experimental” in describing the use of these kits without evidence to support that these kits are safe or effective8. Dr. Lawerence, the presiding Vice President of ACOG attempted to defend the revision to the bulletin citing complaints by fellows of ACOG9. Anne M. Weber, M.D, author of the ACOG practice bulletin vehemently opposed the removal of the term “experimental” to describe synthetic mesh kits for the treatment of urinary incontinence and pelvic organ prolapse. She also acknowledged the lack of evidence to support the indiscriminate use of these kits. In what could be a professionally alienating statement she disclosed the real reason for the change in wording. This reason was also published in the International Urogynecology Journal. She disclosed the explanation she received from an ACOG staff member of the Committee on Practice Bulletins. It was explained to her that the committee recognized the wording would possibly deny payments for some physicians10.
Following the revision to the practice bulletin the US Food and Drug administration released a public health notification in October 2008 about the serious complications. Despite the warning, few women are adequately informed of the unknown long-term safety of these devices or the severe and disabling complications. A systematic review of mesh kits for pelvic organ prolapsed and incontinence between 1950 and 2007 cautions “surgeons should counsel patients that device-related complications that may occur when using these procedures are not rare; most are related to the use of mesh and their management may necessitate surgical intervention under anaesthetic.11”
As synthetic mesh kits continue to ascend, potentially affecting 1 in 10 women, perhaps history will concur with the opinion of women already devastated by complications. The systemic and indiscriminate use of synthetic mesh kits for the treatment of urinary incontinence and pelvic organ prolapse, is among the most egregious social injustices ever perpetrated by a professional medical organization.
References
1) Knight, D., Scott, P., How to treat pelvic organ prolapsed. Australian Doctor. 2010; 23-30 on-line (www.australiandoctor.com) retrieved October, 2010.
2) Nygaard, I., Thom, D., Calhoun, E., Urinary incontinence in women. Urological Diseases in America. The US Department of Health and Human Services, Public Health Service.
3) Wall, L., Brown, D. The perils of commercially driven surgical intervention. American Journal of Obstetrics and Gynecology DOI 10.1016/j.ajog.2009.05.031
4) Baessler, K., Hewson, A., Tunn, R., Schuessler, B., Maher, C. Severe mesh complications following intravaginal slingplasty. Obstetrics and Gynecology. 2005; 106:4:713-716
5) Ordorico, R., Rodriguez, A., Coste-Delvecchio, F., Hoffman, M., & Lockhart, J.
Disabling complications with slings for managing female stress urinary incontinence. British Journal of Urology International. 2008; 102, 333-336
6) Pikaart, D., Miklos, J., Moore, R. Laparoscopic removal of pubovaginal polypropylene
tension-free tape slings. Journal of the Society of Laparoendoscopic Surgeons. 2006; 10:
220-225
7) Rigaud, J., Pothin, P., Labat, J., Riant, T., Guerineau, M., Normand, L., Gleman, P., Robert, R.,Bouchot, O. Functional results after tape removal for chronic pelvic pain following tension-free tape or transobturator tape. Journal of Urology. 2010;184:2:610-615
9) Lawrence, H. Comments on Wall and Brown: Commercial pressures and professional ethics: Troubling revisions to the recent ACOG practice bulletins. International Urogynecology Journal; 2009
10) Weber, A., Response to Wall and Brown:”Commercial pressures and professional ethics: Troubling revisions to the recent ACOG practice bulletins on surgery for pelvic organ prolapsed. International Urogynecology Journal. 2009;20;1523
11) Feiner, B., Jelovesek, J., Maher, C., Efficacy and safety of transvaginal mesh kits in the
treatment of prolapse of the vaginal apex: A systematic review. British Journal of Obstetrics
and Gynecology ;116:15-24
12) Deng, D., Rutman, M., Raz, S., Rodriguez, L. Presentation and management of major complications of midurethral slings: Are Complications Under-reported? Neurourology and Urodynamics 26:46-52 (2007)
13)
I am one of the many women who have had the MiniArc and am experiencing terrible pelvic pain. My GYN/surgeon has never had a patient with problems and is treating for scar tissue. Can you recommend a surgeon who has successfully removed the mesh? I am hesitant for another surgery but cannot live with pain while sitting, driving, etc. I live in the Portland, OR area. Thank you for your input.
I don’t know any specific gyn surgeonsin your area. However, usually the mesh can be removed, especially if it’s a mini-arc. Enough of the mesh should be able to be removed to alleviate the pain. Good luck!
It is unfortunate that a lot of this is true.
Thank you for your input. I will be searching for a skilled surgeon who has experience with removal. Please forward on any names you may find. Shelli