pelvic organ prolapse Archives

Hysterectomy: Impact on Pelvic Floor and Organ Function

by WS

Published on February 13, 2014

60316 views

My life and health were turned upside down after my unwarranted hysterectomy. I touched on the internal and external anatomy changes in a previous article. I am going to go into more detail here on the effects of hysterectomy on the internal anatomy.

Female Anatomy

The uterus sits in the center of the pelvis held in place by four sets of ligaments. The uterus separates the bladder and the bowel and holds those organs in their rightful positions. Once the ligaments are severed and the uterus removed, the bladder and bowel drop down and, without the uterus to separate them, are now adjacent to each other. The nerves and blood vessels that are severed during hysterectomy may also alter the functions of pelvic organs. This female anatomy video explains the anatomical (and other) effects of hysterectomy.

What Every Woman Wants to Know about Hysterectomy

Pelvic Floor Disorders after Hysterectomy

What do medical studies say about the effects of these anatomical changes on the pelvic floor and organ function?

This 2014 U.S. study concluded that hysterectomy is one risk factor for developing pelvic floor disorders. The others are higher Body Mass Index (BMI) and greater parity. There are a number of studies that came to this same conclusion.

This large 31 year Swedish study concluded that hysterectomy, particularly vaginal hysterectomy, even in women with no vaginal births is associated with pelvic organ prolapse surgery. The number of vaginal births further increases this risk.

According to this large Swedish study, vaginal hysterectomy had a higher risk of surgery for pelvic organ prolapse or stress urinary incontinence than other modes of hysterectomy.

Of course, women who undergo pelvic organ prolapse surgery represent only a subset of those who suffer symptoms of bladder and/or bowel dysfunction.

Bladder Function after Hysterectomy

A number of studies have shown no short-term urinary adverse effects of hysterectomy. However, longer-term follow-up shows an increased risk. This large Swedish study over a 31 year period (1973 to 2003) showed a 2.4-fold risk of urinary stress incontinence surgery in women who had hysterectomies for benign conditions. This Danish study of women aged 40 to 60 years also showed a 2.4-fold risk of stress incontinence in women who had a hysterectomy. A small China study showed a 7.6% rate of pelvic organ prolapse and 67.4% rate of urinary incontinence 6 years post total hysterectomy.

A systematic review of 12 MEDLINE articles that used original data published over a 32 year period (January 1966 to December 1997) “was consistent with increased odds for incontinence in women with hysterectomy….Among women who were 60 years or older, summary odds ratio for urinary incontinence was increased by 60% but odds were not increased for women younger than 60 years.” Another review of this same data consistently found an increased risk of incontinence many years after hysterectomy. However, this study also concluded that “Oral estrogen replacement therapy seems to have little short-term clinical benefit in regard to incontinence and is associated consistently with increased risk of incontinence in women aged 60 years and older in epidemiologic studies.”

The latter statement begs the question “Is the association of oral estrogen and incontinence solely from the oral estrogen or could it be that it’s caused by hysterectomy that prompted the use of estrogen?”

Hysterectomized women of ALL ages were at increased odds for urge (1.9) and bothersome urge (2.6) urinary incontinence (but not stress incontinence) according to this Netherlands study of 1,626 women. This French study of 1,700 women also concluded that hysterectomy increases risk of urge, as well as stress, incontinence regardless of age.

In contrast, this analysis of studies done on urodynamics before and after hysterectomy concluded that “Hysterectomy for benign gynecological conditions does not adversely impact urodynamic outcomes nor does it increase the risk of adverse urinary symptoms and may even improve some urinary function.”

This small study compared incontinence / continence at 1 to 3 years post-hysterectomy and again at 4 to 6 years post-op. Interestingly, some women went from being continent to incontinent while others went from being incontinent to continent.

Why the conflicting results? There are a few things that come into play, the more obvious ones being study design and size as well as the follow-up period. Mostly, the results depend on the reason for the hysterectomy and whether a bladder suspension was done at the same time. Two common reasons for hysterectomy are fibroids and uterine prolapse. Both conditions can cause urinary symptoms such as frequent urination and incontinence. So symptoms may improve after hysterectomy and if the bladder was suspended at the time of hysterectomy (in the case of prolapse), that would also explain improvement.

Bowel Function after Hysterectomy

Some studies show that hysterectomy negatively affects bowel function. While this small and short-term 2004 study (comparing pre-operative to 6 and 12 months post-operative) concluded that vaginal hysterectomy does not increase incontinence or constipation, abdominal hysterectomy may increase risk “for developing mild to moderate anal incontinence postoperatively and this risk is increased by simultaneous bilateral salpingo-oopherectomy.” In contrast, this small 2007 study found that vaginal hysterectomy significantly increased anal incontinence at the three-year point and at one and three years for abdominal hysterectomy. However, there was “no significant rise in constipation symptoms or rectal emptying difficulties in either cohort through the follow-up.”

This contradicts this small case control study that showed significant short-term decreased bowel frequency and increased urinary frequency after hysterectomy. It also contradicts this larger Netherlands retrospective study in which 31% of women reported severe bowel function deterioration and 11% reported moderate bowel changes after hysterectomy. In the control group which consisted of women who underwent laparoscopic cholecystectomy, 9% reported “disturbed bowel function.”

Constipation, straining, lumpier stools, bloating, and feelings of incomplete evacuation were reported by women who had undergone hysterectomy in this small study.

Abdominal hysterectomy is associated with a significant risk of fecal incontinence and rectoanal intussusception according to this small retrospective study.

Post Hysterectomy Fistula

Hysterectomy increases risk of fistula as documented in the below excerpt from this article:

The uterus precludes fistula formation from the sigmoid colon to the urinary bladder.

As well as this excerpt from this article:

The most common types of fistula are colovesical and colovaginal, against which the uterus can act as an important protective factor.

Diverticulitis is a known risk factor for fistula formation. This large study looked at the risk of fistula formation in hysterectomized women with and without diverticulitis using data from women hysterectomized between 1973 and 2003. Women who had a hysterectomy but no diverticulitis had a 4-fold risk of fistula surgery compared to women who did not have a hysterectomy or diverticulitis. Women who had a hysterectomy and diverticulitis had a 25-fold risk of fistula surgery whereas non-hysterectomized women with diverticulitis had a 7-fold risk.

Vaginal Vault Prolapse

The International Continence Society defines vaginal vault prolapse as “descent of the vaginal cuff below a point that is 2 cm less than the total vaginal length above the plane of the hymen.” This Obstetrics and Gynecology International article states that “it is a common complication of vaginal hysterectomy with negative impact on women’s quality of life due to associated urinary, anorectal and sexual dysfunction.” The article cited above explains the mechanism for this common complication in section 2 titled “Anatomic Background.”

Table 3 in section 12 compares vaginal and abdominal corrective surgery outcomes using a 5 year follow-up. Vaginal had significantly higher post-operative incontinence and recurrence rates. The re-operation rate due to recurrence was 33% in the vaginal group versus 16% in the abdominal group.

Surgical mesh is used for many pelvic organ prolapse surgeries. And as shown by the TV ads, surgical mesh has high complication rates. It can cause infection and the mesh can protrude into the vagina leaving sharp edges having obvious negative effects on male partners. And removal of all traces of mesh may be impossible because tissue grows around the mesh.

Women who have not had a hysterectomy and have pelvic organ prolapse may choose to use a pessary instead of undergoing surgery to suspend the uterus (and bladder) or undergo hysterectomy. But a pessary may be difficult to hold in place in women who have had a hysterectomy since the walls of the vagina are no longer supported by the uterus and cervix.

Hysterectomy Consequences

Hysterectomy can have serious consequences on bladder and bowel function and increase risk for future surgeries, but the research is mixed, primarily due to differences in methodology. Pelvic organ prolapse is also a possibility. Important variables that increase or decrease the risk for future problems include the reason for the hysterectomy and pre-operative bladder and bowel function. If endometriosis, fibroid or other conditions compromise or affect bladder and bowel function pre-surgery, then odds are they will be affected post-surgery and whether there is improvement or further damage depends upon a number of factors, including the surgeon’s skill. In contrast, and I think where most women are interested, is whether these problems can arise post-hysterectomy when no such problems existed pre-surgery. The answer is yes, there is an increased risk for both urinary and bowel incontinence post hysterectomy.

Additional Resources

This RadioGraphics article details the pelvic organ sequelae that can be caused by obstetric and gynecologic surgeries and the imaging techniques for diagnosing them.

This Medscape article details the Long-term Effects of Hysterectomy.

Why Few Women Trust the FDA

by Chandler Marrs, PhD

Published on July 2, 2012

4030 views

Critics of Lucine and our e-journal Hormones Matter often suggest that we are biased against the pharmaceutical and medical device industries and that, we should trust the FDA on all matters of women’s health. After all, we wouldn’t want to be considered one of those wacky conspiracy, alternative health blogs or a bunch of mommy bloggers (for reference, I rate moms as some of the best arbiters of BS when it comes to health). Admittedly however, much of the information on the blogosphere is horribly slanted or so devoid of actionable intelligence that it offers no more than pablum – even from the more reputable sources. But I digress.

With those criticisms come claims that begin with the ‘FDA approved…’ a particular treatment or device, or ‘after reviewing the data, the FDA found no merit to’ research suggesting that a certain drug or device was indeed dangerous. I have to admit that it often feels like I am biased. Perhaps I am little less apt to trust this industry or the regulatory oversight than others. I am certainly wary of the magic pills (oral contraceptives, HRT, anti-depressants) that are marketed as cures for all that ails the female population (without supporting data). But then, just when I think it is safe to trust again, reports like this come to light.

J&J Sold Vaginal Mesh Implant After Sales Halt Ordered

Bloomberg News reported last week that Johnson and Johnson (J&J) continued to sale Gynecare Prolift, a vaginal mesh implant, for a full nine months after FDA ordered it to halt sales. Prolift is a surgical mesh device used to treat pelvic organ prolapse, a common condition in women who have had children.

The basis of the complaint was the five-fold increase in death and serious injury associated with this product.

Bloomberg News reports:

J&J began selling the Prolift in 2005 without filing a new application after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA, said Matthew Johnson, a J&J spokesman, in an e-mail. The device maker relied on FDA guidance for when companies must submit new applications, Johnson said.

J&J determined the safety of this product on its own. Called ‘equivalence’ this is a common form of FDA approval requiring the applicant show merely that a device or test is ‘equivalent’ to some older, previously approved device or test. With low risk devices or tests this is a mostly reasonable way to garner approval. In higher risk devices, however, such as those that are surgically implanted, meeting equivalence is hardly sufficient for approval, especially if the older devices are themselves, dangerous or otherwise inadequate.

While the FDA ultimately “…disagreed with J&J’s interpretation and required a new application that prompted questions in the August 2007 letter…” to halt sales, this was 2 years after J&J had already been selling the products to surgeons. By then hundreds of millions of dollars had been made and tens of thousands of mesh products had been implanted in women. J&J ignored the letter and continued to sell Prolift.

What’s worse than J&Js blatant disregard for the human safety is that the FDA ultimately caved and cleared the product in 2008, despite the fivefold increase in death and serious injury. Even a halted clinical trial failed to incite sufficient motivation to remove this product from the market. In 2009, the clinical trial designed to evaluate the safety of Prolift was halted when researchers found that >15% of women experienced erosion. Erosion of the mesh caused “pain, scarring, painful intercourse, bleeding scarring and closing of the vagina eroding into the bladder and bowel. Mesh erosion through the vagina is also called exposure, protrusion or extrusion. Many of these problems required additional medical or surgical treatments and further hospitalizations.” Despite the findings of the clinical trial, the products remained on the market.

As of 2010, J&J had reported sales of $295 million in the US alone. J&J did agree to re-label the device and in 2011 the FDA began considering re-classifying vaginal mesh products from a moderate risk product to a high risk product. I guess we should be grateful (insert snark). In the mean time, women continued to suffer and die. It is only recently, after hundreds of lawsuits, that J&J applied to recall Prolift and other vaginal mesh products. According to a J&J spokesperson:

“We came to this decision after carefully considering numerous factors” including “the commercial viability of these products in competitive and declining worldwide markets, the complexities of the regulatory environments in which we operate, and the availability of other treatment options for women,”

Notice, that it was market factors, not product safety, behind the decision. The report goes on to say that products will be phased out on a region by region basis over the next year. I guess there is no rush to recall these products since J&J admits no health or safety concerns and the FDA approved the product. I sure would hate to be the last region in the recall.

So no, I do not trust the FDA to protect my health. I am afraid many other women, some of whom are mommy bloggers (yes, I am a mom and I blog), scientists and proponents of better health don’t either. Yet, we still must make decisions that affect our health and our family’s health. To all the women responsible for family health decision: verify, then trust.

Resource to Verify Medication Safety

AdverseEvents.com : this is a fantastic site run by a private company that allows individuals to list and view adverse events and side effects for every medication on the market. It is free to the user. If you are an Yaz, Yasmin or Ocella user, I encourage you to look up those medications and compare their side effect profiles to other drugs. This site does not list medical devices. If any of our readers know of a similar site for adverse events associated with devices, please share.