Okay, I’ll admit it – ever the STD researcher, I was tempted to focus on the recent NYT article, “A Vaccine May Shield Boys Too.”* Instead, I dedicate this month’s column to a recent news item that has not attracted a lot of attention: the FDA issued an advisory warning against the use of mesh implants that are routinely used for surgical repairs of pelvic floor damage. Warning: This post contains medically accurate language which some readers might find disturbing. (It also contains new medical findings that all readers should find disturbing!)
First, it’s important to know what the pelvic floor is and what functions it serves: in addition to this image from 1918’s Gray’s Anatomy, check out a newer medical illustration included in a recent LA Times article. This muscular structure has the demanding job of supporting the uterus, bladder, urethra, the walls of the vaginal canal and rectum. In other words, it’s pretty darn important. Without functional pelvic floor muscles, women can experience urinary incontinence, fecal incontinence, and uncomfortable/painful sexual intercourse. (Not to mention, it’s more than a little disconcerting to have to manually push your prolapsed organs back into place.)
Surgical repairs of this type of damage are often done to correct prolapses of the uterus and surrounding organs which, to put it bluntly, can feel “as if something is falling out of your vagina.” The problem is that the mesh devices used in many of these surgeries may be harming the sexual and reproductive health of many of the tens of thousands of women who have surgery each year for prolapse.
You might be wondering, how many women are at risk for pelvic organ prolapse? Cigna say the top risk factors are full-term pregnancies (which stretch the pelvic floor), the strain of childbirth, and having a hysterectomy (surgical removal of the uterus). On a recent episode of his TV show, Dr. Oz shared the estimate “almost 50% of women will experience some form or prolapse in their lifetime.”
Thousands of women opt for prolapse surgery every year, and many of these surgeries have involved the use of mesh implant devices to support torn/damaged pelvic floor tissue. As noted in a July 14th LA Times article, “The advisory was issued after an increase in reported complications involving the device.” This article also describes complications as including “pain and urinary problems,” as well as, “erosion, when the skin breaks and the device protrudes, and contraction of the mesh that leads to vaginal shrinkage.” Back in 2008, the FDA’s Public Health Notification and Additional Patient Information documents cited 1,000+ reports of these kinds of serious complications but considered them to be rare. Fast forward to 2011 when these serious complications “have jumped fivefold,” no longer rare.
So, how does this impact a woman’s sex life? The FDA notes, “Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse.” And, male partners of these women are also at risk: “men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.”
With the FDA deciding to not remove the mesh implants from the market, did they do enough to protect patients? Some experts say, “No.” Dr. Diana Zuckerman of the National Research Center for Women & Families points out that these mesh implants have been used, “despite no clinical trials, no testing on humans to see if they’re actually safe and effective.” It is time to advocate strongly for research and development of pelvic floor surgical repair techniques which do not involve the use of synthetic mesh implants.
*This article sheds very little new light on a topic I wrote about over a year ago forMs. Magazine and blogged about back in 2009 – Gardasil is not simply the ‘cervical cancer’ vaccine its initial branding advertised; it also offers several potential health benefits for boys and men.