Respect and Protect the Pelvic Floor

This month, the FDA issued an advisory warning against the use of mesh implants that are routinely used for transvaginal surgical repairs of women’s pelvic floor damage.

Tens of thousands of women opt for surgery each year to correct prolapses of the uterus and surrounding organs caused by damaged pelvic floors–which, to put it bluntly, can feel “as if something is falling out of your vagina.”

On a recent episode of his TV show, Dr. Oz shared the estimate that “almost half of [women] will experience some form of prolapse in [their] lifetime.” Cigna says the top risk factors are full-term pregnancies (which stretch the pelvic floor), the strain of childbirth and hysterectomies.

Many of these surgeries use mesh implant devices to support damaged pelvic floor tissue. The problem is that the mesh devices are harming women’s sexual and reproductive health.

The FDA advisory came in a response to increasing reports of complications stemming from the devices, 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,” reports the Los Angeles Times. 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 do these complications 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.” Male sex partners are also at risk: “Men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed.”

While the FDA issued an advisory, it stopped short of removing 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 that do not involve the use of synthetic mesh implants.

Adapted from a post at Girl w/ Pen, where the author has an ongoing column called Bedside Manners.

Image from the 1918 edition of Gray’s Anatomy.

Comments

  1. This article tells the basics of what you need to know. And,there’s more.

    First of all, many surgeries intended to help women with prolapse or incontinence do more harm than good. Surgery should be the last resort, and mesh should be avoided. Women would be shocked to learn how little we know about how many women are harmed rather than hurt by these procedures.

    Secondly, mesh is just one of many devices that were never tested in clinical trials before being implanted in women (or men). During the last year, the new FDA leadership has tried to strengthen their standards for medical devices, reversing the anti-regulatory policies of the Bush Admin. But the new FDA leadership has been thwarted by device makers who have been lobbying Congress on a daily basis to get them to complain to the FDA about “changing standards midstream” and “stifling innovation.” They are supporting the status quo, which is obviously harming patients. The Senators and Congressmen/women who have been complaining to the FDA about being too burdensome include some of the most liberal Democrats as well as the most conservative Republicans — and include women who are usually good on women’s issues, but not on this.

    I think women deserve better. If you do, I hope you’ll comment on Adina Nack’s excellent article and circulate it to your friends and also contact our nonprofit at info@center4research.org

  2. Thank you, Dr. Zuckerman, and I hope readers will let their Senators and Congressmen/women know how they feel about polices which weaken the FDA’s ability to protect patients.

  3. I am a mesh victim, we are called Meshies. We suffer daily from the erosion, infection and the chemical that seeps from this faulty device. We call it the monster. It takes away our womanhood and our dignity. This device does more then make a boo boo on a man’s penis. It destroys our vaginas, our sex drive and our ability to live a normal life. Please!! if your doc suggests a tvt RUN! I am now crippled like other woman all do to a simple procedure. I would have rather peed myself then live like I do now!

  4. Belle of Acadie says:

    Thank you so much for informing us on this issue. The mesh victims should be compensated for what they must suffer.

Speak Your Mind

*