Pelvic Prolapse Repair Without Mesh: FDA Bans Transvaginal Mesh

pelvic prolapse repair without mesh

When the Food and Drug Administration (FDA) stopped the sale of all transvaginal mesh treatments for pelvic organ prolapse in April 2019, it created a frenzy of misinformation. Pelvic organ prolapse repair without mesh is the only way to repair any necessary treatments related to POP. 

Pelvic organ prolapse, or POP, happens when the muscles and ligaments that hold the vagina weaken, slowly dropping your cervix, rectum, uterus, and bladder. Nearly one-third of all women are affected by the illness, commonly occurring as they age or after delivery.

Living with POP may be lonely and humiliating. A sense of vaginal pressure or a bulge coming out of the vagina, difficulty urinating, incontinence, pelvic pain, or pain during sexual intercourse are all symptoms. Many women suffer in silence for years before seeking treatment or pelvic organ prolapse surgery.

Some women who choose transvaginal mesh surgery to solve their condition have consequences such as bleeding, pelvic discomfort, pain during intercourse, and vaginal wall erosion.

The FDA verdict in 2019 ended a surgical treatment that did not always result in safe and favorable results.

Can a prolapse be fixed without mesh?

Once you are diagnosed with prolapse, your doctors may attempt other nonsurgical treatments without surgical mesh surgery. Such options include:

Pelvic floor exercises (Kegel exercises)

Pelvic floor strengthening exercises. Your clinician may send you to a physical therapist who will assess your pelvic organs’ muscle strength and give you specialized exercises to develop these muscles.

Vaginal pessary

A removable silicone device is inserted into your vagina by your physician to support the drooping organ in place. There are several forms of pessaries. Your doctor or nurse may assist you in finding the correct pessary that fits comfortably.

Some women may benefit from lifestyle changes such as losing weight, avoiding hard lifting, and using absorbent items.

Nonsurgical methods are typically the primary line of treatment for POP since any surgical technique might offer risks or create potential complications. If additional conservative therapies fail, your doctor may suggest abdominal pop surgery.

What can I use instead of mesh for pelvic organ prolapse?

Alternative pelvic floor surgery includes:

· Native tissue repair – where the doctor uses your tissue to repair the prolapse

· Pubovaginal sling – a device that prevents urine leakage by encasing the urethra like a synthetic hammock

· Colposuspension – can be open or laparoscopic biological graft repair uses a graft from a human or animal tissue to support the vaginal prolapse

· Bulking agents – these are injected into your urethra to treat stress incontinence.

How do they repair a prolapsed bladder without mesh?

Bladder prolapse surgery is sometimes known as a bladder lift since it requires moving the bladder back into position, where it is subsequently stitched. Many of these procedures may be combined with other prolapse repair procedures to treat all pelvic floor disorders in a single operation.

Although these operations have very high initial success rates, it is not unusual for symptoms to reappear over time when the patient experiences recurrent prolapse, necessitating another pelvic reconstructive surgery.

Anterior Colporrhaphy (Anterior Vaginal Repair)

An anterior vaginal repair is often done while you are under general, regional, or local anesthesia. The anterior vaginal wall tissue is sliced from the bottom (at the vaginal entrance) to the top and removed from the underlying supporting layer.

Dissolvable stitches are then used to reduce scarring and provide additional support in this location. If this is a repeat operation to correct a bladder prolapse or severe prolapse, a synthetic mesh may be implanted to provide additional support for the vaginal wall.

Retropubic Bladder Surgery

This procedure includes pulling the bladder’s neck upwards and connecting it to the tissues or bones of the pelvis using surgical sutures to keep it in place. This kind of surgery is particularly beneficial if you have a prolapse of the bladder and the urethra (urethrocele). The tube moves urine from the bladder to the outside of your body.

It may be done as an open operation or a laparoscopic (keyhole) surgery via an abdominal incision below the belly button. Because the entrance incision is smaller in laparoscopic (keyhole) procedures, recovery is generally quicker.

This procedure is also used to treat stress urinary incontinence.

Surgery Using a Sling: To keep the bladder in place, a piece of cloth, either medical grade or part of your pelvic tissue, is stitched around the bladder like a sling or a hammock.

What is the controversy with pelvic mesh?

Most short-term clinical studies have indicated good effectiveness and low problem rates for the most commonly used mesh implants (TVT) for incontinence. However, there is accumulating evidence that efficacy and complication rates are greater for pelvic organ prolapse (POP).

There is also no solid data on the long-term effectiveness of the treatments and their use by the general public. However, there are signs that complication rates may be substantially greater than those normally reported.

After pelvic mesh implants were used to treat stress urine incontinence and pelvic organ prolapse in a trial of 2,220 women, 59% indicated that the procedure did not permanently resolve their symptoms, and 58% felt pain during intercourse. However, this was not a scientific study but a consumer survey by the Health Issues Centre, an organization that advocates for consumers’ rights.

As the mesh became more extensively used, women began to report difficulties and class lawsuits were filed against manufacturers all across the globe. The US Food and Drug Administration classified surgical mesh devices as a high-risk device 2012.

Why Did FDA Ban Transvaginal Mesh?

Pelvic Prolapse Repair Without Mesh:

The frequency of mesh complications reported to the FDA after transvaginal POP repair with surgical mesh has increased dramatically during the last several years.

Manufacturers of mesh devices who want to keep selling their products in the United States after they were reclassified from class II (moderate risk) to class III (high risk) in 2016 were required to file premarket approval applications (PMA).

If you or anyone you know is suffering from issues due to transvaginal mesh surgery, contact Tom Plouff for a free consultation. 

Surgery for Pelvic Organ Prolapse

If your POP symptoms are severe enough to get in the way of daily life, medical treatment may be needed to treat pelvic organ prolapse. Treatments that don’t involve surgery are often explored initially.

If these treatments don’t help and your symptoms are severe, a surgical procedure might be possible.

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