Pelvic Organ Prolapse / Stress Urinary Incontinence Repair

If you have been diagnosed with Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI) and treated surgically, transvaginal surgical mesh may have been utilized in your procedure. These mesh products have been associated with severe injuries due to mesh failure, including infections, mesh erosion requiring subsequent revision surgeries, and in some instances, explants of the mesh. The mesh failures can result in life-long and severe chronic pain.

What brought you here

Gynecare (Ethicon) Prolift Anterior, Posterior, and Total Pelvic Floor Repair Systems, Bard Avaulta Pelvic Floor Repair Systems, Boston Scientific Uphold and Pinnacle Pelvic Floor Repair Kits, American Medical Systems (AMS) Apogee, Perigee and Elevate Prolapse Repair Systems and related mesh products. Complications to transvaginal mesh that was used to treat one of two conditions, pelvic organ prolapse (POP) or stress urinary incontinence (SUI), both of which result from weakened muscles in the pelvic area, causing either slippage or leakage.

The alert: FDA Update

You can view the FDA Update in its entirety here

July 13, 2011

On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI.

Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.

The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.

The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.

Summary of Problem and Scope: In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005-2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.

From 2008-2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.

In order to better understand the use of surgical mesh for POP and SUI, the FDA conducted a systematic review of the published scientific literature from 1996-2011 to evaluate its safety and effectiveness. The review showed that transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair. The FDA continues to evaluate the literature for SUI surgeries using surgical mesh and will report about that usage at a later date.

In particular, the literature review revealed that:

Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.

Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.

There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.

While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.

The FDA’s literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.

Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA since the Oct. 20, 2008 FDA Public Health Notification. Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.

Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.

The complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh.

Who brought you here

Pelvic Health Solutions, C.R. Bard, Inc., Boston Scientific, American Medical Systems, and other manufacturers of mesh products.

Symptoms you may have

Mesh erosion, exposure, extrusion, or protrusion (most common complication); pain, infection, bleeding; pain during sexual intercourse; organ perforation; urinary problems. Recurrent prolapse (pelvic slippage), neuromuscular problems, vaginal scarring or shrinkage, emotional problems.

In the news

• Risky pelvic mesh highlights worries about FDA process
• FDA Beefs Up Transvaginal Mesh Warning
• FDA Panel Takes Second Look: Expedited Approval of a Less Invasive Prolapse Treatment May Be Rescinded Following Injury Reports
• ObGyn and Urogynecologic Societies Issue Joint Opinion on Transvaginal Mesh

 

What this means for you

Protect yourself.

1. Order your medical records to confirm that you were treated with transvaginal mesh.

2. See your doctor. Discuss your medical history. Explain your symptoms.

3. Get a diagnosis for treatment of your complications. Order the medical records of that doctor’s visit.

4. Sign up to file a claim against the manufacturer of your mesh implant.