By Sarah Mirando  |  January 28, 2013

Category: Medical Devices
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AMS Vaginal Sling Causes Mesh Erosion & Vaginal Bleeding

By Christina Drury

 

AMS vaginal mesh implantPrimarily intended to repair pelvic organ prolapse (POP) or urinary incontinence, AMS vaginal mesh implants have resulted in unwarranted side effects such as lower levels of intimacy, mesh erosion, vaginal bleeding and the perforation of organs. The overwhelming pain associated with vaginal mesh erosion has resulted in hundreds of vaginal mesh lawsuits being filed against American Medical Systems (AMS) and other mesh manufacturers. Upon careful review of the aforementioned risks involved with vaginal mesh and bladder sling implants, the FDA is now considering reclassification of the device to a higher risk category.

AMS Vaginal Mesh Side Effects

For Noreen, a 57-year old woman with a longstanding problem of urinary incontinence, the solution to her inconveniences was very straightforward: a tension-free vaginal tape (TVT) implant. After the surgery, she became more intimate with her husband and enjoyed a healthy and active lifestyle — until the appearance of vaginal mesh side effects kicked in.


Three years after receiving her TVT implant, Noreen began to experience a surging pain that increased in intensity with every passing day. The pain eventually crippled her physically, emotionally and financially. After spending six months of her life in utter discomfort, while suing medical practitioners for her situation, Noreen finally got her vaginal mesh removed.

Although it is no longer a part of her system, the vaginal mesh implant has had a lasting impact on her life. Her immune system is in a compromised state and she still experiences vaginal pain, albeit of a lower magnitude. Furthermore, the synthetic mesh that holds up the pelvic organs has also been known to induce severe cases of urinary incontinence and constipation. Additionally, the razor-sharp pain experienced during intercourse has prevented these women from being sexually active altogether.  

FDA Aims to reduce Vaginal Mesh Side Effects

With vaginal mesh side effects common amongst women with the implant, it is no surprise that the FDA is flooded with related complaints. Recent studies have shown that there is no evidence suggesting the added benefits of the implant for POP over the available non-mesh treatments. As such, the FDA has swiftly moved to reclassify the vaginal mesh used in the repair of pelvic organ prolapse (POP) from a class 2 (moderate risk) to a class 3 (high risk) medical device. In line with other class 3 devices, the FDA requires the vaginal mesh to undergo human clinical trials in an effort to gain approval for use in POP repair. The reclassification serves to increase consumer awareness on the potential risks associated with transvaginal mesh implants.

Vaginal Mesh Lawsuit Help

If you had vaginal mesh installed to help with urinary incontinence or POP, among other medical reasons, you might be eligible for compensation for your side effects. To find out more about the ongoing litigation and how to get involved, you can visit our Transvaginal Mesh, Vaginal Sling, Vaginal Mesh and Bladder Sling Class Action Lawsuit Investigation page. Compensation may be available for pain and suffering, medical expenses – both current and ongoing, and loss of consortium.

 

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Updated January 28th, 2013

 

All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.

 

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