By Sarah Mirando  |  March 18, 2013

Category: Medical Devices
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FDA Warns of Complications Linked to Vaginal Mesh

By Christina Drury

transvaginal mesh In 2008, the U.S. Food and Drug Administration issued a warning to the public about possible complications linked to vaginal mesh implants in women who required treatment for stress urinary incontinence and pelvic organ prolapse. Up until the alert was issued, the FDA had received approximately 1,000 adverse event reports from nine different surgical mesh manufacturers. Due to this fact, the agency did not consider these complications to be common. However, over the next two years the FDA received an additional 2,874 reports, prompting the agency to issue another warning — this time stating that complications that occur from vaginal mesh devices were not rare.

Vaginal Mesh Causes Numerous Side Effects

Between 2008 and 2010, the most recurrent side effects reported to the FDA included the following complications:

 

  • Bleeding
  • Infection
  • Mesh Erosion (exposure, extrusion, protrusion)
  • Organ Perforation
  • Pain
  • Pain During Sexual Intercourse
  • Urinary Problems


Other complications that were reported also included vaginal scarring and shrinkage, neuromuscular problems, emotional problems and recurrent prolapse.

What to Do If You Experience Vaginal Mesh Side Effects

If you have had a transvaginal mesh device implanted and you are suffering from any of the above mentioned side effects, you should seek medical attention for a comprehensive evaluation. With the help of a team of specialists, such as gynecologists, colorectal specialists, urologists and physical therapists, you may be able to determine whether the effects that you are experiencing are related to the vaginal mesh implant.

Surgery may be considered depending on the severity of the mesh erosion and the site of the complications. If the erosion has taken place in the urethra or bladder, a corrective surgery will be required. Surgical mesh fuses to the natural tissues in your body and can, therefore, be difficult to remove. Secondary fistulas and perforations occur when the vaginal mesh has eroded and caused damage to surrounding tissues and organs. These types of complications are also difficult to correct and may require more extensive care.

What to Do After You Have Been Evaluated

Once you have been evaluated and it has been determined that the complications and side effects that you are suffering from are caused by a transvaginal mesh implant, you should seek legal help. If you or someone you know is currently dealing with pain caused by a defective mesh implant, you may be entitled to receive compensation.

For more information about how to seek compensation from a mesh manufacturer, please visit our Transvaginal Mesh, Vaginal Sling, Vaginal Mesh and Bladder Sling Class Action Lawsuit Investigation page. Submit your information for a free legal review by a team of compensation and legal specialists who will advise you on your individual circumstances. Compensation will be based on the severity of your injuries, which is to be determined.

 

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Updated March 18th, 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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