Doctors used transvaginal mesh as a permanent solution to Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). When used for SUI, it is also called a midurethral sling, bladder sling, or a mesh sling procedure. Although the surgical procedure to implant the mesh was originally thought of as a low-risk procedure, transvaginal mesh implants can result in serious complications and injuries.
Food and Drug Administration (FDA) Warning
The FDA approves all drugs and medical devices before manufacturers can sell them in the United States. This governmental entity will also issue warnings when it discovers that there are problems with a certain type of drug or medical device.
Hospitals and other medical facilities are required to report deaths and serious injuries related to medical devices to the FDA. The FDA tracks this information and uses it as the basis for its warnings and recalls.
In 2008, the FDA issued a warning that described the complications associated with transvaginal mesh. It reported that it had received over 1,000 reports of complications from nine different manufacturers from 2005 to 2008. It listed the most common complications as:
- Mesh erosion through the vaginal wall
- Urinary problems
- Reoccurrence of prolapse and/or incontinence
- Bowel, bladder, and blood vessel perforation (during insertion)
The warning also explained that the vaginal scaring and mesh erosion occasionally decreased the patient’s quality of life significantly because of continued discomfort and pain. In some instances, sexual intercourse was also reported to be painful.
Increasing Transvaginal Mesh Injuries and Complications
At first, the FDA stated that transvaginal mesh complications and injuries were rare, and doctors simply needed to inform their patients of the risks. Then, in 2011, the FDA issued another warning that stated that these complications were actually not rare, and were occurring at a much higher rate than originally anticipated.
The warning also stated that research indicated the mesh procedure really was not any more effective than other procedures to address POP and SUI. Instead, the procedure exposed women to greater risk. Research has found, however, that injuries that involve POP are much more common than those that involve SUI.
Fixing the Problem
Woman who have suffered from transvaginal mesh complications and injuries are usually required to undergo other medical procedures to correct the problem. These procedures include:
- Additional surgeries (some to remove the mesh completely)
- IV therapy
- Blood transfusions
- Draining hematomas or abscesses
There were six women who testified in front of the U.S. Food and Drug Administration about the mesh. Between the six of them, they had suffered through 45 surgeries to correct problems associated with their transvaginal mesh implants. For most, the pain was unbearable.
Others have had the mesh puncture other organs, including the bladder. That means that they can no longer control their bladder and will periodically leak. Blood and urine leakage is not uncommon in that type of situation.
You Have Legal Rights
If you or a loved one has been affected by transvaginal mesh complications or injuries, then you have legal rights. Repeat medical procedures and doctor visits are expensive, and filing a lawsuit may be able to help with these expenses. Contact The Dixon Injury Firm at 855-552-2337 for more information. We are here to help you get the compensation that you deserve.
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