Serious Health Issues Associated With Bard Avaulta Transvaginal Mesh/Sling Products
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For many women, there is nothing more gratifying and joyous than being pregnant and having a child. However, there are some health problems that may occur later in life as a result of child birth. Pelvic organ prolapse is one such problem and it occurs when the pelvic muscles become weak or damaged either because of injury or due to old age and the muscles cannot adequately support the pelvic organs any longer. It is estimated that half of women who have children will suffer from some form of prolapse at some point in their lives and that while the condition itself is not serious or life-threatening, it can still cause a great deal of distress to the patient and ought to be treated.
One such treatment method is a surgical procedure in which a device known as a transvaginal mesh is inserted to help treat the problem; sometimes the device is referred to as a sling. The procedure is still fairly novel and new materials are frequently used by companies trying to develop new designs for the product. Slings and meshes have been promoted as an excellent treatment option for women suffering from some degree of prolapse. One company that makes transvaginal meshes is Bard Avaulta. Their product has been used to treat incontinence and other problems associated with a prolapse. However, there have been problems and now the company and its products have had warnings and recalls issued against them.
The problems affecting the meshes and prompting the recalls and warnings include pain, infection, urinary trouble, recurrence of prolapse, incontinence and vaginal erosion. There have also been some problems reported in the actual process of inserting the mesh in the patient, though these are not generally thought to be a result of a defect in the product itself. In October of 2008, the FDA made a public warning to consumers warning them about the complications that had been reported in conjunction with the insertion and use of the mesh sling. In the FDA public warning, the FDA reported that there had been over one thousand reports of problems which were reported in transvaginal meshes made by nine different manufacturers. The result of the public warning was to alert women who thought that their problems were unique to the problems other women were also having and resulted in calls by consumers for a recall of Bard Avaulta’s product.
This was an important development in the transvaginal mesh problem because many women had been experiencing problems but due to the sensitive nature of their health problems and because of their assumption that it was either an extension of their original health issue or a unique problem to them, these patients were underreporting their problems with the product. The result of the FDA warning and calls by the public for a recall is that there is a rather strong case to be made that the Bard Avaulta product is defective. A defective product which remains on the market and/or which injures a consumer may allow a patient who was injured to recover in a suit or may even result in a class action suit against the manufacturer. As of today, there are still no recalls which have been issued for Bard Avaulta transvaginal meshes or slings nor have any been issued to any of the other eight manufacturers.
For consumers who have been injured, it is important to remember that you are not just an injured consumer, but a victim. If you have been injured, do not be afraid to contact an attorney or an advocacy group, such as Truth in Medicine, to find resources that may be able to help you. To avoid potential injury or to minimize injuries, should they appear, it is important for women to be involved in their own treatment, to engage their physicians in a dialogue and not to suffer in silence. Always remain aware of new findings, studies and reports about meshes and slings but also do not be afraid to question and speak with your physician about these resources as not all reports are complete and accurate. As a consumer of health care products, you should not be subjected to defective or dangerous products; remain vigilant of your own health and any changes you experience after any procedure; your health and well-being are the most important things you have.