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Jean Martin
Jean Martin
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Serious Health Issues Associated With Bard Avaulta Transvaginal Mesh/Sling Products

3 comments

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.

3 Comments

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    As you point out, Jean, pelvic organ prolapse is extremely common in women of all ages. However, women are now learning that it is largely a postural and lifestyle disorder and when they return to their natural pelvic organ support system, their symptoms stabilize and often reverse. Prolapse has very little to do with muscles (and kegels) and everything to do with gravity, the breath, the natural shape of the female spine, and the weight of the pelvic organs themselves.

    Western scientific medicine has taught us that we have a “hole” at the bottom of our torso with a “floor” that holds up the pelvic organs. This is an age-old misconception that has huge implications for women.

    The truth is that the pelvic outlet is at the back of the body (just like in quadrupeds) and in normal anatomy the organs are held toward the front of the body – directly behind the lower abdominal wall. Women today spend virtually all their time slumped into upholstered furniture, car seats, etc., which removes the natural spinal curvatures responsible for pelvic organ support. Once women understand the true nature of their anatomy and make appropriate changes, their symptoms stabilize and often reverse.

    All of the current surgeries for prolapse are based on inaccurate anatomical understanding. Each and every one changes the axis, or direction of force, of the vagina. It is this axis that allows the vagina to maintain its closed, airless, supportive configuration.

    This is a profound paradigm shift that women are learning to make. However, once they understand and see results they are overjoyed that prolapse is ultimately and preferentially within their control.

    Christine Kent, Whole Woman Inc.

  2. BJ Pennington says:
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    It is probably too late for all of us who thought that an implant, like the Bard Avaulta Mesh Sling, would be the answer to a prolapsed bladder and a rectocele repair and being normal again. In less than 3 months post-op, I have had emergency surgery to repair two abscesses the largest one a 3.2 cm on the left posterior to drain them and have the ends of the tapes removed with a diagnosis of a sterile abscess. I am going into my 6th week with open wounds still draining and bleeding. Not sure where to go from here, except that this is ridiculous to say a woman has to put up with this kind of pain, healing, danger to my health, and who knows what the futue holds. If I had to do it all over again, I would have just lived with my problem than to ever have gone through this ordeal.

  3. Jean Martin says:
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    BJ,
    Thank you for your comment. It is so sad to hear stories such as yours of women who have suffered greatly after receiving the vaginal mesh slings. Your story is so typical of the women who have had problems with these products – problems that are worse than the conditions that led to the placement of the vaginal sling. Women need to fight back to prevent manufacturers from promoting products that do more harm than good.