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Consumer Advocates Urge FDA to Recall Transvaginal Mesh Products
Consumer advocates want the FDA to recall transvaginal mesh products because of safety concerns.
November 20, 2011 /Health and Fitness PR News/ -- Consumer advocate group Public Citizen is urging the Food and Drug Administration (FDA) to issue a recall on transvaginal mesh products, which are used in the treatment of pelvic organ prolapse, or POP -- a condition that occurs when pelvic organs, like the bladder and rectum, protrude into a patient's vagina. When treating POP with surgery, transvaginal mesh is used to help keep the organs in place as doctors repair the muscles in that area.
Despite the surgical benefits, transvaginal mesh is associated with serious negative side effects -- such as bleeding, urinary problems and vaginal pain. In fact, the FDA reports that there have been over 3,000 complaints about transvaginal mesh complications made to the agency since 2008. As a result, the FDA issued a warning about the product.
But consumer advocates say that a warning is not enough, and that the side effects of transvaginal mesh products are serious enough to warrant a recall of the devices. In order to make a decision on the issue, and weigh the pros and cons of these devices, the FDA recently listened to debates during an advisory panel -- which included testimony from transvaginal mesh manufacturers, consumer advocates and patients who suffered personal injuries from the use of these products.
During the panel, the pharmaceutical companies that make transvaginal mesh products responded to criticisms by saying they support more testing and reviews of new devices, but since the safety of current transvaginal mesh products has already been established, they should not be subject to a recall.
"For women suffering from pelvic organ prolapse or stress urinary incontinence, surgical intervention and the use of mesh is an important treatment option," Jeff Secunda -- Vice President of Technology and Regulatory Affairs at AdvaMed, a public relations company hired by transvaginal mesh manufacturers -- told MinnPost.com.
The FDA has not made its final recommendation on the issue, but reports say that it may require companies to conduct further studies on transvaginal mesh products.
Article provided by Bohanan & Associates PC
Visit us at www.bohananknight.com
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