Elk Grove Chiropractor Dr. Doug Ferguson DC 95758, Rhino Chiropractic

Update On The Transvaginal Mesh Mess

        Since the announcement of the Food and Drug Administration in 2011 regarding the use of transvaginal mesh, so much developments have been observed. One of these developments was the action of the FDA aimed  at policy changes on their post market surveillance of new products. Within the year, a verdict awarding the plaintiffs over $ 5 million in damages was arrived in California which signified a major development in the transvaginal mesh controversy.  

            The FDA issued a warning on July 13, 2011 about the complications arising from the use of transvaginal mesh devices for the treatment of SUI and POP. According to the FDA, there was no evidence that vaginal meshes were more effective that the traditional methods of treatment. The issue on its safety and effectiveness was also raised by the agency and a panel made up of experts in this field.

            Even before the issuance of the warning, complaints of adverse impacts were already received by the FDA as early as 2005 and this has since doubled. Major complications noted in these complaints were mesh erosion and mesh shrinkage, which resulted to numerous problems such as severe infections, chronic vaginal bleeding, extreme pains in the affected area, pain during sexual contact and a host of other side effects.  

            Steps taken by Boston Scientific, Ethicon, and C.R. Bard in recalling certain products from the market is one development worth noting. As relayed in its letter to the court, Ethicon was recalling four of their products and making appropriate changes in the products usage and marketing activities. After being asked by the FDA for clinical trials to prove its safety and effectiveness, C.R. Bard decided to pull out its products.

            Perhaps the most welcome development to the thousands of women is the promising progress in the legal front. The positive result of the case filed by Christine Scott in California has provided much encouragement to the other women suffering from complications allegedly due to these vaginal mesh devices. For the injuries Scott suffered, C.R. Bard was held responsible by the  jury based on their verdict and cited also for the negligence in the handling of the devices.

Many people believe that compensatory damage awards may set precedence for the forthcoming cases and more significantly give credence and validity to women’s claims of the injuries caused by these mesh devices. Critical implications may be expected on the case scheduled to be heard on February 2013 as a result of the decision. The announcement by the U.S. District Court of West Virginia only a week ago that transvaginal mesh lawsuits against another three manufacturers will start on December next year may as well be good news to the many affected parties.

 

References:

http://www.bloomberg.com/news/2012-07-24/bard-must-pay-5-5-million-over-vaginal-mesh-implants.html

medscape.com/viewarticle/705592_13

**fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm

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