FDA Releases Order to Study Risks of Surgical Mesh

On Wednesday, January 4, the U.S. Food and Drug Administration (FDA) released an order to the makers of transvaginal mesh to step back and study the risks that the mesh poses to female patients. Over the years the FDA has increasingly raised the alarm in regards to the effectiveness and the dangers posed by the surgical mesh. In 2008, it released an initial warning regarding the use of surgical mesh, stating that there are certain dangers (such as vaginal mesh erosion) that are associated with the implementation of the mesh. It was, however, initially noted that such occurrences of these adverse side effects were statistically rare.

In 2011, the FDA again released another warning about the mesh stating that in the span between 2008 and 2011, there had been almost three thousand additional reports linking adverse side effects to the mesh. Problems such as pain and infection, pelvic organ prolapse recurrence and issues with urination were all noted in the initial review and again in the 2011 warning, however, it was also noted that in some cases mesh contraction was also being found in patients – causing vaginal shortening, tightening and pain. It was also mentioned at this time that the mesh had not been proven to be any more effective than traditional methods of repair for pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Now in 2012, the FDA is once again raising the alarm regarding vaginal mesh. The warning is similar to the one the FDA released last year regarding all-metal hips. In the warning, it was stated that the FDA Advisory panel had recommended that the manufacturers of the surgical mesh to study complications that are linked to the usage of the vaginal mesh to help with the treatment of POP and SUI. It was, however, stressed that the warning does not apply to every single usage of the surgical mesh.

If you have suffered adverse side effects from the implantation of defective transvaginal mesh, then you do not deserve to suffer in silence. It is highly encouraged that you get the involvement of a medical injury attorney that you can trust to evaluate your claim and build the strongest case possible. At Arnold & Itkin, LLP we have vast experience in handling cases involving defective medical devices and are prepared to do everything possible to help our clients defend their legal rights. You can be confident knowing that should you choose to work with our firm that we will do everything possible to help you. So what are you waiting for? Contact a defective medical device lawyer from our firm today to discuss the possibility of filing a transvaginal mesh lawsuit.

To learn more about the subject, please visit our site for transvaginal mesh lawsuits.