FDA Marks Transvaginal Mesh Devices as "High Risk"
One of the first real headlines of the 2016 legal landscape involved the FDA's announcement that mesh products that were designed and marketed for transvaginal treatment of pelvic organ prolapse (POP) are now being classified as "High Risk Devices."
The announcement comes as a response to increasing cries from women injured by the transvaginal placed polypropylene mesh device. In addition to the new classification, the FDA will now require the manufacturers of these medical devices to undertake its rigorous Premarket Approval (PMA) process. As a part of this process, manufacturers will have to prove their products are both safe and effective for use in the public.
Women who have already had their lives drastically altered after receiving a mesh device as a part of a POP repair procedure, the announcement should provide encouragement. Their voices and concerns are being heard and hopefully the progress made will prevent others from suffering similar setbacks or pains in the future.
To many, the complaints and demands to address the problems with the transvaginal mesh have become frustrating. Their cries have been ignored far too long and tens of thousands of families have been affected by the defective device despite knowledge of its risks.
The new classification also supports personal injury cases against the manufacturers of the mesh device. Also, the new classification shows that manufacturers aren't willing to make any necessary changes to their products unless compelled by the actions of the FDA.
If you or someone you know has suffered injuries from a POP repair procedure involving a transvaginal mesh, please contact our offices today. Your case evaluation and consultation is free. Our experienced team has been following the transvaginal mesh liability suits from the very beginning and are confident that we can help you receive the compensate you deserve.