Pelvic Mesh Named as a 'High Risk' Medicine by FDARaymond Billings (Author) Published Date : Jan 05, 2016 23:15 IST
Due to the problems that women face when using mesh surgical implants to repair pelvic organ prolapse, the Food and Drug Administration has decided to classify the pelvic mesh as a high-risk, Class 3 medical device, and that manufacturers will be asked to provide them with the approval applications that assures them that their products are completely safe to use prior to releasing it for commercial purposes on the market.
This action was mostly as a result that of the conditions that the women face even after putting the implants where they needed to be: bleeding, pain and infection which often starts after the reproductive organs or the bladder slip out of place, causing urinary issues, constipation and pain. The thing to note is that the law does not extend to products used in treating other conditions such as a hernia or urinary incontinence.
Another reason why FDA was forced to pass the new rule was due to the widespread use of the pelvic mesh. When a woman opts for a pelvic mesh, a plastic mesh is inserted in her body through surgery in order to strengthen the pelvic walls and support the internal organs in case of a prolapse. It has been reported that nearly 200,000 women undergo such operations every year.
This plan came into existence four years back but was only implemented now when the FDA noticed some patients suffering from the drawbacks of having a poor quality pelvic mesh. What makes this case, even more, serious that women having been going for the option of pelvic mesh instead of the traditional repair surgery which uses stitches since a lot of doctors had been promoting the method due to its merits of speeding recovery in its earlier stages.
But now it seems the all the mesh company manufacturers are in trouble as they face tens of thousands of lawsuits filed against them by the patients suffering from the side effects, which include some of the most popular and known manufacturers such as Johnson & Johnson, Endo International and Boston Scientific. Endo International accepted their faults and complied, stating that they would pay more than 830 million dollars to settle the ~20000 personal injury lawsuits filed against them.
FDA has also mentioned the same risks associated with meshes on their website, and adds: Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options.
Pelvic Mesh Named as a 'High Risk' Medicine by FDA