Overview of transvaginal mesh patch recall

The issues surrounding the recall of some of the transvaginal mesh devices in the market has been a very big debate in many quarters in the US in particular. When the masses noticed that the effects of these mesh implants in women is becoming more harmful than beneficial, there was a lot of outcries on the issue. But the masses can only make outcries and protests. This went on in different quarters and drew the attention of the food and drug administration agency in the US. As the agency that is saddled with the responsibility of taking care of the food and drugs that are thrown into the market, and making sure they are of the required standard, they convoked a meeting of medical experts.

After several findings in2008, this same agency came out to issue a warning to the public about the potential danger that is associated with the use of these devices, and the problems that is harbored by the current devices in the market. This triggered a lot of joy among the people who have been suffering the after effects of these meshes, and the next action that many of them took was to seek legal action against all these firms. however, the issue of legal action came when the FDA made it clear that the main problems with the mesh is due to manufacturer’s defects that resulted in the mesh not being finished with the most appropriate materials.

While these issues especially the court cases kept going on, the people started pushing for further action against the manufacturers of these meshes, and the next demands was that all the meshes in the market should be recalled by the agency. This led the agency to once again mandate their advisory panel to set up a committee to look into this. In line with this mandate, the committee set up a 15 person panel to look into the case properly with a view to see if a total recall is the best option to use, or the next action to take.

Now, during the panel meetings, one thing that everybody noticed was that the panel members were met by a completely frustrated set of doctors that are very angry about the effects of the transvaginal mesh implant on their patients. These are people who witnessed these patients on firsthand basis. But, after the whole meetings, the panel instead of recommending a complete recall as all expected, went ahead to consider the reclassification of the procedure and the device as a class 3 device. The result of this is that it is now classified as one of the devices that will require very rigorous premarket testing, before it could ever be distributed generally.

This was followed by an order issued to all the manufacturers of these meshes to make sure they conduct proper safety reviews of all their products before selling them to the public. This is to be done on both the products that are presently in the market and intended new ones.

But this did not go down well with the masses that are agitating for a complete transvaginal mesh patch recall. They went on with their protests and demonstrations, and in January 2012, the FDA issued another set of post market surveillance orders, which was branded 522. This order to all the manufacturers of the transvaginal mesh saw many of the manufacturers gradually withdraw their products from the market.