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thuytienlecao replied to the topic Delay in Recall. in the forum Regulatory Basics for Medical Devices 7 years, 6 months ago
I agree that once a product is in widespread use, unforeseen problems can sometimes lead to a recall and sometimes, it takes a while for the issue to surface so that it could lead to a recall. Furthermore, sometimes, when the problem can be more complicated relating to the whole system’s issue, it may take a long time for a correction to take place.
Here is an interesting case about a controversial product recall: “Transvaginal Mesh”. Transvaginal mesh is a product used to support organs and tissue in the pelvic region, such as the uterus or bladder. However, women who received this mesh have suffered from erosion, organ perforation and resulting pain, infection, bleeding, and in some cases permanent damage.There have been a few small recalls, and the U.S. Food and Drug Administration (FDA) has so far not issued recalls, but for the most part, these devices remain on the market. Highly similar surgical meshes have been used by surgeons to repair hernias and other abdominal issues, and so the FDA allowed the use of those meshes for pelvic repairs, including when implanted into the vaginal wall, without first requiring controlled human studies. After a lot of issues/lawsuits came up, The FDA issued one order to reclassify these medical devices from class II to class III. Even though there are at least hundreds of reported complication and many lawsuits, this is an on-going issue and it has been reviewed for years (earlier than 2011). Overall, when it comes to systematic issue and legal loopholes, it may take quite some time to have a public decision/announcement.Reference: http://www.litigationandtrial.com/vaginal-mesh-implant-erosion-recall/
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm