What is the FDA’s 510(k) Process?
The Food and Drug Administration (FDA) was founded in 1906, but it wasn’t until 1938 in the wake of the Sulfanilamide Disaster that Congress passed the Federal Food, Drug and…
The Food and Drug Administration (FDA) was founded in 1906, but it wasn’t until 1938 in the wake of the Sulfanilamide Disaster that Congress passed the Federal Food, Drug and…
Of the two pathways available to medical device manufacturers seeking FDA approval for new products, the 510(k) process is the cheaper and significantly faster route. But, how safe is it?…
In spite of the seemingly unending cycle of product safety recalls in the U.S. that affect everything from flour to furniture, American shoppers generally regard the country’s consumer goods as…
As the federal agency charged with ensuring the safety of the nation’s pharmaceuticals, medical devices, food supply and a multitude of other products, the F.D.A., plays a pivotal role in…
The U.S. Food and Drug Administration (FDA) first approved transvaginal mesh for surgical use in 1996 as a minimally invasive treatment option for women suffering from pelvic floor disorders, like…
Kentucky has become the third state to file a civil lawsuit against Johnson & Johnson alleging deceptive marketing of transvaginal surgical mesh used to treat pelvic organ prolapse (POP) and…
For years, doctors have told women with vaginal mesh complications that the pain is in their head. Emerging research confirms the pain is in the pelvis and is a real…
Many women are unaware of the medical condition known as pelvic organ prolapse or POP until it happens to them. Pelvic organ prolapse was called the female version of a…
Of the sixty or so pelvic meshes that were or currently are on the market in the United States you may not have heard of the ProteGen mesh, a model…
This is part one of a multi-part series uncovering common myths related to pelvic mesh. Myth Busters Part Two can be found here while Myth Busters Part Three can be…