Pelvic Mesh Injury and the FDA
Pelvic mesh complications have been happening for years. The device – a synthetic mesh material implanted permanently in women to help weak muscle tissues – is known to erode or become exposed, harming the pelvic organs and/or causing severe pain.
As a result, many women have been left with life-altering injuries. These injuries cause extreme pain during sex, sitting down, or even walking. Commonly, the mesh requires multiple surgeries to remove and can lead to humiliating incontinence problems. Some women are completely bedridden and can no longer spend time with their families or live an active life of any kind.
So where was the FDA when all of this was going on?
The FDA has had a strange relationship with transvaginal mesh injuries. There are multiple types of mesh from multiple manufacturers, and each has their own risks and history with the administration. Here are a few ways the FDA has been involved (or not):
October 20, 2008: The FDA releases a warning that treating pelvic organ prolapse with transvaginal mesh can lead to rare but serious complications.
July 13, 2011: The FDA releases a safety communication explaining how the complications are in fact NOT rare at all. In addition, the FDA says, using this mesh isn’t necessarily effective in treating pelvic organ prolapse compared to other traditional treatments. If that all weren’t bad enough, the FDA says this mesh might even make worse the very problems it’s meant to treat.
January 2012: The FDA sends letters to 35 manufacturers of pelvic mesh, ordering new safety studies be performed. Companies involved include Johnson & Johnson, Boston Scientific Corp., Covidien plc, CR Bard Inc. and American Medical Systems. Instead of running the studies, some of these companies take their products off the market entirely.
The FDA has certainly helped increase awareness of transvaginal mesh dangers, but it hasn’t always done the right thing. Johnson & Johnson marketed its Prolift mesh product for three years without FDA approval, starting in 2005. The FDA found out about the product in 2007, then cleared the device in 2008 without sanctions against J&J.
Hopefully the FDA will make wise choices for the products moving forward, so no other women are injured. But if you’ve been injured by pelvic mesh, you need to worry about getting compensation for your injuries.
Our Memphis pelvic mesh injury attorneys can help. Contact us today at 901-327-1212 or via our website for a confidential and free conversation about your case.