In October, we wrote about a dangerous vaginal mesh that has become the focus of personal injury lawsuits and gained the attention of the Food and Drug Administration (FDA). The mesh is commonly used during surgeries to repair pelvic organ prolapse, as well as a condition known as stress urinary incontinence, which manifests as a severe overactive bladder.
Unfortunately, these defective medical devices have caused complications including erosion, bleeding and infection in a significant number of female patients. Between 2008 and 2010, more than 1,500 complaints were submitted to the FDA regarding complications from the mesh.
The FDA brought the issue to the public's attention last July, when it issued a warning letter about the increasing number of complaints and heightened patient safety risks related to the mesh. Recently, the agency took even more decisive action.
Dozens of transvaginal surgical mesh manufacturers recently received letters from the FDA requesting that they each conduct three-year studies of the mesh's side effects and impact on patient quality of life. The FDA additionally requested that each study include several hundred female participants.
The FDA is also considering a move to reclassify the mesh as higher risk than it is currently classified. If this occurs, manufacturers would be required to conduct human clinical trials as a pre-condition for FDA approval.
These regulatory actions are a step in the right direction, but they are of little comfort to the thousands of women who have already been significantly injured by these dangerous medical devices, which should have been more tightly regulated from the beginning.
For this reason, large groups of women are beginning to sue transvaginal mesh manufacturers in order to hold them accountable for their negligence.
Source: Reuters, "FDA wants new studies on surgical mesh implants," Anna Yukhananov, Jan. 5, 2012
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