There are two ways that products can receive FDA (U.S. Food & Drug Administration) approval – a “formal” process referred to as the 501(k), which requires clinical testing and studies, and an “informal” process referred to as the 510(k), which allows products that are similar to those already on the market to be “fast tracked” through the process. Transvaginal mesh (TVM) products were subject only to the latter process. Here’s what it means to the thousands of women who suffered TVM injuries that are now crying foul.
TVM Approval Process
TVM manufacturers, along with the FDA, are being criticized for not conducting more studies and clinical trials before allowing transvaginal mesh products into the marketplace. According to a recent Public Broadcasting Service (PBS) episode of Need to Know, the vaginal mesh implant devices approved to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) by strengthening pelvic muscles and walls may have required further research to establish their safety.
According to PBS, the FDA commissioned an independent panel to determine the efficacy of the “fast track” process used to approve certain drugs and medical devices in 2001. Although the panel reported that the “fast track” process was indeed “flawed,” the FDA chose not to eliminate it.
Transvaginal mesh injury victims say that manufacturers and the FDA handled this matter badly and could have prevented thousands of women from having to undergo surgeries to remove dangerous mesh products. Whether or not that’s true, you cannot sue the FDA.
TVM Manufacturers Are Ultimately Liable
Regardless of how the FDA handled the TVM approval process, manufacturers are ultimately liable for putting unsafe products on the market. Proof of that comes from the recent Johnson & Johnson verdict awarding over $10 million to a South Dakota woman whose Ethicon mesh device become so embedded in her body that it could not be completely removed – even after undergoing 22 surgeries.
If you’ve been injured by a transvaginal mesh device, it’s important to know that you do have options. Contact The Driscoll Firm, LLC, to discuss your situation and determine whether you may be entitled to compensation for medical bills, medical monitoring, lost wages, physical and emotional pain and suffering and more. Consultations are free, confidential and without obligation to do anything further – unless you choose to.