Defective surgical mesh sparks more questions about FDA’s testing process
Many of us in the legal world have been talking about the recent trend in recalled medical devices. Product liability and personal injury lawyers are especially concerned with the continually failing devices, and are concerned about the government process—one that is too rash and too lax on testing—that gets these devices on to the market.
MSNBC.com features an article on a recent device failure and its current investigation. In “Risky pelvic mesh highlights worries about FDA process,” Rita Rubin investigates a device called surgical mesh, intended to counter receding organs. Rubin specifically writes about Janet Holt, a woman who was affected by the uncomfortable organ slippage. When her bladder slipped out of place, her doctor recommended a surgical mesh device to prop up her insides. Unfortunately, this device only escaladed Ms. Holt’s problems, increasing her pain, and leading to multiple surgeries in order to remove the device, which had slowly eroded into her vagina.
Although there is no evidence that pelvic mesh provides benefit, surgical mesh is not getting pulled off the market, despite the rising adverse events the products are causing: “From 2006 to 2007, the FDA received more than 1000 reports of adverse events related to the mesh in women treated for pelvic organ prolapsed or stress urinary incontinence. From 2008, when the FDA first revealed its safety concerns, to 2010, the agency received nearly 3000 more.”
These failing devices are a part of a series of unfortunate events; multiple medical devices are failing and continuing to fail without FDA action. But, all of these defective products and adverse events could be avoided. Rubin cites a study of 113 recalls from 2005 to 2009 found in the journal Archives of internal Medicine reports, “Of those [113 recalls], only 21 of the devices had been required to be tested on patients before receiving FDA approval.”
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