(LegalLaw247.com, February 06, 2012 ) Pittsburgh, PA -- Responding to patient advocates' concern over the safety and effectiveness of vaginal mesh, United States regulators are requesting that Johnson & Johnson, C.R. Bard, Inc., and 31 other vaginal mesh manufacturers provide data on the safety and effectiveness of its products.
This comes to light after nearly 650 lawsuits have been filed by women across the country claiming that vaginal mesh has harmed them. Additionally, there has been heightened scrutiny about the process that the U.S. Food and Drug Administration (FDA) used to clear the device for patient use without prior research or testing.
The FDA wrote a letter to these manufacturers requesting an additional three years of clinical trials to test the safety and effectiveness of the device. A report issued by the agency in July 2011 found a fivefold jump in injuries, malfunctions, and even deaths associated with the device.
The letters ask manufacturers to collect data and results about potential complications of transvaginal mesh. In July, the FDA said that it did not have enough data to warrant an official recall of the device.
In 2010, almost 300,000 synthetic meshes were implanted in women to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI), the agency estimates.
Amy Allina, a policy director at the National Women's Health Network in Washington, said that these letters will only affect products already on the market, but she would like the action to be just a first step toward requiring studies to be done before products reach patients.
The FDA first began warning about vaginal mesh in 2008 when it asked physicians, surgeons and other health care professionals to warn patients of any complications the agency deemed were serious, but rare. The agency also asked surgeons to receive specialized training on how to properly implant the device.
Vaginal mesh products were approved by the FDA's 501(k) system, where devices may be approved for patient use if manufacturers can show that their device is similar to those already on the market, which means newly manufactured products will not require testing or trials prior to approval. However, once a device is developed and is approved through other means by the FDA, all other devices that follow can be approved without human testing even if the original device is faulty and causes complications in patients.
This is what happened with the vaginal mesh devices that Johnson & Johnson, C.R. Bard, Inc., and other manufacturers made. These devices were approved through the 501(k) system even after the original device was shown to hurt women.
If you or someone you love has been adversely affected by a vaginal mesh implant, contact http://www.legalview.com/ to receive a free legal consultation from one of our experienced personal injury lawyers.
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LegalView
Danielle Franklin
9702168847
press-releases@legalview.com
Source: EmailWire.Com
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