(LegalLaw247.com, March 01, 2012 ) Philadelphia, PA - Medical devices manufacturers will have to pay almost double what they pay now to U.S. legislators in order to get their products reviewed over the next five years. The FDA, the agency that will collect the fees, has requested $595 million in a join agreement designed to secure faster and more predictable evaluations.
The agreement which replaces one where Johnson & Johnson and other medical device manufacturers have paid $287 million in the last five years and will expire on Sept. 30. The pact will allow the FDA to hire 200 full-time employees by the end of the five-year program. These employees and the additional money will allow the FDA to increase evaluation staff and possible make the medical device approval process more efficient and safer.
The agency had originally asked for $805 million in fees, and the medical device industry countered with $447 million offer, according to minutes from a meeting in December 2011.
The $595 million agreement will cover approximately 35 percent of the agency's review activities. Currently, the user fees only cover about 20 percent, says Kim Riley, a spokeswoman for the FDA.
Vaginal mesh and other medical devices have received a lot of attention lately. Many women have come forward alleging that the device have harmed them physically and emotionally. The device was approved under the United States FDA's 501(k) approval process where medical devices can get market approval if manufacturers can show that their device is substantially similar to others like it on the market, even if the original device has been shown to harm others or has been pulled from market sale.
Vaginal mesh is a synthetic mesh implanted transvaginally to treat POP, or pelvic organ prolapse, and SUI, or stress urinary incontinence. However, the device has been associated with several serious complications including pain, infection, bleeding, painful urination, painful sexual intercourse and mesh shrinkage. According to a report issued by the FDA in July 2011, the most commonly reported complication is that of mesh erosion where the mesh erodes into surrounding tissues. Because the device is designed to grow around human tissue, it is extremely hard to remove and this complication only makes it worse. To learn more about these complications, please visit LegalView's vaginal mesh portal at http://vaginalmesh.legalview.com/.
If you or someone you love has had a vaginal mesh implanted and is experiencing symptoms consistent with malfunction, please seek medical attention immediately. The next step is to contact LegalView at http://www.legalview.com to speak to medical device lawyers for free to see whether you have grounds to file a lawsuit against the manufacturer.
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LegalView
Danielle Franklin
9702168847
press-releases@legalview.com
Source: EmailWire.Com
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