News on U.S. government agencies, U.S. politics, companies doing business with U.S. federal government. Read U.S. national and local news. This site is not affiliated with United States Government.
(EMAILWIRE.COM, February 29, 2012 ) Pittsburgh, PA -- Over the past year, proponents of an accelerated Food and Drug Administration (FDA) medical device approval process have been citing the European's approval process which allows complex medical devices to reach European market an average of two years sooner than they reach the United States market.
Medical device experts argue that the European approval process is luring manufacturers away and is contributing to the United States' high unemployment rate.
However, an Oxford university professor, Carl Heneghan, who studies medical recalls, says it would unwise for the United States FDA to adopt an approval process similar to the one in Europe. Heneghan says that it would actually harm many people.
The recent breast implant recall which involves the removal of thousands of potentially faulty breast implants that were made by the now-defunct French company, Poly Implants Protheses SA. The recall has created heightened scrutiny about the EU's approval process.
The U.S. FDA's medical device approval process has received criticism over the past few months by thousands of women who say they have been hurt by a device called vaginal mesh. This device is categorized as a device that can receive market approval based on similarity to medical devices already on the market even if those devices, or predicates, have been recalled or are in the process of being recalled. The implants have so far spurred over 650 vaginal mesh lawsuits from women alleging that they have been significantly harmed by having these devices implanted transvaginally.
Vaginal mesh is a synthetic mesh that can be implanted through a woman's vagina, or transvaginally, and is used to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI).
POP occurs when the pelvic muscles and ligaments become so weakened that they can no long hold the pelvic organs in place. These organs, most commonly the bladder, slip out of place and descend, or bulge, into the vagina. A vaginal mesh implant can be surgically inserted to hold these organs in place, but it has been associated with several complications including pain, bleeding and infection.
SUI is common in older women but can be found in younger women as well and is an involuntary loss of urine during physical activity like coughing, sneezing, laughing, or exercising.
LegalView, located at http://www.legalview.com/, is a consortium of four of the nation's top personal injury law firms. LegalView offers up-to-date information on vaginal mesh and a variety of other legal issues including mesothelioma and unsafe durgs. Please, visit LegalView.com to receive a free legal consultation from a medical device lawyers.
About LegalView:
LegalView is a public service brought to you by Legal WebTV Network, LLC, a Limited Liability Corporation created by a group of the nation's most highly respected law firms: Anapol Schwartz; Cohen, Placitella and Roth; James F. Humphreys and Associates; and Lopez McHugh. For more information on the accomplishments and track records of LegalView's superior sponsoring law firms and to get in touch with LegalView attorneys, visit LegalView at www.Legalview.com.
We are pleased to offer you this exciting, new, and entirely free professional resource. Visit our Free Industry resource center today to browse our selection of 600+ complimentary Industry magazines, white papers, webinars, podcasts, and more. Get popular titles including:
