(LegalLaw247.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.
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