It's being reported that vidence has surfaced that indicates that device manufacturer Johnson
& Johnson did not have Food and Drug Administration approval for the
transvaginal mesh product they were selling for three years.
men have already been wounded by vaginal
mesh devices that have caused serious complications for them. According
to a report by Bloomberg.com, the device manufacturer began selling the
Gynecare Prolift vaginal mesh device in March of 2005, which was 3 years before the device was approved by theFDA. Between the time it
was released on the market until it was approved, the FDA received 123
reports of complications associated with the Gynecare Prolift device.
Vaginal mesh devices are ways of treating stress urinary incontinence
and pelvic organ prolapse, which are both conditions dealing with the
weakening of pelvic organs. Complications associated with the devices,
however, can cause even further problems, including recurrence of the
original problems, urinary tract infections, and mesh erosion. Hundreds
of women—more than 550—have filed lawsuits after suffering from
transvaginal mesh complications. They are hoping to gain compensation
that would help cover medical bills they have incurred due to their side
effects.
The Food and Drug Administration reported a fivefold increase in
complications associated with vaginal mesh devices, including deaths and
malfunctions, in July of 2011. This decision resulted in an advisory
panel for the organization recommending that such devices should be
reclassified as “high risk” devices that are in need of human testing
before it can be determined whether or not they are safe.
FDA process questioned.
Read more here: http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf
