(EMAILWIRE.COM, October 24, 2011 ) LegalView, a leading online legal resource, has updated its vaginal mesh portal regarding recent expert testimonies on the safety of the surgical mesh. In September 2011, the United States Food and Drug Administration (FDA) heard testimony from Dr. Michael Carome, Deputy Director of Public Citizen Health Research Group and others regarding the dangers of transvaginal mesh.
Public Citizen, a consumer advocacy watchdog organization, petitioned the FDA in August to ban the medical device due to the rising number of complaints and potential complications.
Transvaginal mesh, or vaginal mesh, is a synthetic device used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). However, the device has been linked to several, serious complications including, but not limited to- severe pain, painful urination, painful sexual intercourse, scarring, bleeding, infection, and worst of all- mesh erosion where the device erodes into surrounding organs and break through the skin.
A POP may occur when the muscles and ligaments that support the pelvic organs become so stretched and weakened that the pelvic organs descend- or bulge into the vagina as result of childbirth, surgery or obesity. A vaginal mesh may be surgically implanted to support these organs and keep them in place.
SUI is an involuntary loss of urine during physical activity like laughing, coughing, sneezing, or exercises. Vaginal mesh has also been used to treat this condition.
Public Citizen petitioned FDA to do the following:
1. Ban marketing of surgical mesh products currently available labeled specifically to treat POP or SUI
2. Recall vaginal mesh products
3. Classify vaginal mesh as a class III device - the most stringent classification by the FDA.
In his testimony, Carome said that vaginal mesh in a POP procedure needlessly expose a patient to a wide array of serious risks, many of which can permanently alter a woman's quality of life.
As a result of hearing testimonies from Carome and other experts, the FDA decided that it was necessary to create stricter pre-market controls over the device. Under these new rules, manufacturers will be required to perform pre-market testing.
However, the FDA did not call for a recall of the device because the agency said there is not enough scientific data to back-up a recall. The agency said that it would like to see more randomized, controlled or cohort studies that cover a three-year period.
Since 2008, the FDA has warned health care professionals about the dangers of this device, but they have been heavily promoted by industry and paid physician consultants. Thousands of women have been harmed as a result; some have been harmed permanently. As a result, thousands of women have contacted vaginal mesh lawyers to pursue litigation.
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Danielle Franklin
9702168847
press-releases@legalview.com
Source: EmailWire.Com
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