Public Citizen, a leading consumer watchdog group, petitioned the U.S. Food and Drug Administration (FDA) regarding the safety of vaginal mesh. Vaginal mesh is a synthetic mesh used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) but has been linked to several serious complications.
In response, the FDA heard testimony from industry experts, including Dr. Michael Carome, Deputy Director of Public Citizen Health Research Group about the dangers of this device.
Some of the complications include, but are not limited to, bleeding, infection, painful sexual intercourse, painful urination, mesh shrinkage, and recurrence of prolapse or SUI. One of the most commonly and consistently reported complications is mesh erosion where the device erodes into surrounding organs and can break through the skin.
Public Citizen's petition called for the FDA to; (1) ban marketing of all currently available surgical mesh products labeled to treat POP and SUI, (2) order a recall of these products, and (3) reclassify the device from a class II to a class III medical device- the most stringent classification the FDA enforces. Under the current classification system, a medical device can get approval if manufacturers can prove that the device is substantially similar to others like it..
"Surgical mesh in POP treatment procedures needlessly exposes patients to a wide array of serious risks, many of which can permanently alter women's quality of life," said Carome.
Despite a deficiency of data that supports the safety of these devices, they have been heavily promoted by industry and paid physician consultants. Thousands of women have been harmed, some even permanently, as a result.
Even though Public Citizen called for a ban on the device, the FDA decided that there was not enough scientific evidence to warrant a vaginal mesh recall. However, the agency did decide that it was necessary to reclassify the device as a class III medical device. Under this new classification, manufacturers will be required to perform pre-market testing.
Vaginal mesh is commonly used to treat POP or SUI. POP is a common condition in women who have undergone childbirth or have had a hysterectomy. In this condition, the pelvic floor's muscles and ligaments become so stretched and weakened that the pelvic organs slip out of place and descend- or bulge- into the vagina.
SUI can be described as an involuntary loss of urine during physical activity such as sneezing, coughing, laughing, or exercises.
Both of these conditions can be treated with vaginal mesh. However, due to potential complications, patients should consult their physicians regarding alternative treatments.
Author Resource:-
There are many dangers that have been associated with trans vaginal surgical mesh, so it is important that patients contact LegalView for a FREE consultation with a Medical Device Attorney.
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