Experts: Vaginal Mesh Is Dangerous, Avoid Use

Experts: Vaginal Mesh Is Dangerous, Avoid Use

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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. These complications have injured thousands of women, some of them permanently..

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.

"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.

They have been heavily promoted by industry and paid physician consultants, despite a deficiency of data that supports the safety of these devices.. Thousands of women have been harmed, some even permanently, as a result.

The FDA decided that there was not enough scientific evidence to warrant a vaginal mesh recall, even though Public Citizen called for a ban on the device.. 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. 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 is an involuntary loss of urine during physical activity such as sneezing, coughing, laughing or exercising..

Vaginal mesh can treat both conditions.. However, due to potential complications, patients should consult their physicians regarding alternative treatments.

About the Author:
To learn more about the dangers of vaginal mesh and to contact a Medical Device Lawyer for FREE, visit LegalView at www.legalview.com/.



Article Originally Published On: http://www.articlesnatch.com


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