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FDA Warns Against Common Treatment for Pelvic Organ Prolapse

(EMAILWIRE.COM, August 30, 2011 ) PHILADELPHIA, PA -- According to recent research studies, as much as 50 percent of women may experience a pelvic organ prolapse, but only a small percentage will need surgical treatment. A pelvic organ prolapse, or POP, is a common condition that occurs among women whose pelvic muscles have become weakened due to childbirth or a hysterectomy.

The condition occurs when the muscles and ligaments that hold the pelvic organs in place become weakened or stretched, causing the bladder, uterus, rectum, small bowel, or vagina slip out of place. Normally, these muscles and ligaments act as a hammock and hold these pelvic organs in place.

In 2002 the U.S. Food and Drug Administration approved a surgical implant called a vaginal mesh to treat POP and incontinence. Synthetic mesh has been used for decades to treat other conditions like hernias and to treat urinary stress incontinence.

There are four different types of mesh used to treat POP. They are: non-absorbable polyester or polypropylene, absorbable synthetics, animal tissues, and combinations of the above. Most gynecological surgeons use polyester or polypropylene types of mesh.

While the device has been approved by the FDA, the FDA has received more than 1,000 manufacturer complaints about the device. Several manufacturers knew that the device was potentially dangerous, but sold and manufactured transvaginal mesh anyway.

Manufacturers of medical devices are required to report any adverse outcomes linked with their devices.

According to a recent FDA report, the most common complication associated with vaginal mesh is known as vaginal mesh erosion where the device protrudes from the skin. Other complications associated with the device include: pain, discomfort, bleeding from the mesh site, infections at the mesh site, pain during intercourse, urinary tract problems and damage to nearby organs.

Some women may not experience any signs of complications for several years because many women and their doctors do not connect a new gynecological problem with a past surgery.

According to the latest analysis of almost 12,000 women, about 10 percent of women experienced mesh erosion within a year after surgery. The average time that erosion of mesh occurs for abdominal implantation is about 15 months and with a vaginal incision, it took about 4 months to be a problem.

If a woman develops pain, infection, or vaginal mesh erosion, the usual course of treatment is to remove the mesh via a vaginal incision. It took an average of two vaginal mesh repair surgeries to remove the implant and to repair any damaged tissue.

Since many manufacturers knew about the dangerous effects of mesh, many women have sought legal counsel from vaginal mesh lawyers. Contact LegalView, a leading online legal resource to receive a free case evaluations if you or someone you know has suffered complications associated with a prolapse surgery.


About LegalView:
LegalView is a public service brought to you by Legal WebTV Network, LLC, a Limited Liability Corporation created by a group of the nation's most highly respected law firms: Anapol Schwartz; Cohen, Placitella and Roth; James F. Humphreys and Associates; and Lopez McHugh. For more information on the accomplishments and track records of LegalView's superior sponsoring law firms and to get in touch with LegalView attorneys, visit LegalView at www.Legalview.com.



LegalView
Danielle Marie Franklin
9702168847
press-releases@legalview.com

Source: EmailWire.com


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