FDA See Rise in Vaginal Mesh Complaints
http://www.lawsays.net/articles/8970/1/FDA-See-Rise-in-Vaginal-Mesh-Complaints/Page1.html
Katie Kelley
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Published on 08/21/2011
In a recent report, the U.S. Food and Drug Administration warned against the use of implanting vaginal meshes as the agency has received more than 1,000 manufacturer complaints
While a vaginal mesh may provide some relief for women who have experienced pelvic organ prolapse after surgery or childbirth, the United States Food and Drug Administration cautions that vaginal mesh surgery may do more harm than good.
Pelvic organ prolapse, or POP, occurs when the pelvic organs- most commonly the bladder, but also includes the uterus, vagina, small bowel or rectum- slip out of place and press against the vagina, causing pain and discomfort.
This occurs when the muscles and ligaments holding these organs in place are weakened or stretched. Most often this occurs during childbirth or after surgery like a hysterectomy.
Physicians can use a vaginal mesh to repair those weakened tissues as one form of pelvic organ prolapse treatment. Implants are inserted to reinforce the vaginal wall. Also, the implant is used to support the urethra to prevent urine leakage. According to MedPage Today, a news service for physicians, approximately 100,000 mesh implants were implanted in the U.S. in the year 2010.
However, the FDA strongly discourages the use of vaginal mesh due to the high risk of complications. In a report released in early August, the agency says they have received more than 1,000 manufacturer complaints about the device.
In its report, the FDA says, "Serious complications associated with surgical mesh for transvaginal repair of POP are not rare. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients [...] and it may expose patients to greater risk."
The FDA reported that the most common complaint was "mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems."
According to several mesh manufacturers, approximately 100,000 have been treated for pelvic organ prolapse with vaginal mesh implants, and of those, 75,000 of those were implanted vaginally.
The FDA warned doctors about the potential risks of vaginal mesh after they saw an increase in manufacturer complaints between 2003 and 2007. The agency recommended that physicians receive specialized training on correct implantation techniques and suggested warning patients of potential complications the agency identified as serious but rare.
Unlike drugs that go through a formal clinical trial period, medical devices can pass that trial period as long as manufacturers can show that the device is "substantially similar" to others like it on the market. Under this system, vaginal mesh implants were approved in 1998 to treat incontinence and in 2002 to treat pelvic organ prolapse.
Pelvic organ prolapse, or POP, occurs when the pelvic organs- most commonly the bladder, but also includes the uterus, vagina, small bowel or rectum- slip out of place and press against the vagina, causing pain and discomfort.
This occurs when the muscles and ligaments holding these organs in place are weakened or stretched. Most often this occurs during childbirth or after surgery like a hysterectomy.
Physicians can use a vaginal mesh to repair those weakened tissues as one form of pelvic organ prolapse treatment. Implants are inserted to reinforce the vaginal wall. Also, the implant is used to support the urethra to prevent urine leakage. According to MedPage Today, a news service for physicians, approximately 100,000 mesh implants were implanted in the U.S. in the year 2010.
However, the FDA strongly discourages the use of vaginal mesh due to the high risk of complications. In a report released in early August, the agency says they have received more than 1,000 manufacturer complaints about the device.
In its report, the FDA says, "Serious complications associated with surgical mesh for transvaginal repair of POP are not rare. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients [...] and it may expose patients to greater risk."
The FDA reported that the most common complaint was "mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems."
According to several mesh manufacturers, approximately 100,000 have been treated for pelvic organ prolapse with vaginal mesh implants, and of those, 75,000 of those were implanted vaginally.
The FDA warned doctors about the potential risks of vaginal mesh after they saw an increase in manufacturer complaints between 2003 and 2007. The agency recommended that physicians receive specialized training on correct implantation techniques and suggested warning patients of potential complications the agency identified as serious but rare.
Unlike drugs that go through a formal clinical trial period, medical devices can pass that trial period as long as manufacturers can show that the device is "substantially similar" to others like it on the market. Under this system, vaginal mesh implants were approved in 1998 to treat incontinence and in 2002 to treat pelvic organ prolapse.