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New Vaginal Mesh Portal

(EMAILWIRE.COM, August 23, 2011 ) PHILADELPHIA, PA- LegalView, a leading online legal resource, has updated its vaginal mesh portal regarding the U.S. Food and Drug Administration's recent evaluation of trans vaginal mesh, a surgical mesh used to repair pelvic organ prolapse in women.

Pelvic organ prolapse is a condition where pelvic organs, including the uterus, bladder or rectum, slip out of place due to muscle or ligament weakness due to childbirth or surgery. Vaginal mesh is a surgical implant that is used to provide support for the vagina or uterus to reduce the reoccurrence of a pelvic organ prolapse, or POP. However, due to the rising number of complaints and complications associated with vaginal mesh, the FDA has released a new updated advisory.

LegalView has published warnings from the FDA, which states that little evidence exists that vaginal mesh, whether implanted either vaginally or abdominally, improves pelvic organ prolapse. Additionally, a review of adverse events reports has led the FDA to caution against its use, as vaginal mesh surgery has been linked to a number of serious complications.

The FDA will review the information in September with a team of outside experts for recommendations on how to proceed.

Dr. William Maisel, a chief scientist for the agency's medical devices arm, said that they are assessing their regulatory options for the product. He said that options include requiring clinical trials to be conducted and changing the classification of the implants to require formal pre-market application approval.

Unlike FDA drugs, many medical devices are cleared without going through a formal clinical trial stage. Manufacturers who can prove that their products are substantially similar to those already on the market can get clearance to sell their devices. Under this system, vaginal mesh was cleared for use in 1998 for treating incontinence and in 2002 for treating pelvic organ prolapse.

Manufacturers estimate that approximately 100,000 women were treated for pelvic organ prolapse with vaginal mesh implants. Of those, 75,000 implants were inserted vaginally.

In 2008, the FDA cautioned physicians about the potential risks of vaginal mesh, citing more than a thousand manufacturer reports of complaints between 2003 and 2007. The FDA recommended that doctors receive specialized training on how to implant the device and warn patients of potential complications as serious but rare.

However, complaints associated with the device have jumped drastically. Serious vaginal mesh complications include erosion, when the skin breaks and the device protrudes, and contraction of the mesh that can lead to vaginal shrinkage.

LegalView applauds the FDA's announcement. LegalView.com provides more information about these devices and information on how to contact a vaginal mesh lawyer.

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.info.





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

Source: EmailWire.com

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