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(EMAILWIRE.COM, September 17, 2011 ) WASHINGTON, D.C. -LegalView, a leading online legal resource, is vigilantly monitoring the United States Food and Drug AdministrationÂ’s feeds regarding the Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee, which will be held on September 8-9, 2011. The panel will discuss further the safety and regulation of vaginal mesh.
Transvaginal surgical mesh is a synthetic mesh that is surgically implanted either vaginally or abdominally to repair a several conditions including pelvic organ prolapse, or POP, and stress urinary incontinence, or SUI. This device has been linked to several serious complications, including mesh erosion, in which the mesh erodes into surrounding tissues and organs.
The FDA issued a report citing more than one thousand manufacturer complaints about the device, including complications such as bleeding, infection, painful urination, painful sexual intercourse, mesh shrinkage, erosion and perforation of the bladder.
It is estimated that in 2010, 100,000 women had surgical mesh implanted to treat POP, 75,000 of those were implanted vaginally. According to the FDA, surgical meshes that are implanted vaginally seem to have more complications associated with them.
During the panel, outside experts discussed and made recommendations regarding the safety and effectiveness of vaginal mesh for POP and SUI. One of the recommendations that will most likely be made is to change vaginal mesh from a class II medical device to a class III medical device, requiring stricter pre-market approval applications from manufacturers. These applications would require that manufacturers show clinical data on their devices. Also, experts at the meeting may decide that clinical studies should be performed to show the risks and benefits of mesh used to treat POP and SUI, and to expand post-market monitoring of the device.
Under the current FDA system, manufacturers do not need to show clinical data on their devices, but can get pre-market approval by showing that their devices are substantially similar to others like it currently on the market. Changing the classification system from a class II medical device to a class III would require significant more testing before a device could be sold. Furthermore, manufacturers would be required to file a supplement with the FDA any time a change is made to a device that affects its safety or effectiveness.
Monitoring the FDAÂ’s feeds is part of LegalViewÂ’s commitment to providing up-to-date information to help prevent women from the potential side effects of vaginal mesh.
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 nationÂ’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 LegalViewÂ’s superior sponsoring law firms and to get in touch with LegalView attorneys, visit LegalView at www.Legalview.com.
LegalView
Danielle Franklin
9702168847
press-releases@legalview.com 
Source: EmailWire.com
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