FDA: Surgical placement of mesh to repair pelvic organ prolapse poses risks

On July 13, 2011 the FDA posted a news release and an alert on the risks of mesh in the treatment of pelvic organ prolapse (POP).  Link to the news release using the title of this post or the link below This is a quick summary and includes this statement by the FDA.

“The FDA issued a safety communication in 2008 due to increasing concerns about adverse events associated with the transvaginal placement of mesh. Since then, the number of adverse events has continued to climb. From 2008 to 2010, the FDA received 1503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007.” 

The full alert can be found at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm  It includes recommendations for healthcare providers and recommendations for patients.  It does suggest consideration of non-surgical options but does not list any specific non-surgical treatments. 

Sherrie Palm from the Association for Pelvic Organ Prolapse Support has posted another side of the story which is also important to consider.  http://pelvicorganprolapsesupport.org/library/sherrie_palm_articles  I would expect other medical professional groups will also formally respond.  Will be interesting to see the results of the meeting in September. 

REFERENCES for Sherrie's post

https://www.augs.org/AboutAUGS/MediaCenter/PressReleases/PelvicFloorDisordersWillImpactasManyasOne/tabid/491/Default.aspx .

http:www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm262752.htm.2011;July 13 .

http://www.intelihealth.com/IH/ihtPrint/WSIHW000/333/8988/14066249.html .

http:www.ehow.com/about_5660232_hernia-mesh-complications.html

http://www.modernmom.com/article/statistics-on-complications-of-cosmetic-surgery .

It is important for PTs to know about this discussion and the resultant regulations or recommendations.   Would be nice if this resulted in more conservative treatment!!! 

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm262752.htm