FDA logo green background 240MND, September 11, 2015 ~ It’s been four years this past week (September 8, 9, 2011)  that the FDA convened a panel of “experts”  to form the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee.

Their goal was to discuss the five-fold increase in complications associated with pelvic mesh.  

The FDA database had received a jump in reports, from mesh erosion, to chronic pain, mesh infections, UTIs, dyspareunia even death.  You can read the agenda here.  Mesh News Desk was there and covered the story here.

The expert panel convened with a consensus to reclassify mesh used for pelvic organ prolapse to “high risk” or Class III that would require greater scrutiny before it could be marketed such as a Premarket Approval (PMA) and clinical trials on humans.  This reclassification proposal applied only to pelvic mesh used for pelvic organ prolapse, (POP) generally a larger piece of polypropylene mesh.

FDA gathering Sept. 9, 2011

FDA gathering Sept. 9, 2011

In May 2014 the agency issued two proposed orders filing them in the Federal Register, one to reclassify and the other to require a PMA.

The public comment period was opened for 90 days and concluded at the end of July 2014. See the comments here.  Many readers of Mesh News Desk voiced their opinion including hundreds of name gathered by the consumer group Corporate Action Network, which then had joined forces with MND gathered signatures and submitted them electronically.

proposed order reclassification

 

What’s happened since then?  

The Federal Register still lists the 2014 proposals as a “Proposed Order.”   In other words, nothing.

 

History of FDA and Pelvic Mesh

* October 2008 ~  In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.”  See here. 

Even with the jump in reports, the agency concluded mesh complications are “rare.”

* July, 2011 ~ The  FDA reported complications from pelvic mesh are “not rare” and that alternative surgeries may offer less risk.  The FDA recommends “…that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.”

The FDA promised to “Continue to monitor adverse events reported to FDA associated with surgical mesh used to repair POP and SUI, as well as assessing any and all data as it becomes available.” By 2013 SUI complication reports were up 36 percent. See MND story here.

P1070344* September 2011 ~ The expert panel recommended surgical mesh be reclassified from class II to class III and require a PMA.

* January 2012 – The FDA issued orders for manufacturers of pelvic mesh to conduct postmarket surveillance studies (522 studies) to address safety and effectiveness concerns of pelvic mesh used for POP. See Press Announcement here.   Companies had three years (January 2015) to complete the studies.   See the letter and companies who received orders here.  As of September, 2015 they are not completed.   See the www.Clinicaltrials.gov.

* May 2014  ~ The FDA posted a proposed order for POP surgical mesh to require a PMA. The 90 day comment period ended July 2014. See it here.  The same day a proposed order went out to upgrade moderate to high risk for POP mesh to a Class III which would require special controls and a higher level of scrutiny.  See it here.   Here are your comments.

The proposal ended July 2014.  The order has not be approved by the FDA.  The 522 studies are not complete.  Pelvic mesh remains Class II, a moderate risk, even though it is a permanent implant that is not designed to be removed, despite complications.

What Can You Do? 

Contact your member of Congress. Sen Charles Grassley, Sen. Claire McCaskill, Rep Donna Edwards, Rep. Darrell Issa might be receptive.

The Government Accountability Office (GAO) advises Congress on how to make government more responsive.

http://www.gao.gov/about/

GAO on Facebook

https://www.facebook.com/usgao

Sen. Claire McCaskill Facebook video

https://www.facebook.com/clairemccaskill/posts/10153527926134707

FDA’s Office of Ombudsman- Dispute Resolution

http://www.fda.gov/downloads/aboutfda/centersoffices/oc/execsec/ucm164330.pdf

Office of Criminal Investigations- OCI

http://www.fda.gov/ICECI/CriminalInvestigations/default.htm