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Four Years Ago: FDA Where Are You on Pelvic Mesh Proposals?

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

 

 

One Comment

  1. Bejah B says:

    Thank you for this Jane, this is very important and I pray that the members of this community will hear you and act. I see it as a kind of “Come to Jesus” meeting. Time for the sleepers to awaken, time for the folks in the balcony seats to come sing in the chorus,

    We can not expect anything to happen if we just sit and watch from the sidelines where we feel safe. We are not safe anywhere. It is like voting…if you do not vote the people lose, if none of us vote we have lost our form of government and our way of life. This country is not on autopilot.

    How hard can it be to write a letter? You will not be placed on a black list or turned over to the House Committee on un-American activities (Can we turn Alex over to that committee per chance? Oh, I forgot corporations are exempt sort of like diplomats who park whereever they feel like parking in Manhattan). Silly me.

    In 20 years you may suffer unpleasant consequences for writing to your elected representatives, for expressing your opinion, but not this year, not on this day. Today we are still relatively free.

    Do you think the defendants like the idea that their victims can communiate with eachother across the world? No, they do not like it at all. We could organize and do a lot more than we are but the truth is, although our hearts are in the right place, very few of us seem to be doing anything except (and forgive me for the brutal remark/wake up all) putting out our hands and asking when we personally are going to get our settlement money.

    We should be asking what we can do to help. Are we just concerned about ourselves? I have not seen anyone offer to contribute a cent of settlement money toward a fund to help those of us with the greatest need. This makes me feel shame. I propose that we support the establishent of a fund (This could be managed by a reputable funding organization) to help our fellow victims with the greatest need by contributing a percentage of our settlement monies. It need not be a set amount. I would love to see a discussion about this. We have all read some heartwrenching stories of people in desperate need of help. Maybe there is a way we can help them. Do you want to see one more person, alone in their bed, take their own life because they could not bear it all any longer?

    Jane, I am going to do what you have suggested this week. (Always good to give oneself a deadline).

    Bejah

    PS The other thing that bothers this victim is that it seems there are many litte mesh organizations like little kingdoms when what we need is one organization within which there could be different sections with differing focuses so we are not expending energy on redundant efforts. So long as we continue with this model I suspect we will not make any meaningful progress. Fortunately it is looking more and more like these defendants are going to hit the wall hard and either be forced into global settlement, file bankrupcy or face remanding to their respective states.

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