Vaginal Mesh Surgeons Respond to FDA

A group of surgeons has recently published their collective response to the 'Safety Communication Update' provided to the FDA by an advisory committee, regarding the use of transvaginal placement of surgical mesh (TVM) for pelvic organ prolapse (POP).  You can read the entire report here:  http://www.cfurogyn.com/Surgeons%20Reply%20to%20FDA%20Report.pdf

Earlier this month, the advisory committee concluded that these mesh devices do not need to be reclassified from Class II to Class III.  While the committee acknowledged that there are very real and significant risks involved with these devices, they did not find enough evidence to reclassify them.  Basically, any device that is classified as Class III may be required by the FDA to undergo a series of randomized trails that demonstrates its safety and efficacy; whereas, Class II devices are not nearly tested to such high standards.  

The surgeons do agree with the FDA that implantation of mesh does carry such risks as mesh erosion, pain, infection, bleeding, pain during intercourse, organ perforation, and urinary problems but they take issue with one of the quotes from the FDAs most recent update:  “Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.”  This group of surgeons argues that patients should be aware that with the exception of mesh erosion, these are all risks of traditional non-mesh surgery as well.  In other words, they feel that the FDAs statements imply that there are multiple risks of TVM that do not exist with traditional repairs and they feel that this is not accurate and is misleading to the public.

Well, all POP surgical procedures carry a certain level of risk and all methods of treatment will have its share of complications.  But the question is about mesh and if the benefits outweigh the risks.  When the surgeons say "...with the exception of mesh erosion…" they change the discussion.   The FDAs advisory committee didn't meet to discuss POP repair 'with the exception of mesh erosion'; they met to discuss mesh and mesh erosion and if the benefits of using mesh outweigh the risks.  It's not entirely clear what the motivation is of this report and it's not clear how many surgeons assisted in writing this report or how many agree with it.

If you are interested in seeking recovery from the manufactures of these mesh devices that caused you pain, please contact a vaginal mesh lawyer.  We suggest finding an attorney who will not make you part of a class action lawsuit and one that that is knowledgeable and successful in this type of complex litigation.