Ethicon Media Monitoring 10/23/2018

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1. AUGS Stands by its use of Polypropylene Mesh Implants

   Oct 22, 2018 | Mesh Medical Device News Desk

   By Jane Akre
   
   
   AUGS, the American Urogynecologic Society concluded its annual members meeting this month.

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. AUGS Stands by its use of Polypropylene Mesh Implants

   Oct 22, 2018 | Mesh Medical Device News Desk

   By Jane Akre

   AUGS, the American Urogynecologic Society concluded its annual members meeting this month. 

   Women injured by the polypropylene (PP) mesh implants, which the society promotes, met with some leadership and had an opportunity to put a face on the real life complications they associate with their mesh implants. See MND story here. 

   Still AUGS stands by its promotion of PP mesh.   

   MND checked in to see if the current thinking of AUGS regarding the use of polypropylene transvaginal mesh medical devices has evolved over the years since more reports of injury are reaching the mainstream medicine and there are approximately 150,000 defective lawsuits facing the mesh manufacturers in the U.S. alone.

   This is a 4 minute read but important information to know for anyone who has a discussion about a mesh implant with her doctor.

   Katy Frame of BRG Communications is answering questions for AUGS.

   MND has a request in to do a Q and A with the current president of AUGS. He prefers your editor sends in written questions which is underway.

   What is the current thinking by AUGS membership on the use of SUI (stress urinary incontinence) and POP (pelvic organ prolapse) mesh?

   CONTEXT:   Since 2012, mesh injuries amassed at more than 104,000 product liability cases filed in one federal court including injuries ranging from mesh-in-place, to life-altering severe complications to death.  Increasingly, experts at trial are blaming polypropylene place in the body or being unstable, shrinking, encasing ligaments and nerves, and hosting antibiotic resistant infections. Chronic pain and infection result with little remedy other than medication.

   POP mesh, generally larger to cover the pelvic floor and support sagging organs, has been reclassified as highest risk by the FDA, Class III but manufacturers were given 30 months to remove it from the market OR prove safety and efficacy via clinical trials. AUGS indicates it is still being used, which will merit further questions.

   For example, former mesh user, Dr. Shlomo Raz (here) has reversed his thinking and now will not use PP mesh because he is seeing complications a decade later.

   As thinking evolves, are there any directives on who should or who should not place transvaginal mesh?

   CONTEXT:  Discovery from trial has shown that Johnson & Johnson, for example, trained a doctors with a range of skills, not all up to the task of learning this blind procedure and assuring patient safety.

   J&J discovery has shown that lower tier doctors were not learning as fast as top tier doctors (here). Often doctors blame mesh injuries on less experienced surgeons. The fact is that weekend cadaver clinics often sufficed for clinical surgical training.

   Frame answers AUGS feels that mesh should be placed by providers who:

   Undergo specialized training in the procedures involved

   Discuss and/or offer a non-mesh procedure, in addition to the mesh procedure

   Provide sufficient information about risks and benefits to guide a patient through the informed consent process, helping a patient make her own decision about final treatment plans

   Is mesh still recommended as a first line treatment, or is there any backing away from that?

   CONTEXT: Many women who MNDhas interviewed with they had had received true informed consent so that they would have known the full range of possible outcomes and complications from their mesh implant.

   See MND ,What you should ask your surgeon (here).

   Alternative surgeries are available and always have been including a Burch procedure (sutures) or using one’s own ligaments to fashion a sling, as an alternative to a polypropylene implant. Many readers state they wish they had known enough to ask for those alternatives first.

   Frame answers, “First line treatment should always consist of nonsurgical approaches, including behavioral and physical therapy.  For patients who do not find relief from nonsurgical options, there are multiple surgical options.

   “AUGS continues to feel that women are better served when their preferences and values are honored through a range of treatment options for SUI and POP, including the option for transvaginally placed polypropylene mesh when appropriate.”

   What are members using for pelvic floor repair now that POP mesh cannot be marketed?

   CONTEXT:  When the U.S. Food and Drug Administration reclassified the larger polypropylene mesh used for pelvic organ prolapse into Class III, highest risk, it gave industry 30 months to remove it from the market OR show it is safe and effective through clinical trials.  POP mesh otherwise must go through more scrutiny before it can be sold.

   See MND story here.

   This answer does not completely put into context the fact that POP mesh is supposed to have undergone a PMA or clinical trials before it is marketed. MND will follow up.

   Frame answers,  “This is not the case in the U.S.”

   What lessons have we learned from the use of transvaginal mesh?

   CONTEXT:  Since mesh implants and corresponding problems have been noted, at least anecdotally, since the late 90’s. MNDwonders what if anything is the take away lesson.

   Frame answers, “Medicine in general is always seeking to improve itself, as the status quo is often suboptimal.  New technologies often provide answers to some questions, while bringing up new ones.

   “Understanding the details of the relative benefits and risks for the individual patient in front of you is the goal of the physician; it is unlikely that new technologies are the right answer for every patient, but it is also the case that having an array of options to learn about and choose from is an advantage for every patient. The key is to have a clear understanding of the benefits and potential risks of new technologies before they are marketed, and that is the role of research.

   ” As the leader in Female Pelvic Floor Medicine and Reconstructive Surgery, AUGS strives to provide a culture of practice where new technologies can be introduced, evaluated, and deployed, and continuously re-evaluated, in an evidence-based and systematic manner.”

   What is current science teaching us about foreign body reaction and autoimmune reaction associated with a permanent polypropylene mesh placement?

   CONTEXT:  There is no doubt that, anecdotally, the incidents of chronic infection is observed in the mesh injured population. Without following up and studying these complications, there is no way to understand whether the polypropylene is a host or biofilms or foreign body reaction is causing the body to go on high alert sparking autoimmune reaction.

   Frame says, “There is good population-based science that there is no association between polypropylene mesh pelvic implantation and development of cancer.  There is also good science that shows some features of implants (density, pore size, architecture) may reduce undesired reactions in vivo.  There is no compelling data suggesting that there is a statistically realistic relationship between mesh implantation and systemic autoimmune responses.

   https://www.meshmedicaldevicenewsdesk.com/augs-stands-by-its-use-of-polypropylene-mesh-implants/

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