Mesh Medical Device News Desk (MND), October 22, 2018 ~ AUGS, the American Urogynecologic Society concluded its annual members meeting this month.
Women injured by polypropylene (PP) mesh implants, which the society promotes, met with some leadership of AUGS. 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.
MND has a request in to do a Q and A with the current president of AUGS. He prefers your editor send in written questions which is underway.
MND Q: 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 in the U.S. consolidated into 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 as an unstable product in the body which shrinks, leads to scar plate formation that encases nerves and hosts 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.
Some doctors have changed their association with mesh. For example, former mesh user, Dr. Shlomo Raz (here) of UCLA, has reversed his thinking and now will not use PP mesh because he is seeing complications a decade later.
The SUI / AUGS Position Statements:
AUGS and SUFU Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction support the use of the midurethral sling to treat incontinence, stress urinary incontinence specifically which is urine leakage associated with coughing, laughing or sneezing. Blaming lawyers and the media the joint statement says, “We are concerned that the multimedia attention has resulted in confusion, fear, and an unbalanced negative perception regarding the midurethral sling as a treatment for SUI.” it goes on to say that perception is not shared by the international medical community or women who are satisfied with their midurethral slings.
This paper answers common questions asked about slings and polypropylene including safety and polypropylene, cancer and recalls.
These are talking points a doctor might answer to his patients. Includes responding to the FDA that complications are “not rare,” about autoimmune disease, about incidents of cancer, assuring readers polypropylene is safe and effective.
The POP/ AUGS Position Statements:
AUGS states there are no bans on mesh at this time and the society strongly opposes any restrictions by state or local medical organizations, insurance companies or healthcare systems that ban currently available surgical options. Any laws of that kind undermine the doctor-patient relationship.
April 2017 study on management of mesh and graft complications in gynecologic surgery. It says vaginal mesh exposure may be entirely asymptomatic. POP grafts may be placed abdominally (sacrocolpopexy) or transvaginally.
MND Q: 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 have, in some cases, sufficed for clinical surgical training.
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
MND Q: Is mesh still recommended as a first line treatment, or is there any backing away from that?
CONTEXT: Many women who MND has interviewed wish 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.
AUGS says, “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.”
MND Q: 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 a higher level of FDA scrutiny, specifically premarket approval (PMA) before it can be sold.
See MND story here.
AUGS says, “This is not the case in the U.S.”
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, therefore leaving few choices for POP mesh still one the market MND will follow up.
MND Q: 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. MND wonders what, if anything, is the take away lesson.
AUGS 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.”
MND Q: 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, infection, or foreign body reaction is causing the body to go on high alert sparking autoimmune reaction.
AUGS 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.
Relevant Research includes:
- Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical Trial,
This is unusual study because it was longer in length, five years, and it is rcent. it concludes among women who had undergone vaginal surgery for apical pelvic organ vaginal prolapse, there was no difference in surgical failure between uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF). It really does not responsive to the above question about autoimmune reactions.
- SUPER Trial, Charles Nager, MD, https://www.ncbi.nlm.nih.gov/pubmed/27054798
MND – This trial is currently underway and compares a hysterectomy to a native tissue repair leaving in the uterus yet suturing the top of it to the body using suture (apical suspension). Again this response does not address autoimmune reactions to a mesh implant. ###
MND, AUGS Breaks with the Father of Gynecology, July 4, 2018
MND, AUGS Responds to 60 Minutes on Mesh, May 11, 2018
MND, AUGS President Calls Out Anti-Mesh Movement While Admitting to Mistakes, October 18, 2016
MND, AUGS Prolapse Consensus Announced with Patient Advocates, October 16, 2016
MND, Urogyn Society AUGS: Plaintiffs, Defense and Dissent, October 10, 2016
MND, AUGS: Mesh Procedures Left After Litigation, October 4, 2016
MND, AUGS – Patient Presence Missing from Urogyn Society Meeting, October 3, 2016
MDN, AUGS Defends Polyproylene Mid-Urethral Mesh Slings, September 25, 2016
MND, Augs Survey on Pelvic Mesh Complications, September 21, 2016
MND, Q&A: Dr. Anthony Visco, AUGS President, April 3, 2013
MND, Highlights from AUGS Informed Consent Toolkit, March 30, 2013