***For The Attention of Health Minister Jackie Doyle Price, and members of The Parliamentary Debate on Vaginal Mesh Implants to be held on 18/10/17.***
Corruption, an undeniable reality in healthcare, is arguably the most serious ethical crisis in the sector today. It is multidimensional in nature and includes multiple stakeholders (Rodwin, M.A., 2012). From the pharmaceutical companies, manufacturing plants, medical researchers, product designers, to the doctor’s surgeries and hospitals who have been sold on “the latest innovative treatment available, and at a lower cost to traditional surgeries”, by sales reps, who are invested in doing a good job, there are systemic problems that need to be challenged and investigated. Some of these practices are criminal. We women have been used and abused by the sector. Our regulatory controls are allowing these untested, unsafe medical devices to be used in that abuse (Kumar, M.U., et al., 2017). I urge our government and regulators to include this in any investigations into this medical device scandal.
Without it, your words of sympathy are meaningless, and add further insult to life-changing injury. Further surgeries using this dangerous medical device will continue to harm more women unnecessarily (Keltie, K., et al. 2017). When you injure a woman with mesh, you injure her children, her grandchildren, her partner, her siblings, her parents, her cherished friendships. You injure her so badly, she will become suicidal with pain. She will be crippled and unable to wear underwear because it triggers continuous nerve pain. She will lose her independence, her mobility, her income, her sex life, her agency in the real world of daily living. Sometimes she will even lose organs. She will never be the same again.
We are speaking out, despite our difficult circumstances because, we’ve done the research, and we see where the root of this is (Getzsche, P.C., 2012). Patients are stakeholders too, and we have a right to be heard and taken seriously. Undermining our voices, or complicity accepting a deeply problematic and flawed reasoning by industry, serves only to deny access to safe healthcare. Not only that, it increases the costs of patient care and contributes to ill-health and the needless suffering of patients. We are the evidence of that (Zimmerman, R., 2011).
Traditional urogynaecological surgeries do not pose the same risk of serious injury as these vaginal mesh procedures do (Brincat, C., Brubaker, L., 2016). Yes, they involve a longer recovery time and are more invasive, but when ” minimally invasive” surgery can do the same damage internally to a woman’s pelvic area as a blade to the skin, it’s time to have a serious look at all the facts, and to suspend mesh surgeries pending investigation.
“Previous evidence on synthetic meshes and biological grafts suggested some benefit, though the trials were smaller and arguably poor quality. This large well-designed study indicates that these materials give no additional benefit, with additional adverse effects.” (Glazener, C. M., et al., 2017).
I was 36 when I had this surgery for stress incontinence. It was inconvenient and restrictive to a point, but not life threatening. I’m now 44, unable to work, mostly bed bound, and have a catheter and multiple autoimmune complications attributed to the assault on my body that I’ve endured because of this medical device. The polypropylene mesh is now known to degrade inside the human body, causing autoimmune reactions and the formation of biofilm infections (Lakovlev, V. V., et al., 2015). I have had multiple revision surgeries since 2011 and was seriously ill with lifethreatening infections in 2015. I retired from my job as a lecturer on grounds of illhealth in 2013 at the age of forty. It was devastating. It still is.
Many medical professionals have and will continue to argue, that many woman benefit from these surgeries and experience no complications. That isn’t something I’m denying. But without long term studies, how can we have confidence in this statement and accept it as true? Many women can be fine for years, but complications set in several years later. So my question to you is this; is it worth it for me and the thousands of other women who have complications? Is it worth successfully curing one woman’s incontinence with a surgical intervention that can so seriously disable others? Until the truth comes out, this is a risk that you have the power to minimise for many other unsuspecting women. I urge you to look at the facts, and to really listen to what we are saying. We have been accused of sensationalism and referred to as hysterical women by anyone defending use of these surgeries (many of whom have conflicts of interest with the pharmaceutical industry). They gaslight and undermine us, when they should be including patient advocates respectfully, in a move towards tackling the systemic problems and corrupt practices within the sector.
Corruption in healthcare and medicine is a complex and difficult problem. “It is complex because of it’s deep roots in the social, cultural, economic, political, legal, and ethical value systems of individuals, communities, and countries. It is a difficult problem because it defies easy answers and resists any single-track, copy-book model of solutions” (Rodwin, M.A., 2012).
The phenomenon of mesh victims support groups has grown exponentially in recent years. This year alone has seen the UK Sling The Mesh Facebook group rise to over 3,000 members. The patient movements emerging globally on social media, are undeniably important. In a world where medical evidence can be skewed to the benefit industry, and regulatory controls are potentially not fit for purpose, it is time for an extensive review of all the information at our disposal. Patient victims of adverse incidents, have a right to be part of this conversation, and can contribute much to the discussions. I urge you today, to begin that process by suspending vaginal mesh surgeries pending further investigation.
Rodwin, M.A. (2012) Conflicts of Interest, Institutional Corruption and Pharma: An Agenda for Reform, The Journal of Law, Medicine & Ethics.Vol 40, Issue 3. Available from http://www.issuesinmedicalethics.org/articles/corruption-in-healthcare-and-medicine-why-should-physicians-and-bioethicists-care-and-what-should-they-do/?galley=html [Accessed 14/10/17]
Kumar, M.U., et al., (2017) Product Recall Decisions In Medical Device Supply Chains: A Big Data Analytic Approach to Evaluating Judgement Bias, Production and Operate Management. Available from: doi.org/ doi:10.1111/poms.12696 [Accessed 14/10/17]
Keltie, K., Elneil, S., et al., (2017) Complications Following Vaginal Mesh Procedures For Stress Urinary Incontinence: An Eight Year Study of 92,246 Women, Scientific Reports. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5607307/ doi:10.1038/541598-017-11821-w [Accessed 14/10/17]
Dwan, K., et al., (2013) Systemic Review of Empirical Evidence of Study Publication Bias and Outcome Reporting Bias – An Updated Review. PLoS ONE 8(7): E66844.doi: 10.1371/journal.pone.0066844 [Accessed 14/10/17]
Zimmerman, R., (2011) Surgery Under Scrutiny: What Went Wrong With Vaginal Mesh. Available from: http://www.wbur.org/commonhealth/2011/11/ surgery-under-scrutiny-vaginal-mesh [Accessed 14/10/17]
Brincat, C., & Brubaker, L., (2016) Mesh, Graft, or Standard Repair For Prolapse Surgery? The Lancet, Volume 389, No.10067, p334-336, 28 Jan 2017, doi: 10.1016/SO140-6736(16)32595-8 [Accessed 14/10/17]
Glazener, C. M., et al., (2017) Using Mesh Does Not Improve Results In Vaginal Prolapse Surgery. Available from: https://discover.dc.nihr.ac.uk/portal/article/4000775/using-mesh -does-not-improve-results-in-vaginal-prolapse-surgery [Accessed 14/10/17]
Lakovlev, V. V., et al. (2015) Degradation of Polypropylene In Vivo: A Microscopic Analysis of Meshes Explanted From Patients. Journal of Biomedical Materials Research, doi:10.1002/jbm.b.33503 [Accessed 14/10/17]
Rodwin, M.A. (2012) As above.