I was asked to write this article for the O&G Magazine and this has been published this week. As this is unlikely to be read by many women from the general public I have reproduced the article in my blog (with a few more added pictures for interest.)
Woman in Pain (Original painting by Katie Martel 2002)
History of Pelvic Mesh Problems
The first mesh implant for stress urinary incontinence (SUI) was the ProteGen Sling and it was cleared for use in the US in 1996 and mesh for use for Pelvic Organ Prolapse (POP) was authorised by the FDA in 2002.(1) Since this time between 6-20% of women who have undergone mesh surgery have suffered multiple complications across many domains. (2) These include mesh exposure and erosion of the vaginal wall (3), bladder and urinary tract injuries (4), urinary retention (5), nerve damage and persistent pelvic pain (PPP) (4,6) including dyspareunia leading to significant mental health issues for the woman and damaging relationship breakdowns. (7) There have been severe depressive symptoms due to the ongoing distress caused by mesh complications including death by suicide.(7,8) The physical, mental and financial cost to women due to mesh implantation has been huge.
Across these decades a common feature for women has been the inability to be believed by many of their health care providers about the severity of their symptoms. One wonders if this medical gaslighting has contributed to increased severity of the persistent pelvic pain women have experienced?
Australian Commission on Safety and Quality in Health Care
In Australia, women and their health providers now have access to guidelines produced by the Australian Commission on Safety and Quality in Health Care which have clear guidance about the best practice pathway to managing all pelvic floor dysfunction, including mesh implantation. (9) This was created using peer-reviewed evidence, through consultations with clinicians and via consumer forums with women around Australia to hear and understand the complexities facing women with mesh complications. These personal stories are important to listen to when attempting to treat women with persistent pelvic pain.
This extensive process of investigation has ensured that the available evidence and a breadth of views were considered in the development of resources now available to women and their health care providers on mesh implantation. The question is are they accessed and utilised when a patient with mesh implantation sits before the health professional? Secrecy or ignorance about the best approach to managing the complications of mesh is no longer an excuse. The information is clearly articulated in this document and is available to read on the internet regardless of where you live in this vast wide country of Australia.
Biopsychosocial Approach to Managing Persistent Pelvic Pain
Evidence tells us that persistent pelvic pain is more effectively treated when a biopsychosocial approach to pain is undertaken. (10) Pelvic health physiotherapists in Australia use this best practice approach to managing persistent pelvic pain by adapting the model extensively researched and taught by Australian physiotherapists and pain researchers, Professor Lorimer Moseley and Dr David Butler.
Taken from The Protectometer Moseley and Butler 2015
A biopsychosocial approach includes understanding about the interplay between the biological, psychological and social aspects of the patient’s condition. This has been an ongoing struggle for pelvic health physiotherapists to convince those schooled only in the medical model of treatment of pain, that understanding the influence of other factors is important in fixing persistent pelvic pain.
Silence for so many years surrounding the consequences of mesh implantation, the extent of the problem, the ongoing use of mesh for many years despite the compelling evidence to the contrary has fuelled the injustice that many women feel around their mesh situation. The women in Australia are also facing significantly reduced compensation payouts due to the large costs subtracted by the very legal team who were instrumental in bringing the dreadful stories of these women into mainstream media. (11)
Value of Questionnaires
Factors such as injustice that women may feel about their situation with mesh implantation can be measured by the Injustice Experience Questionnaire. (12) This has a scoring range between 0-52 (subscales Blame/Unfairness and Severity/Irreparability) with a score of greater than 30 representing a severe risk of ongoing disability at one year. The injustice suffered by these women is having an impact on the severity of their pain. If this is not recognised and addressed as a part of the treatment of the patient, then the recovery of the patient will be stifled.
Anger and rumination add to the psychological burden for women who have mesh injuries. The Pain Catastrophisation Scale is a measure of pain-related thoughts and beliefs measuring rumination, magnification and helplessness. However, currently there are no validated measures that are specifically designed to assess pain associated with pelvic mesh implants. Considering the burden that women have suffered with this catastrophic failure of the health care system more research is required. (13)
Social influences such as family, friends and work colleagues and their ability to maintain a relationship with a woman in constant pain are also factors in pain amplification. Health professionals being curious about these impacts rather than dismissive will help with understanding the complexity of a women with persistent pain from failed and problematic mesh implantation.
Anxiety associated with mesh implantation (with associated complications and those without complications) leads to adrenaline/cortisol release which amplifies pain. Thoughts are chemical processes and may provoke inflammatory responses in the relevant tissues. Over the years women have formed support groups on Facebook which can be seen both as a ‘saviour’ and ‘escalator’ of their anxiety. Finally realising the extent of the mesh problems and feeling validation when the numbers of women with similar symptoms was revealed is often helpful for them, but hearing the terrible stories of suffering within a group can be triggering for many women and contribute to anxiety about their condition, catastrophising, heightened central sensitisation of their nervous system and ultimately worsening of their pain.
The patient’s inability to work because of persistent pain adds to financial distress and heightens anxiety. These patients also incur high medical expenses undergoing the necessary treatment by health professionals for their mesh complications adding to their financial hardship.
Physiotherapy Assessment and Treatment of Persistent Pelvic Pain with Vaginal Mesh
Physiotherapy assessment of the patient with persistent pelvic pain involves listening to their story. This provides validation to the patient that the therapist in front of them has an understanding of how important their story is to the fabric of their treatment plan and creates a therapeutic alliance with the patient. Baroness Cumberlege in her 2020 report on Medical Devices Safety Review ‘First Do No Harm’ said ‘that the system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns. Listening to patients is pivotal to that’.(14)
Assessing the patient’s urinary system function (with a bladder diary, a pre/post void ultrasound and noting any history of any urinary frequency, urgency and urinary leakage), bowel function (including regularity, stool consistency, any associated pain and faecal control); sexual dysfunction (pain with sex, fear avoidance of intimacy, loss of sensation and complex feelings of loss of being a ‘broken’ woman associated with their predicament); any pelvic nerve pain and referred pain; the state of their pelvic floor muscle activity; and their tissue quality guides treatment strategies.
Asking the patient about their goals and expectations from their physiotherapy interaction ensures that the therapist is addressing the patient’s concerns rather than the therapist’s preconceived ideas about what they believe to be important.
Education is the cornerstone of any pelvic health physiotherapy treatment. Teaching bladder voiding position, efficient pain-free bowel emptying, and good bladder and bowel habits is important to address the biological problems associated with mesh implantation complications.
Taken from Pelvic Floor Essentials 2022 by Sue Croft OAM
Bladder residuals leading to chronic urinary tract infections; urinary leakage due to failed effectiveness of sling procedures; overactive bladder leakage; or removal of the offending sling leading to the reinstatement of the pre-existing stress urinary incontinence are all distressing problems well-served by the conservative strategies taught by pelvic health physiotherapists.
If pain is a high priority, it is incumbent upon the physiotherapist to ‘sell’ the persistent pain message in a scientific and credible way, completely dispelling any belief the patient may have from previous health professional encounters that the pain is in the patient’s head.
The pelvic floor muscles are often overactive with the patient increasing the muscle tone inadvertently by over-clenching in response to pain, to leakage of urine or faeces or to stress and anxiety. Vandevelde 2001 showed that the pelvic floor muscles behave as ‘first responders’ in response to stress and anxiety, reinforcing the concept that the pelvic floor muscles are hardwired to protect. (15) Other muscles in the pelvis are also often implicated. Referral patterns of tension from obturator internus can be seen with other presenting conditions such as coccydynia, Piriformis Syndrome, low back pain, sacro-iliac joint pain among others.
Teaching patients about: regular daily pelvic floor muscle down-training, pelvic nerve and pelvic muscle stretches, the value of regular belly breathing to enhance the parasympathetic nervous system response over the fight/ flight sympathetic nervous system upregulation, body scanning to assess muscle tightness and subsequently relaxing the overactive muscles, and changing posture into a more slumped and relaxed posture to facilitate abdominal and pelvic muscle relaxation are all invaluable treatment strategies which give self-efficacy and empower the patient to self-manage their pelvic pain more effortlessly.
Child’s pose is a helpful pelvic muscle and nerve stretch
Woven into the effective treatment of these biological factors is the important concept of teaching effective pain science to the patient. Understanding the concept of central sensitisation is pivotal to explaining how persistent pain upregulates. This involves teaching the concept that pain is not always solely about the issues in the tissues. Measuring the degree of central sensitisation through the Central Sensitization Inventory: Part A and Part B (CSI) allows objective measurement of the progress of the patient with their pain management. (16)
Treatment of the sensitized nervous system includes graded exposure to the perceived threat which allows for reorganisation of the sensori-motor cortex through novel non-threatening stimuli and movement. For example, if dyspareunia is an ongoing problem once there has been mesh removal, a pelvic health physiotherapist will teach the patient how to use vaginal trainers (dilators) to gain graded exposure to penetration as well as the importance of good arousal, good tissue quality (from local oestrogen if age appropriate) and the use of an effective lubricant.
Femmax Dilators (able to be purchased from PelvicFloorExercise.com.au)
Health professionals working with patients with persistent pain from mesh implantation must be conscious of the importance of the language and words used. This is fundamental to maintaining a good therapeutic alliance with the patient. Encouraging the patient to be kinder to themselves when they may have a sense of hopelessness from years of persistent pelvic pain is also important when fixing pain.
Understanding pain science empowers the patient to have greater autonomy over their treatment process which ultimately helps their financial situation. If the concept of central sensitisation is explained well to the patient, it makes complete sense to them and can often lead to a faster decrease in pain and symptom resolution increasing the credibility of the physiotherapist. This allows you to assist the patient to change the narrative of their pain story without ever disputing or diminishing the importance of the biological factors at play.
Physiotherapy treatment of PPP associated with mesh implantation decreases catastrophising, empowers women with self-management strategies to treat their pelvic health issues throughout their life and explains why their symptoms can flare unexpectedly despite long periods of improvement with their condition, allowing them to self-manage the flare and return to a high quality lived experience.
- Heneghan CJ, Goldacre B, Onakpoya I, Aronson JK, Jefferson T, Pluddemann A, Mahtani KR. Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process. BMJ Open. 2017 Dec 6;7(12):e017125. doi: 10.1136/bmjopen-2017-017125. PMID: 29212782; PMCID: PMC5728256.
- Glazener CM, Breeman S, Elders A, Hemming C, Cooper KG, Freeman RM, et al. Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT) 2017;389(10067):381–392. Incidence of mesh complications
- Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Marjoribanks J. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2016 Feb 9;2(2):CD012079. doi: 10.1002/14651858.CD012079. PMID: 26858090; PMCID: PMC6489145.
- Kasyan G, Abramyan K, Popov AA, Gvozdev M, Pushkar D. Mesh-related and intraoperative complications of pelvic organ prolapse repair. Cent European J Urol. 2014;67(3):296-301. doi: 10.5173/ceju.2014.03.art17. Epub 2014 Aug 18. PMID: 25247091; PMCID: PMC4165670.Cc
- Chughtai B, Mao J, Buck J, Kaplan S, Sedrakyan A. Use and risks of surgical mesh for pelvic organ prolapse surgery in women in New York state: population-based cohort study. BMJ. 2015 Jun 2;350:h2685. doi: 10.1136/bmj.h2685. Erratum in: BMJ. 2015;350:h3060. PMID: 26037077; PMCID: PMC4451585.Cc
- Abed H, Rahn DD, Lowenstein L, Balk EM, Clemons JL, Rogers RG; Systematic Review Group of the Society of Gynecologic Surgeons. Incidence and management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systematic review. Int Urogynecol J. 2011 Jul;22(7):789-98. doi: 10.1007/s00192-011-1384-5. Epub 2011 Mar 22. PMID: 21424785.Cc
- Dibb, B., Woodgate, F. & Taylor, L. When things go wrong: experiences of vaginal mesh complications. Int Urogynecol J(2023). https://doi.org/10.1007/s00192-022-05422-zCc
- Welk B, Reid J, Kelly E, Wu YM. Association of Transvaginal Mesh Complications With the Risk of New-Onset Depression or Self-harm in Women With a Midurethral Sling. JAMA Surg. 2019 Apr 1;154(4):358-360. doi: 10.1001/jamasurg.2018.4644. PMID: 30624560; PMCID: PMC6484799.
- Reproduced with permission from the Treatment options for complications of transvaginal mesh (including options for mesh removal, developed by the Australian Commission on Safety and Quality in Health Care (ACSQHC). ACSQHC: Sydney (2018)
- Mardon A, Leake H, Szeto K, Astill T,Hilton S, Moseley GL, Chalmers K. Treatment recommendations for the management of persistent pelvic pain: a systematic review of international clinical practice guidelines (2021) https://doi.org/10.1111/1471-0528.17064
- The role of perceived injustice in the experience of chronic pain and disability: Scale development and validation. Sullivan, M.J.L., Adams, H., Horan, S., Mahar, D., Boland, D., Gross, R.(2008). Journal of Occupational Rehabilitation, 18: 249-61.
- Todd J, Aspell JE, Lee MC, Thiruchelvam N. How is pain associated with pelvic mesh implants measured? Refinement of the construct and a scoping review of current assessment tools. BMC Womens Health. 2022 Sep 30;22(1):396. doi: 10.1186/s12905-022-01977-7. PMID: 36180841; PMCID: PMC9523957.
- First Do No Harm – The report of the Independent Medicines and Medical Devices Safety Review Baroness Cumberlege, Sir Cyril Chantler and Simon Whale
- Van der Velde J, Laan E, Everaerd W. Vaginismus, a component of a general defensive reaction. an investigation of pelvic floor muscle activity during exposure to emotion-inducing film excerpts in women with and without vaginismus. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(5):328-31. doi: 10.1007/s001920170035. PMID: 11716000.
- Neblett R, Cohen H, Choi Y, Hartzell MM, Williams M, Mayer TG, Gatchel RJ. The Central Sensitization Inventory (CSI): establishing clinically significant values for identifying central sensitivity syndromes in an outpatient chronic pain sample. J Pain. 2013 May;14(5):438-45. doi: 10.1016/j.jpain.2012.11.012. Epub 2013 Mar 13. PMID: 23490634; PMCID: PMC3644381.
“I would like to respectfully acknowledge the Yuggera people, Traditional Owners of the land on which I am writing and Elders both past and present. I also recognize those, whose ongoing effort to protect and promote Aboriginal and Torres Strait Islander cultures, will leave a lasting legacy for future Elders and leaders.”