Research

Characterization and quantification of oxidative stress induced particle debris from polypropylene surgical mesh
Explanted polypropylene (PP) surgical mesh has frequently been reported to show surface alterations, such as cracks and flaking. However, to date the consequence of PP mesh degradation is not clearly understood, particularly its potential to influence the biological host response of surrounding tissues. The authors were not aware of any previous studies that attempted to characterise, quantify or identify any particles released from PP mesh after exposure to an oxidative stress environment. The findings of this study indicated that oxidative stress alone is a major factor in the production of PP particle debris.
Nano Select. DOI: 10.1002/nano.202200243. March 2023.

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In vitro characterisation of the erosion of soft tissues by surgical mesh
This paper described a preliminary study to generate and measure the erosion of soft tissue by a surgical mesh material. It found significant differences in the rate of erosion depending on the applied force and the direction of loading, and on the presence of connective tissue. The authors concluded: “In our opinion, the phenomenon of mesh erosion should be more extensively investigated and different mesh products characterised in order to prevent future clinical complications.”
Journal of the Mechanical Behavior of Biomedical Materials 101: 103420. January 2020.

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The failure of polypropylene surgical mesh in vivo
With the use of polypropylene for certain surgical operations being questioned, this study reviewed the existing state of knowledge and used some simple biomechanics analysis to make recommendations for future work. Study author David Taylor concluded: “On balance my conclusion is that stress-corrosion failure is the most likely explanation but currently no experimental results exist to prove conclusively that this failure mechanism occurs in vivo. Further work is needed, especially the analysis of explanted material, to resolve this urgent problem.”
Journal of the Mechanical Behavior of Biomedical Materials 88: 370-376. December 2018.

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Autoinflammatory/autoimmunity syndrome induced by adjuvants (Shoenfeld’s syndrome) in patients after a polypropylene mesh implantation
This study acknowledges that plastic can act as an adjuvant for autoimmune diseases such as fibromyalgia, as well as allergies, irritable bowel syndrome and chronic fatigue. It concluded: “We postulate that polypropylene mesh implants may increase the risk of developing (auto)immune diseases by acting as an adjuvant.”
Best Practice and Research Clinical Rheumatology 32(4): 511-520. August 2018.

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Foundation for an evidence-informed algorithm for treating pelvic floor mesh complications: a review
To address evidence gaps on the management of complications related to mesh in pelvic
floor surgery, this study created an evidence-based algorithm, including defining evidence gaps. Researchers acknowledged that the quality of evidence was low, but that “the available evidence provides a framework for planning diagnosis and management of mesh-related complications”. – Note the Tweetable abstract, which states: “Removal of mesh must balance resolution of complications with the risk of removal and recurrence of pelvic floor symptoms.” If it is so difficult removing mesh, then why are surgeons implanting it?
BJOG 125(8): 1,026-1,037. July 2018.

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Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices
In 2017, a total of 22 Canadian physicians of varying specialty, region, organisation and career stage perceived adverse medical device event (AMDE) reporting as unnecessary, not possible or futile due to multiple factors. Physicians viewed AMDEs as an expected part of practice that they could manage by switching to different devices or developing workaround strategies for problematic devices. Their beliefs and behaviour “were reinforced by limited healthcare system capacity and industry responsiveness”.
BMJ Quality and Safety 27(3): 190-198. February 2018.

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Informed consent checklists for midurethral slings: a common-sense approach
The US Food and Drug Administration’s (FDA’s) warning about the use of transvaginal mesh to treat pelvic organ prolapse – and the use of single-incision slings to treat incontinence – led to a “tremendous” rise in the number of lawsuits for medical negligence regarding the use of any polypropylene mesh in the vagina. However, the same FDA document did not question the use of polypropylene midurethral slings and polypropylene for sacrocolpopexies – and despite the evidence and recommendations from respected international scientific societies, the authors of this article said there were constantly being called on by patients to defend the use of midurethral slings. Therefore, this clinical opinion aimed to provide an expert clinician’s perspectives and legal point of view on this controversial topic, and discussed the role of a preoperative checklist supplementary to the standard informed consent form.
International Urogynecology Journal 28: 1,639-1,643. August 2017.

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Is vaginal mesh a stimulus of autoimmune disease?
We see hundreds of women in support groups globally suffering autoimmune diseases such as fibromyalgia and Lichen schlerosus. This study, by Bilal Chughtai, stated there was no link between mesh and autoimmune conditions. – Yet interestingly Mr Chughtai received about $140,000 in payments in the year before this study was published.
American Journal of Obstetrics and Gynecology 216(5): 495.E1-495.E7. May 2017.

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Degradation of polypropylene in vivo: a microscopic analysis of meshes explanted from patients
A study of explanted meshes shows that the average rate of problems of all types of mesh is 10%.
Journal of Biomedical Materials Research. Part B, Applied Biomaterials 105(2): 237-248. February 2017.

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Drugs and medical devices: adverse events and the impact on women’s health
This study from 2017 looks at a range of women’s medicines and devices – including mesh – and says: “Historical precedence has described a generation of morbidity and mortality associated with unrecognised sex- and gender-specific adverse events that continue to affect individuals today.
“Although significant advances have been made to recognise and prevent additional gender bias in future drug and device trials, continued scrutiny and vigilance should be practised among manufacturers and researchers as novel sex- and gender-specific adverse events continue to occur.”
Clinical Therapeutics 39(1): 10-22. January 2017.

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Host response to synthetic mesh in women with mesh complications
This study explores how, in women with complications, mesh induces a proinflammatory response that persists years after implantation. Removed meshes show degradation, and pain is consistent with fibrosis.
American Journal of Obstetrics and Gynecology 215(2): 206.E1-206.E8. August 2016.

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Obturator neuralgia: complete resolution after laparoscopic retropubic sling removal: a report of 2 cases
This article reports two cases of severe leg and groin pain following the placement of a retropubic mesh tape sling (RP). Two premenopausal women suffered groin pain after RP sling insertion. The RP slings were successfully removed by a combined laparoscopic and vaginal approach, and both patients’ pain resolved. The article concluded: “Laparoscopic RP sling removal from the retropubic space is safe and should be considered in patients who have obturator neuralgia after RP sling insertion.”
Journal of Genital System & Disorders 5: 4. June 2016.

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Evolution of midurethral and other mesh slings – a critical analysis
After the US Food and Drug Administration (FDA) issued a warning on the use of mesh in pelvic organ prolapse, this paper reviewed the early experimental studies that were used “as an intellectual cornerstone to justify the use of mesh in prolapse surgery, wrongly so, as our wrok was based on strengthening ligaments, not creating stiff vaginal tissue, which needs to be elastic at all times”.
The paper added: “We found that our early works shed considerable light not only on the many issues giving rise to the FDA warnings – for example, tape erosion, infection, obstructed urination, organ, and – vascular damage, but also on many clinical controversies, surgical cure of ‘mixed’ incontinence, urgency, pelvic pain, and ‘obstructed’ micturition.
Neurourology and Urodynamics 32: 399-402. 2013.

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Why I use mesh: a personal perspective
Jason Cooper says mesh erosion is easy to fix – yet few surgeons can successfully remove the plastic implants once they have embedded into a woman’s pelvic tissue after six weeks. He also says as time goes on surgical skill will improve to implant these devices – yet they have been around 20 years and still srugical skill hasn’t improved, and all the time women are injured.
International Urogynecology Journal 23: 971-973. May 2012.

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Degradation, infection and heat effects on polypropylene mesh for pelvic implantation: what was known and when it was known
“Many properties of polypropylene mesh that are causative in producing the complications that our patients are experiencing were published in the literature prior to the marketing of most currently used mesh configurations and mesh kits. These factors were not sufficiently taken into account prior to the sale of these products for use in patients. This report indicates when this information was available to both mesh kit manufacturers and the US Food and Drug Administration.”
International Urogynecology Journal 22(7): 771-774. April 2011.

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Polypropylene vaginal mesh grafts in gynecology
Donald Ostergard wrote in 2010 that scar tissue causes mesh contraction to less than 50% of the implanted size, which results in dyspareunia and tension on the pelvic mesh attachments. Such contraction may cause pelvic pain and subsequent erosion into adjacent organs. An individual response in fibrosis also exists, with some individuals being “high responders”.
Manufacturers need encouragement to develop meshes that are inert and incorporate without contraction along with routine clinical tests to detect high responders to avoid complications. Polypropylene is not inert within the human body.
Obstetrics and Gynecology 116(4): 962-966. October 2010.

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Vaginal mesh contraction: definition, clinical presentation, and management
This study of prolapse mesh says vaginal mesh contraction is a serious complication after prolapse repair with armed polypropylene mesh.
Obstetrics and Gynecology 115(2 Pt 1): 325-330. February 2010.

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Foreign body reaction to biomaterials
A brief, focused overview of events leading to foreign body reaction was the aim of this study, which concluded: “The consequences of the reaction to the material surface can be devastating… Broadening our understanding of the complex cell/material interactions will contribute to the development of novel biomaterials and tissue-engineered constructs that direct biological responses.”
Seminars in Immunology 20(2): 86-100. April 2008.

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Sexual function after tension-free vaginal tape procedure
This study of 52 women reported a third of the sexually active women reported an improvement of their sexual life after a tension-free vaginal tape (TVT) procedure, 14.3% a worsening, and 52.4% reported no change. Deterioration of sexual function was significantly associated with de novo urge, dyspareunia and sensation of postvoid residual urine volume. The report said: “Our investigations showed that the influence of the TVT procedure on female sexual function is evident, but of low impact, and in general will not be of relevance.”
Urologia Internationalis 78(2): 126-129. 2007.

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The tension-free vaginal tape reviewed: an evidence-based review from inception to current status
This research explores how much of the data for tension-free vaginal tape are from non‐peer‐reviewed small case series often “published” as abstracts. As a result, the conclusions should be interpreted cautiously.
BJOG 112(5): 534-546. May 2005.

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Polypropylene mesh in vaginal surgery: risk analysis and alternatives
This presentation by Tom Margolis concludes: “The risks of polypropylene mesh in prolapse and stress urinary incontinence surgery clearly outweigh the benefits. There are several superb alternatives to mesh that have a 0% mesh complication rate.”

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News and discussion

Editorial: use of surgical databases in urogynaecology – April 2019
This article says a database should be used to log mesh complications. Read the article – You don’t say! This should have happened since 1997!

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Efforts to evaluate materials in medical devices to address potential safety questions – April 2019
Statement by Scott Gottlieb, US Food and Drug Administration (FDA) commissioner – and Jeff Shuren, director of the Center for Devices and Radiological Health – on efforts to evaluate materials in medical devices to address potential safety questions. Read the full statement

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BJOG Perspectives: Dr Jekyll and Mr Hyde – 2019
Swati Jha, of Sheffield Teaching Hospitals NHS Foundation Trust, discusses how the tension-free vaginal tape (TVT) retropubic and TVT obturator became the Jekyll and Hyde of continence surgery. Read the article

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GSK will resume paying doctors to promote its drugs after policy U-turn – October 2018
In response to this BMJ article, editor Fiona Goodlee wrote: “We don’t let judges or journalists take money from the people they are judging or reporting on: we shouldn’t let doctors do this either. Paid opinion leaders are a blot on medicine’s integrity, and we should make them a thing of the past.”

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The trial that launched millions of mesh implant procedures: did money compromise the outcome? – October 2018
The BMJ goes in search of Ulf Ulmsten, the obstetrician who invented mesh, and uncovers how the original evidence was mired in a multimillion pound deal, industry-funded research and undisclosed conflicts of interest. Read the article

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British Society of Urogynaecology database user guide: recording mesh/graft complication surgery – March 2018
This document offers a step-by-step guide on how to record a complication on the database. However, consultants cannot add a mesh complication to the database if the original operation was carried out by another surgeon. Instead – and as explained on page 4 – they have to gain the patient’s consent to contact the original surgeon. Read the guide

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EU to upgrade mesh risk – February 2017
EU Council report outlines plan to upgrade mesh to a higher-risk medical device by 2020. Turn to pages 469-470.

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FDA reclassifies implanting hooks as high risk – January 2016
The US Food and Drug Administration (FDA) upgrades the trocars (hooks used to implant vaginal mesh) to a higher risk device. Read the report

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BAUS Section of Female, Neurological and Urodynamic Urology response to the NHS England, Mesh Working Group – Interim report, December 2015
British Association of Urological Surgeons (BAUS) response includes many ideas to strengthen up protection for women and develop more robust reporting systems. Read the full response

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Managing pain after vaginal mis-surgery – March 2015
Associate professor Chris Maher speaks at the Urogynecological Society of Australasia’s annual scientific and general meeting. Watch the video

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Papantonio: Johnson & Johnson continues to kill women – The Ring of Fire, May 2014
US attorney Mike Papantonio speaks to a lawyer who has called for a criminal investigation into Johnson & Johnson after it was found thousands of documents were destroyed and hard drives wiped clean with information on relating to mesh implants. Watch from 2:20…

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The rise and fall of the vaginal mesh – 2014
Urogynaecology specialist Swati Jha writes in BJOG about how “clinicians need to be prepared for greater scrutiny of their practice by the legal profession”. Read the article

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Ethics and surgical innovation: challenges to the professionalism of surgeons – December 2013
Writing in the International Journal of Surgery, Peter Angelos writes: “To uphold professionalism, surgeons must be driven by altruistic motives rather than self-interest. They must not allow the lure of the new and potential for financial benefit to influence their assessment of whether an innovative procedure truly benefits the patient.” Read the article

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Mary Madden: Should we assume medical devices work until proven otherwise? – April 2013
In this BMJ article, Mary Madden asked the Medicines and Healthcare products Regulatory Agency whether it should have stricter controls on medical devices. The MHRA said: “We think that requiring pharmaceutical-style clinical trials for medical devices would be disproportionate. There is a limit to what extent devices can be assessed pre-market. Unlike medicines, it is not feasible to accurately predict the likelihood or time to failure for new medical devices via pre-market studies. In practice, such studies of sufficient size and diversity are either impractical or so onerous that they would block the product’s development process.” – Thus admitting patients are the human guinea pigs. Read the full article

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Coding for pelvic reconstruction surgery – October 2012
This presentation – sponsored by Boston Scientific – encourages doctors to NOT quote mesh removal in operations, but, instead, to refer to it as foreign body removal to keep complication rates low. View the presentation

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Committee on the Safety of Devices meetings – July 2011 and July 2012
Committee minutes from 2011 and 2012 can be read here. Note in particular page 4 of the 2012 minutes: “If a device is causing havoc but functioning normally, it can only be removed from the market if the device itself is not performing properly or was unsafe.” – The MHRA and the CE mark are a waste of time.

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Polypropylene: The Definitive User’s Guide and Databook – April 1998
This book by Clive Maier and Theresa Calafut shows that polymers are potentially toxic substances that should not be used in medical devices. See Tables 10.4, 10.5 and 10.6.

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Testimony of Ethicon employees
Watch Ethicon employees give evidence in mesh trials here. – Link courtesy of leading lawyers Mazie, Slater, Katz & Freeman.

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• Top image: Hernia mesh. By Superbass – Own work, CC BY-SA 4.0, https://commons.wikimedia.org/w/index.php?curid=128156757