Disclaimer: the opinions expressed in this article are solely those of the author.
Most people would answer ‘yes’. We trust our physicians because they have experienced years and years, a large portion of their lives, perhaps, in education, and hours upon hours of gruelling training. We trust them to make decisions with us – the patient – and our best interests in mind – it says so in the Hippocratic Oath, which all of them have sworn by. So, we assume that the medical professionals looking after us would not be swayed by financial gain to behave otherwise. A lot of women, unfortunately, are living proof that this isn’t always the case.
The Bleeding Edge (2018), is a documentary following the stories and lived experiences of patients affected by faulty medical devices, mostly based in the US. The vast majority of these patients are women. It also delves deep into the corruption of the medical device industry and investigates the financial links between these huge companies and medical institutions such as the FDA. In a word, the misconduct exposed by the film is frightening.
The devices mentioned include the transvaginal mesh, cobalt joint replacements, and Essure, a permanent contraceptive for women. As well as this, victims of Da Vinci robot surgery are featured. The film focuses mainly on the struggles of the survivors of Essure implants, and how the long-term repercussions of the procedure have affected their day-to-day life.
Essure was marketed as an alternative to having one’s ‘tubes tied’. It offered a completely safe option for sterilisation – the only problem was that its safety wasn’t actually ensured. As expected, issues started arising in the women who had the device implanted.
‘I’ve had a headache since 2011,’ one woman said. She had to give up her active lifestyle due to the crushing chronic pain; headaches every day, all day. At one point she had to have a lumbar spinal tap to relieve the pressure in her skull.
However, the effects of Essure span wider than just chronic pain. Another victim had to have a hysterectomy aged just 31.
The surgeons were only ‘trained’ how to implant the device, not how to remove it. Most attempts at retrieving the device resulted in it fragmenting and scattering, left behind. Immune systems go into overdrive, triggering connective tissue disorders, targeting the joints, and eventually deteriorating them. Perhaps the most ironic adverse effect after the implantation is unexpected pregnancies – the very thing the device was meant to prevent, it failed to do. Sometimes the babies themselves have been affected by the implant – one quote from the documentary read: ‘there have been more than 800 failed pregnancies associated with Essure.’
One of the most frustrating things experienced when watching the film is how the women’s claims are repeatedly dismissed by medical professionals. An example includes a woman who experienced extremely heavy menstrual bleeding post-op. Her physician told her it was because of the fact she was Latina. This just highlights how women in general, and especially women of colour, are intimidated by their own doctors, and their real problems are minimised, causing incredible harm in lots of cases. Furthermore, if a woman is of a certain age, their issues are said to be associated with oncoming menopause. Even then, women struggle to find guidance and support with said issues.
The Problem with Transvaginal Mesh
Perhaps the most relevant issue to the UK, however, is the use of transvaginal mesh, and more particularly, its connections with the well-known company Johnson & Johnson. The story starts in 1997, when Swedish obstetrician Ulf Ulmsten developed transvaginal mesh, as a treatment for Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP) in women. These problems are common in women after childbirth. Johnson & Johnson came into the picture around this time – allegedly, the company paid Ulmsten $1 million to test its effectiveness in procedures treating these conditions. It is proposed that ‘the payment was conditional on the study proving successful’ and that ‘this…compromised the results of that trial.’ (BMJ, 2018) Of course, J&J rejected these allegations strongly. Further along the timeline, in 2003, the British National Institute of Health and Care Excellence (NICE), among other institutions, warned against the use of mesh implants. Why?
In The Bleeding Edge, we learn more about the terrible adverse effects of the mesh in women. It starts as pain and discomfort, leading to fever, nausea, and vomiting. Essentially, the mesh is used to ‘reinforce a weakened vaginal wall or support the urethra or bladder neck.’ (Llamas, 2020) Use of the mesh can be traced all the way back to the 1950s when it was used to treat hernias, and this was a safe practice. The problem lies in that for surgeries for POP and SUI, the mesh is inserted vaginally. Problems associated with the implant include: ‘…the trauma of insertion, foreign body reaction to the implant in terms of inflammation, infection and/or rejection, contraction of the mesh causing pain, and the stability of the prosthesis over time.’ (Barski and Deng, 2015)
Essentially, the mesh causes the tissue to scar, so the mesh shrinks and contracts, forming a hardened structure. This affects the surrounding tissues – vagina, bladder, urethra – which all need to be able to move in subtle ways in order to function properly but are now stuck in place. The surgeons, as with Essure, are not trained on how to remove the mesh, which is basically impossible to do so completely. The scarring continues and the body tries to eject the mesh, which it can’t do. The mesh can only be removed partially. One woman who is followed in the documentary, Tammy, has had as many as 19 surgeries associated with the mesh – she’s lost count.
The implications of an adverse reaction to the mesh surpass just the physical. The psychological ramifications of being unable to play with one’s children, to be intimate with one’s partner, and to live a generally normal life, are extensive. The amount of debilitating pain these women must have experienced is incomprehensible, and the pain doesn’t go away. As well as this, the sheer amount of money required to pay for surgeries after the implantation as massive – and lots of women can’t work as normal due to the pain. Some women are left homeless, single mothers have to put their children in care. This is a life-long issue that has to be lived with, paid for, and fought against. Women in this situation have to cope with the fact that the supposed benefits of this procedure are far outweighed by the ‘side-effects’ of it. They are incredibly angry that not only were they not told of the potential risks of the implant, but that they were also misled, by not only these companies like J&J, but also their own doctors.
In 2008, the FDA published a statement acknowledging the complications associated with the transvaginal mesh for SUI and POP. Despite this, the mesh would continue to be used for years to come. Women started to fight back: in 2012, the first lawsuits went to trial. C.R. Bard, another company producing mesh products, paid out $3.6 million to a woman who experienced such complications. The company withdrew its mesh from the market around this time. Then, in 2013, J&J lost its first federal lawsuit. It was only in 2016 that ‘all manufacturers stopped marketing surgical mesh intended for transvaginal repair of POP.’ (Kent, 2020).
The tide started to turn when the media got involved. In 2017, the British Medical Journal published an investigation which exposed over 60 manufacturers who sold mesh without clinical trials, and with weak evidence of safety and effectiveness. In the same month, the BBC broadcast an episode of Panorama which examined the role of Ethicon, part of the Johnson & Johnson family of companies, which ‘failed to properly warn UK doctors of the risks associated with transvaginal mesh and had inadequately tested its kits before selling them. (…)Ethicon’s TVT-Secur implant(…)was available(…)after being tested on only 31 women for 5 weeks and in sheep.’ (Kent, 2020)
In 2018, the British government halted the sale of mesh, only to reinstate it. Baroness Cumberlege, Chair of The Independent Medicines and Medical Devices Safety Review, outlined certain conditions that allowed mesh to be considered safe to use. These recommended that the surgeon had to be properly trained to perform the surgeries and that they had performed them regularly. A register of devices was encouraged to be created to track any complications of devices as they occur. The same year saw the start of the MHRA’s 5-year Corporate Plan, and one of the more relevant priorities outlined was: ‘introducing a combined reporting system for adverse incidents…to ensure patient safety,’ as well as ‘working with our partners across the UK, Europe and globally to prevent…substandard products entering the supply chain.’ (MHRA, 2018) As of 2019, NICE stated that the mesh implants could be offered on the NHS, so long as these guidelines were followed, but a ‘pause’ on these surgeries has remained in place since then. That same year, transvaginal mesh for POP was banned in the US, but there is no news on whether the same can be said for SUI procedures.
How common are adverse incidents?
It is important to ask how common these adverse incidents are in comparison to other treatments for the same condition. In a booklet published by NICE intended for women about to have surgery to treat their SUI, three different options were outlined, one of them being mesh (retropubic mesh sling surgery). For all intents and purposes, this option seems like the best one in terms of effectiveness, compared to the others. Taking colposuspension for example, which doesn’t use any mesh, according to the booklet, for every 100 women on average who undergo this surgery, after 1 to 5 years, about 70 women felt their symptoms improved and 30 did not. After over 5 years, about 55 women felt their symptoms improved, and 45 did not. As for retropubic mesh sling surgery, for every 100 women who had this surgery, about 75 had improved symptoms and 25 did not, after 1 to 5 years. More than 5 years after, about 60 women had improved symptoms and 40 did not. Just looking at these numbers, having the mesh surgery would seem like the obvious choice. Thankfully, the booklet does explicitly state the potential complications of mesh procedures, as well as advising that it is not always possible to treat these complications successfully.
In general, it is difficult to find exact figures on the frequency of adverse incidents involving mesh implants, and such numbers vary wildly between studies. For example, an 8-year long study of over 90,000 women found that 9.8% of patients which had surgical mesh insertion for SUI ‘…experienced a complication peri-procedurally, within 30 days or 5 years of the initial mesh insertion procedure,’ and that this is likely a lower estimate of the true incidence. (Keltie et al., 2017)
A different study found that 61 of 1439 (4.2%, a relatively low incidence) of women who had a vaginal sling procedure to treat urinary incontinence showed mesh erosion after the operation. (Kokonali et al, 2014) A Scottish study that lasted 19 years and included over 13,000 women who had an incontinence procedure using mesh was completed in 2016. It found that these procedures actually had a lower risk of immediate complications compared with non-mesh surgeries (adjusted relative risk [aRR] 0·44 [95% CI 0·36-0·55]). During the same period, there were 1279 women who underwent a first, single prolapse procedure that used mesh.
In these women, there was a substantially increased risk of later complications compared to non-mesh surgeries for this purpose (3·15 [2·46-4·04]). From this study, it was suggested that mesh procedures for incontinence could be supported, but shouldn’t be recommended for primary prolapse repair. (Morling et al., 2017)
The real problem is less so about how common these complications are, but more so about how serious they are when they do occur. The physical and psychological side-effects of these incidents may well be relatively rare, but they significantly reduce the quality of life for those affected when they do occur. As well as this, another major issue is that there isn’t enough information about the very long-term problems that could arise when there are complications. Furthermore, it is important to examine why so many women were allowed to have mesh procedures for POP when there wasn’t enough testing done to ensure the safety and effectiveness of the treatment beforehand.
Money, Power, and Medicine
In America, it could probably be predicted how deeply entrenched the industry is within the medical sector, since it is privatised, unlike in the UK. AdvaMed (Advanced Medical Technology Association) is a self-described ‘trade association that leads the effort to advance medical technology in order to achieve healthier lives and healthier economies around the world.’ As well as this, their mission is described as advocating ‘…for the highest ethical standards and patient access to safe, effective and innovative medical technologies that save and improve lives.’(AdvaMed) This company is the main lobbying group for the medical technological devices industry. The documentary shows how they target politicians, secretly funding their political campaigns. This way, they have a huge amount of influence in the US government. These companies can’t be trusted to act in the best interest of patients: those who are directly affected and targeted, by these devices and implants. There is seemingly no escape from these unscrupulous and shadowy corporations.
Worryingly, in the UK, it seems as though individual clinicians, and even institutes such as The Royal College of Surgeons, have financial links with industry. During 2016 to 2017, RCS received ‘funding partnerships’ with 68 companies, including Ethicon, which is a branch of Johnson & Johnson. The Royal College of Obstetricians and Gynaecologists also has ties to Ethicon – £133,402 was given to the College in 2015. (Gornall, 2018)
It has been said that the UK is worse than the US in terms of publishing information about these links and making them readily available. In the UK, the general public doesn’t have free access to this information. However, it must be said that UK agencies such as the MHRA (the Medicines and Healthcare products Regulatory Agency) have a good reporting system for adverse incidents that is easy to use for concerned patients as well as healthcare professionals. The one used by the MHRA specifically is called the Yellow Card Scheme, now an app, which has been continuously improving in terms of accessibility for all who may need it. Even so, it has been reported that the number of complaints from practitioners is less than would be expected.
This is especially troubling in recent times, with the amount of pressure put on the NHS to treat those suffering with and reduce the spread of Covid-19. We have seen already how willing the government is to potentially sacrifice the nation’s health in order to boost the economy and ‘move the country forward.’ Can we really trust those in power to make the right decisions for those of us who are at risk?
The bottom line is that the institutions and individuals that are meant to be looking after our health can be easily influenced by financial gain to put patients in potential danger. This goes against all the ethical principles of medicine. Our medical care providers are meant to practice beneficence and non-maleficence, and yet there is proof of them acting in a manner that says otherwise. It should be said, however, that the vast majority of people working in health and medicine are the best and brightest that the country can offer. We should all be especially grateful for the UK health system since the privatisation of healthcare in the US has made it much easier for economic greed to override the desire to provide high-quality and safe medical care. Documentaries like The Bleeding Edge shine a light on the corrupted relationship between medicine and money, masked lightly under the guise of innovation, which seems to be the expression of the decade.
The Bleeding Edge is currently available on UK Netflix.
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