In 2018, following mounting public pressure from several national campaigns, Jeremy Hunt, Health and Social Care Secretary, ordered an independent review into the issues surrounding vaginal mesh. This investigation revealed significant shortcuts were taken during the research and implementation of these products. Thousands of patients are thought to have been affected, with many suffering from years of pain, and immense financial gain for the pharmaceutical industry.
Vaginal mesh
A vaginal mesh is a net-like implant, made of polypropylene, used to treat stress urinary incontinence and pelvic organ prolapse. These issues often arise after prolonged stress on the bladder neck or a weakened vaginal wall as a result of multiple pregnancies or other health conditions. The implants were introduced in 1998 and have been offered to thousands of individuals across the world since then.
The issues that arose
Over time, adverse effects began to emerge. Meshes have sticky surfaces that promote bacterial adherence. Removal poses problems too as meshes integrate over time with the nerves and blood vessels in the tissue of the pelvic region. Over 100,000 women have sued mesh manufacturers across the world. Patients have experienced both physical and emotional turmoil from their vaginal meshes, and many tried to raise their concerns which were ultimately met with indifference from healthcare professionals, who refused to take responsibility or escalate care.
Regulation of devices
In Europe, medical devices are regulated by notified bodies, commercial organisations of which there are over 50. These bodies deal directly with device manufacturers who must make their devices in accordance with three European Union Directives (in place since the early 1990s). Depending on a device’s class of risk, manufacturers may be able to self-certify that they meet the requirements of the three directives. Once approval is obtained, a certificate of conformity is issued and devices can be put on the market for countries within Europe. Clinical data is also required to show that the new devices are at least as safe and effective as those currently on the market, known as the chain of equivalence. However, the depth of this evidence can be very limited.
In the US, the practices are a little different. The regulation of all medical devices is overseen by one organisation, the Food and Drug Administration. As with the EU, new devices must also be at least as safe and effective as those currently on the market.
What went wrong?
Around the time of approval of the mesh, there was no new clinical trial data for all of the 61 mesh devices. Different devices were made of different materials with differing compositions. Moreover, the devices were only tested with small animals and for a short period of time. This raises two issues. Firstly, this did not test the long term effects of these implantable devices and, secondly, the results obtained may not be translatable to humans.
In 2005, a Cochrane review and the UK National Institute of Health and Care Excellence highlighted the lack of research on the long term use of vaginal meshes. Randomised studies followed, which raised previously unidentified issues such as mesh erosion and dyspareunia (painful sexual intercourse). Furthermore, in 2014, an assessment of vaginal meshes by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) ruled that there was a lack of evidence surrounding their clinical effectiveness and research published to date could not prove that the benefits outweighed the potential harms. This review was updated in 2016, to report that women with pelvic organ prolapse treated with vaginal mesh were more likely to require a further operation than those without the mesh.
Campaigns
Six big campaigns were launched to help individuals have their voices heard.
List of campaigns
- #MASHEDUPBYMESH
- Mesh UK Charitable Trust
- Sling the Mesh Campaign
- Welsh Mesh Survivors
- Meshies United Group UK
What is a review?
Ultimately these campaigns led to a review. In February 2018, The Independent Medicines & Medical Devices Safety Review was launched into the use of surgical mesh alongside a hormone pregnancy test Primodos and an anti-epileptic drug sodium valproate. The team consisted of experts with previous experience of large scale reviews and holding leadership positions within healthcare. Members of the team visited patients and their families to discuss their experiences. The completed review, titled “First Do No Harm” was published on the 8th July 2020. It revealed that the NHS, professional bodies, pharmaceutical and device companies, and policymakers did not do enough to keep patients safe.
Actions to take forward
A list of 9 recommendations have been made to protect future patients. One of the principal recommendations is a new independent Patient Safety Commissioner with links to Parliament. They will listen and advocate for patients’ rights and to raise issues with the government. The report recognised that further research and rigorous testing is needed. Healthcare professionals must listen to and provide sufficient information to their patients.
For further reading, check out these resources
- In the news
- The results of the 2018 review
- The campaigns
- A paper on “Transvaginal mesh failure: lessons for regulation of implantable devices”
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