Introduced to the NHS in 1998 these vaginal mesh implants were used to treat urinary stress incontinence and pelvic organ prolapse in women – particularly following childbirth or a hysterectomy.
Despite the lack of rigorous testing, thousands of women received a mesh implant and many are now experiencing the following complications:
- Chronic and debilitating pain
- Infections
- Haematoma
- Bleeding
- Difficulty urinating
- Incontinence
- Tissue and organ damage resulting from mesh erosion or protrusion
- Nerve damage
- Pain during sexual intercourse (dyspareunia)
- Mobility issues and recurrent organ prolapse
- Vaginal erosion or scarring
As some campaigners compare mesh to the thalidomide disaster, this ‘scandal’ represents another situation where doctors, surgeons and manufacturers have potentially failed women. The British Medical Journal’s (BMJ) Editor in Chief has described the vaginal mesh controversy as a “shameful episode”1.
NHS data2 suggests one in 15 women will experience problems with vaginal mesh implants, resulting in them having to have further surgery to have them removed.
The timeline
- In December 2017 NICE recommended that mesh only be used to treat pelvic organ prolapse under ‘research circumstances’ – which effectively banned the use3.
- In Feb 2018 Jeremy Hunt, the former Health Secretary, announced a £1.1M investment into a database for vaginal mesh recipients and to “to improve clinical practice and identify issues”4.
- In July 2018, the Government announced a period of ‘high vigilance restriction’ on the use of a group of procedures, including the vaginal mesh procedure, to treat stress urinary incontinence and pelvic organ prolapse, in England5. This is currently in place.
So what is vaginal mesh and why was it used?
A mesh implant is a latticed piece of plastic (tape, ribbon or mesh) which is inserted into the body to hold tissues and organs in place. Vaginal mesh is also known as transvaginal mesh or transvaginal tape is made from polypropylene or other synthetic materials.
It was commonly used as a treatment for pelvic organ prolapse and stress incontinence in women. Pelvic organ prolapse is defined as the dropping or bulging of a pelvic organ (uterus, bowel, bladder) into the vagina.
Mesh has also been used to repair a hernia – in both men and women. In some cases the mesh was used to treat rectal prolapse.
Insufficient testing and disregard for women’s welfare
Allegations have been made against manufactures of this product, claiming that weak and insufficient research and testing was carried out and the risks and complications were not fully explained to surgeons.
A review published in the British Medical Journal in December 2017, revealed that 61 manufacturers sold mesh without clinical trials, with safety and effectiveness evidence shown to be weak6.
Also in December 2017, a BBC Panorama investigation revealed that Ethicon had failed to properly warn UK doctors of the risks associated with transvaginal mesh and had inadequately tested its kits before selling them. The investigation claimed that Ethicon’s TVT-Secur implant (taken off the market in 2012), was available for use after being tested on only 31 women for five weeks, and in sheep7.
Transvaginal mesh and medical negligence
The TVM plastic has been known to harden inside the body, and also break down and slice through organs and vaginal walls, cause infection in the neighbouring tissues and organs and release chemicals into the body resulting in autoimmune conditions. Symptoms do not always appear straight after surgery with some women reporting complications years later.
Dr Fiona Godlee, The BMJ’s Editor in Chief and Professor Carl Heneghan of Oxford University’s Centre for Evidence-Based Medicine, say the post-marketing assessment of vaginal mesh has been “a shameful episode in the history of implantable devices8.”
Devonshires Claims is investigating allegations against several manufacturers of the mesh – including J & J, Boston Scientific and American Medical System – to determine whether the products were safe to use.
Because many women have claimed that the risks of mesh implants were never fully explained to them, questions arise as to whether there was informed consent.
As well as the pre-operation consent procedure, other potential areas of negligent care and treatment include:
- Concerns that surgeons carrying out the procedure were not adequately trained
- Surgeons failing to offer alternative and less intrusive treatment to women
- Failures in post-operative care and assessment
- Problems can still occur when the implants have been removed
Due to the potential negligence of medical professionals, victims may be entitled to obtain compensation from the NHS Trust or private healthcare organisation.
Legal claims
USA
In October 2019, J & J and its Ethicon agreed to pay $117M in compensation. The attorneys general stated that J&J and Ethicon had “misrepresented or failed to adequately disclose possible adverse effects” to patients and surgeons, and that they were aware of the risks and complications of these implants9.
Under this multistate settlement, J & J and Ethicon must fully disclose the risks of these mesh implants and that further surgery may be required to treat future complications.
Australia
In November 2019, 700 Australian women, fitted with the vaginal mesh, won a landmark case against companies owned by Johnson and Johnson10.
The case against these companies alleged:
- Johnson and Johnson and its associated companies knew of the potential complications
- These organisations took part in “aggressive promotion” to doctors
- Downplayed and minimised the complications and the risks of the mesh
- Failed to investigate complaints
- Tried to stop regulators in France from publishing a report which warned of the risks
Federal court justice Anna Katzmann in the case commented: “Ethicon [an arm of Johnson & Johnson] conducted no or no adequate clinical trials on the devices before taking them to market,”
The court heard the devices were allowed on to market because they had been cleared for sale in the European Union. But Katzmann said there was “widespread and systematic noncompliance” with the EU requirements.
Vaginal mesh compensation claims
If you received a vaginal mesh implant and developed pain and other complications you may be entitled to claim compensation. Our defective medical products solicitors investigate implants, eye lenses and other products.
We may also be able to support patients who have were advised to have other surgical mesh procedures, such as rectopexy and stapled transal rectal resection (STARR), involving the implantation of rectal mesh.
Time limit
The time limit for making a compensation claim for injuries caused by the vaginal mesh, is 3 years from the date that you became aware that your symptoms were associated with the mesh. This means that even if the mesh was fitted over 3 years ago – and you are only now experiencing pain and discomfort, you could still be entitled to claim compensation.
We advise women to contact their GP or consultant to determine the source of their symptoms and if they can be linked to the mesh implant.
Do I need to pay to start a vaginal mesh compensation claim?
Contact us today to start your free no-obligation case review to determine whether you could claim compensation for your vaginal mesh implant.
Devonshires Claims’ medical negligence team supports victims of medical negligence throughout England and Wales. Whether you received negligent care and treatment in relation to surgery, childbirth, gynaecological negligence or the misdiagnosis of a serious medical condition you could be entitled to claim compensation.
We offer a ‘No Win No Fee’ agreement. This means that you will not be charged any upfront legal costs in order to start your medical negligence compensation claim and if your claim is not successful, you will not incur any costs*.
Contact our compensation experts today to discuss your case. Call us on 0333 900 8787, email admin@devonshiresclaims.co.uk or complete our online form.
References
- https://www.bmj.com/company/newsroom/investigation-exposes-vaginal-mesh-scandal-that-has-left-thousands-of-women-irreversibly-harmed/
- https://www.theguardian.com/society/2017/aug/15/scandal-of-vaginal-mesh-removal-rates-revealed-by-nhs-records
- https://www.nice.org.uk/news/article/mesh-for-vaginal-wall-prolapse-should-only-be-used-in-the-context-of-research-says-nice
- https://www.theguardian.com/society/2018/feb/21/jeremy-hunt-launches-review-into-handling-of-surgical-mesh-scandal
- https://improvement.nhs.uk/documents/5122/MESH_letter_-_Extension_of_pause_on_the_use_of_vaginal_mesh_29_March_2019.pdf
- https://bmjopen.bmj.com/content/7/12/e017125
- https://www.bbc.co.uk/news/uk-scotland-42307953
- https://www.bmj.com/content/363/bmj.k4205
- https://www.reuters.com/article/us-johnson-johnson-settlement-mesh/johnson-johnson-agrees-to-pay-about-117-million-to-settle-u-s-states-mesh-probe-idUSKBN1WW2EK
- https://www.theguardian.com/australia-news/2019/nov/21/australian-women-win-landmark-vaginal-mesh-class-action-against-johnson-johnson
