Raising a Complaint About Your TVT Procedure6th Mar 2018
In the UK alone, around 15,000 women per year undergo Tension-Free Vaginal Tape (TVT) operations, also known as a mesh patch, TVTO and TOT. The procedure, which has been in use since the early 2000s, involves placing a mesh tape beneath an organ which needs supporting, like a sling or hammock, to hold the organ in its correct position. It was regularly used to treat stress urinary incontinence and pelvic organ prolapse, which can occur following childbirth or after a hysterectomy.
This procedure was considered the ‘gold standard’ due to its quick operating and reduced recovery times, and has become much more common than the traditional version of the surgery where stitches were used to provide support for the organs.
However, research has shown that the women who have undergone the mesh implant procedure are three times more likely to suffer complications than if they had undergone the traditional procedure. Whilst women were told that the risk of complications was 1-3%, the latest figures reveal almost 10% of women are experiencing problems after their operation.
During the period 2007-2015 in the UK, of the 92,000 women who had vaginal mesh implants, there were 703 adverse incidents relating to operations for stress urinary incontinence, and a further 346 adverse incidents relating to operations for pelvic organ prolapse.
The term ‘adverse events’ does not reflect the true nature of the complications arising from these operations; women are suffering chronic, debilitating pain due to nerve damage, repeated urinary tract infections, pelvic pain while walking, and pain during intercourse from the mesh cutting through the vaginal wall.
It’s therefore not surprising that many women are raising formal complaints, suing the manufacturers and the hospitals that performed their operations, and calling for the mesh to be banned to prevent any more women suffering the same fate.
Can I make a complaint about my TVT procedure?
Yes – regardless of the severity of the side effects you’re experiencing since your operation, if you’re unhappy with the treatment you have received then you can make a complaint to the NHS.
Complications you may wish to make a complaint about include:
- Chronic pain/nerve damage
- Mesh erosion into the vagina or urethra
- The operation not having the intended effect
- Sexual dysfunction or pain during intercourse
- Recurrent bladder infections/interstitial cystitis
- Vaginal bleeding
- Increased urgency to urinate
- Inability to urinate
Another reason you may wish to complain is if you believe you did not give ‘informed consent’ when you agreed to have the procedure, and therefore did not fully understand the risks associated with the operation. For consent to be valid, it must be:
- Voluntary – made by the person themselves and not influenced by pressure from medical staff, family or friends
- Informed – where the person has been given all possible information about the procedure, including benefits, risks and alternative treatments
- Capable – the person giving consent must be able to understand the information given to them and therefore able to make an informed decision
Since 2013, when the full risks of the procedure became apparent, everyone being advised to have the procedure should have been made fully aware of the potential risks. Yet many are still having this procedure without being fully aware, as they are not receiving a full explanation of the risks.
Senior doctors believe that this could be the most significant medical scandal since thalidomide, and as such, they are calling for a public inquiry into the use of tape.
How do I make a complaint?
Figures from 2010 show that whilst 603 mesh implants were removed, only 15 adverse incidents were reported to the MHRA – demonstrating that unfortunately, most women were not aware of where to report their complaints.
Fortunately, as the scope of problems occurring from TVT operations has become apparent in recent years, more women are making official complaints.
You can make a complaint in writing, by email, or by speaking to your hospital directly (this would always be your first port of call, in order to try and treat the symptoms you’re experiencing).
You can make a complaint to either the organisation that provided your healthcare (the hospital) or the organisation that commissioned that NHS service (in this instance, it will be your local clinical commissioning group (CCG)).
There is a time limit for NHS complaints – this is either 12 months from the date the event happened (your operation) or 12 months from the date you first became aware of the problem. As complications can occur years after you had your operation, you just need to be aware that you should raise your complaint within 12 months of experiencing symptoms.
You don’t have to go through the process alone. Your hospital’s Patient Advice and Liaison Service (PALS) offer free, confidential advice, support and information on health-related matters.
You can also speak with your local authority’s Independent Advocacy Service, which provides support for those who are making, or thinking about making, a complaint about their NHS care or treatment. You can find your local service via your local council’s gov.uk website.
If you don’t feel comfortable complaining directly to your hospital, you can make your complaint to the commissioner of the services (the CCG) instead.
Once you have raised your complaint, you should receive an acknowledgement in writing and the offer of a discussion about your complaint within three working days.
After the complaint has been investigated, you will receive a written report outlining the findings of the investigation and, where appropriate, and apology, and information regarding what’s being done as a result of your complaint.
If you are not satisfied with the response you receive, you can raise your complaint to the Parliamentary and Health Service Ombudsman or the Care Quality Commission, who will carry out their own independent investigation.
Though you won’t receive any compensation by going through the NHS complaints procedure, it can help to answer your questions about what went wrong. It is also a good idea if you are considering taking legal action. The report you are given can prove useful to your case as it will often give you – and your solicitor – more information regarding what went wrong.
What should I do next?
More than 800 women in the UK are already taking legal action against their NHS provider and the mesh manufacturers
If you’re suffering since your surgery and have been informed by a surgeon that your TVT mesh was incorrectly inserted, you may able to claim compensation in order to help rebuild your life.
Coles Miller partner Lydia Barnett is a specialist TVT claims solicitor. She deals with cases personally and always with the utmost compassion and sensitivity.
Lydia answers some frequently asked questions in this video.
To start your claim, or book a free initial chat, get in touch and Lydia will call you back at a time that suits you.