If you are considering TVT or other mesh surgery, it is advisable to find out as much as you can about TVT, the operation, the risks and any possible complications.
TVT: a permanent implant
You should be aware that the TVT ‘tape’ is a permanent implant which is very difficult to remove once inside the body. Do not expect it to be safe because it has been approved for use by an EU Notified Body, or because it is used by NHS surgeons. If you have been following the news on hip and breast implants, you will be aware that approval does not always mean that the implant is safe or has been fully tested or monitored. I will be posting about the regulation of medical devices shortly.
Do your research
Read the Government health warnings
You should also be aware that there are warnings on the United States government’s FDA and Canada’s Health Canada websites about the use of mesh. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) have issued postings and leaflets on the use of mesh, but they appear to hold the view that the benefits of mesh outweigh the risks. In the United States there are hundreds of lawsuits filed by people who allege that they have been harmed by these devices. If your doctor does not discuss these issues with you then you should ask yourself whether you are receiving fully informed consent.
Review the manufacturer’s data and information on adverse reactions
Gynecare, the manufacturers of the TVT tape, have produced some of their own literature and information about TVT surgery. If you study their figures which they give in support of their product, you may be surprised to see erosion rates of up to 19% quoted in their data: Published Clinical Data and RCTs – see table on page 2: “from the only four published RCTs comparing Gynecare TVT Retropubic and Sparc. You should also read the adverse reactions mentioned on page 15 of their Patient Information Leaflet as shown below:
• Punctures or lacerations or injury to vessels, nerves, bladder, urethra, or bowel may occur during instrument passage and may require surgical repair.
• Transitory local irritation at the wound site and a transitory foreign body response may occur. This could result in extrusion, erosion, fistula formation or inflammation.
• Improper placement of the TVT device may result in incomplete or no relief from urinary incontinence or may cause urinary tract obstruction.”
Join a Support Group to find out more
There are at least two internet support groups in the UK which you can join and ask questions about the use of mesh. There are other health forums such as TalkHealth, Hystersisters, the Bowel and Bladder Foundation, and other on-line discussion forums where you can ask about mesh used for pelvic organ prolapse or stress urinary incontinence.
Read literature from surgeons
The British Association of Urological Surgeons (BAUS) has published a Patient Information Leaflet which gives some information on TVT/TOT surgery.
Visit MHRA web page on mesh
Make a list of questions to ask your surgeon
The MHRA have suggested a list of Questions to Ask your surgeon if you are considering undergoing insertion of vaginal tapes for stress urinary incontinence. I have given my thoughts on these questions and have suggested some improvements as shown below:
1. MHRA QUESTION: “What are the different devices available?
TVT is the device that has been approved by NICE as the ‘gold standard’. This was on the basis of data which suggested that TVT was more cost-effective than the alternatives of colposuspension and autologous slings, although NICE guidance recognises that studies showed no significant benefit from this surgery compared to more traditional surgeries not involving mesh. You may be only offered either TVT or you may be offered TOT, a more recent development.
You could ask: What are the different surgical options for the treatment of my stress incontinence or pelvic organ prolapse – both mesh and non-mesh?
2. MHRA QUESTION: What are the pros and cons of different devices?
The pros and cons of different devices should instead be: What are the advantages and disadvantages of mesh surgery and what are the advantages and disadvantages of any non-mesh surgical options? Patients should be made aware that there are alternatives to mesh such as colposuspension which have been well tested and proven to be effective, and these should be discussed, along with their complications.
3. MHRA QUESTION: What happens if this particular surgery does not work?
This suggests you are asking what will happen if the mesh does not cure incontinence. It might be better to be more specific and ask: What are the chances that my stress incontinence will not be cured? What happens if I am not continent after this surgery? Will I need further surgery? What kind of surgery? Would this be further mesh implants or something different?
The surgery may fail for other reasons. For instance, the mesh may cause debilitating or chronic nerve pain. What will be proposed then? You may want to ask: What happens if I suffer from acute or chronic pain problems after the surgery? Will the mesh be cut or removed? What treatments will I have? Will the pain be resolved?
Another result of failed mesh surgery may be bladder emptying difficulties. A better question would be: What happens if the mesh causes voiding difficulties? Will I be taken back to surgery within days for the mesh to be pulled down and will this resolve the problem? If not, what will happen if the voiding does not resolve over days/weeks? Will I need to have part of the tape cut? When would this be done? Will I remain continent? What happens if the tape is cut and voiding does not improve? Can the mesh be removed?
Another complication is mesh erosion. A good question to ask would be: What happens if the mesh causes erosion into the vagina, bladder, urethra or other area? What are the symptoms? How will it be identified and treated? What happens if, after treatment, the tape erodes again?
Another common problem after surgery is urge incontinence. A good question to ask would be: What happens if the mesh causes other voiding issues such as frequency or urge incontinence? How will this be treated? Can this be treated successfully?
In severe cases of infection, pain or long-term voiding obstruction, the mesh may have to be removed. You might want to ask questions such as: What happens if the mesh is infected? Can you remove the mesh fully? Have you ever removed a full mesh? What was the outcome of these removals? Will I remain continent if the tape is cut or removed?
4. MHRA QUESTION: Has the surgeon performed this operation before and if so in how many patients?
This is a good question in some respects because a surgeon would have to be up front and honest, so if they avoid answering this directly, it may be an indication of lack of experience. There are certainly studies which suggest that surgeon skill can influence the outcome of this surgery. However, it is not guaranteed that the surgeon the patient sees during the consultation will perform the actual surgery – so a question to then ask an experienced surgeon would be: Are you going to be performing my surgery? Can you guarantee that you will be performing my surgery?
5. MHRA QUESTION: Has the surgeon performed an audit of his or her results of the procedure proposed?
In theory, this is a good question but the patient would need to be able to compare the surgeon’s stated figures with national or published figures.
In reality, patients often feel very vulnerable when faced with the thought of surgery, and may be wary of upsetting the surgeon in any way by questioning whether his/her skills are ‘up to the job’. If the surgeon has done an up-to-date audit, he/she should be obliged to give this in written format to the patient showing their results against any national or published figures. Be aware, however, that what some surgeons consider a “successful outcome” in their statistics might be based on the continence status of patients post-operatively and might not take into account long term complications such as de novo urge incontinence, pain, erosion or voiding difficulties.
6. MHRA QUESTION: If so, what were the success and complication risks
You could certainly ask this but you would need to bear in mind that many women do not return to their first surgeon when seeking remedy for their complications for various reasons. Many women seek treatment elsewhere for mesh complications at some point if they are not happy with their implanting surgeon. What happens if the patient does not return to the surgeon – do they simply leave them off the figures? How can they be sure that women they have operated on have not suffered complications if the average follow-up is between 6-12 weeks?
Perhaps the patient could ask: What are the complications and problems you have come across in your practice? Do you follow up women after their surgery? When? For how long?
What do you Think?
What questions would you advise asking before surgery? Did you ask questions like these? Do you wish you’d asked these questions prior to your surgery?
Please feel free to comment on these questions or give your own suggestions, so that other women can be well informed when considering this surgery.