Practical information for patients about surgical mesh.
1. What products are known as surgical mesh?
Most modern mesh products are made of polypropylene (plastic) and are made up of a weave of fibres and supplied in varying shapes and sizes depending on the intended use.
Sometimes doctors will use a different word to describe the surgical mesh they are recommending for use.
for example: Sling, Tape, Patch, Graft, Ribbon, Gause, 'device' and 'suture like material'. Sometimes the mesh is referred to by its trade name: eg TVT, TOT, Proceed, Lynx.
Mesh is sometimes used to treat stress urinary incontinence, rectal, vaginal, uterine and bladder prolapse and for hernia repairs.
2. Questions to ask your doctor if you are considering a surgical mesh implant.
• Do you have any written information that I can take away with me?
• Before signing the consent form on the day of the operation, will there be an opportunity to contact you with any questions I have regarding the operation?
• Can you explain all my possible options including non-surgical treatment, surgery with mesh and surgery without mesh?
• Why is mesh being suggested for me and what are the benefits over non mesh alternatives?
• What are the benefits of alternative options being used instead of mesh?
• What brand of mesh will be used?
• What results have your other patients had?
• How many mesh operations have you performed using this particular mesh?
• How many removals of mesh have you undertaken?
• How many mesh -related complications have you come across?
• What will my follow up care be like after the operation?
• What side effects can I expect after surgery and what side effects should I report to you?
• What happens if I experience complications or unusual symptoms in years to come?
• What are the risks associated with using this mesh product?
• If there is a complication will you be able to completely remove the mesh device?
• What happens if this surgery does not correct my problem?
• What are the long term effects of complications?
• How will these long term complications impact on my other body symptoms or organs?
• What is the management of these symptoms once they occur?
3. Recognising the symptoms of surgical mesh complications.
• Pain (at the site of the mesh implant, including vaginal, groin, pelvic, referred pain down leg and back pain)
• Urinary tract infection ( often recurring).
• Difficulty urinating
• Pain during sexual intercourse (dyspareunia)
• Although not as common, painful sex experienced by the partner when they feel the mesh during sexual intercourse. (hispareunia)
• Onset of auto-immune disorders
Surgical mesh device implants have been known to cause erosion (where mesh pushes against and into the surrounding tissue, nerves and organs). Although not as common mesh can cause extrusion (where mesh pushes through or perforates surrounding tissue, nerves and organs). Mesh can cause scarring and adhesions.
Mesh is no longer thought of as inert, there has been significant research to show that after implantation the mesh can break down, shrink and change over time.
4. Steps to take when you start experiencing any of these symptoms.
• Visit your GP or surgeon and discuss these symptoms. If you do not feel as though your questions were satisfactorily answered ask to be referred to another surgeon or seek a second opinion from another GP.
• Ask your GP/surgeon to fill out an ACC45 and ACC2152 to lodge a treatment injury claim with ACC.
• Ask your surgeon if they will be lodging a an Adverse Event report to Medsafe.
5. Accident Compensation Corporation (ACC).
If you have been diagnosed with mesh related complications you may be entitled to make a treatment injury claim to ACC. This claim would be for financial assistance for medical costs, household help, loss of income and childcare. See more here:
• You are able to request the help of an ACC advocate to help you with your claim. Getting your treatment injury accepted by ACC and dealing with ACC can sometimes be difficult. See more here: http://accesssupport.co.nz/?gclid=CI-9tYrYp8ECFUccvAodGqwA9A
6. How to lodge an Adverse Event Report to Medsafe.
Full details here: http://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp
If you have made a claim to ACC for treatment injury they will notify Medsafe on your behalf (regardless of weather they accept your claim or not) so you do not need to.
If you have not made a claim to ACC for a treatment injury you can take these steps:
a. Ask your GP or nurse or surgeon to complete the report form on your behalf.
The link to that report form is here: http://www.medsafe.govt.nz/downloads/adverse-event-report-hcp.docx
b. Complete your own report. The link to the patient report form is here: http://www.medsafe.govt.nz/downloads/adverse-event-report-consumers.docx
To complete the form you will need a copy of your full medical notes including your INTRAOPERATIVE REPORT from the day the mesh was implanted into your body.
This report and your full medical notes are held on file by the HOSPITAL where you had mes implanted. You will need to contact the hospital to request these notes. (They may ask for photo ID). They MUST keep these records for 10 years and must provide you with a copy within 20 working days.
In your file there will be the type of mesh used, brand, bar code, model and batch number. This is needed in order to complete the form for Medsafe.
(This is also helpful to have if you are seeking a second opinion from another surgeon).
7. Possible questions to ask your doctor when discussing mesh removal if required due to an adverse event.
It is really important to discuss with your surgeon the possibility of having a full removal of the surgical mesh device over having a 'snip' or partial removal.
If your doctor is unable to do this you should ask if they can refer you to someone who has the skills to achieve a complete explant.
• How many mesh removals have you previously done, partial or full?
• Do you believe in removing as much mesh as possible or will you only remove what is easily accessible?
• Are you able to remove the mesh where it has been fixated ie. staples, sutures, arms, anchors? (This is sometimes dependent on the surgeon’s surgical experience in mesh removal and whether they have been able to remove mesh from their patient's Sacral Promontory area before.)
• Have you previously removed mesh from the obturator muscle, obturator fossa (bone) or sacral area before? Are you able to do this?
• Please explain the potential problems when cutting the mesh or leaving a part of the device in the deep tissues?
• If I am having a partial removal, how much of the mesh will be left in place? Where will the mesh be cut back from?
• Please provide a photo of the mesh once it has been removed (and/or retin the actual mesh for you - a small portion will be sent to a laboritory for testing.)
• Please can I recieve a copy of the labratory report? (Talk to your surgeon first about what they would be specifically testing for, so you have a good understanding of why this could potentially be needed.)
Some surgeons will snip a mesh tape to release the tension if it has been identified as being too tight. Ask for more detailed information before going ahead with this procedure. Ask whether the tape is more likely to curl, fold bunch once it has been cut and what would the surgeon would do to repair this if this became a problem. (It can make it much harder for a surgeon to remove the mesh fully once the tape has been snipped)
• Do I need a trans-labial ultrasound scan to ascertain exactly where the mesh is? Is this is possible?
• How many surgeries will need to be done to remove the mesh?
• Will it only be you operating or how many other surgeons will be involved during your mesh removal procedure?
• Are you able to fix the problem without using more mesh?
• How many native tissue repair have you done and how regularly do you do them?
• Have your patients had any problems with native tissue repairs?
• Can you fix incontinence at the same time as the removal of mesh?
• How many patients improve, symptoms stay the same or get worse after mesh removals?
• Is there a possibility that I may become incontinent after removing the mesh?
• Do you think that I will need a urinary catheter to void after the operation and how long would this be for?