VAGINAL MESH FAQ. How do you decide who should get mesh as part of their repair?

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1 VAGINAL MESH FAQ How do you decide who should get mesh as part of their repair? Each patient with pelvic organ prolapse (POP) is considered individually. In younger women, women with an uncomplicated prolapse and women who have had no prior vaginal surgery use of mesh would be extremely unusual. Mesh is only used once I feel all other options have been exhausted and if the patient and I together feel this is the best option for her. Is every patient given written information on the procedure they are having before the operation? Yes. Everyone is sent home with some reading material around their operation whether it be for mesh or any other operation, and they are shown a DVD while still in hospital. They are also generally advised that if they have questions and wish to be seen again before their operation they can contact the rooms. How many operations involving major uro-gynaecological procedures associated with pelvic floor dysfunction do you do per working week? Most of the major surgery I do involves pelvic organ prolapse. I operate every week. Who do you report adverse events to? Adverse events at the time of operation or in the post-operative period are reviewed by the Gillies Hospital surgical review committee. This is a group of independent surgeons that review the case and the surgeon is also invited to the review. How do you assess the patient s quality of life after having one of these procedures? There is a questionnaire that all patients are encouraged to fill in prior to surgery and at their postsurgery follow up that is to assess this. Do you take ongoing pain into account when evaluating success? Very much so. Are recurrent UTI s monitored? Yes. Probably more by the primary care giver i.e. GP but we do ask all patients if they have had issues and if this becomes an issue later the GPs will generally re-refer. If the extrusion rate is less than 2.3cm, is mesh removal thought of as viable? Approximately half of mesh exposures will heal with oestrogen cream and time. This conservative management is usually offered initially and if there are still issues at follow up then removal is recommended. However this affects everyone differently. I know of at least 2 ladies who have refused to have anything done as they have no symptoms so we continue to follow them up.

2 Is referred pain considered as related to mesh complications? Everyone with pain is assessed as an individual as there are no two people the same. Certainly if it was felt the mesh was responsible for the referred pain this would be considered a complication. Does age play a role in the decision not to remove surgical mesh? No although health may. Signing of the consent form seems to be done on the day of operation. Given the concerns raised by the FDA and others about mesh, and the right for patients to proper informed consent, do you think that this should be done earlier giving the patient more time to understand exactly what type of procedure they are having and have a greater understanding of the possible complications associated with surgical mesh? There is a lot of counselling with regard choices and risks of procedure in the clinic at the time of placing someone on the surgical waiting list. I endeavour to send everyone home with written information so they can read this at their leisure. I m happy to see them back in clinic to further discuss options if they wish. By the time they get to the day of surgery I would hope they are happy with what is going to happen and the possible risks they are taking. Although I go through the procedure and risks again on the day of surgery and sign the consent form the patients should have had every opportunity prior to that generally stressful time to discuss any concerns. This is my practice for all operations. Not just vaginal mesh for pelvic organ prolapse. Following the suspension of surgical mesh procedures in Scotland and investigations being carried out overseas by several countries; has this prompted you to establish new guidelines for the use of surgical and for informed consent procedures? I have specific selection criteria that need to be met prior to considering a vaginal mesh and since Johnson & Johnson has pulled their meshes I use the information leaflet designed at Auckland Hospital which covers the recommendations of the FDA IUGA UGSA and RANZCOG. I also attend a monthly Multidisciplinary meeting which include Urogynaecologists, Urologists, Radiologists, Physios and Nurses, at which our more complex patients are presented and management options discussed. This includes patients from both the private and public sector. As the women with recurrent prolapse are obviously more complex will be at putting anyone being considered for vaginal mesh for prolapse through this meeting as a further check. All options and recommendations from this meeting are then taken back to the patient who then has a say, with this information, on what they would like to proceed with or not. Do you as a surgeon implanting surgical mesh have the necessary skills to achieve a full explant of the mesh devices implanted? Yes, although I will seldom explant an entire mesh alone. There are 3 surgeons who have been trained to place vaginal mesh for POP at OneSixOne. A full explant of a vaginal mesh placed for prolapse is a highly risky procedure for the patient concerned. Therefore the decision to explant is not taken lightly and generally this will be done as a team i.e. more than one urogynaecologist and urologists and/or colorectal surgeons as appropriate

3 How do you deal with complications? Patients with complications after surgery involving mesh insertion are discussed at our regular multidisciplinary meeting, including anyone from my private practise. If the mesh is to be removed or explanted this would be a team approach with Urogynaecology working with Urologists or colorectal surgeons depending on the complication. We are fortunate at OneSixOne that we have a team of Urogynaecology surgeons who are happy to work together to the benefit of our patients. TVT Some people still consider TVT a vaginal mesh and with that I agree but there is a huge body of research behind TVT or sub urethral slings that to shows that it is a safe procedure. All regulatory bodies apart from Scotland have come out and said exactly that. The latest being the Australian TGA (therapeutic goods administration) who have just finished a review into Urogynaecological surgical mesh implants. They state. Specifically, the review found that the use of urogynaecological surgical mesh devices for the surgical treatment of stress urinary incontinence and abdominal pelvic organ prolapse repair is adequately supported by the evidence. This is in line with the FDA s statement. The risk of significant complications in having a TVT or like sub urethral sling placed is rare. However it is a foreign body and issues do happen. The majority are to do with the way they are placed by the surgeon not the mesh material itself. Vaginal prolapse Information about vaginal surgery Using mesh Prolapse is a weakness of the supporting structures of the vagina, allowing the pelvic organs to press against the vaginal wall, producing a bulge. This can cause pressure, discomfort, difficulty with passing bowel motions and sometimes pain. Prolapse is not dangerous or life threatening but it can be distressing and bothersome, limiting physical and sexual activity. Repair using mesh Vaginal prolapse repair using mesh is only used for severe prolapse or where prolapse has recurred after a traditional repair. Vaginal mesh can be placed in any area of the vaginal walls, depending on the prolapse. This is usually done under a general anaesthetic or regional block such as a spinal anaesthetic. It involves making an incision in the vaginal skin such that the mesh can be inserted. The vaginal wall is then closed with dissolvable stitches. A catheter is placed in the bladder and a pack or large tampon in the vagina to apply pressure to the wound(s). Vaginal mesh surgery is only performed by surgeons who specialise in this technique or by a gynaecologist supervised by a doctor with the necessary training and experience.

4 Complications The success rate of the surgery is about 85-90%. Serious complications are uncommon with this type of surgery. However, no surgery is without risk. The main potential complications of all vaginal surgery include: 5-15% of women will develop recurrent prolapse. 10% of women develop a post-operative vaginal infection despite having antibiotics at the time of surgery. 1-5% develop a urinary tract infection. 5% may develop urinary leakage that was not present before surgery, especially after a large prolapse is repaired. 1% have difficulties passing urine, necessitating prolonged (i.e. longer than 1 week) postoperative catheterisation. 1-5% experience constipation or failure to correct pre-operative symptoms like incomplete bowel evacuation. Rarely, the bladder, urethra, bowel or ureters may inadvertently be damaged. This is usually repaired during surgery but further surgery may be required. Less than 1% of patients have excessive bleeding requiring blood transfusion. Clots can form in the legs or lungs after surgery. Risks specific to vaginal mesh include: In 5-10% of women the mesh shows through the vaginal skin (mesh exposure). This is usually treated with vaginal oestrogen and/or simple re-suturing but if exposure persists further surgery may be required. Stopping smoking and pre- and post-operative vaginal oestrogen have been shown to decrease this risk. Very rarely, the mesh can show through into the bladder or the bowel. This can require further surgery. Equally rarely, a fistula may form (i.e. a false tract between the vagina and the bladder or bowel). This may require further surgery. 5% can have ongoing vaginal pain or pain with intercourse that may require further surgery or intervention. Other options for treatment You have the option of not being treated for prolapse. If symptoms are tolerable, it does not require treatment. You can try using a ring pessary to support the vaginal walls (which does not require surgery). Sometimes pelvic floor exercises can improve symptoms. The vaginal surgery can be performed with no mesh. The surgery can also be approached from the abdomen with or without mesh. While your doctor is offering you the vaginal approach using mesh at this time, you can further discuss each of these options. You can choose. What to expect after surgery? You will be given medication for post-operative pain. Remember that Panadeine increases the risk of constipation so ensure that you have an adequate intake of fibre and fluids in your diet. If constipation is a problem, use the Lactulose or Laxsol that has been prescribed or you can discuss options with your pharmacist.

5 You may have some light vaginal discharge for 4 to 6 weeks. This should be light bleeding or spotting only and may vary as healing occurs and your stitches dissolve. Do not use tampons, pads are a better option. You may feel the vagina to be lumpy or raised; this is vaginal tissue, NOT the return of your prolapse and should improve within 6 months. We recommend that you do not self-examine or self-assess your operative site until you have been examined by the doctor post operatively. What to do after surgery Start pelvic floor exercises after 4 weeks. Go for walks but do not carry anything over 7kg. Remember to rest. If you are tired and uncomfortable, you have been doing too much and need to slow down. When emptying your bladder, sit on the toilet, feet flat, and lean forwards. Drink 6-8 glasses of fluid per day. Limit your caffeinated drinks to 1 per day. Ensure your fibre intake is 30g per day minimum. Do not stand for long periods (i.e. longer than 30 minutes at a time). Do not drive a car for 4 weeks. Do not make a bed for 2 weeks. Do not hang out washing for 4-6 weeks. Do not use your vaginal oestrogen for 4 weeks. Do not stretch upward for 6 weeks. Do not do any lifting for 6 weeks (i.e. anything over 7kg). Do not lift anything over 15kg for the rest of your life. Do not have sexual intercourse for 6 weeks. Follow-up appointment You will be seen in clinic 6 to 8 weeks after the operation. If everything is well, the success of your operation should be permanent. Dr Mairi Wallace 161 Gillies Avenue Epsom, Auckland Tel:

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