Recently there has been a great deal of interest in this area with multiple media reports highlighting the complications of these devices. Patients are understandably concerned and GP colleagues are requesting information/guidance in this controversial space.
Where are we now?
The withdrawal of trans vaginal mesh (TVM) for prolapse and the reduction of available slings provides a challenge to Gynaecological and Urology specialists in their management of patients with incontinence and prolapse. In many senses we have gone back to historical operations, with the limitations of native tissue repairs and (potentially) more morbidity.
However attention focused on TVM has highlighted the need for proper assessment of surgical devices before they are introduced into the market.
www.tga.gov.au/media-release/strengthening-assessment-medical-devices-and-information-consumers
A number of initiatives have commenced:
- The Senate enquiry has looked at the scope of the problem and received input from:
- patients who have had complications as a result of trans vaginal mesh
- clinicians who operate to insert and those who manage mesh complications
- representatives of government bodies including regional WA health representatives and the TGA
- Local experts who have submitted, including Drs Nic Tsokos, Michelle Atherton and Jessica Yin
- Australian Commission on Safety and Quality in Health Care (ACSQHC) have formed a working group to help guide and make recommendations with respect to the management of female Stress Urinary Incontinence (SUI) and POP. The working group includes urologists, urogynaecologists, colorectal surgeons, a physio, a RACGP rep and 2 TGA reps. It is anticipated that within 6 months final documents including patient information brochures, suggested clinical pathways and GP info will be created. In addition, credentialing criteria, ongoing skill maintenance and a possible TV mesh registry will be addressed.
- A Mesh Information phone line and dedicated mesh complication clinic has been established at KEMH. While the Urogynaecology Department has always handled complex mesh patients, a help line and extra resources have been allotted to deal with an increasing number of potential patients. (See below for further information).
Whilst these initiatives are laudable, the recommendations may not be available for some time. At the coalface GPs are today being inundated with patients requesting information, investigations and referrals that may be outside their scope of expertise.
Additional changes in the industry
The TGA has now removed all TV prolapse mesh and single incision slings (“Minislings”) from the Australian Register of Therapeutic Goods (ARTG)\. Essentially this means that TV mesh prolapse repair is no longer a surgical option (unless confined to a clinical trial where it would require approval by the TGA through a special access scheme). Minislings have also been cancelled from the registry. This leaves retropubic and obturator mesh midurethral slings as an option to treat stress incontinence.
www.tga.gov.au/alert/tga-actions-after-review-urogynaecological-surgical-mesh-implants#actions
www.tga.gov.au/alert/tga-actions-after-review-urogynaecological-surgical-mesh-implants
Johnson & Johnson have ceased supply of all TV mesh slings in Australia (Jan 2018). This includes TVT (ironically the best studied MUS), TVT-exact, TVT-Abbrevo and TVT-O. Boston Scientific and Coloplast have agreed to comply with the recent TGA requirement to update the wording in their product IFUs, so these 2 companies will continue sales of their sling products.
Important points for our GP colleagues
Transvaginal Prolapse Mesh. Whilst initially promising a more durable result in comparison to native tissue repairs, TV prolapse mesh has, over time, declared itself as problematic with complications being evident many years after insertion. By and large TV prolapse mesh has been abandoned except in very specific recurrent prolapse and usually after assessment of the patient by a multidisciplinary team (see above TGA recall).
Abdominal mesh sacroplexy is still offered as a surgical option without, it seems, the same rate of long-term complications.
Mesh midurethral slings (MUS) are still regarded as the gold standard operative management of stress urinary incontinence. It is recognised, though, that very significant complications can occur with these slings particularly if they are over tightened, placed in patients with suboptimal tissues or intraoperative bladder perforation goes unrecognised. Fascial slings are an alternative choice for patients who have already experienced a complication with a mesh MUS or who are reluctant to undergo a mesh sling. Full discussion of the pros and cons of each operation should be mandatory and patients should be encouraged to get a 2nd opinion if they are at all concerned.
Referral: is it a mesh problem?
In WA the centre with the most experience in dealing with recurrent prolapse and mesh complications is that of the Urogynaecology unit at KEMH. This unit is staffed by Urogynaecologists, Urologists, Pelvic floor physiotherapists, with access to imaging and interventional radiology, Pelvic Pain Specialists and Colorectal services are available. It is a public service and many of the clinicians do offer similar assistance through their private rooms.
One of the challenges faced is determining exactly what operation has been done and what device has been implanted. To assist, ANY information regarding the operation, surgeon, hospital location etc should be included with a referral. Original operative notes may help identify the location (or, sometimes, the absence) of mesh.
4D ultrasound imaging may be helpful in locating mesh but currently we are seeing a situation where patients are pressuring their GPs for 4D US without any specialist assessment beforehand. In some cases patients have requested this imaging despite the fact that they do not have a mesh sling.
Imaging should limited to patients who have had a proper specialist assessment such that appropriate clinical information can be requested from the radiologist. Recently one of the private imaging services has ceased doing 4D ultrasounds because of the number of inappropriate referrals.