Pelvic Mesh – Consumer Update

Background

Pelvic Mesh refers to polypropylene mesh implants to treat women treated for stress urinary incontinence or pelvic organ prolapse. There has been significant media coverage on the topic, including an acknowledgement by the AMA that their role in developing mesh products and that it was “not their finest hour”. Media coverage highlights the little known reality that when a pelvic mesh implant goes wrong, it can go badly wrong, with life-changing, permanent effects. This is of particular concern given that stress urinary incontinence is not a painful or life-threatening condition. Complications can occur any time from straight after surgery to years afterwards. The Therapeutic Goods Administration (TGA) has recently banned all transvaginal mesh implants to treat pelvic organ prolapse. The Health Consumers’ Council has joined the call of all Consumer Councils across Australia to call for a complete ban. The TGA list of complications from the implants is on the  bottom of this page.

1800 Mesh Line – 1800 962 202

WA Health have created a 1800 number based at King Edward Memorial Hospital, answered from 8.30-4pm with a Message Bank for after hours or when the line is busy. The person answering the phone is not a doctor, nurse or midwife. The purpose of the 1800 Line is to gather information about women who have had mesh whether or not they have had complications. Women will also be supported in obtaining their medical records and will be referred for medical follow up if required. HCC encourages you to ring the line if you have any concerns. There is also a new WA Health website page with information on Mesh. Also, we have created a short survey for you to give feedback about your call to the 1800 Mesh Line and encourage you to provide feedback on your experience.

Senate Inquiry

In 2017-18 a Senate Inquiry was undertaken entitled “Number of women in Australia who have had transvaginal mesh implants and related matters” which highlights that we simply don’t know how many women have had these implants, and how many of them have suffered complications. A public hearing was held in Perth on 25th August 2017. You can listen to the recording here.

As part of the Senate Inquiry submission process, the Health Consumers’ Council worked with all the equivalent bodies across the nation to work on a consumer-informed submission to the Inquiry. Health Issues Centre Victoria hosted an anonymous survey which yielded more than 1700 responses, a significantly larger number than the 100+ adverse reports the TGA had collected. Our Submission is now in the public domain: Combined Australian State HCCs Final Report Transvaginal Mesh Senate Inquiry 31052017

You can also read our Open letter to the Australian Commission on Safety and Quality in Health Care  which is a combined response with Mesh Support Groups across Australia as well as health consumer councils across Australia. The Commission is responsible for many of the Recommendations. We are urging them to ensure they are all implemented, and in partnership with women affected by mesh implants.

Peer Support Group

Women face many barriers when seeking treatment after things have gone wrong. Getting diagnosed can be very difficult, and most of the care is poorly co-ordinated and mainly in the private sector, causing a cost burden to the women impacted. The Australian Pelvic Mesh Support Group is a key resource for women affected. At the beginning of 2017 there were 400 members but this number has ballooned out to more than 1,000 in the wake of the media coverage. There is also a WA specific Mesh Facebook Group, WA Mesh Ladies.

A face to face facilitated therapeutic support group runs at Women’s Health and Family Services, 227 Newcastle Street, Northbridge. The group meets 12.30-2.30, on the third Thursday of the month. The first meeting for 2018 is 17th January 2018. See the flyer for further details.

Consumer information Sheet

The health consumers councils across Australia have developed a Consumer Information Sheet which appears below and is also available as a PDF. Please contact us on info@hconc.org.au or 9221 3422 if you have any comments or concerns.

For women who have had, or are considering having surgery to treat stress urinary incontinence and pelvic organ prolapse

If you have been diagnosed with pelvic organ prolapse or stress urinary incontinence, it is important to explore non-surgical options such as physiotherapy and pessaries. It is important that all non-surgical options have been exhausted before surgery is considered.

Surgery for these two conditions are usually involves a mesh insertion or implant. It might be called tape or a sling. It is all the same from a consumer perspective and these products are collectively known as mesh. The Therapeutic Goods Advisory Website has an updated list of complications associated with surgery using mesh. https://www.tga.gov.au/alert/urogynaecological-surgical-mesh-complications

Mesh implants have been offered to women since the late 1990s. The procedure is considered to be only partially reversible, and some women have travelled to America at their own expense to have mesh removed.

There may be other surgical options such as native tissue repair for you to discuss with your clinician. Before you consent to any surgical procedure, it is important to ask all the questions you need so you understand what you are consenting to. The Choosing Wisely campaign has created these questions to help you get started. http://www.choosingwisely.org.au/resources/consumers/5-questions-to-ask-your-doctor

1.      Do I really need this test or procedure?

Tests may help you and your doctor or other healthcare provider determine the problem and the procedures that may help to treat it.

2.      What are the risks?

Will there be side effects? What are the chances of getting results that aren’t accurate? Could that lead to more testing or another procedure?

3.      Are there simpler, safer options?

Sometimes all you need to do is make lifestyle changes, such as eating healthier foods or exercising more. Another option to ask your doctor about is native tissue repair.

4.      What happens if I don’t do anything?

Ask if your condition might get worse — or better — if you don’t have the test or procedure right away.

Stress urinary incontinence is not a life-threatening condition so consider carefully before undergoing any surgery. Do not consider surgery until all non-surgical options have been exhausted.

5.      What are the costs?

Costs can be financial, emotional or a cost of your time. Where there is a cost to the community, is the cost reasonable or is there a cheaper alternative?

What help can I access?

Having A Say

  • The Therapeutic Goods Administration (TGA) is seeking information from members of the public about complications. https://www.tga.gov.au/alert/urogynaecological-surgical-mesh-complications
  • The Australian Commission into Safety and Quality in Healthcare is also undertaking work develop guidance for consumers, clinicians and health services on the use of transvaginal mesh products for the treatment of pelvic organ prolapse and stress urinary incontinence. Consumer consultations were undertaken and further work is progressing as noted on the webpage. The Commission formed the Reference Group prior to the Senate Inquiry being announced. See https://www.safetyandquality.gov.au/our-work/transvaginal-mesh/ for more details.

Complications associated with use of Pelvic Mesh

These are listed on Australia’s Therapeutic Goods Administration (TGA) website as follows: https://www.tga.gov.au/alert/urogynaecological-surgical-mesh-complications

  • punctures or lacerations of vessels, nerves, structures or organs, including the bladder, urethra or bowel (these may require surgical repair)
  • transitory local irritation at the wound site
  • a ‘foreign body response’ (wound breakdown, extrusion, erosion, exposure, fistula formation and/or inflammation)
  • mesh extrusion, exposure, or erosion into the vagina or other structures or organs
  • as with all foreign bodies, mesh may potentiate an existing infection
  • over-correction (too much tension applied to the tape) may cause temporary or permanent lower urinary tract obstruction
  • acute and/or chronic pain
  • voiding dysfunction
  • pain during intercourse
  • neuromuscular problems including acute and/or chronic pain in the groin, thigh, leg, pelvic and/or abdominal area
  • recurrence of incontinence
  • bleeding including haemorrhage, or haematoma
  • seroma
  • urge incontinence
  • urinary frequency
  • urinary retention
  • adhesion formation
  • atypical vaginal discharge
  • exposed mesh may cause pain or discomfort to the patient’s partner during intercourse
  • mesh migration
  • allergic reaction
  • abscess
  • swelling around the wound site
  • recurrent prolapse
  • contracture
  • scarring
  • excessive contraction or shrinkage of the tissue surrounding the mesh
  • vaginal scarring, tightening and/or shortening
  • constipation/defecation dysfunction
  • granulation tissue formation.

 

Author: Pip Brennan, Executive Director of the Health Consumers’ Council. Consumer Member on the Australian Commission on Safety and Quality in Health Services Transvaginal Mesh Reference Committee.