A GLOBAL HEALTH CRISIS – PELVIC MESH IMPLANTS
It has taken some time for the scale and extent of the impact of pelvic mesh implants for women to treat stress urinary incontinence and pelvic organ prolapse. Once hailed as the perfect solution for an enduring surgical fix for these non-life-threatening conditions, it has left a swathe of women with permanent, life altering consequences. Persistent pelvic pain at rest. Inability to have sex. Inability to continue working, and the financial impact often amplified by failed marriages as the lack of intimacy took its toll. The full list of complications is listed on the Therapeutic Goods Administration mesh hub.
In 2017 Australia undertook a Senate Inquiry – entitled Number of women in Australia who have had transvaginal mesh implants and related matters. We literally did not know how many women had been impacted. There were 13 recommendations in the final report, with a mix of federal and state responsibilities to effect implementation. There was even one on effective informed consent processes. It was clear from submissions and hearings that women were not informed about the potential horrific consequences of their choice, and that the mesh is extremely complex to remove. With the divide of responsibility between state and federal governments and the fact that most of the implant surgeries were performed in private hospitals, it is difficult to track real progress. Some meshes have been banned from use, but by no means all. Many women are still unaware that their sequelae of symptoms are related to their mesh implants. GPs and specialists may also be unaware.
WA PELVIC MESH SUPPORT GROUP
The peer support group the WA Pelvic Mesh Support Group has its own website and is an essential stakeholder in WA’s response to the mesh crisis.
WA PELVIC MESH COMPLICATIONS CLINIC
This clinic has been set up in King Edward Memorial Hospital and has been operating since 2017. There is a committee of clinicians and consumers who meet to discuss the clinic’s model and progress, as this area is complex and changing. The committee continues to aim to advance the recommendations of the Inquiry.
UNFINISHED BUSINESS – A NATIONAL FORUM ON THE IMPACT OF MESH IMPLANTS
A National Mesh Implant Forum was held in Melbourne on Friday April 5, 2019, to consider all aspects of Australia’s mesh implant crisis. The Forum was proudly convened by the Health Issues Centre and Health Consumers NSW, Health Consumers Queensland, Health Consumers’ Council (WA), Health Consumers Alliance of South Australia, Health Care Consumers (ACT), Health Consumers Tasmania.
The event brought together mesh injured consumers, carers, regulatory authorities, health officials, the Chair of the Senate Inquiry into mesh and consumer advocates to create solutions and bring about real change. The forum considered not only the impact of pelvic mesh, but the emerging parallel crisis involving people who have received hernia mesh implants. A full report is available here.
NEW REPORT – HERNIA MESH IMPLANTS – CONSUMER SURVEY
Health Issues Centre Victoria initiated the Mesh Device and Implant Failure study late last year and of the respondents, a sizeable 183 patients have already reported major problems with their hernia mesh implants. 70 per cent of these are men. You can read the report here.
According to publicly available figures nearly 100,000 Australians are hospitalised for hernia each year. However, the numbers of patients that go on to have pelvic mesh implants and that are negatively impacted is not known. People who would like to report complications of hernia procedures using mesh can complete the survey here.
PELVIC MESH FAQs
What is pelvic mesh?Pelvic Mesh refers to polypropylene mesh implants to treat women treated for stress urinary incontinence or pelvic organ prolapse.
What are the complications of pelvic mesh?Complications include pain, inflammatary reactions to the mesh, persistent infections, bleeding, with the mesh kinking, moving or migrating and causing damage to surrounding organs.
The actual number of women who experience complications may be under-reported, so while some women experience the benefits from implants, other women experience any or all of these complications as they are listed below from Australia’s Therapeutic Goods Administration (TGA) website: 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.
I've been told that it is a new type of mesh, or that it's a sling. Is this the same?Mesh, tape, sling - it is all polypropylene mesh. It is a complex area and rapidly changing so clinicians may not be aware that they are in essence, all the same. If you don't want mesh, you have the right to request native tissue repair or a procedure like a Burch colposuspension. It is your body and you need to feel confident you are providing informed consent.
What are the alternatives to using mesh for incontinence and prolapse?Non-surgical options includes physiotherapy and pessaries. Surgery should be considered a last resort when all other options have been exhausted.
There are surgical options which don't include mesh such as Native Tissue Repair and Burch Colposuspension. Have a look at the Australian Commission on Safety and Quality in Healthcare's resources on this page for Pelvic Organ Prolapse and Stress Urinary Incontinence and remember the key advice that surgery should be the last resort when all other options have been exhausted.
You will be the one who will bear the consequences if you do have complications from the mesh, so it's important that you provide informed consent. 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 - plus it is useful to ask how many of the same procedures your surgeon has done, and what the outcomes have been. Any reluctance to answer this question may signal you have not found the right surgeon for you.
Is mesh banned?No it is not banned. It has been banned for some, but not all types of pelvic organ prolapse surgery, but for the most common surgery, stress urinary incontinence, it has not been banned. From 1 December 2018, all new surgical mesh devices seeking approval from the TGA will need to meet the higher evidentiary requirements of a Class III medical device. This does not apply to mesh devices already on the TGA register however.
Can I get the mesh taken out?It is very difficult to fully remove mesh. Women are offered partial removals of mesh, for example snipping of the part protruding through the vaginal wall. Many women do not want partial removals as the remaining mesh frays and causes ongoing issues, and it may be more difficult to get the rest of the mesh out. Some women have taken the decision to self-fund and travel overseas to where other surgeons more experienced in full mesh removal may be able to provide assistance. We are continuing to work on this as a nation and the options are continually evolving. The WA Pelvic Mesh Support Group can be an important source of support to find out latest options, or you can call the Health Consumers Council on 9221 3422/ 1800 620 780 for country callers, or email info@hconc.org.au
What help is available for women?- You can call the WA Pelvic Mesh Clinic line at King Edward Hospital on 1800 962 202. This is answered from 8.30-4pm Monday to Friday, 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. You will be linked with the Mesh Clinic for an appointment if appropriate. Unfortunately there are currently long waiting times for appointments.
- In WA there is the WA Pelvic Mesh Support Group which can connect you with women who have had these procedures
- Take this information sheet to your trusted health provider to discuss your current or future options
What has been done about regulating mesh?The Therapeutic Goods Administration (TGA) regulates medications and medical devices. However, the evidence required to register a device is by no means as comprehensive as that required to register a medication.
What can I do to report complications?You can register your complications on The Therapeutic Goods Administration (TGA) website here: https://www.tga.gov.au/alert/urogynaecological-surgical-mesh-complications
You can also call the Mesh Line if you are in WA on 1800 962 202
What happened about the Senate Inquiry into mesh?A Senate Inquiry into pelvic mesh was held in 2017, and the Recommendations have largely been accepted by our nation's Health Minister, who apologised to women harmed by mesh implants. They are currently in the early stages of being implemented, and health consumer councils across Australia are working with key bodies to ensure that there is a more consistent approach across Australia.
What about hernia mesh?Hernia mesh is emerging as the next key area of interest. The complications are very similar, as is the negative impact on people, and the difficulties they can face in getting help. A new peer group has been started in WA - Mesh Too Western Australia.
Pelvic Mesh refers to polypropylene mesh implants to treat women treated for stress urinary incontinence or pelvic organ prolapse.
Complications include pain, inflammatary reactions to the mesh, persistent infections, bleeding, with the mesh kinking, moving or migrating and causing damage to surrounding organs.
The actual number of women who experience complications may be under-reported, so while some women experience the benefits from implants, other women experience any or all of these complications as they are listed below from Australia’s Therapeutic Goods Administration (TGA) website: 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.
Mesh, tape, sling - it is all polypropylene mesh. It is a complex area and rapidly changing so clinicians may not be aware that they are in essence, all the same. If you don't want mesh, you have the right to request native tissue repair or a procedure like a Burch colposuspension. It is your body and you need to feel confident you are providing informed consent.
Non-surgical options includes physiotherapy and pessaries. Surgery should be considered a last resort when all other options have been exhausted.
There are surgical options which don't include mesh such as Native Tissue Repair and Burch Colposuspension. Have a look at the Australian Commission on Safety and Quality in Healthcare's resources on this page for Pelvic Organ Prolapse and Stress Urinary Incontinence and remember the key advice that surgery should be the last resort when all other options have been exhausted.
You will be the one who will bear the consequences if you do have complications from the mesh, so it's important that you provide informed consent. 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 - plus it is useful to ask how many of the same procedures your surgeon has done, and what the outcomes have been. Any reluctance to answer this question may signal you have not found the right surgeon for you.
No it is not banned. It has been banned for some, but not all types of pelvic organ prolapse surgery, but for the most common surgery, stress urinary incontinence, it has not been banned. From 1 December 2018, all new surgical mesh devices seeking approval from the TGA will need to meet the higher evidentiary requirements of a Class III medical device. This does not apply to mesh devices already on the TGA register however.
It is very difficult to fully remove mesh. Women are offered partial removals of mesh, for example snipping of the part protruding through the vaginal wall. Many women do not want partial removals as the remaining mesh frays and causes ongoing issues, and it may be more difficult to get the rest of the mesh out. Some women have taken the decision to self-fund and travel overseas to where other surgeons more experienced in full mesh removal may be able to provide assistance. We are continuing to work on this as a nation and the options are continually evolving. The WA Pelvic Mesh Support Group can be an important source of support to find out latest options, or you can call the Health Consumers Council on 9221 3422/ 1800 620 780 for country callers, or email info@hconc.org.au
- You can call the WA Pelvic Mesh Clinic line at King Edward Hospital on 1800 962 202. This is answered from 8.30-4pm Monday to Friday, 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. You will be linked with the Mesh Clinic for an appointment if appropriate. Unfortunately there are currently long waiting times for appointments.
- In WA there is the WA Pelvic Mesh Support Group which can connect you with women who have had these procedures
- Take this information sheet to your trusted health provider to discuss your current or future options
The Therapeutic Goods Administration (TGA) regulates medications and medical devices. However, the evidence required to register a device is by no means as comprehensive as that required to register a medication.
You can register your complications on The Therapeutic Goods Administration (TGA) website here: https://www.tga.gov.au/alert/urogynaecological-surgical-mesh-complications
You can also call the Mesh Line if you are in WA on 1800 962 202
A Senate Inquiry into pelvic mesh was held in 2017, and the Recommendations have largely been accepted by our nation's Health Minister, who apologised to women harmed by mesh implants. They are currently in the early stages of being implemented, and health consumer councils across Australia are working with key bodies to ensure that there is a more consistent approach across Australia.
Hernia mesh is emerging as the next key area of interest. The complications are very similar, as is the negative impact on people, and the difficulties they can face in getting help. A new peer group has been started in WA - Mesh Too Western Australia.