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Ethicon Media Monitoring 09/02/16
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Patient fears surgical mesh agonies won't stop despite changes
Sep 2, 2016 | New Zealand Doctor Online
By Keira Stephenson
Carmel Berry awoke after a uterine prolapse repair feeling as though someone had left a needle inside her. It took two years before doctors realised surgical mesh had triggered an ongoing foreign body response. -
Surgical mesh statement
Sep 2, 2016 | New Zealand Doctor Online
By Ian Page
Sufferers of surgical mesh complications, feel that their concerns are not being taken seriously and a number of surgeons are still brushing aside safety concerns about mesh, or are not informed enough themselves to be able give their patients enough information to make informed consent. -
Patient Advocates Wanted for Training
Sep 1, 2016 | Mesh Medical Device Newsdesk
If you have worked with others to help with mesh-induced injuries, this workshop may be the next step in your journey.
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Patient fears surgical mesh agonies won't stop despite changes
Sep 2, 2016 | New Zealand Doctor Online
By Keira Stephenson
Carmel Berry awoke after a uterine prolapse repair feeling as though someone had left a needle inside her. It took two years before doctors realised surgical mesh had triggered an ongoing foreign body response.
The condition has left Ms Berry on so much pain medication, she shakes.Ms Berry and fellow surgical mesh sufferer Charlotte Korte petitioned Parliament in 2014.
In Parliament last week, health minister Jonathan Coleman tabled his response to a health select committee interim report on their petition. Dr Coleman said the Government would:
• investigate options for a centralised surgical mesh registry to record complications
• communicate with medical colleges to review best practice around informed consent for surgical mesh patients
• encourage health providers to ensure coding information is consistent so complications can be identified and monitored
• encourage adverse events reporting as applicable
• endorses ongoing education for surgeons on use of surgical mesh and mesh removal surgery, and
• consider expanding Medsafe’s role to assess the quality and safety of medical devices.
Ms Berry and Ms Korte are disappointed by the “soft” wording in both the committee’s report and Dr Coleman’s response.
The minister agrees with the report, Ms Berry notes, but she says the Government has set no timeline and no accountability or key performance indicators. A registry should have been set up two years ago, but they are only now “investigating options” for one.
The women also want mandatory reporting of mesh-related adverse events.
ACC accepts more than 600 claims
ACC has accepted more than 600 claims for injury related to surgical mesh, but it says only about 10 per cent of sufferers make claims, Ms Berry says. Some have private insurance, others do not think they have a treatment injury.
A Medsafe adverse event report shows the agency received 101 reports into adverse events surrounding surgical mesh between 2005 and 31 May 2016. Only 16 were from patients themselves, two from health professionals, 56 from ACC, and the rest from manufacturers and suppliers.
Survey shows almost 90 per cent not warned
In a survey released by the group Mesh Down Under, of which Ms Berry and Ms Korte are members, very few of the 57 respondents were warned of the potential risks associated with surgical mesh.
Ninety-one per cent were not offered any alternative treatment, a media release from Mesh Down Under says.
It says 80 per cent required one or more revision surgeries, and one person needed 71 operations; 44 per cent said mesh hadn’t cured their condition. Despite this only 20 per cent had reported their cases to Medsafe.
The survey also showed that of those patients who told their GP about their problems with mesh, 75 per cent found their GP had little or no knowledge of mesh complications.
Specialty well aware of risks
Chair of the NZ Committee of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists Ian Page says the specialty is well aware of the risks and benefits of “all treatments for the conditions we are asked to treat”.
“Mesh is not particularly different in that regard,” Dr Page says in a statement for New Zealand Doctor.
He points out that the college and other medical bodies have clear guidelines around consent, with specific information sheets relating to the issues around mesh, including the lack of robust evidence for its use in pelvic organ prolapse.
Dr Page encourages patients who feel they haven’t been adequately informed to go to the health and disability commissioner.
A plea for GPs
Ms Berry asks that GPs finding their patients still have pain at their six-week check-up after surgery to “please take it seriously”.
She would also like GPs referring patients to specialists, to be able to explain the risks of mesh, refer them to research and invite patients to come back and talk to them if there are any complications.
Baddock supports registry
NZMA GP Council chair Kate Baddock says she has been in support of a surgical mesh registry for some time.
Dr Baddock says there can occasionally be complications with non-gynaecological use of mesh, but in pelvic repairs, the mesh is generally much closer to the surface and the tissue can become eroded allowing the mesh to poke through.
She believes there is now much greater shared decision-making around surgical mesh for gynaecology, and surgeons are much more thoughtful and careful about using it and explaining the risks to patients.http://www.nzdoctor.co.nz/news/2016/september-2016/02/patient-fears-surgical-mesh-agonies-won't-stop-despite-changes.aspx
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Sep 2, 2016 | New Zealand Doctor Online
By Ian Page
Statement for New Zealand Doctor from Ian Page chair of the NZ Committee for the Royal Australian and New Zealand College of Obstetricians and Gynaecologists
Sufferers of surgical mesh complications, feel that their concerns are not being taken seriously and a number of surgeons are still brushing aside safety concerns about mesh, or are not informed enough themselves to be able give their patients enough information to make informed consent.
They are also concerned that the surgeons are only worried about the safety risk of one type of mesh, when they have met people suffering from mesh complications from all types of mesh, from tape, to mesh for treating hernias.
Do you think their concerns are well-founded?
In general I doubt their concerns are well-founded, although there will always be episodes that occur which support them. Overall the specialty is well aware of the risks and benefits of all treatments for the conditions we are asked to treat. Mesh is not particularly different in that regard. It has, as with drugs, taken a while for all the complications to become apparent. It takes even longer for their frequency to be ascertained so that adequate information can be given to patients to assess the risk: benefits of undertaking any treatment.
What is the college doing to address these concerns, especially around truly informed consent?
Guidance regarding consent for the use of Mesh can be found at http://www.ranzcog.edu.au/document-library/polypropylene-vaginal-mesh-implants-for-vaginal-prolapse.html . The Medical Council of New Zealand1, the Health and Disability Commissioner Act2 and RANZCOG3 all make their expectations around consent clear. Consent is recognised as a process of communication between the doctor and the patient, and requires the active participation of both. It is not for the College to regulate the practice of doctors, which responsibility lies with MCNZ, although we have advised the use of IUGA information sheets with regard to Mesh surgery. Where patients feel they have not been fully informed we encourage them to return to discuss their concerns with their doctor. Should that not satisfy their concerns they are able to take the matter up with the Health and Disability Commissioner.
For consent to be fully-informed all the information regarding risk and benefit has to be available to the doctor and the patient. This requires both short and long-term follow-up of treatments, whatever their nature, and this principle applies to all interventions. To put the information into context, the exact numbers of interventions and their outcomes (good and bad) also need to be available so that the level of risk can be determined. The outcome of doing nothing also has to be included in the discussion.
Are surgeons offering or able to offer alternatives to using mesh and why or why not?
The initial discussion with any patient is to ascertain whether or not they would benefit from treatment, and then to ascertain just how bad their symptoms are. That sets the stage for advising as to the most appropriate treatment. Surgeons have always been able to offer alternatives to Mesh, as usually there were treatment options that pre-dated the arrival of Mesh. However those options were by no means perfect, which is why new ideas have been adopted in the hope of improving outcomes.
Do you support a registry of all mesh implants?
It is clear that, as with all procedures and medications, the information available is unlikely to be complete and therefore accurate. The introduction of a Registry for data collection with respect to Mesh surgery and its complications would require significant resources from the Ministry of Health but the College would be supportive of such a Registry being established.
Would you like to see better clinical trials required to ensure the safety of mesh?
All products and drugs have to undergo assessments before they are licensed for use. The greater the number of trials, the better the quality of the information they will provide. However the trade-off is that it will take longer to get the information, and so can delay the introduction of useful treatments.
Are there surgeons who are able to remove mesh from patients who are experiencing complications?
The principles surrounding this are no different to those that apply to any procedure. The doctor performing a procedure should have had adequate training in the procedure, and the management of its complications. There are multiple gynaecologists in both Auckland and Wellington with formal training in the use of Mesh and experience in its insertion and removal.
http://www.nzdoctor.co.nz/un-doctored/2016/september-2016/02/Surgical-mesh-statement.aspx
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Patient Advocates Wanted for Training
Sep 1, 2016 | Mesh Medical Device Newsdesk
If you have worked with others to help with mesh-induced injuries, this workshop may be the next step in your journey.
An Introductory Patient Training Workshop (attached and below) in DC on Oct 14-15 is offered by the National Center for Health Research. The goal is to help patient advocates understand the research issues that are key to developing safe and effective medical treatments.
Please share with any patient advocates (patients or family members) who are interested in learning about the research issues pertaining to how to advocate for safe, effective, and more affordable medical treatments. There are only a couple more spots left so anyone working as a patient advocate already would be most suitable for this opportunity.
http://www.meshmedicaldevicenewsdesk.com/patient-advocates-wanted-training/
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