Transvaginal Mesh Implants - links and statements
Published: 26 April 2017
Links and statements referred to in tonight's story
WEBLINKS FOR COMPLAINTS
Relevant Healthcare Complaints Commission for each state
NSW & ACT: www.hccc.nsw.gov.au
Australians Pelvic Mesh Support Group – https://www.facebook.com/groups/AustralianPelvicSupportGroup/ OR email Caz Chisholm (founder) email firstname.lastname@example.org
From a spokeswoman for the TGA:
• TGA regulates transvaginal meshs in accordance with an internationally harmonised risk based approach.
• All urogynaecological meshes approved for supply in Australia have undergone conformity assessment to demonstrate that the device complies with requirements for safety and performance and received their conformity assessment certification either from a EU certification body or the TGA.
• The TGA has been monitoring urogynaecological meshes since 2008, and in 2010 undertook a post market review of this family of products. The review found that, at that time, the reported rate of complications was low.
• When complications did occur it found that this was closely linked to the skill and training of the surgeon and the patient selection.
• In 2013, TGA commenced a more extensive clinical review of each individual urogynaecological mesh device that was available and on the Australian Register of Therapeutic Goods and in August 2014, the TGA published a web statement on the results of a review by clinical experts. The findings re-enforced the importance of appropriate patient selection, surgeon experience and the need for informed patient consent. As a consequence of the review product delistings occurred in August 2014, February 2015 and November 2015.
• To date (20 April 2017), the TGA has received 205 adverse event reports, involving 227 patients, associated with the use of these devices. Compared with the 100,000 devices estimated to have been sold in Australia since 2000, this represents 0.2%.
• The TGA is working closely with the Australian Commission on Safety and Quality in Health Care with respect to the safety of these devices and has been engaged with international regulators on the issue. The TGA’s current positon is aligned with the other regulators in relation to regulatory action.
• On 15 February 2017, the Senate referred the matter to the Senate Community Affairs References Committee for inquiry and report into the number of women in Australia who have had transvaginal mesh implants and related matters. It is expected that interested parties such as individual patients, patient groups, health professionals and associated colleges, industry and government will be making submissions. The inquiry is expected to report back to the Senate by 30 November 2017.
• Urogynaecological mesh devices manufactured using materials that are of a biological nature are classified as Class III medical devices and have undergone a detailed assessment of the device prior to approval which has included the requirement for conformity assessment certification by the TGA and that the conformity assessment procedures have been applied in its manufacture.
• As most urogynaecological meshes are classified as risk Class IIb the conformity assessment was undertaken by EU certification bodies.
• However, since 2014 the TGA has implemented increased pre-market scrutiny for all applications for these devices. In addition to the EU approval, all new applications for these devices are subjected to a pre-market assessment by TGA which includes assessment of the clinical evidence.
• Post-market monitoring by the TGA is carried out to ensure the ongoing regulatory compliance and safety of medical devices supplied to the Australian market. In support of the TGA's postmarket monitoring activities, the sponsor of a medical device has ongoing responsibilities once a device has been included in the Australian register.
STATEMENT FROM ETHICON (distributor of Johnson & Johnson):
Patient safety is our first priority. We empathize with all women suffering from pelvic organ prolapse and stress urinary incontinence, which can be serious and debilitating conditions, and are always concerned when a patient believes they have experienced an unexpected or undesirable outcome.
Ethicon's devices are among the most studied products for these conditions. TVT, TVT-O and PROLIFT were developed by surgeons seeking to address the shortcomings of other treatment options for stress urinary incontinence and pelvic organ prolapse. As other devices emerged, Ethicon continued to work in conjunction with doctors to provide them with additional options. These devices have helped millions of women suffering from stress urinary incontinence and pelvic organ prolapse. The success experienced by the vast majority of women who have been helped by these devices mirrors the scientific data and demonstrates that the devices should remain available as options for women, and their healthcare providers, who could benefit from their use in the future.
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) issued a position statement on mid-urethral slings, stating that mid-urethral slings “…have been shown to be as effective as more invasive traditional surgery with major advantages of shorter operating and admission times, and a quicker return to normal activities, together with lower rates of complications. This has resulted in mid-urethral slings becoming the operation of choice in Europe, the United Kingdom, Australasia and the USA for treatment of stress urinary incontinence.” The statement continued: “There is robust evidence to support the use of mid-urethral slings from over 2,000 publications making this treatment the most extensively reviewed and evaluated procedure for female stress urinary incontinence now in use.”
For more information, please review the following website of the UroGynaecological Society of Australasia: http://www.ugsa.org.au/news.php
With regard to the number of complaints received, in the period between 2004/5 – 2013, the rate was less than 0.2% for Ethicon tape devices, and less than 0.1% for Ethicon mesh.
In addition, I’d like to point you to a variety of third-party reports that address many of the topics raised in your inquiry, particularly your questions about clinical evidence:
• Position statement on midurethral slings by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and the Urogynaecological Society of Australasia (UGSA) (March 2014)<http://www.ugsa.org.au/data/Position_statement_on_midurethral_slings_C-Gyn_32_2.pdf>
• Medicines and Healthcare Products Regulatory Agency, A Summary of the Evidence on the Benefits and Risks of Vaginal Mesh Implants (October 2014)<https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/402162/Summary_of_the_evidence_on_the_benefits_and_risks_of_vaginal_mesh_implants.pdf>
• Cochrane, Mid-urethral sling operations for stress urinary incontinence in women (July 2015)<http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006375.pub3/abstract;jsessionid=5C6FE8342F49C31093DFCA984C6A983D.f01t02?systemMessage=Wiley+Online+Library+will+be+disrupted+on+11th+July+2015+at+10%3A00-16%3A00+BST+%2F+05%3A00-11%3A00+EDT+%2F+17%3A00-23%3A00+SGT+for+essential+maintenance.+However+there+may+be+a+possible+delay+so+the+start+time+may+change.++Apologies+for+the+inconvenience.>
• European Commission Scientific Committee On Emerging And Newly Identified Health Risks, Final Opinion on the Safety of Surgical Meshes Used in Urogynecological Surgery (December 2015)<http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_049.pdf>
• The Scottish Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women: Final Report (March 2017)<http://www.gov.scot/Publications/2017/03/3336>
• Position Statement: Mesh Midurethral Slings for Stress Urinary Incontinence by American Urogynecologic Society; the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction; The American Association of Gynecological Laparoscopists; The American College of Obstetricians and Gynecologists; The National Association for Continence; The Society of Gynecologic Surgeons; Women’s Health Foundation (June 2016)<http://www.augs.org/p/cm/ld/fid=814>
As noted in the Cochrane Review, “[m]id-urethral sling operations have been the most extensively researched surgical treatment for stress urinary incontinence (SUI) in women and have a good safety profile.” There are over 1000 studies involving mid-urethral slings, including particularly Ethicon’s TVT and TVT-O devices.