Approval in Australia

First urogynaecological meshes approved for supply in Australia

first adverse event

TGA receives the first adverse event report relating to a urogynaecological mesh

Safety Communication Recommendation

The US-FDA issues a Safety Communication recommending that surgeons should undertake specialised further training and should notify patients that mesh is permanent, complications can occur, and these cannot always be resolved with further surgery.

TGA investigates Australian adverse event reports for urogynaecological meshes and consults an expert panel. It is agreed that the TGA will continue to monitor mesh reports and emerging clinical evidence.

TGA and NZ Medsafe seek advice from the Medical Device Incident Review Committee. The committee emphasises the need for informed patient consent and surgeon training when using such devices.

US-FDA releases statement

A literature review demonstrates conflicting information on the success rates for transvaginal mesh placement and further investigation is required.

Health Canada & TGA Review

Health Canada releases a notice to hospitals informing healthcare professionals of the complications associated with urogynaecological mesh. TGA undertakes a targeted postmarket review of specific urogynaecological meshes in response to a report that meshes are difficult to visualise once implanted.

FDA releases advise about adverse events

FDA releases an updated communication advising that adverse events a no longer considered rare, there is no compelling evidence of greater success with mesh in posterior compartment, and some evidence of greater efficacy in anterior compartment. All patients should be advised that long-term data on safety of mesh is limited and alternatives to mesh should be discussed.

TGA postmarket review

FDA issues orders for manufacturers to conduct postmarket surveillance. TGA publishes a web article, Concerns with urogynaecological surgical mesh implants. TGA commences a comprehensive postmarket review of published literature for urogynaecological meshes.

Urogynaecological Devices Group established

Australian Department of Health establishes a Urogynaecological Devices Working Group to consider the available clinical evidence and to contribute to the postmarket review activities being undertaken by the TGA. TGA commences a broad review of all urogynaecological meshes available in Australia.

International reports of complications

Health Canada issues an updated notice to hospitals and patients advising that Health Canada continues to receive reports of complications, including some serious and life altering events. Scottish Cabinet Secretary for Health and Wellbeing appeals to NHS Scotland to suspend transvaginal mesh procedures pending the outcome of an independent review. The MHRA releases a statement that there is no regulatory justification for removing surgical mesh from use in UK hospitals. TGA reports on the postmarket review into all urogynaecological meshes available for supply in Australia and there is a significant reduction in the number of urogynaecological meshes available on the Australian market.

International Reviews and reports

New Zealand report into the safety of surgical mesh is published. Scottish independent review into urogynaecological mesh – interim report is published. NHS England Releases the Mesh Working Group Interim Report. European Commission (SCENIHR 2015) report into the safety of urogynaecological meshes suggests limiting mesh surgical procedures wherever possible, certification systems for surgeons, and appropriate patient selection and counselling. A Cochrane Review is released comparing mesh to native tissue repair for POP and reports that while permanent mesh has some advantages over native tissue, there are also disadvantages in its routine use. The Lancet publishes a Scottish multi-centre trial into urogynaecological mesh (PROSPECT study). It finds no benefit in using mesh for surgical treatment of POP in comparison to traditional surgical methods. TGA is considering taking appropriate regulatory action.

Mandatory reporting and recommendations of adverse events

FDA reclassifies urogynaecological POP mesh as Class III – a high risk device. Manufacturers are given 30 months to provide updated evidence. The reclassification does not apply to all implantable meshes. NZ House of Representatives Health Committee releases a report that includes a recommendation for the establishment of a centralised surgical registry. RANZCOG releases a response welcoming the report and the recommendation that meshes remain available as a surgical option. The Australian Pelvic Mesh Support Group meets with Ministerial Advisors and senior Department of Health officers. This meeting includes discussion on how to encourage patient adverse event reporting in Australia. TGA publishes a web article urging the reporting of adverse events relating to urogynaecological surgical mesh. Health Canada considers powers to require mandatory reporting of adverse events by healthcare institutions – Vanessa’s Law. RANZCOG publishes a statement advising that transvaginal mesh is not recommended as the first line of treatment for any vaginal prolapse. Surgeons should consider clinical trial recruitment for use of any new mesh types.

Class action Suit and regulatory reclassification of all surgical mesh

The EU confirms regulatory reclassification of all surgical mesh to Class III and Australia proposes to commence the regulatory process to reclassify all surgical meshes as Class III (the USA the reclassification of meshes which occurred in 2016 is limited to urogynaecological mesh used in POP). Scottish independent review into urogynaecological mesh – final report published. 4 July, 2017 a class action against Johnson & Johnson Medical Pty Ltd and Ethicon commences in the Federal Court of Australia.  30 November, 2017, the TGA announced that it had decided to remove transvaginal mesh devices solely used for the treatment of POP from the Australian Register of Therapeutic Goods (ARTG). In making this announcement, the TGA advised that, following a review of the latest international studies and the clinical evidence for each product, it was of the belief that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks the devices pose to patients. The ACSQHC reached a similar conclusion in September 2017.

Senate Enquiry

On 15 February 2017, the Senate referred the following matter to the Senate Community Affairs References Committee for inquiry and report: “Number of women in Australia who have had transvaginal mesh implants and related matters”

The Liberal National Government invest $2.3 million

The Liberal National Government will invest $2.3 million over three years to improve health outcomes for the more than 20,000 women who undergo pelvic floor surgical procedures each year. Government funding will support the establishment of a Pelvic Floor Surgery Clinical Quality Registry to collect information about the safety of medical procedures and transvaginal surgical mesh devices which are used in the treatment of pelvic organ prolapse and stress urinary incontinence.

Johnson & Johnson / Ethicon class action won November 2019

On the 21st of November 2019 we welcomed the Court’s decision which found that Johnson & Johnson vaginal mesh and tape implants were not fit for purpose or of merchantable quality. Federal Court Judge Anna Katzmann also found that Johnson & Johnson and Ethicon Sàrl and Ethicon, Inc. were negligent and driven by “commercial opportunities”.
The class action, which is the largest women’s health action in Australian history, was filed by Shine Lawyers on behalf of over 10,000 Australian women who have been left with life altering complications after receiving Johnson & Johnson vaginal mesh or tape implants. This has been part of a global health crisis involving these products, which have had a devastating impact on hundreds of thousands of women whose lives were put on hold as they endured chronic and debilitating pain.

Boston scientific class action

This class action is on behalf of women who have received Boston Scientific vaginal mesh or sling implants through Shine Lawyers. The class action was filed in the Federal Court on the 22nd of March, 2021.

American Medical Systems Mesh (also known as Astora)

Also brought about by Shine Lawyers on 7th September 2021. You are a member of the AMS / Astora Mesh Class Action if you received one or more of their implants before 31 July 2018 and suffered complications as a result.

Second class action against Johnson & Johnson/Ethicon

Wednesday, 7 April, Shine Lawyers filed a second class action in the Federal Court on behalf of women who were implanted with defective mesh products after 4 July 2017

Friday 5th November Ethicon/Johnson & Johnson Special Leave date

The High Court of Australia is the last avenue available to J&J to appeal the Full Federal Court’s judgment delivered on 5 March 2021. In order to commence a formal appeal, J&J must be granted what is known as ‘special leave’ by the High Court. If the High Court refuses to grant special leave to J&J, then the decision of the Full Federal Court, in favour of the Lead Applicant and group members, will stand. If the High Court grants special leave to J&J to appeal the Full Federal Court’s decision, then Shine Lawyers and J&J (the ‘parties’) will proceed to a further hearing of the appeal before the High Court.The High court DENIED the appeal, therefore the next stage is settlement hearing for this case to be finalised.