Update: Filing of bankruptcy proceedings
In 2018, a class action was commenced in the Federal Court of Australia against American Medical Systems, LLC (AMS) on behalf of Australian women alleging that certain pelvic mesh and sling implants for the treatment of pelvic organ prolapse and stress urinary incontinence were defective and caused complications.
In February 2021, Astora Women’s Health, LLC (Astora) was substituted for American Medical Systems Medical.
On 16 August 2022, Astora commenced bankruptcy proceedings in the United States by filing a Chapter 11 Case in the United States Bankruptcy Court.
On 26 October 2022, the Federal Court of Australia recognised Astora’s bankruptcy.
The Federal Court of Australia, in recognition of the United States proceedings, placed ‘stay’ or hold on the Astora Class Action. A stay means that no further legal action can take place against Astora in Australia without approval of the Court, or Astora’s representative Mr Mark Bradley.
As a result of the bankruptcy proceedings, Shine Lawyers is taking steps to protect group members’ claims in the United States Bankruptcy proceedings. A Notice of the Commencement of the United States Bankruptcy proceedings is available here.
If you do not know what type of implant you received, you can request a copy of your operation report and product label from the hospital where you had the operation. If you need any assistance, please contact us on 1800 884 139 or firstname.lastname@example.org.
You should seek separate legal advice if you believe you have a claim against a surgeon, or any other person. Time limits apply to bringing these claims. You should seek independent legal advice urgently regarding these time limits.
What is the Astora Mesh Class Action about?
This class action relates to implants manufactured by American Medical Systems, LLC who supplied the implants in Australia (the AMS implants).
The AMS implants have been used to relieve stress urinary incontinence and pelvic organ prolapse, but have resulted in severe complications for many Australian women. These proceedings are brought on behalf of all women who have had one of the following implants inserted and suffered complications as a result:
Perigee Transobturator Anterior Prolapse Repair System;
Apogee Vaginal Vault and Posterior Prolapse Repair System;
Elevate Anterior and Apical Prolapse Repair System;
Elevate Apical and Posterior Prolapse Repair System;
SPARC Sling System;
MONARC Subfascial Hammock System;
MiniArc Single-Incision Sling System;
MiniArc Precise Single-Incision Sling System;
MiniArc Pro Single-Incision Sling System;
RetroArc Retropubic Sling System.
If you have received an AMS implant and want to be part of the class action, please contact us on 1800 884 139 or at email@example.com.
For more information about the products involved and further details about the class action, please see our FAQ section below.
The implants and complications that are covered by these proceedings are described in our pleadings accessible below.
Frequently Asked Questions
What is a class action?
When Governments, large companies or institutions do the wrong thing and people are harmed or suffer loss as a result, an individual can have little to no means of bringing a legal claim.
Class actions are an important mechanism within Australia’s legal system that allow large groups of people to come together to pursue a claim collectively.
For a class action to take place, there are three criteria that need to be met:
There must be 7 or more people that have claims against the same defendant; and
The claims relate to the same or similar circumstances; and
The claim must relate to at least one common issue of law or fact.
For more information about how class actions resolve, click here.
How long do class actions take to resolve?
It can take up to several years for a class action to resolve. The time taken from case commencement through to resolution and settlement administration depends on the particular case, and the nature of the claim.
For more information about class actions and how they work, click here.
Does it cost anything to join a class action?
Shine Lawyers is committed to ensuring that everyone, regardless of their background or financial situation, has access to justice. We run our class actions in a way that means you are not exposed to any costs or financial risk, so joining a class action will cost you nothing.
When a class action is successful, the legal fees and costs to run the class action are deducted from the settlement amount that is approved by the Court. If the class action is unsuccessful, we will ensure there are no out-of-pocket costs to you.
Will my contact details be kept private?
Yes, your contact details will remain confidential and we will seek your consent before disclosing any of your personal information (including before such disclosure is required by the Court).
Shine Lawyers will only use your personal information strictly for the purpose of the legal proceedings.
What implants are included?
The implants that we are investigating include:
Perigee Prolapse Repair System;
Apogee Vaginal Vault Prolapse Repair System;
Elevate Prolapse Repair System;
SPARC Self Fixating Sling System;
Monarc Subfascial Hammock;
MiniArc Single Incision Sling;
MiniArc Precise Single Incision Sling;
RetroArc Retropubic Sling System.
MiniArc Pro Single Incision Sling
The AMS implants are used to treat pelvic organ prolapse and stress urinary incontinence caused by weakened or damaged pelvic floor tissue.
It will be claimed that the implants were not fit for their purpose, were not of acceptable or merchantable quality and were not as safe as persons are generally entitled to expect, contravening the Trade Practices Act and Competition and Consumer Act. It will be alleged that AMS were negligent.
We are not investigating these implants or polypropylene mesh used in hernia repair.
What are some of the most common complications?
Many women have suffered complications because of the faulty mesh implants, including:
Recurrent stress urinary incontinence
Mesh erosion, also known as mesh extrusion or exposure, occurs when the mesh erodes through the vaginal wall or into nearby organs.
The US Food and Drug Administration (FDA) issued an announcement on 20 October 2008 advising of the serious complications associated with surgical mesh placed through the vagina to treat pelvic organ prolapse.
On 13 July 2012, the FDA issued an update advising that the serious complications associated with transvaginal mesh for pelvic organ prolapse were not rare.
Have the AMS mesh and tape implants been recalled?
While the AMS implants were not recalled, they are no longer available on the Australian market.
Is the class action against the doctors?
You may be angry or disappointed in your doctor and feel that they should have known the mesh was defective. You may also feel that your doctor was slow to respond to the side-effects you were experiencing.
While these feelings are completely valid, legally they do not amount to negligence on the part of your doctor.
Because of this, our legal team is investigating a claim against the manufacturers rather than the doctors who prescribed them.
What could I potentially claim in this class action?
You may be entitled to compensation, and if you are considered eligible for this then it will be assessed based on your injuries and whether they are ongoing.
However, you may be able to claim for:
Pain and suffering as well as loss of enjoyment of life
Past and future loss of earnings
Loss of earning capacity
Paid care and help such as nurses, gardeners, etc.
Past and future medical expenses
Meet the Astora Mesh Class Action team
Shine Lawyers’ Astora Mesh Class Action team includes some of the firm’s most experienced litigators, solicitors and support staff. You can learn more about the team running this class action by clicking on their profile below.