Johnson & Johnson / Ethicon Class Action

This class action includes any person who was implanted, in Australia, with one or more of the tape and mesh implants listed below used to treat stress incontinence or prolapse and suffered complication(s).

The implants are:

• Gynecare Prolift Pelvic Floor Repair Systems (Anterior, Posterior and Total);
• Gynecare Prosima Pelvic Floor Repair Systems (Anterior, Posterior and Combined);
• Gynecare Prolift+M Pelvic Floor Repair Systems (Anterior, Posterior and Total);
• Gynecare TVT;
• Gynecare TVT - Abbrevo;
• Gynecare TVT – Secur;
• Gynecare TVT Exact;
• Gynecare TVT - Obturator; and
• Gynecare Gynemesh PS Nonabsorbable polypropylene Mesh.

How do I find out the type of implant I received?

You may request a copy of the operation report directly from the hospital where you underwent your mesh surgery. Alternatively, you can request this information from your treating surgeon who performed your mesh surgery.

Shine Lawyers can make these inquiries for you and assist you in confirming your implant type(s).

What happens if I have received more than one implant or an implant from another

You remain a group member of this class action even if you have received an Ethicon/Johnson & Johnson implant and another implant from a different manufacturer.

If you have been implanted with a mesh or tape implant manufactured by American Medical Systems you may also be a group member in a second class action being advanced by Shine Lawyers against Astora Women’s Health, LLC (Astora) (formerly known as American Medical Systems, LLC) or Boston Scientific Incorporation.

If you believe that you have received an implant manufactured by Boston Scientific Incorporation or Astora please send the details of your procedure and a copy of any records you hold to [email protected].

The following is a list of the implants included in the AMS class action:

• Apogee Vaginal Vault Prolapse Repair System;
• Perigee Prolapse Repair System;
• Elevate Prolapse Repair System;
• MiniArc Single-Incision Sling;
• MiniArc Precise Single-Incision Sling;
• MiniArc Pro Single-Incision Sling System;
• RetroArc Retropubic Sling System;
• Monarc Subfascial Hammock; and
• Sparc Self-Fixating Sling System.

If you are group member in this class action you will be required to supply some records relevant to your assessment – including medical records. We recommend keeping a record of any medical practitioners you have attended in relation to your mesh or tape complications.

Please be aware medical records are usually destroyed after a period of 7 years, we therefore recommend you contact your medical practitioner and request that your medical records are not destroyed.

What do I do with my medical records?

If you hold a copy of any records in relation to your implant or treatment, please send these to our mesh legal team by email to [email protected] or by post to:

Shine Lawyers – Class Actions PO Box 12011 George Street QLD 4003

We will keep a copy of any relevant records on file.

The Court has determined that the Ethicon/Johnson & Johnson mesh and tape implants cause the following complications:

• a chronic inflammatory reaction of the tissues surrounding the implants, which is affected by conditions which affect the immune response and healing, including autoimmune and connective tissue disorders;
• extrusion or erosion of the mesh into surrounding organs, including the vaginal wall, bladder or urethra;
• infection;
• chronic pain;
• pain during sexual intercourse (dyspareunia);
• abstinence from sexual intercourse (apareunia);
• difficulty voiding;
• offensive vaginal discharge;
• de novo or recurrent urinary incontinence;
• damage to surrounding organs, nerves, ligaments, tissue and/or blood vessels;
• haemorrhage;
• leg weakness;
• psychiatric injury;
• the need for re-operation or revision surgery associated with complications;
• the need to remove the implant or part of the implant;
• complications associated with the removal of the implanted device or part of the implanted device, which might prove difficult or impossible, including aggravation of existing complications;
• difficulty defecating; and
• recurrence of prolapse.

Where can I go to get advice on whether the complications I am suffering is related by my implant?

If the class action is resolved by way of a settlement at or following the mediation in May 2020, a settlement framework will be established for the purpose of assessing women’s complications and whether they are related to their Ethicon/Johnson & Johnson implants.

At this stage, we are not in a position to review individual women’s cases for the purpose of advising whether their implants are the cause of their complications. Until a process is established either as part of a settlement or otherwise to assess registered group members’ claims, we encourage you to seek advice from your treating doctor.

At this stage we are unable to provide any specific advice as to what compensation may be payable to group members who are found eligible to participate in compensation as part of any settlement or court framework.

Group members may be entitled to the following types of compensation depending on their individual circumstances:

• pain and suffering;
• past and/or future out-of-pocket expenses;
• past and/or future care and domestic assistance;
• past and/or future economic loss or loss of income.

As part of any award for compensation, certain refunds may be required to be paid back to Medicare, Private Health Funds and other entities such as Centrelink. Whether or not refunds are owed will depend on the specific circumstances of each registered group member’s claim and will be determined when calculating compensation.

Participating in the mesh class actions will not expose you to any out of pocket costs.

All costs will be borne by Shine Lawyers and in the event of a successful outcome, any costs payable to Shine Lawyers will be deducted from, and will not exceed, any compensation you may be entitled to.

Unfortunately, it is not possible to provide timeframes or estimates of when we expect the class action to resolve.

Future timeframes depend on many factors, including whether a settlement can be reached as well as the outcome of Ethicon and Johnson & Johnson’s application for special leave to appeal the Full Federal Court’s judgment to the High Court of Australia.

A hearing will be held later this year for the High Court to determine whether special leave should be granted to Ethicon and Johnson & Johnson.

We will continue to send updates to group members advising them of developments as they are available.

If you have completed and returned a Claimant Registration Form and have decided that you no longer want to be involved in the class action, you are free to make this choice, and you are not obligated to participate.

However, if you decide not to participate and a settlement(1) is reached, you will not be able share in the settlement sum, or bring a separate claim against the Respondents.

If a settlement is not reached, we may proceed to an individual assessment process as part of a judgment(2). If this occurs and you have not completed a Claimant Registration Form you will still be able to participate in that assessment process. However, if you choose not to participate in that process, you will not be able to bring a separate claim against the Respondents.

1. settlement is an agreement between the parties that is intended to resolve the dispute, this agreement must be approved by the Court.

2. judgment is the decision of a judge or judges and is the final determination of the matter, this includes after any appeal.

Who should I speak to about the treatment I am receiving?

As we are not medical professionals, unfortunately we are unable to provide you with advice regarding your treatment options.

If you have any concerns regarding your own health, complications or treatment, we suggest that you speak with your doctor or specialist. If you are unhappy with your treatment or advice, it is advisable that you seek a second professional opinion.

Is it normal to feel depressed or suicidal?

We understand that women have suffered enormously in relation to their implants and that this can be overwhelming and cause you to feel alone. If you feel depressed, anxious or suicidal we urge you to contact your GP or Lifeline Australia to ensure you get the help you need. You can call Lifeline at any time on 13 11 14.

Where can I connect with other women experiencing these issues?

We understand that these complications can leave women feeling isolated. There are a number of support groups available online on social media which may provide an opportunity for you to connect with other women.

Please keep in mind that any information you provide online or elsewhere may be considered at a later stage in the assessment of your potential claim.

Where you are located isn't necessarily a barrier when it comes to obtaining the services of a lawyer. Shine Lawyers have offices in the following locations, but as part of our service offering, home or hospital appointments can be arranged at your convenience.

The short answer is no, however the manufacturers have ceased supplying the following implants:

• GYNECARE GYNEMESH PS Nonabsorbable PROLENE Soft Mesh.
• GYNECARE PROLIFT Total, Anterior and Posterior Pelvic Floor Repair Systems;
• GYNECARE PROSIMA Anterior, Posterior and Combined Pelvic Floor Repair Systems;
• GYNECARE PROLIFT+M Total, Anterior and Posterior Pelvic Floor Repair Systems; and
• GYNECARE TVT SECUR System.

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 don’t amount to negligence on the part of your doctor.

Because of this, our legal team has made the decision to pursue claims against the manufacturers rather than the doctors who prescribed them.

This class action is separate from any other class action, including those in the United States. While we endeavour to keep a close eye on settlements and court outcomes in other jurisdictions, these have no direct impact on Australian proceedings.