Transvaginal Mesh - frequently asked questions

All persons meeting the following criteria, or their estate, are covered by the class action:

• You currently reside in Quebec
• You have had a transvaginal mesh product(s), specified below, implanted between November 14, 2016 and April 27, 2023, or, you had an earlier implanted mesh product and received relevant medical care as documented by medical records after November 14, 2016
• Your implant is one of the following Coloplast devices: Aris, Exair, Minitape, Novasilk, Omnisure, Restorelle Direct Fix Anterior, Restorelle Direct Fix Posterior, Supris or T-Sling

AND

• You claim to have suffered damages in connection with the implantation of one of these transvaginal mesh products.

To find out more about the different categories of indemnity and the exclusions to the agreement, go to How will the Special Master determine which damage tier my case belongs to?

The claim period is now over.

The Settlement provides, among other things, for financial compensation for eligible members who have suffered damage following the implantation of transvaginal mesh products. Compensation under the Agreement for eligible claimants ranges from $2,000 to $55,000. You can consult the assessment criteria that will guide the determination of compensation.

Coloplast will also pay to settle members' valid claims with the Régie de l'assurance maladie du Québec, the costs of administering the Settlement, and Class Counsel's legal fees and disbursements.

Under the terms of the Settlement, all claimants' files will be analyzed by an independent certified urologist, also known as the “Special Master” within the Settlement Agreement. This Special Master has been jointly selected by the Parties to the class action. The Special Master will analyze the medical files received and determine the amount of compensation to which the claimant is entitled, based on the damages suffered and according to the criteria set out in Schedule D of the Settlement.

Transvaginal mesh devices are implanted for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP).

No. The following Coloplast devices are covered by the Settlement, i.e.:

• Aris,
• Exair,
• Minitape,
• Novasilk,
• Omnisure,
• Restorelle Direct Fix Anterior,
• Restorelle Direct Fix Posterior,
• Surpris,
• T-Sling.

BE ADVISED that on April 28, 2023, the Court also authorized the discontinuance of the class action with respect to the Altis and Restorelle Y mesh products. Therefore, prospective members who have received an Altis or Restorelle Y product are no longer covered by the class action. Limitation periods (i.e. prescription) are no longer suspended and began to run again on June 12, 2023. After the limitation periods, your right to sue will be extinguished.

The claim period under the settlement agreement approved by the Superior Court on November 29, 2023, is now over. You can no longer submit a claim.

If you did NOT submit your claim form on time, you will not be eligible for any benefits under the Settlement Agreement.

No. Firstly, the claim period is now over. Secondly, on April 28, 2023, the Court authorized a discontinuance with respect to the subclass of potential indirect claimants (including spouses and common-law partners). As a result, the members of this sub-class are no longer covered by the class action and are not included in the Settlement Agreement.

Limitation periods (i.e. prescription) are no longer suspended and have begun running again on June 12, 2023. After the limitation periods, your right to sue will be extinguished.

If you have submitted a claim, your medical records has been reviewed by an independent certified urologist (“Special Master” in the Agreement) who has determined whether you were eligible to receive compensation under the Agreement and, if so, the amount of that compensation. The Special Master was chosen by mutual agreement by the parties.

The Special Master has made this determination based on the assessment criteria agreed upon by the parties and set out in Schedule D of the Agreement (see answer to the question How will my benefit be calculated?).

On May 21, 2025, Judge Poulin delivered a final decision regarding the claimants who requested a review of the Special Master's determination.

The Special Master, an independent certified urologist, has determined which of the following five tiers your case belonged to, taking into consideration the elements detailed below.

If you belong to Tier 1, you are not eligible for compensation under the Agreement.

Tier 1: Not eligible for inclusion in the Agreement (exclusion)

1. Product in place ("PEP") with no current adverse events
2. Claimants with Altis, Restorelle Y, Restorelle M, Restorelle L, Restorelle XL and Restorelle Contour or biological implants
3. No post-implant medical records provided
4. Claimants implanted with another manufacturer’s surgical mesh implant(s) to treat stress urinary incontinence and/or pelvic organ prolapse where either: (1) the claimant settled with the other manufacturer and there is no indication in the medical records that the Coloplast device directly contributed to the alleged injuries; or (2) the medical records demonstrate that the other surgical mesh implant(s) to treat stress urinary incontinence and/or pelvic organ prolapse directly contributed to the alleged injuries/subsequent procedures
5. Claimants with prior pelvic surgeries that contributed to the alleged injuries/subsequent procedures as noted in the medical records
6. Claimants whose medical records include a notation, prior to the date of surgery, from a doctor indicating that there was a robust discussion of the risks, benefits and adverse events
7. Claimants with post-implant procedures that were never recommended by a physician and for which there are no documented complaints related to her surgical mesh implant(s) in any medical records
8. Claimants who had exposures that were effectively treated with estrogen cream
9. Claimants whose medical records demonstrate that the surgical technique used to place the surgical mesh directly contributed to the alleged injuries (e.g., subsequent notation that the sling was placed around the bladder neck)
10. Medical records demonstrate claimant noncompliance with postoperative instructions
11. Post-procedure hematoma within the first week after implant and/or abscess occurring within 12 weeks after the implant procedure that was in direct relation to the alleged injuries.
12. Claimants whose alleged injuries are caused by preexisting overactive bladder
13. Claimants whose alleged injuries are caused by preexisting interstitial cystitis
14. Surgeon implemented poor patient selection (patient had a preexisting history of any condition listed under the “Contraindications” section in the applicable Instructions for Use, including but not limited to pregnancy or desire for future pregnancy; known active urinary tract infection and/or infection in operative field; abnormal urethra (e.g. condition, including known or suspected pelvic pathology; sensitivity/allergy to polypropylene))

Tier 2 : Recovery range of up to $2,500

1. Subsequent in-office procedure with or without local anesthetic
2. SUI claimants with subsequently placed full-length slings to treat voiding dysfunction
3. POP claimants with subsequently placed POP mesh to treat prolapse in different compartments

Tier 3 : Recovery range between $2,000 and $35,000

1. One revision procedure
2. One revision recommended by a physician
3. Documented history of chronic pain, subsequent to the implant, treated by trigger point injections and/or nerve blocks.

NOTE : A “revision,” as used within this document, is defined as a subsequent surgical procedure performed in an operating room under general anesthesia or monitored anesthesia care (“MAC”) (i.e., an anesthesia specialist provides care during the surgery), recommended by a physician, wherein the device was partially or completely removed. The reason for the removal must be either infection of mesh material as confirmed by pathology, documented chronic pain, or documented exposure or extrusion.

Tier 4 : Recovery range between $2,000 and $50,000

1. Two revision procedures, as defined above

Tier 5 : Recovery range between $2,000 and $55,000

1. Three or more revision procedures, as defined above.
2. Extraordinary injuries (includes organ perforation by the mesh unrelated to surgical error, fistula if related to the mesh).

Class Counsel's legal fees will be paid by the Defendant. No percentage will be deducted from your compensation to pay Class Counsel's fees. However, once your compensation has been calculated, certain taxes will be deducted from your compensation and a percentage depending on the total amount of your compensation after deduction of taxes will be paid to the Fonds d'aide aux actions collectives, in accordance with the Règlement sur le pourcentage prélevé par le Fonds d'aide aux actions collectives.

The Special Master has also taken into consideration the following factors to determine the precise amount of your compensation: 

Class Counsel's legal fees will be paid by the Defendant. No percentage will be deducted from your compensation to pay Class Counsel's fees. However, once your compensation has been calculated, a percentage depending on the total amount of your compensation will be paid to the Fonds d'aide aux actions collectives, in accordance with the Règlement sur le pourcentage prélevé par le Fonds d'aide aux actions collectives.

In accordance with the Settlement Agreement, the class counsel have submitted a report detailing all accepted claims to the Court in order to request the necessary authorization for the distribution of compensation.

The hearing is scheduled for September 18th, 2025.

As soon as the Court's distribution order becomes final, i.e., 31 days after the notice of judgment is issued, Coloplast will be able to send us the funds necessary for the payments. Subsequently, the payments will be able to be issued.

Your compensation will be paid by cheque and sent by mail.

It is IMPORTANT to inform us of any change of address. Otherwise, you may not receive your cheque.

No, you had 15 days after receiving the Special Master's decision to request a review. As the deadline has expired, you can no longer request a review of the Special Master's decision.

You can no longer apply to the Court’s managing Judge for a final adjudication of your claim. You had to do so within 15 days of receipt of the Special Master’s final assessment.

The Fonds d'aide (also known as FAAC) is a provincially-created organization whose function is to provide financial aid to class representatives to enable them to bring a class action. FAAC is entitled to a portion of the indemnities paid in certain class actions under Quebec legislation. These percentages are detailed in the Regulation respecting the percentage withheld by the Fonds d’aide aux actions collectives.

The Proactio team cannot advise you in this regard. Please consult an accountant or tax specialist.

You can no longer object to the Settlement Agreement. The deadline to object was August 4, 2023.

On November 29, 2023, Justice Poulin declared that the modified Agreement is reasonable, fair, adequate and in the best interests of the class members. She thus approved the modified Agreement.

The Agreement as modified and approved by the Superior Court on November 29, 2023, binds all class members who have not opted-out.

You can no longer opt-out of the class action. The deadline to opt-out was August 4, 2023.

The Agreement as modified and approved by the Superior Court on November 29, 2023, binds all class members who have not opted-out.

If you have opted-out of the class action, you cannot claim compensation under the modified Settlement.