Information Regarding the Transvaginal Implantation of Surgical Mesh Devices for the Treatment of Pelvic Organ Prolapse and Stress Urinary Incontinence

Starting date:

May 13, 2014

Type of communication:

Information Update

Subcategory:

Medical Device

Source of recall:

Health Canada

Identification number:

RA-39507

• Issue
• What you should do
• Report health or safety concerns
• Related AWRs
• Media enquiries
• Public enquiries

Issue

OTTAWA – Health Canada is informing patients about the potential risk of complications associated with transvaginal implantation of surgical mesh devices for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).  Although many women treated with these devices have had good outcomes, Health Canada continues to receive reports of complications.

The use of transvaginal mesh devices for POP and SUI repair has been associated with reports of acute or chronic pain, pain during sexual intercourse, mesh erosion and shrinkage, infection, urinary problems, organ or blood vessel perforation, nerve damage, bleeding, vaginal tightness and/or shortening, and recurrent POP and SUI.  Additional surgery may be required and may not fully correct some complications.

Health Canada is reviewing labelling related to these products to determine if it provides appropriate safety information. Additional safety information in the labelling will be requested, as needed.

It is important to recognize that there is a risk of complications with any surgical procedure. Some of these complications can also occur with non-mesh surgery.  There may be some similar risks when using transvaginal mesh devices to treat POP and SUI, but the complications differ in their severity, how frequently they occur, and how they are managed. 

POP occurs when the tissues holding the pelvic organs weaken and the pelvic organs fall into the wall of the vagina.  The organs involved in POP may include the bladder, the uterus, the vagina, the small bowel, and/or the rectum. The mesh products reinforce the weakened vaginal wall in order to treat POP. SUI is an involuntary leakage of urine during an activity such as sneezing, coughing, laughing or physical movements.  The mesh products support the urethra in order to treat SUI.

In Canada, medical devices such as surgical mesh are subject to a rigorous review process regarding their safety and effectiveness prior to being approved for use.

The Department continues to monitor the safety of surgical mesh devices for the treatment of SUI and POP and will inform Canadians, as appropriate, if new safety information is identified.

What you should do

• Before surgery, ask your surgeon about all POP and SUI treatment options, including non-surgical and surgical (with or without mesh), and understand the pros and cons of each treatment option. 
• Ask for and review a copy of the patient information that comes with the mesh product, if available.
• Discuss any questions and/or concerns with your health care professional.
• If you have had a mesh procedure to treat POP or SUI without complications or symptoms, continue with routine follow-ups as recommended by your surgeon. Contact your surgeon if you develop any complications.

Report health or safety concerns

To report a side effect to a health product to Health Canada:

• Call toll-free at 1-866-234-2345
• Visit Health Canada’s Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Related AWRs

Surgical Mesh - Complications Associated with Transvaginal Implantation for the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse - Notice to Hospitals

2014-05-13 | Health products

Advisory

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709