OTTAWA, May 13, 2014 /CNW/ - 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
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
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
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
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.
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SOURCE: Health Canada
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