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The Toronto, Canada newspaper, The Globe and Mail, on May 7, Monday night published, “Time to discuss risks of surgical meshes.”
These are embarrassing issues to discuss says newspaper columnist, Andre Picard, because they involve so-called “private parts.” Most reporters don’t usually write about organs that protrude through the vagina or urine leakage when one moves, or coughs, which may explain why you haven't heard much about synthetic mesh (unless you read this site and others!).
Getting to the facts, Picard says that 25,000 Canadians undergo surgery to treat stress urinary incontinence (SUI) every year and about 5,000 women undergo surgery for pelvic organ prolapse (POP).
Picard says “more than 90 percent of the SUI surgeries and 30 percent of the POP surgeries include the insertion of a mesh.”
The Globe and Mail story adds that in 2010 Health Canada, that country’s version of our Food and Drug Administration (FDA), issued a warning that complications from mesh are possible including pain, vaginal and urinary infections, injuries to the bowel, bladder, and vagina.
(A July 13, 2011 FDA Safety Notification came out strongly suggesting that these complications are Not Rare and that a mesh repair may present more risks than benefits.)
Picard says the complication rate of mesh repair ranges from 2 to 15 percent, (though there is no data that has been made clearly available to date). Manufacturers say the complications may be due to “the skill and experience of surgeons, not the product itself.”
The Globe and Mail makes reference to a CTV News (Canadian television) story done April 18, by reporter Avis Favaro, who profiled two women injured by synthetic mesh who have joined a class action lawsuit in that country.
Favaro told MDND today, “We didn’t expect the response we got. We were flabbergasted by it and taken aback by the level of complications and their similarities.”
After her April story she says a flood of women began emailing and calling the station. CTV News did a second story about some of the women who had come forward. One Canadian lawyer told her his cases went from 15 to 200.
Favaro and the Globe and Mail report on a women suffering constant burning pain from her knees to navel. Another had been unable to work and has been on long-term disability for two years. Another had her mesh pierce her vaginal wall. One woman who contacted the station reported that bits of purple mesh fibers were being expelled in her urine. Thoughts of suicide were a constant message.
MDND reported in November 2011 about the first Canadian mesh cases to be filed. Since then at least two class actions have been formed.
The Globe and Mail reminds readers that mesh is not intended to be removed so a long-term implant may be especially difficult to remove.
“In fairness, it has to be said that most patients have had good results with meshes. And, of course, every surgery involves risks.”
“But there are some basic questions that remain unanswered: Were the products properly tested before being used extensively? Were women adequately warned about the potential complications? Were other treatments such as Kegels (pelvic-strengthening exercises) and pessaries (small plastic devices inserted in the vagina or rectum for pelvic-floor support) discussed with patients who were given meshes? Were surgeons implanting the mesh competent?”
At least the columnist admits that the media is reluctant to talk about problems “down there” and that may have contributed to a lack of public awareness.
Learn More:
Globe and Mail, "Time to Discuss Risks of Surgical Meshes" - May 7, 2012
Globe and Mail Comments:
MDND: Canadian Courts Take Aim at Ethicon, April 23, 2012
MDND: CTV – Canadian Class Action Lawsuit, April 18, 2012
MDND: First Canadian Transvaginal Mesh Case Filed, November 9, 2011
Health Canada, Safety Notification, February 4, 2010
FDA, Notice, July 13, 2011 – FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical mesh for Pelvic Organ Prolapse:
This is a much more strongly worded (compared to the 2008 FDA notice) caution about surgical mesh, questioning whether benefit is worth the risk, but falls short of a recall.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htmDA,
