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Is Health Canada in Denial About the Mirena IUD Warnings?

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Smiths Falls, ONOn her gynecologist’s advice, Katie had a Mirena IUD inserted for birth control back in 2008, two years before Health Canada issued a warning about uterine perforations.

During her first follow-up with the gynecologist, Katie complained about a lot of cramping. She was told the string was where it was supposed to be and cramping was normal, but heavy bleeding constantly for more than a month was not normal. Then the bleeding stopped: Katie wondered if she could be pregnant.

“The first pregnancy test came out positive so I took several more, just to be certain,” says Katie. “By the time I went back to my gynecologist, I hadn’t had my period for two months. Still, she told me it was impossible to be pregnant.”

Doctors aren’t always right and it is possible to become pregnant with an IUD. Katie had a miscarriage and says she had heavy bleeding for the next several months. She needed to get the Mirena taken out. “My doctor couldn’t find the Mirena and not even an ultrasound found it,” Katie explains. It was finally found behind her uterus, after surgery with general anesthesia.

“Some time after the Mirena was removed, my partner and I decided it was time to have another child - our son was three years old at the time,” Katie says, “but it took well over three years and during that time I had three ectopic pregnancies. My daughter was born prematurely; she is healthy now but I was so worried and I know this was all caused by the Mirena.”

Last year Health Canada received reports of 52 uterine perforations involving the Mirena IUD as well as several reports from Canadian women who said that the device migrated to other parts of their bodies after insertion. One Canadian doctor, however, says that the Mirena has fewer risks than the earlier models and there is a one in 1,000 chance the uterus could be perforated when the IUD is inserted, a possibility of pelvic infection in the first three weeks, and a one to two percent chance that the device will slip out.

Many people disagree with that statistic. Last month, CTV news reported that increasingly, lawsuits are being filed in Canada and the US against Bayer, the maker of Mirena, alleging that women haven’t been properly warned about rare but potentially serious risks associated with the intrauterine device.

Bryan McPhadden, a Toronto-based lawyer who is in the process of starting a national class-action lawsuit against Bayer Inc., told CTV news that the Mirena IUD has been found next to the lung, on the hipbone and on the tailbone of some patients. He said the current labeling of Mirena in Canada “doesn’t mention the possibility it might migrate out of the uterus and be found virtually anywhere in the abdomen.” Or, in Katie’s case, behind her uterus.

The FDA updated the Mirena labeling in July 2008 to include the warning: “Delayed detection of perforation may result in migration outside the uterine cavity, adhesions...”

Is there a delayed reaction to Mirena warnings by Health Canada?

Katie is still suffering side effects from the Mirena, six years later. “Recently, I wound up in ER with severe cramping and an ultrasound found that I have cysts,” Katie says. “They told me that the cysts would burst with my period, and they do, but I am in agony every month. My gynecologist finally admitted that all these problems are because of the Mirena.

“When I hear anyone saying they are getting a Mirena, I tell them my story. I am thankful - and I am sure they are even more thankful - that I can get my story out to the public. When I had the Mirena implanted, I was told that I wouldn’t get pregnant for five years; I was never warned of side effects and not a word about how it could migrate…”

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