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Essure Complications Required Boxed Warning, Says Health Canada


Essure Complications Required Boxed WarningWhen women of childbearing years no longer wish to birth children, they frequently seek out a permanent birth control option. For a long time, the primary option was sterilization, until Essure and similar devices came to market. Essure, manufactured by Bayer, is an implant that is shaped like a spring. The device is inserted into each Fallopian tube, in order to block sperm and prevent pregnancy.

Many women were attracted to this birth control option because it releases no hormones and no anesthesia is required for implantation. Unfortunately, many women are experiencing serious complications due to Essure implantation. In response to numerous lawsuits on behalf of affected women, Health Canada is now requesting that the product box be revised to include warnings of possible side effects/complications.

The Food and Drug Administration (FDA) in the United States is looking at developing a boxed warning and checklist as well.

Reported complications have included perforation or migration of the Essure device.

Many women have experienced severe pain in the stomach and pelvis. If such complications occur, the symptoms should be immediately reported to a medical doctor.

Oftentimes, the device needs to be removed in order to stop symptoms, or to prevent further complications.

Essure has been sold in Canada since 2002. Canada accounts for only 1% of total units sold. Health Canada has received 18 adverse reports of Essure complications. Of those 18 reports, 10 women had to have their Essure device removed. Allergies and menstrual bleeding issues were the most frequently reported ailments.

An Essure side effect lawsuit is currently underway in Canada. The class-action suit, which affects 184 women, is undergoing certification at this time. Bayer is taking the claims seriously and has agreed to make changes to current labeling and packaging.

The company is also developing an information sheet about Essure that the patient and healthcare provider can review prior to implantation.

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