Health Canada is warning doctors to make sure their patients are aware of the serious health risks associated with the Essure permanent contraceptive, which may include severe pain, menstrual bleeding, unintended pregnancy, migration of the device and allergic reactions.
Free Confidential Lawsuit Evaluation: If you or a loved one suffered complications after receiving a contraceptive implant, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the Problem?
June 1, 2015 – Health Canada issued a “Dear Healthcare Professional Letter” yesterday advising the public and medical communities to be aware of the numerous reported complications associated with the Essure birth control device. The letter further stated that Bayer will include a “black box” warning on Essure’s labeling, and that Health Canada is developing a patient checklist to ensure that women are aware of the contraceptive’s risks before undergoing the procedure.
“These include menstrual bleeding, unintended pregnancy, chronic pain, perforation and migration of device, allergy and sensitivity or immune-type reactions,” some of which have led to surgery, including hysterectomy to remove the implant, according to the letter.
A class action lawsuit was filed against Bayer in April on behalf of 184 Canadian women who claim they suffered adverse health complications after receiving Essure, according to the Toronto Star. About 8,000 implants were sold in Canada between 2002 and 2014, and about 750,000 women have been implanted with the device worldwide, according to Bayer.
In response to thousands of complaints filed with the U.S. Food and Drug Administration (FDA) and a huge increase in social media activity, Health Canada ordered a safety review of Essure last fall. A summary of the review appeared last week on the agency’s website.
The review was also prompted by a study published last year in the British Medical Journal (BMJ) which found that Essure recipients had a 10-fold increased risk of reoperation than laparoscopic surgery (2.4% compared to 0.2%) in the first year after having the device implanted. Bayer claims that Essure is more than 99% effective, about the same as tubal ligation. The BMJ study also found that rates of unintended pregnancy with Essure and tubal ligation were about the same.
Do I Have an Essure Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Essure lawsuits. We are handling individual litigation nationwide and currently accepting new birth control side effects cases in all 50 states.
Free Confidential Case Evaluation: Again, if you were injured by Essure birth control side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.