Essure Implant Risks Lead to Safety Notice in Canada Over Endometrial Ablation Procedure Same Day
Canadian health officials are warning that the risk of Essure implant complications could be increased if women undergo an endometrial ablation procedure on the same day the birth control coils are placed inside their body.
Health Canada issued a field safety notice earlier this month, recommending that the two procedures not be performed on the same day. The warning and recommendations will soon be added to Essure instructions for use in that country.
Essure is designed for women who want permanent birth control, involving the placement of bendable coils into the fallopian tubes. The procedure causes scar tissue to form around the coils and block the tubes.
Did You Know?
Millions of Philips CPAP Machines Recalled
Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.Learn More
Although it is marketed as a safe and effective means of preventing pregnancy, thousands of women have reported suffering Essure implant problems and injuries in recent years.
Endometrial ablation is a procedure where the lining of the uterus is surgically destroyed to reduce menstrual flow. It is often performed on women suffering heavy menstrual bleeding, bleeding that lasts longer than eight days or for women suffering anemia due to excessive blood loss.
“In women who have previously undergone an endometrial ablation, the Essure procedure should only be performed if visualization and accurate localization of the tobal ostia is possible,” Health Canada warns. “Performing an Essure procedure after an endometrial ablation may be associated with the following: unsatisfactory micro-insert location and increased risk of perforation or creation of false passage.”
The warning comes amid a growing number of Essure lawsuits filed by women in both the U.S. and Canada who say Bayer failed to provide adequate warning about the implant risks.
In October 2015, an Essure class action lawsuit was filed in Saskatchewan, Canada on behalf of women across the province who have been implanted with the birth control device. That lawsuit claims that the company failed to adequately test the device, failed to provide adequate safety warnings to Health Canada, physicians and patients, and failed to adequately train doctors on how to insert or remove the coils.
Similar claims are being pursued by dozens of women throughout the U.S., who are pursuing individual product liability lawsuits against Bayer for selling a defective and unreasonably dangerous birth control implant.
Last year, the FDA held advisory panel meetings to review the safety of Essure. After considering recommendations from the panel of outside experts, the FDA announced in late February 2016 that much stronger Essure warnings will be required to make sure doctors and women are informed of the potential risks.
Although the product has been sold for the past 14 years, Bayer has also been ordered to conduct additional studies to better understand the safety of the Essure implant, raising questions about why the manufacturer failed to take these steps years ago after receiving complaints.
An estimated 750,000 women worldwide have undergone Essure sterilization procedures since the device was introduced in 2002. Bayer purchased the Essure product from the original developer, Conceptus, for about $1.1 billion in 2013.
As Essure lawyers continue to review and file potential cases for women nationwide, it is ultimately expected that Bayer could face hundreds, if not thousands, of lawsuits in courts throughout the U.S.
"*" indicates required fields
More Top Stories
A Tepezza hearing loss lawsuit accuses the manufacturer of failing to warn doctors to conduct hearing tests, which could have helped a woman avoid permanent hearing damage.
A South Dakota man has filed one of the first gastroparesis lawsuits against Ozempic manufacturers, alleging that users have not been adequately warned about the risk of severe vomiting and long-term stomach side effects.
The U.S. Navy has received more than 129,000 Camp Lejeune water contamination claims, according to court records.