Canadian drug and device regulator Health Canada on Monday said it is working with Bayer to develop better risk communication for the permanent birth control device Essure after a safety review of the device found the its risks are not adequately communicated.
The agency also says it is working with Bayer to update Essure's labeling and says it will increase its monitoring of the device.
Background and FDA Review
Essure is marketed as a non-surgical alternative to tubal ligation and consists of a pair of nickel-titanium coils that are inserted into the fallopian tubes, prompting scarring which physically blocks a woman's eggs from being fertilized.
Essure has been the subject of controversy in the US, where the Facebook group Essure Problems has drawn renewed attention to the device. Since coming on the market in 2002, there have been thousands of reports citing serious adverse events linked to the device, including pain, inflammation, menstrual irregularities, hair loss and fatigue. These, and other issues, such as device migration, have prompted many women to have the device surgically removed.
In February, after completing its own review of Essure, the US Food and Drug Administration (FDA) ordered Bayer to conduct a 2,000 patient postmarketing study comparing outcomes for patients who received Essure to those of patients who underwent tubal ligation. The agency also said it will require a black box warning label for the device and released a draft guidance containing proposed language for the label.
However, despite calling for a stronger warning label and a new study, FDA concluded that Essure was still safe and effective, and is "an appropriate option for the majority of women."
Health Canada Review
Health Canada says it launched its review into the safety of Essure after learning of numerous reports of safety issues related to the device, as well as a study published in The BMJ last September. The study found that women implanted with Essure had a much greater risk of undergoing reoperation compared to women who underwent surgical sterilization.
According to Health Canada, more than 8,000 units of Essure have been sold in the country, accounting for roughly 1% of the devices sold worldwide. When Health Canada began its review in November 2015, it had only received 18 adverse event reports linked to the device, though ten of those reports state that the device had been surgically removed as a result of complications.
However, because many of the symptoms reportedly caused by Essure "are not rare in the general population," Health Canada says it is "difficult to determine if the Essure device itself is the cause."
As a result, Health Canada says it is working with Bayer to craft a risk communication strategy "that includes a general discussion of the Essure device, the types of adverse events reported in Canada and internationally, a summary of Health Canada's safety review activities and recommendations to healthcare professionals and their patients to help better understand the risks associated with Essure."
Additionally, the agency is working with Bayer to update Essure's labeling and that it plans to review the results of the FDA-mandated postmarketing study when it is completed.