Health Canada is conducting a safety review of Essure – a controversial birth control device that’s placed in the fallopian tubes – as Canadian women join a class-action lawsuit that alleges the spring-like device led to major complications.
Essure, made by Bayer, is dubbed as the “only permanent birth control with a non-surgical procedure.” A small spring-like device is placed into each fallopian tube by a doctor. The inserts are supposed to act as a natural barrier that keeps sperm from reaching eggs, preventing pregnancy.
The issue is thousands of women have complained about severe abdominal pain, bloating and discomfort during sex, according to Tony Merchant, principal of Merchant Law Group, which launched a class-action lawsuit in Canada that’s going through the certification process now.
He says that so far, about 130 women across Canada have joined the lawsuit. He suspects more will join in the subsequent months.
“The device has caused, in a large number of women, severe pain, pain when they have sexual relations, but pain even without sexual relations, bloating and the device migrates. It moves, it’s defective,” he told Global News.
Essure’s website says that about 750,000 devices have been sold worldwide – Merchant estimates that about 75,000 were sold in Canada.
In cautionary tales told on Facebook and to the media, women describe grappling with migraines, abdominal bloating and pain in the pelvic area.
Bayer says its product is “highly effective” with a “positive safety profile for women.”
“Patient safety is Bayer’s top priority. Bayer continuously collects, analyzes and reports all adverse event data it receives and works closely with health authorities worldwide, including the FDA and Health Canada, in monitoring the safety profile of Essure,” it said in a statement to Global News.
“As a matter of policy, Bayer does not comment on active litigation,” it said.
Health Canada, for its part, says it conducted a post-market safety review of Essure and confirmed its overall benefits. But right now, it’s carrying out a safety review that’ll look into potential risks of using the device.
“If at any time a new risk to health is identified, Health Canada will take the appropriate action to protect the health and safety of Canadians,” the federal agency told Global News in an email.
The review should be completed by the end of spring 2016.
The FDA has also been studying Essure’s safety and efficacy. Read more.
“More rigorous research is needed to better understand if certain women are at heightened risk of complications,” Dr. William Maisel, chief scientist for the FDA’s device center, told the Associated Press in February.
The agency said in a statement that Essure is an “appropriate option for the majority of women,” but that “some women may be at risk for serious complications,” especially if the device shifts out of position and punctures the uterus or other organs.