Health Canada warns of risk of serious complications with Essure birth control implants
Woman describes major pelvic pain and bleeding rashes that ended after implants removed
Women who have received Essure permanent birth control implants should be aware of potential complications, some serious, Health Canada says.
In a letter to health-care professionals and the general public on Tuesday, Health Canada said complications have been reported in some patients using Bayer's Essure tubal implant.
Unlike other permanent birth control methods in which surgeons perform a keyhole procedure through the belly to tie the Fallopian tubes or clip them, Essure is implanted through the cervix. It expands and the scar tissue forms to block the tubes over the course of three months.
According to the notice, complications include:
- Menstrual bleeding.
- Unintended pregnancy.
- Chronic pain.
- Perforation and migration of device.
- Allergy and sensitivity or immune-type reactions.
Susan Hill, 38, of Carievale, Sask., about 290 kilometres southeast of Regina, had Essure inserted in 2009 after completing her family with two healthy boys.
"Major pelvic pain like stabbing, abdominal pain," Hill recalled. "I went to the ER on several occasions for that not knowing what it was," Hill recalled. "It would just take your breath away, it was like you got stabbed with a knife. Unbelievable."
Hill experienced bleeding rashes on her hands, torso and ankles for 3½ years. When doctors couldn't pinpoint the cause of the rash, she changed her lifestyle to avoid potential food and metal allergens, including taking off her wedding ring.
She had the birth control implants removed in 2013.
"I woke up from that surgery feeling like a million bucks," Hill said. Within 24 hours, the rash on her torso was gone and the pelvic pain disappeared.
Dr. Jennifer Blake, CEO of the Society of Obstetricians and Gynaecologists of Canada, said the group had been expecting Health Canada's safety review.
Blake welcomed the checklist for doctors and patients that Bayer and the regulator are developing because it will help ensure women fully understand all aspects of this method of contraception, the need to use birth control until the tubes are sealed and it permanently blocks sperm.
The procedure isn't widely available in this country, Blake said.
"In Canada, we know that there aren't that many done, but there also aren't that many complaints," Blake said.
"You look at the research studies that have followed women to see how many women have concerns afterward, there aren't big numbers that come up, so it's really hard to understand what's going on in the States and the social media phenomenon because it's not matching what we're seeing."
The risks and benefits are discussed with patients, Blake said.
'Listen to the women'
Hill is one of 184 women in Quebec, Ontario and Saskatchewan who are part of a class-action lawsuit that alleges the spring-like device led to major complications. Regina-based Tony Merchant's lawsuit is going through the certification process.
Hill said she's speaking out because she wants to help protect other women from the pain and suffering she experienced.
"I am very disappointed in Health Canada. I believe they need to do their homework. They need to listen to the women."
Blake said pain is complicated, but women typically experience it soon after receiving the implant and that's the time to remove it. Otherwise, women may end up needing a hysterectomy. "If it's not working, it's not working."
Bayer said it is updating the product labelling and developing a patient information sheet to be reviewed by the patient and the health-care professional before the device is implanted.
"It is imperative that women consult with their health-care professionals before making any contraceptive choice, to fully understand both the risks and determine the best option to meet their needs. It is also important for women to continue that dialogue any time they have any concerns or questions about a product or procedure," a spokeswoman for Bayer said in an email.
The U.S. Food and Drug Administration announced plans for a similar checklist and boxed warning in February.