- Essure is a non-surgical and non-hormonal permanent birth control device
- It has been pulled from all other markets outside the US due to safety concerns
- The FDA placed a safety warning on the label in 2016, but has now restricted sales
The FDA has restricted the sale of the implanted birth control Essure after women claimed they were left suicidal and in crippling pain from the device.
Germany-based manufacturer Bayer insists that the benefit or risk profile of Essure had not changed and remained positive – despite it being pulled from every other market outside the US.
In early 2016, the FDA slapped the strongest safety warning label on the device following thousands of complaints, and asked Bayer to conduct a post-market study.
Concerns around the device included abdominal pain, abnormal uterine bleeding and device migration.
Essure, approved by US regulators in 2002, is a non-surgical and non-hormonal permanent birth control device.
Essure (pictured) has been pulled from all other markets outside the US due to safety concerns. The FDA placed a safety warning on the label in 2016, but has now restricted sales
WHAT IS THE ESSURE DEVICE THAT HAS CAUSED CONTROVERSY AROUND THE WORLD?
Essure is a permanent birth control procedure that involves inserting a tube into women’s fallopian tubes.
It is non-hormonal and causes the build-up of scar tissue that prevents eggs from reaching the womb.
Accoding to Essure.com, it is 99.3 percent effective when used as a sole method of contraception.
Vaginal bleeding, abdominal discomfort and cramping are expected after the procedure.
Long-term risks include pain of varying intensity.
The device went onto the market in 2002, but more than 34,000 women across the world have complained of side effects in the years since.
In the US, around 15,000 women have reported complications to the FDA, including pain, allergic reactions and ‘migration of device’.
Allergic reactions are thought to occur due to the device containing nickel and polyester.
The controversy surrounding the device, which has escalated rapidly, has led to protests in the streets outside medical conferences.
It was temporarily suspended in the EU in August last year and hospitals in the UK were urged to avoid using the devices.
Bayer, which manufactures the controversial implant, pulled the product from the market completely. It is only available in the US.
Bayer claims Essure, a permanent birth control method, is 99.3 percent effective in preventing pregnancies.
However, the French National Agency for Medicines and Health Products in Saint-Denis, data showed that it didn’t work for 4.8 percent of patients.
The risk was just 0.69 percent for laparoscopic surgery, according to the study that was led by Dr Kim Bouillon.
Essure implants can be placed into women in less than 15 minutes, making them an ideal option for surgeons before evidence began to mount over their dangers.
More than 15,000 women have reported complications from their Essure in the US to the FDA, including pain, allergic reactions and ‘migration of device’.
The NHS does not have figures for the total number of women who have been fitted with Essure or those who have had it removed.
And the Medicines & Healthcare Products Regulatory Agency has previously been criticized for failing to respond to the evidence surrounding the device’s risk.