Women warned against use of 'Essure' contraceptive

NAIROBI: The United States Food and Drug Administration (FDA) body has warned women against the use of the Essure contraceptive.

This is over cases of unintended pregnancies, miscarriages and even still births according to testimonies of over 5,000 women who have filed grievances with the US based health administration.

FDA has consequently issued a new, mandatory clinical study for device to determine heightened risks for particular women.

It also intends to impose changes to product labelling by introducing a boxed warning and a Patient Decision Checklist to help to ensure women receive and understand information regarding the benefits and risks of this type of device.

There are about 750,000 women globally using Essure with 70 per cent being in the United States.
In Kenya, Essure was introduced back in 2011 alongside Turkey, Latin America and three other African countries by Woman Care Global.

"The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them," said William Maisel Deputy director for science and chief scientist at the FDA.

Maisel added: "They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications."

Essure is a permanent form of birth control that aims to prevent conception but women have to use another form of contraceptive for three months before it takes effect.

"While the FDA believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control, some women may be at risk for serious complications. These may include persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions," read a statement by FDA.

According to Planned Parenthood, over 500 million women prefer Essure as it is surgery free as no incisions are done, does not contain any hormones, and has room for easy recovery (within 24 hours).