After multiple known complications, a lawsuit, and a documentary exposing the controversial sterilization device, the manufacturer Bayer has officially announced the sale of Essure will end by December 31, 2018.
First approved by the FDA in 2002, Essure has been used by approximately 750,000 women worldwide. The device was designed to be a nonsurgical alternative to a tubal ligation. The irreversible birth-control device consists of a metal coil which is inserted into each fallopian tube by a doctor in a 10 minute procedure. Over the course of three months, scar tissue forms around the coils and prohibits sperm from reaching eggs, preventing pregnancy.
However, thousands of women have reported complications including autoimmune problems, pregnancy, and the migration of the coils into the pelvis or abdomen. Many of the women experiencing these issues had severe problems resulting in the device needing removal. In fact, Bayer has been served with lawsuits representing over 16,000 women throughout the years. Recently, Netflix released a documentary titled The Bleeding Edge, which exposes the controversial device.
In response to the complaints over the years, the FDA has mandated Bayer add a black warning box to the product’s packaging as well create a checklist for doctors to use while discussing the potential risks with clients. After further complaints about doctors not properly informing clients about the risks of Essure, the FDA forced Bayer to limit sales to only doctors who guaranteed women were being told about the risks and told Bayer it would be held responsible should a doctor fail to do so.
Bayer and the FDA still hold firm that the device is effective, and women who have not experienced problems can continue to use it.
Bayer pulled Essure from markets outside of the United States last September citing “commercial reasons,” leaving America its sole market.
Last month the company released an official statement announcing Essure will no longer be sold in the United States beginning December 31, 2018.
However, Bayer did not say the decision to stop manufacturing the device was related to complaints. It cited Essure’s plummeting sales which it attributed to a decline in the use of permanent contraception; the increase in use of reversible IUDs; and “inaccurate and misleading publicity” regarding the implant.
Angie Firmalino, who had Essure implanted in 2009 and experienced pain and bleeding leading to a hysterectomy, has since become one of the main advocates against Essure, starting a Facebook group in 2011 called “Essure Problems” which now as 38,000 members.
Firmalino said she was “blown away” by Bayer’s announcement, and added, “it took way too long but we won.”
If you or someone you know has experienced problems which may be related to Essure, the FDA recommends patients see their doctor immediately.