Essure Contraceptive Implant Complications

By Petr Ková? MUDr. Haví?ov (Own work) [CC BY-SA 4.0 (], via Wikimedia Commons

When a new contraceptive implant device hit the market more than a decade ago, it was hailed as a breakthrough for women who did not want to have more children. Essure was a sterilization device that was permanent and done in a doctor’s office, usually taking under ten minutes.


Now, thirteen years later there are thousands of women who claim they have been seriously injured by the device. The women are urging the Food and Drug Administration to recall the device and to issue a public warning about its complications.

Troubling information on the women using Essure was published in the April 24th, 2015 after a long awaited eight year delay. Many patients have filed lawsuits against Bayer HealthCare Pharmaceuticals and representatives of patient advocate groups plan to meet with company officials to discuss concerns.

Essure is a small coil made from metal and polyester and it is inserted into a woman’s fallopian tubes. The goal of the device is permanent sterilization. The U.S. Food and Drug Administration approved it after fast-tracking through the review process. The device was the first of its kind and offered as an alternative to surgical sterilization, in addition to a promised fast recovery.

Since that time, the FDA has received more than 4,000 reports of serious complications such as back and pelvic pain, heavy prolonged menstrual periods and piercing of the fallopian tubes. It’s been reported that the device has become wedged in other organs.

According to a petition filed with the Food and Drug Administration, an inspector received 16,047 reports against the original manufacturer Conceptus between 2011 and 2013, at which time Bayer took controlling interest in the company. Both the FDA and Bayer stated that Essure’s benefits outweighed the risks associated with it.

The device is sold in more than twenty countries and Bayer reports about 750,000 women all over the world use it. Company officials did not comment about how many women in the United States use Essure, but it did state dangerous complications are fairly rare.
Dr. Edio Zampaglione, the vice president for the U.S. medical affairs and women’s affairs at Bayer stated, “There are no signals, nothing that would indicate a problem with Essure. The events being reported and seen are expected for this type of procedure.”

However, in interviews with more than a dozen different women, many said the risks were unexpected.
Many women have experienced non-stop bleeding and severe pain, fatigue, migraines, and joint pain, while some have had the device become lodged into organs and it becomes broken apart.


Essure was the first device to offer females an alternative to surgical tubal ligation, and it was considered a game changer. Small coils were inserted into each fallopian tube and without surgery, an incision or general anesthesia. Once inserted into the tubes, the coils made from nickel titanium alloy and polyethylene terephthalate, scar tissue forms and blocks sperm from reaching the ovum. The process of scaring the tubes can take up to 90-days and women must use back up birth control until a physician confirms the tubes are blocked.

However, many women reported pain and other serious side effects during clinical trials. In a safety trial conducted with 269 female’s ages 23 to 45, Essure was successfully inserted into 200. In nine women, a coil poked a hole in the fallopian tube, was expelled or became lodged in another area of the body.

In Conclusion

Because there is no other contraceptive like Essure and due to the fact Bayer refuses to disclose how many women in the country are using it, experts are having a difficult time determining to judge if the risks are enough to pull it from the market. The Food and Drug Administration said they are concerned about the coils moving outside the fallopian tubes, but would not go so far as to confirm the device was flawed.


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