Essure is a permanent birth control that can be implanted without requiring surgery. It is also a non-hormonal contraceptive and does not interfere with the natural menstrual cycle. It was originally made by Conceptus, which was later bought by Bayer.
How does Essure work?
Essure involves two coils that are made of stainless steel, nickel titanium and polyethylene fibers that are inserted into the fallopian tubes via a thin, metal catheter.
The coils are positioned at the entrance of the fallopian tubes, where the coils expand and become fixed to the walls of the tubes. Scar tissue then builds around the coils, which blocks the fallopian tubes and prevents sperm from reaching eggs.
Women are required to go to a three-month follow-up appointment to ensure the fallopian tubes are fully blocked.
Is Essure permanent?
Yes, Essure is intended to be a permanent birth control system. Although it is designed for permanent implantation, women who would like to become pregnant or who suffer from Essure side effects can have the Essure removed or reversed during an operation. The complexity of the surgery depends on the position and condition of the device, the surgeon’s preferred method of removal, and how long the device has been implanted.
The complexity of the surgery depends on the position and condition of the device, the surgeon’s preferred method of removal, and how long the device has been implanted.
What are Essure birth control side effects?
Women who have been implanted with Essure should be aware of the following side effects.
The most frequent Essure side effects
According to the FDA database, the most frequent Essure side effects were:
- Pain/abdominal pain
- Heavier menses/menstrual irregularities
- Weight fluctuations
The most frequent device problems
According to the FDA, the most frequent device problems were:
- Patient/device incompatibility (such as allergy)
- Migration of the device or component
- Device not operating as expected
- Device breakage
- Device positioned improperly
- Device difficult to insert
Have there been warnings regarding Essure birth control?
On February 29, 2016, the FDA announced it was taking action to understand better the potential risks associated with Essure. Among the actions it took was requiring a mandatory clinical study to determine the heightened risks for women who use Essure. The study will also compare the risks associated with Essure to the risks associated with laparoscopic tubal ligation.
At the same time, the FDA announced its intent to require a boxed warning to help women understand the risks associated with Essure.
“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, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “They also reflect our recognition that more rigorous research is needed to understand better if certain women are at heightened risk of complications.
The FDA’s activities were the result of a September 24, 2015, advisory committee meeting regarding Essure complications. The panel was asked to discuss the safety and effectiveness of Essure. Among the topics the panel was asked to consider:
- Recommendations on ways to mitigate the potential risks of Essure
- Additional physician training concerning device removal
- Whether additional post-market data on Essure is required
- Whether the risk-benefit profile of Essure is acceptable
The FDA notes that from 2002 through 2015, it received 9,900 medical device reports concerning Essure. Included in those were 631 reports of pregnancy in patients who used Essure; 294 of these resulted in pregnancy loss with 96 women reporting ectopic pregnancy.
Has there been research about Essure problems?
So far, the majority of research conducted on Essure safety and effectiveness has been conducted by the companies responsible for making and marketing the birth control implant.
Concerns have been raised about at least one of those studies. According to The New York Times, the FDA approved Essure in 2002 but required women in post-market Essure trials to be followed for four more years because the device was approved after only one to two years of safety data. Of the 518 women originally included in one of the trials, only around 360 were followed for five years. And although that trial ended in 2007, results of the trial were not published until 2015.
Yes, lawsuits concerning Essure have been filed. In August 2016, a California judge ruled that 14 Essure lawsuits can proceed. So far, none of the lawsuits have gone to trial, nor have they resulted in a settlement.
Among the allegations made against Bayer are designing a faulty product, negligence, and failure to warn about the risks.
How do I know if I have an Essure lawsuit?
If you or a loved one has had Essure implanted and suffered complications . As a result, you may be eligible to file a lawsuit to compensate you for economic and non-economic damages, including compensatory and punitive damages.
Have there been Essure settlements?
So far, there have not been any settlements announced concerning Essure.
When can I file an Essure lawsuit?
Each state has a different statute of limitations. Our lawyers will review your case with you and determine if you are within the statute of limitations. If you think you have a claim against Bayer, contact a lawyer as soon as possible, to reduce the chances of the statute of limitations running out.