Essure is a permanent birth control device created by Bayer. The device consists of a flexible coil that is inserted into the fallopian tubes to prevent pregnancy. In the following months after the coil is implanted, scar tissue grows around the inserts and blocks the fallopian tubes, creating an effective method of contraception. According to the device’s website, it is a highly effective form of birth control with a 99.3% effectiveness rate and over 750,000 women and their doctors have chosen Essure as their method of birth control. However, in 2016 the FDA announced that the Essure device would be given a “black box” warning on its label due to serious complications. Among these complications include severe physical reactions, miscarriages and multiple deaths.
The Essure device was first introduced in 2002 by Conceptus Inc., a branch of Bayer AG. The insert itself is a coil made up of stainless steel on an inner layer and nickel titanium alloy on outer layer. The coil contains polyethylene terephthalate to induce the growth of scar tissue once placed in the fallopian tubes. Additionally, Essure is non-hormonal.
The process to insert Essure is considered to be minimally-invasive by its manufacturer. The small coil inserts are carefully placed into the fallopian tubes with a catheter. It is an in-office procedure that does not require incisions or anesthesia of any sorts. Some women have reported an average procedure time as quick as 7 minutes, almost five times faster than the manufacturer-listed average of 36 minutes. Women return to their physician’s office three months after placement for an Essure Confirmation Test to ensure that the coils are still placed in the correct location and that scar tissue has created a barrier.
While Essure has been an effective and convenient form of birth control for many since its first use over a decade ago, there have been thousands of reports of severe negative side effects. Some threats Essure presents are minor incidents including abdominal pain after implementation, menstrual abnormalities, bleeding, fatigue and headaches. Other Essure-related side effects involve far more serious consequences such as device breakage, nickel-induced allergies, ectopic pregnancies and organ perforation.
Since its introduction in 2002, the FDA has noted more than 15,000 negative events or incidents deriving from the usage of Essure. Furthermore, between 2015 and 2016 there were an alarming 11,192 adverse events linked to Essure reported to the FDA. Lastly, there has been a confirmed 26 deaths linked to the device. The adverse results of this contraceptive method have created a large-scale controversy leading to several campaigns against the device as well as the creation of a website dedicated to women sharing their personal stories regarding their unfortunate experiences with Essure.
While the FDA has not recalled Essure, it released a “black box” warning for the device in 2016. A “black box” warning means that on the label of the prescription drug, or in this case, device, there is a mandatory warning of any potential adverse effects of the product due to more frequent evidence of dangers associated with the prescription in question. As the FDA and Bayer have refused to pull Essure from the reach of consumers, some Congressmen have taken the issue as far as introducing a bill demanding a product recall.
The rising occurrence of complications and side-effects linked to Essure are important to take into consideration if you or someone close to you have used this device. If you think that you or a loved one have fallen victim to any of the adverse effects mentioned in this article due to the usage of Essure, you should immediately report these incidents to the FDA. Then, contact one of our attorneys at Schneider Hammers and let us take care of your defective medical product case. We are committed to representing you effectively and strategically against medical manufactures to ensure you receive the compensation you deserve.