Created by Conceptus, a Bayer subsidiary, Essure was a low-impact alternative for tubal ligation.
Essure is as birth control method by placing flexible coils inside the fallopian tubes. Soon after being on the market, women started complaining about pain and unintented pregnancies.
Essure is a minimally invasive form of sterilization for women developed and brought to market by Bayer AG subsidiary Conceptus. Essure is in fact a type of coil that is inserted into the fallopian tube which prevents fertilization.
It has been legal in the US since its approval by the FDA in November 2002.
The impetus behind Essure’s development was to create a relatively low impact alternative to tubal ligation which has long been the standard method for female sterilization.
That procedure requires a surgeon to cut or block the fallopian tubes via a small incision in the abdomen.
Tubal ligation is a major surgical procedure carried out in a hospital. One which typically requires the use of general anesthesia. Essure by contrast is done in the doctor’s office often with only local anesthesia.
During the Essure placement procedure, flexible coils are inserted through the vagina into the fallopian tubes. In theory, once these coils are in place they prompt tissue to grow through and around them. This tissue growth typically takes 3 months and at the end of that time the fallopian tubes should be blocked by the new tissue.
As a result sperm is unable to reach the eggs and pregnancy is prevented. The whole placement procedure takes about 10 minutes.
As stated, the desired tissue growth typically takes 3 months. At that time a follow-up visit is scheduled during which a radiologist performs tests to ensure the fallopian tubes are indeed completely blocked. During the 3 month growth period the patient is required to practice some other form of birth control, but once adequate tissue growth is confirmed the alternative birth control methods can be abandoned.
Studies on Essure continued after it won approval and by 2009 it seemed to most that Essure had proven itself a safe and effective procedure.
By 2009 most, especially those at Bayer and Conceptus, were touting Essure’s safety and effectiveness. There were few, if any, dissenting voice to be heard; in public at least. But behind the scenes evidence was beginning to mount of problems including:
● Perforations in the fallopian tubes.
● Persistent pain and bleeding.
● Unintended pregnancies.
● And even some possibly related deaths.
Concerns began to be raised over the methodology employed during the approval process for Essure. It is, after all, a device intended to remain in place for life and yet it was approved based only on a handful of short-term studies.
In fact only 2% or women in the original study had been followed up on after 2 years. And this, as we say, for a device intended to be in place potentially for decades.
By 2013 thousands of women had begun to complain of serious side effects. As a result many opted for surgical extraction of the device. What followed this surge in negative news was the filing of lawsuits against both Conceptus and Bayer AG.
The bulk of the lawsuits filed in the wake of revelations regarding Essure seek restitution for harm done based on the allegation that the company did not fully disclose possibly severe side effects. The testing methodology is also being taken to task for being woefully inadequate.
The number of lawsuits alleging product liability and/or medical malpractice now stands in the hundreds with more being filed nearly every day. In the most serious cases women have suffered significant abdominal damage due to the device shifting position and puncturing the fallopian tubes.
Litigants state that if they had known the true risks associated with the Essure device they would have chosen an entirely different method of birth control, of which there are many.
Many claim in their Conceptus Essure lawsuit that the company knowingly hid information from the FDA having to do with an increased risk of abdominal injuries in an effort to gain product approval and that, since winning approval, they have failed to inform the public about the true, known risks associated with the product.
A Federal judge in Philadelphia recently ruled that a lawsuit brought against Bayer by 5 women for misleading advertising related to the Essure device would be allowed to proceed over Bayer’s strong objections (source).
District Judge John R. Padova determined that the women’s claims were reasonable and that Conceptus – and by extension Bayer – had failed to warn users about all the potential risks involved with the device.
In October of 2016 a California judge ordered that scores of lawsuits brought against Essure by nearly 1,000 women were to be centralized in Alameda County Superior Court.
The previously disparate lawsuits will be heard together in what are known as Judicial Council Coordinated Proceedings. This is intended to streamline the adjudication efforts for the various plaintiffs and make it easier for them to coordinate their efforts.
Following up on the October ruling, US District Judge Michael Fitzgerald granted a motion by plaintiffs in a major Essure lawsuit to have their case remanded to Superior Court in Los Angeles. This represents a legal setback for Bayer, Conceptus’ parent company, which had filed a motion several weeks earlier to have the Essure lawsuit moved to Federal Court.
This lawsuit against Essure will now join the dozens of complaints mentioned above in those Judicial Council Coordinated Proceedings.
The FDA in November finalized its guidance on Essure. The new guidance requires the product to carry what’s called a “black box” warning on its label. The new label should note “significant and/or common adverse events” associated with the device, its insertion, its use or its removal.
The label should also include a statement that these risks must be relayed to the patient during pre-insertion consultations.
The new FDA guidance also calls for a patient checklist which highlights the risks and benefits of the device. This checklist should be used by the patient and then reviewed with the attending physician. Both patient and physician should then sign off on the checklist.
As of this writing the FDA has received more than 9,900 adverse medical device reports concerning the Essure device. These reports have originated with both doctors and patients and all allege that the Essure permanent birth control device has caused serious side effects, including at least 2 confirmed deaths and several as yet unconfirmed deaths. So where do things go from here?
Bayer has recently set up 2 toll-free numbers for users of the Essure device who wish to lodge complaints. The company insists it wants to hear from any women experiencing problems with Essure regardless of how great or seemingly insignificant.
They also, however, go to great pains to insist that so far, any reports coming into their toll-free reporting service are “consistent with clinical trials and… what the FDA is seeing.” Though to be sure they are undoubtedly biased in their interpretation of the data.
In 2015 the US Congress held hearings during which they took testimony regarding a citizen’s petition which had been filed with the FDA regarding Essure.
As a result the FDA undertook an investigation into its own approval process with regard to the Essure device to try and discern if the process had been either poorly planned or somehow corrupted. As of this writing the investigation is still ongoing.
Note: In June of 2016 a bill was introduced in the US House of Representatives aimed at helping women who may have been injured by use of the Essure permanent birth control coil.
The bill, if passed as is by both the House and Senate and signed by the President would hold Bayer responsible for any and all injuries and/or deaths related to use of the Essure device. The bill is not expected to see significant movement until 2017.
● In mid-2015 the FDA announced that its OBGYN devices panel would review Essure’s safety because of the explosive growth in negative reports regarding the device. That investigation has not as of this writing reached any final conclusion.
● An evidence based review of available data announced in November 2015 resulted in the new “black box” guidance detailed above and designed to alert the public to the dangerous complications that may result from use of the Essure device.
● FDA also requested that Bayer conduct a brand new surveillance program that should follow at least 2,000 users of the device for a minimum of 3 years. During that time the safety and effectiveness of the device is to be compared with other contraceptive methods. (It should be noted that some patients-rights activists have voiced displeasure with the 3 year timetable, feeling it is still grossly inadequate for a device which is intended to be installed for life.)
In late 2015 the British Medical Journal published a study which concluded that the Essure permanent contraceptive device was no better at preventing pregnancy than a standard laparoscopic procedure.
The study also concluded that women who underwent insertion of the Essure device ran a 10-fold higher risk of reoperation than patients who opted for laparoscopic sterilization instead.
The Essure contraceptive coil hit the market with much fanfare but has proven itself over time to be a mixed blessing at best and downright dangerous at worst.
If you believe you are suffering significant or unexpected side effects from an Essure coil it may be in your best interest to investigate joining an Essure class action lawsuit or filing an individual Essure lawsuit of your own.