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FDA Updates Adverse Event Reporting with Essure
The FDA has issued a letter (PDF) to Bayer outlining conditions for submitting additional post-market information about the Essure system. The letter applies to reportable injuries from social media in relation to ongoing litigation regarding the Essure system.
FDA granted Bayer's request for a variance from some reporting requirements, but imposed other conditions for reporting to ensure the public health.
Per the conditions, Bayer is required to start providing medical device reports to the FDA in July 2020 and continue submitting additional events on a monthly basis. The agency will make these events publicly available on its Problems Reported with Essure web page.
Overview
The Essure procedure was developed by Conceptus Inc., a subsidiary of manufacturer Bayer AG. The contraceptive device is inserted into each of the recipient’s Fallopian tubes by a certified doctor. The inserts work to form a natural barrier that keeps sperm from reaching the egg, thereby preventing pregnancy.
Essure was approved by the FDA on November 4, 2002. According to Bayer, Essure kits are sold in at least 23 countries, and about 750,000 of the contraceptives are currently in use worldwide.
What’s the Problem?
On May 3, 2015, an article published in the New York Times reported that the FDA had received over 4,000 adverse event reports associated with the Essure contraceptive. These serious injuries included severe pain, perforated organs, tubal sterilization, heavy menstrual periods, and coils that pierced recipients’ Fallopian tubes and became lodged in other internal organs.
In a pre-approval clinical trial [3] that involved 269 women ages 23 to 45, Essure was successfully inserted into 200 patients. However, in 9 women the contraceptive perforated the Fallopian tube, was expelled or became stuck elsewhere in the body. Additionally, nearly 1 in 10 women complained of painful intercourse / abdominal pain, and 1 in 8 reported painful menstrual periods during the first 3 months.
During a later trial of 518 women, only 449 were able to rely on Essure. In 21 patients, the contraceptive pierced their Fallopian tubes, was expelled or migrated to other parts of the body. At least 8 women required a hysterectomy or surgery to remove a misplaced stainless steel inner coil. As in the first trial, participants complained of back pain, abdominal pain, and pain during intercourse.
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Essure Side Effects
Our lawyers are reviewing potential Essure lawsuits for women who suffered one or more of the following complications after being implanted with the Essure system:
- Hysterectomy
- Migration of device component outside of Fallopian tubes
- Pain
- Device breakage
- Bleeding
- Allergic reactions
- Fracturing of the device
- Perforation of Fallopian tubes
- Unplanned pregnancies
- Female sterilization
- Miscarriage
- Ectopic pregnancy
- Unwanted pregnancy
- Scar tissue
- Hair loss
- Weight fluctuations
- Death
Essure Lawsuit Allowed to Proceed in Philadelphia Supreme Court
April 3, 2019 - A federal judge in Philadelphia will allow 6 women who have filed lawsuits against Bayer AG over Essure injuries to proceed with their personal injury claims, and 3 others to pursue breach-of-warranty suits. Bayer had requested a partial summary judgment on all 12 plaintiffs involved in the class action, citing statutes of limitations.
Essure Study Receives New FDA Protocol
December 20, 2018 - The FDA required Bayer to issue an update on new steps to revise Bayer’s post-marketing study of its Essure device, to ensure that accurate long-term safety data is collected following removal of the IUD from the U.S. marketplace.
The trial will now follow women who were implanted with Essure for 5 years instead of the initially requested 3, giving the FDA “longer-term information on adverse risks of the device, including issues that may lead women to have the device removed.”
5th Death Linked to Essure
At least 3 late-term miscarriages and 2 patient deaths have been linked to the Essure contraceptive, according to ABC News. The latest fatality occurred in a woman who died while her doctor was implanting the device.
According to the report, the woman ‘coded’ when the doctor tried to insert the 2nd coil into her Fallopian tube. Additionally, it says that “prior to the coding the patient was noted to be shaking a lot and experienced generalized seizure activity.”
An autopsy revealed that the woman’s uterus had been punctured – though the pathologist was unable to say for certain whether Essure caused her death.
Conceptus Cited for Failing to Conduct Follow-Up Studies
Following clinical trials, the FDA was concerned that test subjects were only monitored for a year or 2, while the Essure contraceptive was meant to last a lifetime. The agency approved Essure on the condition that trial participants would be followed for 4 more years.
Of the 269 women involved in the first trial, only 171 were followed for the full 5 years. Of these, 5 women required hysterectomies and at least 1 became pregnant, according to a heavily-redacted FDA report.
At least 270 adverse events were reported among the cohort, including dozens involving pain and heavy menstrual periods. However, investigators determined that only 17 of these were caused by Essure, which made them conclude that pain and bleeding were rare among users.
In the larger trial involving 518 participants, only 366 (app. 70%) were followed for the full 5 years. Of these, 15 women had hysterectomies; however, only 2 of were considered to be ‘possibly’ associated with the device. Other findings from the trial included:
- 38% experienced unusually heavy periods on a recurring basis
- 1 in 20 had recurrent pelvic pain
- 1 in 15 had recurrent painful periods
- Nearly 1 in 25 had recurring pain with intercourse
- 1 woman reported persistent pain
These data were published on April 24, 2015 in the Journal of Minimally Invasive Gynecology [5].
Sales of Essure Contraceptive Restricted by FDA
April 11, 2018 - The FDA announced on Monday that it would be implementing new requirements to protect women from Essure. Moving forward, only patients who sit down with their doctors and discuss the risks associated with the device, and whom sign a document indicating they understand these hazards, will be eligible to receive the implant.
Essure Recalled in Brazil
February 22, 2017 - Brazil’s National Health Surveillance Agency (ANVISA) has recalled Essure from the Brazilian market [6]. Anvisa is suspending the importation, distribution, marketing use and dissemination of Essure. It is also recalling units that had already been distributed.
Missouri Essure Lawsuit Proceeds After Judge Denies Bayer’s Motion to Dismiss
December 21, 2016 - A federal judge in Missouri has denied Bayer’s motion to dismiss state court lawsuits filed by 32 women who claim they were injured by the Essure permanent birth control device. U.S. District Judge Henry E. Autry ruled that the federal questions raised “are not substantial” and remanded the lawsuit back to the state court where it was originally filed.
MDL Proposed for Essure Medical Devices
July 26, 2016 - Plaintiffs' lawyers have filed a motion with a panel of federal judges to create a multidistrict litigation (MDL) for lawsuits alleging injuries from the Essure birth control device, according to Reuters.
The motion seeks to consolidate before U.S. District Judge Gerald McHugh in the Eastern District of Pennsylvania 30 complaints that have been filed by over 1,000 plaintiffs. McHugh is already overseeing at least 3 lawsuits over the contraceptive.
FDA Used Flawed Data to Approve Essure Permanent Birth Control Device: Study
June 6, 2016 - FDA used faulty data to approve the Essure contraceptive and other high-risk medical devices, according to a new study published in Obstetrics and Gynecology [10].
The researchers classified Essure among 18 medical devices posing the greatest risk to patients that were approved by the FDA between 2000 and 2015. Essure received approval based on short-term evidence and insufficient post-market follow-up, according to the study.
Essure Patients 10x More Likely to Need Additional Operations: Study
In the first large, controlled study of Essure, researchers at Weill Cornell Medicine in New York found that women implanted with the birth control device were 10 times more likely to require additional operations compared to women who underwent traditional sterility surgery, according to the Wall Street Journal [12].
“A more than 10-fold high occurrence of re-operation during the first year following Essure-based surgery is a serious safety concern,” the study’s authors reported in the online version of the British Medical Journal (BMJ) [13].
The study looked at the records of 8,048 women who were implanted with Essure, and 44,278 others who underwent tubal ligation, or traditional ‘tubes tied’ surgery in New York state from 2005-2013. Reoperations 1 year afterward were the main outcome measured.
"Essure helped them avoid surgery in some instances, but they are still facing a 10-fold high risk of getting that surgery done," Dr. Art Sedrakyan, lead author of the study, told NBC News [14]. "That translates to one in 49 or 50 women getting this surgery again. And that surgery is likely to be much more complicated than the laproscopic approach that they should be considering."
FDA Orders 'Black Box Warning' on Essure Labeling
February 29, 2016 - The U.S. Food & Drug Administration (FDA) [17] announced today that it will require German drugmaker Bayer AG to include a new 'black box warning' on Essure labels "designed to call attention to serious or life-threatening risks." FDA also called upon Bayer to perform surveillance in order to assess "risks of the device in a real-world environment," and said the agency will use the results to "determine what, if any, further actions related to Essure are needed to protect public health."
The company is required to follow over 2,000 Essure recipients for a minimum of 3 years.
Congressman Introduces ‘E-Free Act’ to Ban Essure
November 4 - Representative Mike Fitzpatrick (D-PA) introduced today a bipartisan bill called the 'E-Free Act' which would require the FDA to remove Essure from the U.S. market, according to NBC News [18].
"The FDA has received over 5,000 formal complaints related to the device and over 22,000 women have joined together on Facebook to share their stories of how the Essure device ruined their lives," Fitzpatrick said. "Essure has caused at least five fetal deaths in women who became pregnant after Essure was placed. At least four women have been killed by Essure."
FDA Panel Evaluates Safety of Essure Birth Control
On September 24, 2015, the FDA convened its Obstetrics and Gynecology Devices Panel to evaluate the safety and effectiveness of the Essure procedure, and to determine whether additional post-marketing studies are needed.
The panel was called after a large number of Essure recipients reported adverse events to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) [20] database. These reports included incidences of incomplete procedures, device migration, tubal perforations, intractable pain and bleeding leading to hysterectomy, device-related deaths and hundreds of unintended pregnancies.
Related Article: IUD Perforation Symptoms & Treatment Info
See all related medical device lawsuits our lawyers have taken on.
Get a Free Essure Lawsuit Evaluation With Our Lawyers
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Essure Lawsuits. We are handling individual litigation nationwide and currently accepting new birth control side effects cases in all 50 states.
Again, if you or a loved one was injured by the side effects of Essure birth control, you should contact our law firm immediately. You may be entitled to compensation by filing a class-action suit and our lawyers can help.
