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 Essure birth control. The letter applies to reportable adverse events from social media in relation to ongoing litigation regarding Essure.
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 adverse event 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.
Essure is a permanent, non-surgical sterilization procedure that was developed by Conceptus Inc., a subsidiary of Bayer AG. The contraceptive 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 injuries included severe back / pelvic pain, heavy menstrual periods, and coils that pierced recipients’ fallopian tubes and became lodged in other organs.
In a pre-approval clinical trial 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, and 1 in 8 reported painful menstrual periods during the first 3 months.
During a later trial (PDF) 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 coil. As in the first trial, participants complained of back pain, abdominal pain, and pain during intercourse.
Essure Side Effects
Our lawyers are reviewing potential lawsuits for women who suffered one or more of the following complications after being implanted with Essure:
- Migration of device outside of fallopian tubes
- Allergic reactions
- Fracturing of the device
- Perforation of fallopian tubes
- Ectopic pregnancy
- Unwanted pregnancy
Essure Class Action Lawsuit Allowed to Proceed in Philadelphia Court
April 3, 2019 – A federal judge in Philadelphia will allow 6 women who have filed lawsuits against Bayer AG over injuries alleged from its Essure birth control device 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 – FDA on Thursday issued an update on new steps to revise Bayer’s post-marketing study of its Essure birth control 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 (PDF).
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’ linked to Essure. 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.
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 of 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. Anvisa is suspending the importation, distribution, marketing use and dissemination of the Essure birth control device. 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 a state court lawsuit 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.
California Essure Lawsuit Remanded to State Court
November 22, 2016 – U.S. District Judge Michael Fitzgerald last week granted a motion by plaintiffs in Jacqueline Alexander et al. v. Bayer Corp. et al. to remand the case to Superior Court in Los Angeles County. Bayer filed a motion in mid-October to have the lawsuit removed from state to federal court. However, after Fitzgerald’s ruling, it will join at least 55 other similar complaints that have been coordinated for pretrial handling.
FDA Finalizes Guidance on Essure
November 3, 2016 – The FDA has finalized its guidance requiring a “black box” warning and patient decision checklist for the Essure permanent contraceptive. While the final guidance retains most of the recommendations made in the draft version, both the language of the boxed warning and patient decision checklist have been updated.
California Essure Lawsuits Coordinated in Alameda County
October 7, 2016 – A California judge has ordered that dozens of lawsuits filed by over 900 women in the state alleging complications from the Essure permanent birth control device will be centralized in Alameda County Superior Court. The complaints will be heard together as Judicial Council Coordinated Proceedings (JCCP), which will facilitate efficient adjudication and coordinate efforts on behalf of the plaintiffs, according to Superior Court Judge Winifred Y. Smith.
FDA Approves Bayer’s Essure Postmarket Surveillance Study
September 5, 2016 – The FDA has signed off on Bayer’s updated postmarket surveillance study plan for the Essure permanent birth control device. The study will look at 2 groups of 1,400 women who chose either Essure or laparoscopic tubal sterilization (“tubes tied” procedure) as their method of birth control. The final report on the study will not come until 2023, though in March 2017, a 6-month report will be released and in September 2017 a 1-year report will be released, according to the Regulatory Affairs Professionals Society (RAPS).
Judge Allows California Essure Lawsuits to Proceed
August 5, 2016 – Judge Winifred Y. Smith has preserved lawsuits filed on behalf of 14 women who were allegedly injured by Essure, allowing them to proceed by finding that the claims were not preempted under federal or state law. While the ruling specifically addressed claims in just 11 consolidated cases filed in California State Court, it improves the chances for recovery of thousands of women across the U.S. who claim they were injured by Essure birth control.
MDL Proposed for Essure Litigation
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.
Bill Targeting Essure Side Effects Reaches House Floor
June 9, 2016 – A bill aimed at helping women injured by the Essure permanent birth control device was introduced yesterday to the U.S. House of Representatives, according to NBC News. The bill, known as Ariel Grace’s Law, attempts to hold Bayer responsible for any injuries or deaths associated with the use of Essure.
FDA Used Flawed Data to Approve Essure, Study Finds
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. 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.
Advocacy Group Calls for Investigation into FDA’s Handling of Essure
April 28, 2016 – ‘Essure Problems’ has sent a letter to rep. Jason Chaffetz, leader of the U.S. House Committee on Oversight and Reform, requesting a probe into the FDA’s oversight of the Essure permanent contraceptive, according to FierceMedicalDevices. The letter cited multiple reasons why Congress should investigate the agency’s oversight on the contraceptive, stating that clinical trials for Essure “were inadequate and inappropriate from the beginning.”
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.
“A more than 10-fold high occurrence of reoperation 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).
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. “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.”
660 Reports of Unintended Pregnancy
From the time Essure was approved in 2001 through 2010, at least 660 women in the U.S. reported unintentional pregnancies after receiving the contraceptive, according to CNN. Bayer blamed a third of those cases on the patients, as women are supposed to return to their doctor after 3 months to make sure the device is working, and are supposed to use another form of birth control in the meantime.
FDA Reviewing Complaints with Essure Following Public Outcry: ABC News Video
First Lawsuit Filed Against Bayer Over Essure Side Effects
In July 2014, the first lawsuit was filed against Bayer HealthCare over complications allegedly caused by Essure, according to ABC News. The complaint, filed on behalf of plaintiff Heather Walsh in Philadelphia civil court, accuses Bayer of intentionally misleading Essure recipients and violating the conditions upon which the company received approval from the FDA.
According to the lawsuit, 3 Essure coils (not 2, as are normally implanted) punctured Walsh’s fallopian tube, leading to 5 hospitalizations, a hysterectomy, and auto-immune and adhesion disorders.
Health Canada Expands Warning on Essure Side Effects
June 1, 2016 – Health Canada issued a “Dear Healthcare Professional Letter” yesterday warning doctors and patients to be aware of the numerous reported complications associated with Essure. The letter further advised that Bayer will include a “black box” warning on the contraceptive’s labeling, and that Health Canada is developing a patient checklist to ensure that women are aware of Essure’s risks before receiving the implant.
“These include menstrual bleeding, unintended pregnancy, chronic pain, perforation and migration of device, allergy and sensitivity or immune-type reactions,” some of which have led to surgery to remove the implant, according to the letter.
Pennsylvania Judge Clears Way for Essure Lawsuit
March 30, 2016 – Federal Judge John R. Padova has ruled that a lawsuit filed by 5 women allegedly injured by Essure side effects may proceed in court. While Padova dismissed some of the plaintiffs’ claims based on preemption, he also ruled that the premarket approval status that currently protects Bayer and Essure from litigation did not prevent the plaintiffs from pursuing legal action over other claims. Specifically, an allegation of fraudulent misrepresentation was unsuccessfully pled and dismissed by Padova, while plaintiffs’ negligent misrepresentation claim was validated.
FDA Orders ‘Black Box Warning’ on Essure Labeling
February 29, 2016 – The U.S. Food & Drug Administration (FDA) 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.
“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
On September 24, 2015, the FDA convened its Obstetrics and Gynecology Devices Panel (PDF) to evaluate the safety and effectiveness of Essure, 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) database. These reports included incidences of incomplete procedures, tubal perforations, intractable pain and bleeding leading to hysterectomy, device-related deaths and hundreds of unintended pregnancies.
Judge to Rule on Lawsuits Challenging Essure Preemption Status
When the FDA approved Essure in 2002, the agency granted the manufacturer preemption status — meaning those injured by the device cannot file a lawsuit against the company. However, 5 recent complaints allege that Conceptus, Essure’s original manufacturer, breached its warranty and committed fraud in clinical trials to get the contraceptive approved, according to ABC News.
Specifically, the lawsuits claim Conceptus violated the conditions of its Premarket Approval (PMA) process and should no longer be protected under preemptive status. If the judge rules against Bayer and agrees that fraud was committed, law firms around the country will be able to take on Essure cases.
North Carolina Mom Takes on Bayer
A woman from Winston-Salem, North Carolina has filed a lawsuit against Bayer alleging serious side effects from Essure birth control. 34-year-old Monica O’Neil says she suffered excruciating pain and cramping so severe she was unable to even stand up after receiving the contraceptive.
“There’s women who suffer from the same complaint,” O’Neal said. “I’m thinking well it’s not just me then, this really needs to come off the market.”
FDA Guidance on Essure Birth Control Expected Feb. 2016
November 24 – The U.S. Food and Drug Administration (FDA) expects to release new guidance on Essure after the device was linked to more than 15,000 adverse events, including at least a dozen deaths, according to a press release issued today. In its announcement, FDA called the Essure issue a ‘high priority,’ and said it is working expeditiously to conduct an evidence-based review of the available data.
Do I Have an Essure Lawsuit?
Please note, Schmidt & Clark, LLP is no longer accepting Essure lawsuits.
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.