Update: FDA Issues New Guidance For Reporting Essure Problems
The FDA has issued new conditions (PDF) to Bayer for submitting post-market information about Essure birth control. Per the updated guidelines, 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 website.
The Essure birth control system is a permanent sterilization device which consists of small coils that are inserted into the fallopian tubes during a transcervical procedure. The implant works by promoting the growth of scar tissue in and around the coils, thereby preventing pregnancy. Essure was developed by Conceptus Inc., a subsidiary of Bayer HealthCare, and approved by the U.S. Food & Drug Administration (FDA) in November 2002.
What’s the Problem?
Bayer markets Essure as a safe and effective form of permanent birth control without surgery. However, since it first hit the market in 2002, the contraceptive has been linked to more than 5,000 adverse event reports submitted to the FDA.
The first concerns about Essure’s health risks were raised in 2013, when women across the U.S. began to come forward to talk about the “excruciating” pain and other serious health complications they experienced after being implanted with the device. Although Essure has been aggressively marketed by Bayer as cheaper, safer and more convenient than traditional tubal ligation (tubectomy), several thousand women who chose the Essure system as their method of birth control have suffered devastating side effects, with some requiring a hysterectomy to remove their reproductive organs along with the implant.
Essure Side Effects
Our lawyers are accepting potential lawsuits on behalf of women who suffered one or more of the following complications after receiving 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 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.
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 Essure “Black Box” Warning
November 3, 2016 – The FDA has announced that it will require Essure to carry a boxed warning and patient decision checklist. The labeling will warn about adverse events associated with Essure, including perforation of the uterus and/or Fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions.
California Essure Lawsuits Centralized in Alameda County
October 7, 2016 – California Superior Court Judge Winifred Y. Smith has consolidated dozens of lawsuits filed by more than 900 women alleging complications from Essure in Alameda County Superior Court. Centralizing the complaints as part of a Judicial Council Coordinated Proceedings (JCCP) will streamline the litigation and potentially bring a faster resolution to the suits, according to Smith.
Plaintiffs Seek MDL for Essure Lawsuits
July 26, 2016 – Plaintiffs’ lawyers have asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) to form a multidistrict litigation (MDL) for lawsuits alleging injuries from Essure, according to Reuters. In a motion filed Thursday, the lawyers asked to consolidate 30 such complaints filed on behalf of more than 1,000 plaintiffs before U.S. District Judge Gerald McHugh in the Eastern District of Pennsylvania. McHugh is already handling 3 lawsuits over the contraceptive.
FDA Orders ‘Black Box’ Warning, New Post-Marketing Study on Essure
February 29, 2016 – After months of deliberation, the FDA announced today that it will require a ‘black box’ warning (PDF) and new-postmarketing research for Bayer’s Essure permanent birth control device. The agency says it will require Bayer to design and conduct a large observational study enrolling at least 2,000 women over a period of 3 years, comparing Essure recipients and patients who underwent tubal ligation to identify the risks associated with both procedures. Click here to learn more.
Congressman Introduces Bill to Take Essure Off U.S. Market
November 4 – Representative Mike Fitzpatrick (D-PA) introduced his ‘E-Free Act’ to congress today, the 13th anniversary of Essure receiving pre-market approval from the FDA. If passed, the bill would force the FDA to pull the device off the U.S. market. Click here to learn more.
Thousands of Women Injured by ‘Permanent’ Birth Control: Ring of Fire Video
Essure Patients More Likely to Need Additional Surgeries, Study Finds
Women who chose permanent sterilization with Essure were 10 times more likely to be back for surgery within a year compared to women who had their tubes tied (tubal ligation), according to a new study published in the online edition of the British Medical Journal (BMJ). The study, which looked at 52,326 women who were sterilized in New York State from 2005 to 2013, found that:
- 2.4% of the 8,048 women who received Essure required another operation within 1 year.
- Only 0.2% of the 44,278 women who had traditional, minimally invasive sterilization needed another operation.
- Most of the repeat operations — which often involved removal of the patient’s fallopian tubes — were required because of complications with Essure or because of device failure.
- Essure was as effective as laparoscopic tubal ligation at preventing pregnancy; however, the implant was associated with significantly higher hospital charges, with median charges of $7,832 compared with $5,068 for tubal ligation.
- More than half of Essure recipients underwent general anesthesia, although the contraceptive is marketed as an easy 10-minute office procedure that does not require general anesthesia.
“This study is important because it looked at Essure women in the real world, not the more ideal world of clinical trials,” said Diana Zuckerman, president of the National Center for Health Research (NCHR). “The very high rate of reoperations — 10 times as high with Essure — is likely to add to concerns about the accuracy of the clinical trial data provided to the F.D.A.”
660 Reports of Unintended Pregnancy
Between 2001 and 2010, at least 660 Essure patients reported getting unintentionally pregnant, according to CNN. Bayer blamed a third of these cases on women not returning to their doctor’s office 3 months after receiving the implant as required, and for failing to use another form of birth control in the meantime.
Erin Brockovich Leads Fight Against Permanent Birth Control Procedure
The public outcry against Essure has led famed consumer advocate Erin Brockovich to launch a grassroots campaign against the procedure. Brockovich, who rose to fame by filing a multimillion dollar groundwater contamination case against PG&E, is campaigning to have Essure taken off the U.S. market.
“There’s something wrong with the device, in my opinion,” Brockovich said. “It’s a form of permanent birth control, and women’s organs are being perforated … It’s ridiculous that at any level we try to defend this. If 30 women did suffer harm for unknown reason, we’d investigate. We have thousands injured. I don’t think it’s safe.”
Clinical Trials & Approval Process
The FDA’s pre-marketing approval (PMA) of Essure was based on 2 non-randomized, non-blinded prospective studies that lacked a comparator group and enrolled a total of 926 women, according to the New England Journal of Medicine (NEJM). The agency determined that 97% of women with bilateral Essure placement could rely on the implant.
However, this perceived reliability was not based on an intention-to-treat analysis, and only took into account women who underwent successful Essure implantation and had 3-month follow-ups showing correct placement and bilateral tubal occlusion (data indicated a 14% failure rate for the 1st attempt at bilateral coil placement).
Due to these exclusions, the declared reliability rate was only based on 664 (89%) of the 745 women who underwent an Essure implantation attempt, and did not account for 181 women who subsequently chose not to undergo the procedure, did not pass screening tests or were excluded for other reasons.
Of the 745 women who underwent an attempted Essure procedure, only 632 (85%) were followed up at 1 year for effectiveness and 682 (92%) for safety outcomes. Just 197 (25%) were followed for effectiveness at 2 years, which further limited the evaluation of adverse events and Essure safety.
As another condition of approval, FDA required a separate study examining day-of-procedure outcomes achieved when 40 doctors attempted Essure placement in 20 patients each. The trial was stopped early after enrolling 514 women. Despite successful bilateral placement in only 458 (89%) patients, 38 device malfunctions and 13 periprocedural adverse events, Essure was considered to be safe in women who had successful bilateral placement.
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 contraceptive. Researchers will look at 2 groups of 1,400 women who chose either Essure implantation or laparoscopic tubal sterilization as their method of birth control. The study’s main safety endpoints will include chronic abdominal / pelvic pain, bleeding, allergic reactions and surgical removal of the device, while Essure’s effectiveness will be determined by its ability to protect against pregnancy.
‘Essure Problems’ Requests Probe into FDA’s Handling of Birth Control Implant
April 28, 2016 – The patient advocacy group ‘Essure Problems’ has sent a letter to congress asking it to conduct a probe into the FDA’s alleged lack of oversight regarding Bayer’s Essure contraceptive, according to FierceMedicalDevices. The letter cited multiple reasons why Congress should probe the agency’s handling of the contraceptive, stating that clinical trials for Essure “were inadequate and inappropriate from the beginning.”
FDA Says to Expect New Essure Guidance by Feb. 2016
December 2, 2015 – The U.S. Food & Drug Administration (FDA) issued a press release regarding new guidance for the Essure birth control implant set to be released in February. And while the announcement is a step in the right direction, many are wondering what’s taken the agency so long to act on the matter.
North Carolina Woman Alleges Serious Injuries from Essure
34-year-old Monica O’Neill suffered extreme cramping and pain after receiving an Essure implant in 2010, according to CBS affiliate WFMY News 2. O’Neill claims she initially wanted to have her tubes tied, but after her doctor recommended Essure, she developed severe complications which may require a hysterectomy to treat. Click here to learn more.
Birth Control Alternatives
With concerns about the potential side effects of Essure, there are a number of other birth control procedures available for women who desire permanent sterilization. These include:
- Tubal ligation (tubectomy)
- Laparoscopic surgery
Can I File an Essure Class Action Lawsuit?
In most cases, pre-market approval protects a manufacturer from product liability lawsuits, but several complaints filed against Bayer over Essure side effects allege that the drugmaker violated the conditions for approval by “actively concealing” adverse reports from the FDA, thereby rendering the approval invalid and exposing the company to litigation. If the judge rules against Bayer in these complaints, law firms around the country will be able to take on Essure cases.
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 injury cases in all 50 states.
Free Confidential Case Evaluation: Again, if you suffered organ perforation, device migration or other complications after receiving the Essure contraceptive, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.